Folic Acid

Folic Acid Tablet USP

Folic Acid Description

Folic Acid, N-[p-[[(2-amino-4-hydroxy-6-pteridinyl) methyl]-amino]benzoyl]-L-glutamic acid, is a B complex vitamin containing a pteridine moiety linked by a methylene bridge to para-aminobenzoic acid, which is joined by a peptide linkage to glutamic acid. Conjugates of Folic Acid are present in a wide variety of foods, particularly liver, kidneys, yeast, and leafy green vegetables. Commercially available Folic Acid is prepared synthetically. Folic Acid occurs as a yellow or yellowish-orange crystalline powder and is very slightly soluble in water and insoluble in alcohol. Folic Acid is readily soluble in dilute solutions of alkali hydroxides and carbonates, and solutions of the drug may be prepared with the aid of sodium hydroxide or sodium carbonate, thereby forming the soluble sodium salt of Folic Acid (sodium folate). Aqueous solutions of Folic Acid are heat sensitive and rapidly decompose in the presence of light and/or riboflavin; solutions should be stored in a cool place protected from light.

The structural formula of Folic Acid is as follows:

C19H19N7O6 M.W. 441.40

Each tablet, for oral administration, contains 1 mg Folic Acid.

Folic Acid Tablets USP 1 mg contain the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, lactose monohydrate, sodium starch glycolate and stearic acid

Folic Acid - Clinical Pharmacology

Folic Acid acts on megaloblastic bone marrow to produce a normoblastic marrow.

In man, an exogenous source of folate is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic Acid is the precursor of tetrahydroFolic Acid, which is involved as a cofactor for transformylation reactions in the biosynthesis of purines and thymidylates of nucleic acids. Impairment of thymidylate synthesis in patients with Folic Acid deficiency is thought to account for the defective deoxyribonucleic acid (DNA) synthesis that leads to megaloblast formation and megaloblastic and macrocytic anemias.

Folic Acid is absorbed rapidly from the small intestine, primarily from the proximal portion. Naturally occurring conjugated folates are reduced enzymatically to Folic Acid in the gastrointestinal tract prior to absorption. Folic Acid appears in the plasma approximately 15 to 30 minutes after an oral dose; peak levels are generally reached within 1 hour. After intravenous administration, the drug is rapidly cleared from the plasma. Cerebrospinal fluid levels of Folic Acid are several times greater than serum levels of the drug. Folic Acid is metabolized in the liver to 7,8-dihydroFolic Acid and eventually to 5,6,7,8-tetrahydroFolic Acid with the aid of reduced diphosphopyridine nucleotide (DPNH) and folate reductases. TetrahydroFolic Acid is linked in the N5 or N10 positions with formyl, hydroxymethyl, methyl, or formimino groups. N5-formyltetrahydroFolic Acid is leucovorin. TetrahydroFolic Acid derivatives are distributed to all body tissues but are stored primarily in the liver. Normal serum levels of total folate have been reported to be 5 to 15 ng/mL; normal cerebrospinal fluid levels are approximately 16 to 21 ng/mL. Normal erythrocyte folate levels have been reported to range from 175 to 316 ng/mL. In general, folate serum levels below 5 ng/mL indicate folate deficiency, and levels below 2 ng/mL usually result in megaloblastic anemia.

After a single oral dose of 100 mcg of Folic Acid in a limited number of normal adults, only a trace amount of the drug appeared in the urine. An oral dose of 5 mg in 1 study and a dose of 40 mcg/kg of body weight in another study resulted in approximately 50% of the dose appearing in the urine. After a single oral dose of 15 mg, up to 90% of the dose was recovered in the urine. A majority of the metabolic products appeared in the urine after 6 hours; excretion was generally complete within 24 hours. Small amounts of orally administered Folic Acid have also been recovered in the feces. Folic Acid is also excreted in the milk of lactating mothers.

Indications and Usage for Folic Acid

Folic Acid is effective in the treatment of megaloblastic anemias due to a deficiency of Folic Acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.

Contraindications

Folic Acid is contraindicated in patients who have shown previous intolerance to the drug.

Warnings

Administration of Folic Acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient.

Precautions

General

Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurologic manifestations remain progressive.

There is a potential danger in administering Folic Acid to patients with undiagnosed anemia, since Folic Acid may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress. This may result in severe nervous system damage before the correct diagnosis is made. Adequate doses of vitamin B12 may prevent, halt, or improve the neurologic changes caused by pernicious anemia.

Drug Interactions

There is evidence that the anticonvulsant action of phenytoin is antagonized by Folic Acid. A patient whose epilepsy is completely controlled by phenytoin may require increased doses to prevent convulsions if Folic Acid is given. Folate deficiency may result from increased loss of folate, as in renal dialysis and/or interference with metabolism (e.g., Folic Acid antagonists such as methotrexate); the administration of anticonvulsants, such as diphenylhydantoin, primidone, and barbiturates; alcohol consumption and, especially, alcoholic cirrhosis; and the administration of pyrimethamine and nitrofurantoin. False low serum and red cell folate levels may occur if the patient has been taking antibiotics, such as tetracycline, which suppress the growth of Lactobacillus casei.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate carcinogenic potential and studies to evaluate the mutagenic potential or effect on fertility have not been conducted.

Pregnancy

Teratogenic Effects

Pregnancy Category A

Folic Acid is usually indicated in the treatment of megaloblastic anemias of pregnancy. Folic Acid requirements are markedly increased during pregnancy, and deficiency will result in fetal damage (see INDICATIONS AND USAGE). Studies in pregnant women have not shown that Folic Acid increases the risk of fetal abnormalities if administered during pregnancy. If the drug is used during pregnancy, the possibility of fetal harm appears remote. Because studies cannot rule out the possibility of harm, however, Folic Acid should be used during pregnancy only if clearly needed.

Nursing Mothers

Folic Acid is excreted in the milk of lactating mothers. During lactation, Folic Acid requirements are markedly increased; however, amounts present in human milk are adequate to fulfill infant requirements, although supplementation may be needed in low-birth-weight infants, in those who are breast-fed by mothers with Folic Acid deficiency (50 mcg daily), or in those with infections or prolonged diarrhea.

Adverse Reactions

Allergic sensitization has been reported following both oral and parenteral administration of Folic Acid.

Folic Acid is relatively nontoxic in man. Rare instances of allergic responses to Folic Acid preparations have been reported and have included erythema, skin rash, itching, general malaise, and respiratory difficulty due to bronchospasm. One patient experienced symptoms suggesting anaphylaxis following injection of the drug. Gastrointestinal side effects, including anorexia, nausea, abdominal distention, flatulence, and a bitter or bad taste, have been reported in patients receiving 15 mg Folic Acid daily for 1 month. Other side effects reported in patients receiving 15 mg daily include altered sleep patterns, difficulty in concentrating, irritability, over activity, excitement, mental depression, confusion, and impaired judgment. Decreased vitamin B12 serum levels may occur in patients receiving prolonged Folic Acid therapy.

In an uncontrolled study, orally administered Folic Acid was reported to increase the incidence of seizures in some epileptic patients receiving phenobarbital, primidone, or diphenylhydantoin. Another investigator reported decreased diphenylhydantoin serum levels in folate-deficient patients receiving diphenylhydantoin who were treated with 5 mg or 15 mg of Folic Acid daily.

Overdosage

Except during pregnancy and lactation, Folic Acid should not be given in therapeutic doses greater than 0.4 mg daily until pernicious anemia has been ruled out. Patients with pernicious anemia receiving more than 0.4 mg of Folic Acid daily who are inadequately treated with vitamin B12 may show reversion of the hematologic parameters to normal, but neurologic manifestations due to vitamin B12 deficiency will progress. Doses of Folic Acid exceeding the Recommended Dietary Allowance (RDA) should not be included in multivitamin preparations; if therapeutic amounts are necessary, Folic Acid should be given separately.

Folic Acid Dosage and Administration

Oral administration is preferred. Although most patients with malabsorption cannot absorb food folates, they are able to absorb Folic Acid given orally. Parenteral administration is not advocated but may be necessary in some individuals (e.g., patients receiving parenteral or enteral alimentation). Doses greater than 0.1 mg should not be used unless anemia due to vitamin B12 deficiency has been ruled out or is being adequately treated with a cobalamin. Daily doses greater than 1 mg do not enhance the hematologic effect, and most of the excess is excreted unchanged in the urine.

The usual therapeutic dosage in adults and children (regardless of age) is up to 1 mg daily. Resistant cases may require larger doses.

When clinical symptoms have subsided and the blood picture has become normal, a daily maintenance level should be used, i.e., 0.1 mg for infants and up to 0.3 mg for children under 4 years of age, 0.4 mg for adults and children 4 or more years of age, and 0.8 mg for pregnant and lactating women, but never less than 0.1 mg/day. Patients should be kept under close supervision and adjustment of the maintenance level made if relapse appears imminent. In the presence of alcoholism, hemolytic anemia, anticonvulsant therapy, or chronic infection, the maintenance level may need to be increased.

How is Folic Acid Supplied

Folic Acid Tablets USP, 1 mg are Light Yellow, Round, biconvex tablets debossed “I” on the left side of the bisect and “G” on the right side of bisect on one side and “210” on other; supplied in bottles of 100 (NDC 76282-210-01) and 1000 (NDC 76282-210-10).

Dispense in a well-closed container with child-resistant closure.

Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]

Manufactured by:

InvaGen Pharmaceuticals, Inc.

Hauppauge, NY 11788

Manufactured for:

Exelan Pharmaceuticals, Inc.

Peachtree City, GA 30269

Rev: 12/11

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 76282-210-01

Folic Acid

Tablets, USP

1 mg

EXELAN PHARMACEUTICALS, INC

Rx Only

100 Tablets

Folic Acid  Folic Acid  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 76282-210 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Folic Acid (Folic Acid) Folic Acid 1 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE   SILICON DIOXIDE   LACTOSE MONOHYDRATE   SODIUM STARCH GLYCOLATE TYPE A POTATO   STEARIC ACID

Product Characteristics Color YELLOW (Light Yellow) Score 2 pieces Shape ROUND (Biconvex) Size 7mm Flavor Imprint Code IG;210 Contains

Packaging # NDC Package Description Multilevel Packaging 1 76282-210-01 100 TABLET In 1 BOTTLE None 2 76282-210-10 1000 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090035	04/06/2010

Labeler - Exelan Pharmaceuticals, Inc. (967795266)

Registrant - InvaGen Pharmaceuticals, Inc. (165104469)

Establishment
Name	Address	ID/FEI	Operations
InvaGen Pharmaceuticals, Inc.		165104469	MANUFACTURE, ANALYSIS

Revised: 12/2011Exelan Pharmaceuticals, Inc.

Levsin

Generic Name: hyoscyamine (hye oh SYE a meen)

Brand Names: Anaspaz, Cystospaz, Ed Spaz, HyoMax, HyoMax DT, HyoMax FT, HyoMax SL, HyoMax SR, Hyospaz, Hyosyne, IB-Stat, Levbid, Levsin, Levsin SL, Levsinex SR, NuLev, Nulev, Symax Duotab, Symax FasTab, Symax SL, Symax SR

What is Levsin (hyoscyamine)?

Hyoscyamine produces many effects in the body, including relief from muscle spasms.

Hyoscyamine also reduces the fluid secretions of many organs and glands in the body, such as the stomach, pancreas, lungs, saliva glands, sweat glands, and nasal passages.

Hyoscyamine is used to treat many different stomach and intestinal disorders, including peptic ulcer and irritable bowel syndrome. It is also used to control muscle spasms in the bladder, kidneys, or digestive tract, and to reduce stomach acid. Hyoscyamine is sometimes used to reduce tremors and rigid muscles in people with symptoms of Parkinson's disease.

Hyoscyamine is also used as a drying agent to control excessive salivation, runny nose, or excessive sweating.

Hyoscyamine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Levsin (hyoscyamine)?

Do not take hyoscyamine if you are allergic to it, or if you have kidney disease, a bladder or intestinal obstruction, severe ulcerative colitis, toxic megacolon, glaucoma, or myasthenia gravis.

Before taking hyoscyamine, tell your doctor if you have heart disease, congestive heart failure, a heart rhythm disorder, high blood pressure, overactive thyroid, or hiatal hernia with gastroesophageal reflux disease.

Avoid taking antacids at the same time you take hyoscyamine. Antacids can make it harder for your body to absorb hyoscyamine. If you use an antacid, take it after you have taken hyoscyamine and eaten a meal.

Hyoscyamine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase drowsiness and dizziness while you are taking hyoscyamine.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Hyoscyamine can decrease sweating and you may be more prone to heat stroke.

What should I discuss with my healthcare provider before taking Levsin (hyoscyamine)?

Do not take hyoscyamine if you are allergic to it, or if you have:

• kidney disease;


• 
  

  an enlarged prostate or problems with urination;

  
  


• 
  

  intestinal blockage;

  
  


• 
  

  severe ulcerative colitis, or toxic megacolon;

  
  


• 
  

  glaucoma; or

  
  


• 
  

  myasthenia gravis.

  
  

To make sure you can safely take hyoscyamine, tell your doctor if you have any of these other conditions:

• 
  

  heart disease, congestive heart failure;

  
  


• 
  

  a heart rhythm disorder;

  
  


• 
  

  high blood pressure;

  
  


• 
  

  overactive thyroid; or

  
  


• 
  

  hiatal hernia with GERD (gastroesophageal reflux disease).

  
  

FDA pregnancy category C. It is not known whether hyoscyamine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Hyoscyamine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Levsin (hyoscyamine)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your medication may come with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Hyoscyamine is usually taken before a meal. Follow your doctor's instructions.

Do not crush, chew, or open an extended-release tablet or capsule. It is specially made to release medicine slowly in the body. Breaking or crushing the pill would cause too much of the drug to be released at one time. Your doctor may want you to break an extended-release tablet and take only half of it. Follow your doctor's instructions.

Measure the oral liquid form of hyoscyamine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

The sublingual tablet form of this medication must be placed under the tongue, where it will dissolve. Do not swallow the sublingual tablet whole or wash it down with water. You may drink water after the pill has completely dissolved in your mouth.

Before using hyoscyamine oral spray for the first time, you must prime the spray pump. To do this, spray 3 test sprays into the air and away from your face. Prime the spray pump at least 1 test spray any time you have not used the oral spray for longer than 2 days. Spray until a fine mist appears.

After using the oral spray, try not to swallow right away. Do not rinse your mouth or spit for 5 to 10 minutes after using the oral spray.

Store this medication at room temperature away from moisture and heat.

Do not use hyoscyamine oral spray for more than 30 sprays, even if there is medicine still left in the bottle.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include headache, dizziness, dry mouth, trouble swallowing, nausea, vomiting, blurred vision, hot dry skin, and feeling restless or nervous.

What should I avoid while taking Levsin (hyoscyamine)?

Avoid taking antacids at the same time you take hyoscyamine. Antacids can make it harder for your body to absorb hyoscyamine. If you use an antacid, take it after you have taken hyoscyamine and eaten a meal.

Hyoscyamine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase drowsiness and dizziness while you are taking hyoscyamine.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Hyoscyamine can decrease sweating and you may be more prone to heat stroke.

Levsin (hyoscyamine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using hyoscyamine and call your doctor at once if you have any of these serious side effects:

• 
  

  diarrhea;

  
  


• 
  

  confusion, hallucinations;

  
  


• 
  

  unusual thoughts or behavior;

  
  


• 
  

  fast, pounding, or uneven heart rate;

  
  


• 
  

  rash or flushing (warmth, redness, or tingly feeling); or

  
  


• 
  

  eye pain.

  
  

Less serious side effects may include:

• 
  

  dizziness, drowsiness, feeling nervous;

  
  


• 
  

  blurred vision, headache;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  nausea, vomiting, bloating, heartburn, or constipation;

  
  


• 
  

  changes in taste;

  
  


• 
  

  problems with urination;

  
  


• 
  

  decreased sweating;

  
  


• 
  

  dry mouth; or

  
  


• 
  

  impotence, loss of interest in sex, or trouble having an orgasm.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Levsin (hyoscyamine)?

Tell your doctor about all other medicines you use, especially:

• 
  

  amantadine (Symmetrel);

  
  


• 
  

  haloperidol (Haldol);

  
  


• 
  

  an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);

  
  


• 
  

  phenothiazines such as chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), perphenazine (Trilafon), prochlorperazine (Compazine, Compro), promethazine (Pentazine, Phenergan, Anergan, Antinaus), thioridazine (Mellaril), or trifluoperazine (Stelazine); or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

  
  

This list is not complete and other drugs may interact with hyoscyamine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Levsin resources

• Levsin Side Effects (in more detail)
• Levsin Use in Pregnancy & Breastfeeding
• Drug Images
• Levsin Drug Interactions
• Levsin Support Group
• 1 Review for Levsin - Add your own review/rating

• Levsin Prescribing Information (FDA)


• Levsin MedFacts Consumer Leaflet (Wolters Kluwer)


• Hyoscyamine Monograph (AHFS DI)


• Anaspaz MedFacts Consumer Leaflet (Wolters Kluwer)


• HyoMax Prescribing Information (FDA)


• Hyosyne Prescribing Information (FDA)


• Hyosyne Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• IB-Stat Spray MedFacts Consumer Leaflet (Wolters Kluwer)


• Levbid Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• NuLev Orally Disintegrating Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Symax Duotab Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Levsin with other medications

• Anesthesia
• Crohn's Disease
• Endoscopy or Radiology Premedication
• Irritable Bowel Syndrome
• Urinary Incontinence

Where can I get more information?

• Your pharmacist can provide more information about hyoscyamine.

See also: Levsin side effects (in more detail)

Iomeprol

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

V08AB10

CAS registry number (Chemical Abstracts Service)

0078649-41-9

Chemical Formula

C17-H22-I3-N3-O8

Molecular Weight

777

Therapeutic Category

Contrast medium

Chemical Name

1,3-Benzenedicarboxamide, N,N'-bis(2,3-dihydroxypropyl)-5-[(hydroxyacetyl)methylamino]-2,4,6-triiodo-

Foreign Names

• Iomeprolum (Latin)
• Iomeprol (German)
• Iomeprol (French)
• Iomeprol (Spanish)

Generic Names

• Iomeprol (OS: USAN, JAN, BAN)
• Iomeprolo (OS: DCIT)
• B 16880 (IS: Bracco)

Brand Names

• Imeron
  Bracco Imaging, Germany



• Iomeron
  Altana, Belgium; Altana, Luxembourg; Auremiana, Slovenia; Bracco, Austria; Bracco, Czech Republic; Bracco, Hungary; Bracco, Israel; Bracco, Italy; Bracco, Luxembourg; Bracco, Norway; Bracco, Poland; Bracco Eisai, Japan; Bracco SpA, Denmark; Bracco Suisse, Switzerland; Initios, Finland; Initios, Sweden; png Gerolymatos, Greece; Regional, Australia; Regional Health, New Zealand; Rovi, Spain; Santa-Farma, Turkey



• Ioméron
  Bracco, France

International Drug Name Search

Glossary

BAN	British Approved Name
DCIT	Denominazione Comune Italiana
IS	Inofficial Synonym
JAN	Japanese Accepted Name
OS	Official Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

capecitabine

Generic Name: capecitabine (KAP e SYE ta been)

Brand Names: Xeloda

What is capecitabine?

Capecitabine is a cancer medication that interferes with the growth of cancer cells and slows their spread in the body

Capecitabine is used to treat breast cancer and colon or rectum cancer that has spread to other parts of the body.

Capecitabine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about capecitabine?

You should not take this medication if you are allergic to capecitabine or fluorouracil (Adrucil), or if you have severe kidney disease or a metabolic disorder called DPD (dihydropyrimidine dehydrogenase) deficiency. Do not use capecitabine if you are pregnant. It could harm the unborn baby. Use effective birth control while you are taking capecitabine, whether you are a man or a woman. Tell your doctor if a pregnancy occurs during treatment. You should not breast-feed while you are taking capecitabine.

Before you take capecitabine, tell your doctor if you have liver or kidney disease, a history of coronary artery disease, or if you are also taking folic acid (contained in many vitamin and mineral supplements), leucovorin (Wellcovorin), phenytoin (Dilantin), or a blood thinner (warfarin, Coumadin).

While taking capecitabine, you will need blood tests at your doctor's office on a regular basis. Do not miss any appointments. You must remain under the care of a doctor while you are taking capecitabine.

Call your doctor at once if you have a serious side effect such as severe vomiting or diarrhea, fever or flu symptoms, pain or redness of your hands or feet, jaundice (yellowing of the skin or eyes), chest pain, sudden numbness or weakness, or fainting.

What should I discuss with my healthcare provider before taking capecitabine?

You should not take this medication if you are allergic to capecitabine or fluorouracil (Adrucil), or if you have:

• severe kidney disease; or


• 
  

  a metabolic disorder called DPD (dihydropyrimidine dehydrogenase) deficiency.

  
  

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use capecitabine:

• kidney disease;


• liver disease;


• 
  

  a history of coronary artery disease; or

  
  


• 
  

  if you are also taking folic acid (contained in many vitamin and mineral supplements), leucovorin (Wellcovorin), phenytoin (Dilantin), or a blood thinner (warfarin, Coumadin).

  
  

FDA pregnancy category D. Do not use capecitabine if you are pregnant. It could harm the unborn baby.

Use birth control to prevent pregnancy while you are taking capecitabine, whether you are a man or a woman. Tell your doctor if a pregnancy occurs during treatment.

It is not known whether capecitabine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking capecitabine. People over 80 years old may be more likely to have certain side effects from this medication.

How should I take capecitabine?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Capecitabine is usually given in a treatment cycle of 2 weeks on and 1 week off. This 3-week cycle is repeated up to 8 times (24 weeks). Your capecitabine dosage may be different. Follow your doctor's instructions.

During the weeks when you take capecitabine, take the medication once in the morning and once in the evening, unless your doctor tells you otherwise. You may also be given other medications as part of a combination cancer treatment.

Capecitabine should be taken with food or within 30 minutes after eating a meal. Take this medication with a full glass (8 ounces) of water.

To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Your kidney and liver function may also need to be tested. Do not miss any follow-up visits. You must remain under the care of a doctor while you are taking capecitabine.

Store capecitabine at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

See also: Capecitabine dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include fever, nausea, vomiting, diarrhea, blood in your stools, coughing up blood.

What should I avoid while taking capecitabine?

Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends.

Capecitabine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  severe diarrhea (more than 4 times per day, or during the night);

  
  


• 
  

  vomiting (more than once in 24 hours);

  
  


• 
  

  nausea, loss of appetite, eating much less than usual;

  
  


• 
  

  weakness, feeling light-headed, hot or dry skin;

  
  


• 
  

  pain, tenderness, redness, swelling, blistering, or peeling skin on your hands or feet;

  
  


• 
  

  fever, chills, body aches, flu symptoms;

  
  


• 
  

  swelling, white patches, or sores in your mouth or throat;

  
  


• 
  

  jaundice (yellowing of the skin or eyes);

  
  


• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  
  


• 
  

  sudden numbness, weakness, headache, confusion, or problems with vision, speech, or balance; or

  
  


• 
  

  slow heart rate, weak pulse, fainting, slow breathing (breathing may stop).

  
  

Less serious side effects may include:

• 
  

  stomach pain or upset, constipation;

  
  


• 
  

  tired feeling;

  
  


• 
  

  temporary hair loss;

  
  


• 
  

  mild skin rash;

  
  


• 
  

  headache, dizziness;

  
  


• 
  

  altered sense of taste;

  
  


• 
  

  back pain, joint or muscle pain;

  
  


• 
  

  eye irritation.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Capecitabine Dosing Information

Usual Adult Dose for Breast Cancer:

For use in the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated (e.g., patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents). (Resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse within 6 months of completing treatment with an anthracycline-containing adjuvant regimen.)

The recommended dose of capecitabine is 1,250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2,500 mg/m2 total daily dose) for 2 weeks followed by a 1 week rest period given as 3 week cycles. Capecitabine tablets should be swallowed with water within 30 minutes after a meal.

Alternatively, a dose of 1,000 mg/m2 administered orally twice daily (morning and evening; equivalent to 2,000 mg/m2 total daily dose) for 2 weeks with 1 week rest may be may be appropriate.

Usual Adult Dose for Colorectal Cancer:

For use as first line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred:

Recommended dose: 1,250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2,500 mg/m2 total daily dose) for 2 weeks followed by a 1 week rest period given as 3 week cycles. Capecitabine tablets should be swallowed with water within 30 minutes after a meal.
Alternate dose: 1,000 mg/m2 administered orally twice daily (morning and evening; equivalent to 2,000 mg/m2 total daily dose) for 2 weeks with 1 week rest may be may be appropriate.

For use as adjuvant treatment in patients with Dukes' C colon cancer:

Recommended dose: 1,250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2,500 mg/m2 total daily dose) for 2 weeks followed by a 1 week rest period given as 3 week cycles for a total of 8 cycles (24 weeks). Capecitabine tablets should be swallowed with water within 30 minutes after a meal.

What other drugs will affect capecitabine?

Tell your doctor about all other medications you use, especially:

• 
  

  bosentan (Tracleer);

  
  


• 
  

  fluoxetine (Prozac);

  
  


• 
  

  fosphenytoin (Cerebyx);

  
  


• 
  

  montelukast (Singulair) or zafirlukast (Accolate);

  
  


• 
  

  rifampin (Rifater, Rifadin, Rifamate);

  
  


• 
  

  selegiline (Eldepryl, Emsam, Zelapar);

  
  


• 
  

  voriconazole (Vfend);

  
  


• 
  

  cancer medication such as paclitaxel (Taxol) or tamoxifen (Soltamox);

  
  


• 
  

  heart or blood pressure medications such as amiodarone (Cordarone, Pacerone), carvedilol (Coreg), losartan (Hyzaar, Cozaar), or torsemide (Demadex);

  
  


• 
  

  type 2 diabetes medications such as glimepiride (Amaryl), glipizide (Glucotrol), nateglinide (Starlix), pioglitazone (Actos, Actoplus Met), repaglinide (Prandin), rosiglitazone (Avandia, Avandamet), or tolbutamide (Orinase); or

  
  


• 
  

  sulfa drugs (Bactrim, Gantanol, Gantrisin, Septra, SMX-TMP, and others).

  
  

This list is not complete and there may be other drugs that can interact with capecitabine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More capecitabine resources

• Capecitabine Side Effects (in more detail)
• Capecitabine Dosage
• Capecitabine Use in Pregnancy & Breastfeeding
• Capecitabine Drug Interactions
• Capecitabine Support Group
• 7 Reviews for Capecitabine - Add your own review/rating

• capecitabine Advanced Consumer (Micromedex) - Includes Dosage Information


• Capecitabine Professional Patient Advice (Wolters Kluwer)


• Capecitabine MedFacts Consumer Leaflet (Wolters Kluwer)


• Capecitabine Monograph (AHFS DI)


• Xeloda Prescribing Information (FDA)


• Xeloda Consumer Overview

Compare capecitabine with other medications

• Breast Cancer
• Breast Cancer, Metastatic
• Colorectal Cancer
• Non-Small Cell Lung Cancer
• Pancreatic Cancer
• Prostate Cancer
• Renal Cell Carcinoma
• Stomach Cancer

Where can I get more information?

• Your doctor or pharmacist can provide more information about capecitabine.

See also: capecitabine side effects (in more detail)

Influenza Virus Vaccine

Pronunciation: IN-floo-EN-za
Generic Name: Influenza Virus Vaccine
Brand Name: Fluzone Intradermal

Influenza Virus Vaccine is used for:

Protecting against certain strains of influenza (flu) in patients between 18 and 64 years old.

Influenza Virus Vaccine is a vaccine. It works by stimulating the body to produce antibodies against certain types of the flu virus, which helps your body to fight the infection.

Do NOT use Influenza Virus Vaccine if:

• you are allergic to any ingredient in Influenza Virus Vaccine, including egg proteins, or to egg products


• you have had a severe allergic reaction (eg, rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue) to a prior flu vaccination

Contact your doctor or health care provider right away if any of these apply to you.

Before using Influenza Virus Vaccine:

Some medical conditions may interact with Influenza Virus Vaccine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a fever, cold, respiratory tract infection, or other infection or recent illness


• if you have asthma or other breathing problems, a nervous system disorder, or blood or bleeding problems (eg, hemophilia, low blood platelet levels)


• if you have cancer or immune system problems (eg, HIV, weakened immune system)


• if you are receiving radiation treatment or chemotherapy


• if you have a history of Guillain-Barré syndrome

Some MEDICINES MAY INTERACT with Influenza Virus Vaccine. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Corticosteroids (eg, prednisone) or other medicines that may weaken the immune system because they may decrease Influenza Virus Vaccine's effectiveness. Ask your doctor if you are unsure if any of your medicines may weaken the immune system

This may not be a complete list of all interactions that may occur. Ask your health care provider if Influenza Virus Vaccine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Influenza Virus Vaccine:

Use Influenza Virus Vaccine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Influenza Virus Vaccine is usually given once a year in September, October, or November.


• Influenza Virus Vaccine is given as an injection at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions.


• Do not use Influenza Virus Vaccine if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• If you miss a dose of Influenza Virus Vaccine, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Influenza Virus Vaccine.

Important safety information:

• If you have a fever, cold, respiratory tract infection, or other illness, contact your doctor before you receive Influenza Virus Vaccine. You may need to receive your injection at a later time.


• Influenza Virus Vaccine contains killed viruses. It cannot cause you to develop the flu.


• Influenza Virus Vaccine is not a cure for the flu. It must be given before you are exposed to the flu in order to be effective.


• Influenza Virus Vaccine is only effective for 1 flu season. You will need to receive the flu vaccine each year.


• Influenza Virus Vaccine is not effective against all strains of the flu virus. It may also not protect everyone who receives it.


• Influenza Virus Vaccine does not protect against other respiratory viruses.


• Tell your doctor if you will be receiving any other vaccines.


• Caution is advised when using Influenza Virus Vaccine in CHILDREN; they may be more sensitive to its effects, especially injection-site reactions.


• Influenza Virus Vaccine should be used with extreme caution in CHILDREN younger than 18 years old and in ELDERLY patients older than 64 years old; safety and effectiveness in these patients have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Influenza Virus Vaccine while you are pregnant. It is not known if Influenza Virus Vaccine is found in breast milk. If you are or will be breast-feeding while you use Influenza Virus Vaccine, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Influenza Virus Vaccine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

General body discomfort; headache; mild fever; mild itching, pain, redness, swelling, tenderness, or hardening of the skin at the injection site; muscle aches; shivering.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); decreased movement of the face muscles; decreased movement or sensation in the arm or shoulder; muscle weakness; numbness or tingling of the hands or feet; severe or persistent headache or fever; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Influenza Virus Vaccine:

Influenza Virus Vaccine is usually handled and stored by a health care provider. If you are using Influenza Virus Vaccine at home, store Influenza Virus Vaccine as directed by your pharmacist or health care provider. Keep this product, as well as syringes and needles, out of the reach of children and away from pets.

General information:

• If you have any questions about Influenza Virus Vaccine, please talk with your doctor, pharmacist, or other health care provider.


• Influenza Virus Vaccine is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Influenza Virus Vaccine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Influenza Virus Vaccine resources

• Influenza Virus Vaccine Use in Pregnancy & Breastfeeding
• Influenza Virus Vaccine Drug Interactions
• Influenza Virus Vaccine Support Group
• 1 Review for Influenza Virus - Add your own review/rating

Compare Influenza Virus Vaccine with other medications

• Influenza Prophylaxis

Diazepam Tablets BP 2mg

1. Name Of The Medicinal Product

DIAZEPAM TABLETS BP 2mg

2. Qualitative And Quantitative Composition

Each tablet contains 2mg Diazepam PhEur.

3. Pharmaceutical Form

White uncoated tablets.

White, circular, flat, bevelled-edge uncoated tablets, impressed “C” and the identifying letters “DA” either side of a central division line on one face.

4. Clinical Particulars

4.1 Therapeutic Indications

Adults

1) The short-term relief (2-4 weeks) only, of anxiety which is severe, disabling, or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short-term psychosomatic, organic or psychotic illness.

2) Cerebral palsy.

3) Muscle spasm.

4) As an adjunct to certain types of epilepsy (eg myoclonus).

5) Symptomatic treatment of acute alcohol withdrawal.

6) As oral premedication for the nervous dental patient.

7) For premedication before surgery

Children

1) Control of tension and irritability in cerebral spasticity in selected cases

2) As an adjunct to the control of muscle spasm in tetanus

3) Oral premedication (see section 4.4)

4.2 Posology And Method Of Administration

Posology

As an anxiolytic, the lowest effective dose should be employed; dosage regimes should not exceed beyond 4 weeks and treatment should be gradually withdrawn. Patients who have received benzodiazepines for a long time may require an extended withdrawal period. Long-term chronic use is not recommended.

Adults:

Anxiety states, obsessive-compulsive neuroses, and other psychiatric disorders: 5-30mg daily in divided doses.

Insomnia associated with anxiety: 5-15mg before retiring.

Cerebral palsy: 5-60mg daily in divided doses.

Upper motor neuronic spasticity: 5-60mg daily in divided doses.

Muscle spasm of varied aetiology, fibrositis, cervical spondylosis: 5-15mg daily in divided doses.

Adjunct to the management of some types of epilepsy: 2-60 mg daily in divided doses.

Alcohol withdrawal: 5-20mg, repeated if necessary in 2 to 4 hours.

Oral premedication in dental patients: 5mg the night before, 5mg on waking and 5mg two hours before the appointment.

Oral Premedication before surgery: 5mg-20mg.

Children:

Alternative presentations of diazepam are recommended for paediatric usage in order to obtain suitable doses of less than 5mg.

Spastic children with minimal brain damage: 5-40mg daily in divided doses.

Oral Premedication before surgery (see section 4.4): 2mg-10mg

Elderly and debilitated patients:

Doses should be half the above recommended doses.

Renal and hepatic impairment (see section 4.4):

The use of diazepam in hepatic impairment may precipitate coma, therefore the dose should be reduced or an alternative drug considered. In severe renal impairment the dose should be reduced.

Method of Administration

For oral administration.

4.3 Contraindications

• Known hypersensitivity to benzodiazepines and any other ingredients in diazepam tablets

• Phobic or obsessional states; chronic psychosis (paradoxical reactions may occur)

• Acute pulmonary insufficiency; respiratory depression (ventilatory failure may be exacerbated)

• Myasthenia gravis (condition may be exacerbated)

• Sleep apnoea (condition may be exacerbated)

• Severe hepatic insufficiency (elimination half-life of diazepam may be prolonged)

• Acute porphyria

• Diazepam should not be used as monotherapy in patients with depression or those with anxiety and depression as suicide may be precipitated in such patients.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.4 Special Warnings And Precautions For Use

• Duration of Treatment - The duration of treatment should be as short as possible depending on the indication, but should not exceed 4 weeks including tapering off process. Treatment should not continue beyond 4 weeks without re-evaluation of the patient's condition. Where long-term therapy is essential, it is recommended that the patient's requirements be reviewed on a regular basis.

It may be useful to inform the patient when treatment is started that it will be of limited duration and to explain precisely how the dosage will be progressively decreased. Moreover it is important that the patient should be aware of the possibility of rebound phenomena, thereby minimizing anxiety over such symptoms should they occur while diazepam is being discontinued.

• Dependence and Withdrawal - Withdrawal symptoms occur with benzodiazepines following normal therapeutic doses given for short periods of time.

Use of diazepam may lead to the development of physical and psychic dependence. The risk of dependence increases with the dose and duration of treatment, and in patients with a history of alcoholism and drug abuse.

Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms (see Section 4.8 Undesirable Effects).

Rebound insomnia and anxiety: a transient syndrome whereby the symptoms that led to treatment with diazepam may recur in an enhanced form on withdrawal of treatment. It may be accompanied by other reactions including mood changes, anxiety or sleep disturbances and restlessness. Since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage is decreased gradually.

As sudden discontinuation of benzodiazepines may result in convulsions, particular care should be taken in patients with epilepsy, other patients who have had a history of seizures or in alcohol dependants.

• Tolerance - Limits of tolerance in patients with organic cerebral changes (particularly arteriosclerosis) or cardio-respiratory insufficiency may be very wide; care must be taken in adapting the dosage with such patients.

Some loss of efficacy to the hypnotic effects of diazepam may develop after repeated use for a few weeks.

• Alcohol should be avoided during treatment with diazepam (additive CNS depression).

• Amnesia - diazepam may induce anterograde amnesia. The condition occurs most often several hours after ingesting the product and therefore to reduce the risk patients should ensure that they will be able to have uninterrupted sleep of 7-8 hours. Anterograde amnesia may occur using therapeutic doses, the risk increases with higher doses.

• In cases of loss of bereavement, psychological adjustment may be inhibited by benzodiazepines.

• Diazepam should be used with caution in patients with a history of alcohol or drug abuse as these are patients predisposed to habituation and dependence.

• Hypo-albuminaemia may predispose patient to higher incidence of sedative side effects.

• Extreme caution should be used in prescribing diazepam to patients with personality disorders.

• Benzodiazepines should not be used in patients with severe hepatic insufficiency as they may precipitate encephalopathy.

• Cerebral sensitivity is increased in severe renal failure; therefore lower doses should be used (see section 4.2).

• Hypnotics should be avoided in the elderly who are at risk of becoming ataxic and confused and so liable to fall and injure themselves. If, based on clinical need, a decision to treat is nevertheless taken, treatment should be initiated a lower dose (see section 4.2).

• Caution should be exercised when using diazepam peri-operatively in children, as effects and timing of response may be unreliable and paradoxical effects may occur.

• Reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using benzodiazepines. Should this occur, use of the drug should be discontinued. They are more likely to occur in children and the elderly.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The following drug interactions with diazepam should be considered:

• Increased sedation or respiratory or cardiovascular inhibition may occur if diazepam is given concomitantly with other CNS depressant properties such as; antipsychotics (for example clozapine), narcotic analgesics, antidepressants (for example fluvoxamine), hypnotics, general anaesthetics, antihistamines, lofexidine, nabilone, disulfiram, muscle relaxants, alcohol.

In case of narcotic analgesics, enhancement of euphoria may occur, resulting in an increase in dependence.

• Plasma concentrations of zotepine are increased.

• Cimetidine, oestrogen-containing contraceptives, disulfiram, erythromycin may inhibit hepatic metabolism of diazepam.

• Ulcer-healing-drugs: Omeprazole and cimetidine may increase the plasma concentration of diazepam.

• Antibacterials: Isoniazid may inhibit diazepam metabolism. Rifampicin may increase the metabolism of diazepam.

• Antivirals: Concomitant use of diazepam with amprenavir and ritonavir should be avoided, as there is an increased risk of prolonged sedation and respiratory depression.

• Antiepileptic drugs: Pharmacokinetic studies on potential interactions between diazepam and antiepileptic drugs have produced conflicting results. Both depression and elevation of drug levels, as well as no change, have been reported. Phenobarbital taken concomitantly may result in an additive CNS effect. Therefore, special care should be taken in adjusting the dose in the initial stages of treatment.

• Alcohol: The sedative effects may be enhanced when diazepam is used in combination with alcohol. Concomitant intake with alcohol should be avoided.

• Antihypertensives, diuretics, nitrates: Enhanced hypotensive effects may occur. Enhanced sedative effect with alpha blockers or moxonidine.

• Dopaminergics: Concurrent use with benzodiazepines may decrease the therapeutic effects of levodopa.

• Baclofen or tizanidine (enhanced sedative effect)

• Antacids (concurrent use may delay absorption of diazepam).

• Azoles (voriconazole, fluconazole): Itraconazole, ketoconazole, and to a lesser extent fluconazole are potent inhibitors of the cytochrome P450 isoenzyme CYP3A4 and may increase plasma levels of benzodiazepines. The effects of benzodiazepines may be increased and prolonged by concomitant use. A dose reduction of the benzodiazepine may be required.

• Theophylline increases metabolism of diazepam which possibly reduces the effect.

• Grapefruit juice inhibits CYP3A4 and may increase the plasma concentration of diazepam and may increase the extent of sedation and amnesia. This interaction may of little significant importance in healthy individuals; however what is not clear is whether other factors such as old age or liver cirrhosis increase the risk of adverse effects with concurrent use.

4.6 Pregnancy And Lactation

The safety of diazepam in human pregnancy has not been established. It should not be used in the first and third trimesters. There may be a small increase in the risk of congenital malformation, particularly oral cleft with the use of benzodiazepines in the first trimester but a causal relationship has been established.

If the product is prescribed to a woman of childbearing potential, she should be warned to contact her physician regarding discontinuance of the product if she intends to become or suspects that she is pregnant.

If, for compelling medical reasons, the product is administered during the late phase of pregnancy, or during labour at high doses, effects on the neonate, such as hypothermia, hypotonia and moderate respiratory depression, can be expected, due to the pharmacological action of the compound.

Moreover, infants born to mothers who took benzodiazepines chronically during the latter stages of pregnancy may have developed physical dependence and may be at some risk for developing withdrawal symptoms in the postnatal period.

Benzodiazepines are found in the breast milk, Reports have demonstrated milk: plasma concentration ratios to vary between 0.2 and 2.7. There is therefore a risk of accumulation in the breastfeeding child. Benzodiazepines should not be given to breast feeding mothers.

4.7 Effects On Ability To Drive And Use Machines

Sedation, amnesia and impaired muscular function may adversely affect the ability to drive or use machines. If insufficient sleep occurs, the likelihood of impaired alertness may be increased (see also Interactions).

Impaired function and sedation may occur the following morning and for several days after.

4.8 Undesirable Effects

During the first week of administration or when high doses are used they may have a sedative effect and cause some degree of drowsiness. In such cases there is an advantage in administering half the total daily intake at night, the remainder being given in divided doses during the day.

The elderly and debilitated are particularly sensitive to the effects of central depressant drugs and may experience confusion, especially if organic brain changes are present; the dosage of diazepam should not exceed one-half that recommended for other adults.

Skin and appendages disorders

Allergic reactions (skin rash or itching) occur rarely.

Central and peripheral nervous disorders

Drowsiness, sedation, unsteadiness, ataxia is common (these effects are dose-related and may persist into the following day even after a single dose). Headache, vertigo, dystonic effects occur rarely. Impaired motor ability, dizziness, muscle weakness, tremor, slurred speech.

Vision disorders

Visual disturbances occur rarely.

Psychiatric disorders

Libido fluctuations occur rarely. Anterograde amnesia, concentration difficulties, abnormal psychological reactions, behavioural adverse effects include paradoxical aggressive outbursts, excitement, confusion and the uncovering of depression with suicidal tendencies.

Gastro-intestinal system disorders

Gastrointestinal upsets occur rarely. Increased salivary secretion.

Liver and billiary system disorders

Jaundice occurs rarely.

Endocrine disorders

Gynaecomastia.

Cardio disorders

Hypotension occurs rarely.

Respiratory system disorders

Respiratory depression.

Blood disorders

Blood dyscrasias occur rarely.

Urinary system disorders

Urinary retention occurs rarely.

Body as a whole-general disorders

Fatigue, anaphylaxis.

Withdrawal effects

Withdrawal symptoms: Development of dependence is common after regular use, even in therapeutic doses for short periods, particularly in patients with a history of drug or alcohol abuse or marked personality disorders. Discontinuation of the therapy may result in withdrawal or rebound phenomena (see 4.4 Special Warnings and Special Precautions for Use). Symptoms of benzodiazepine withdrawal include anxiety, depression, impaired concentration, insomnia, headache, dizziness, tinnitus, loss of appetite, tremor, perspiration, irritability, perceptual disturbances such as hypersensitivity to physical, visual, and auditory stimuli and abnormal taste, nausea, vomiting, abdominal cramps, palpitations, mild systolic hypertension, tachycardia, and orthostatic hypotension.

Rare and more serious symptoms include muscle twitching, confusional or paranoid psychosis, convulsions, hallucinations, and a state resembling delirium tremens. Broken sleep with vivid dreams and increased REM sleep may persist for some weeks after withdrawal of benzodiazepines.

4.9 Overdose

Features

The symptoms of diazepam overdose are mainly an intensification of the therapeutic effects (ataxia, drowsiness, dysarthria, sedation, muscle weakness, profound sleep, hypotension, bradycardia, nystagmus) or paradoxical excitation. In most cases only observation of vital functions is required.

Extreme overdosage may lead to coma, areflexia, cardio-respiratory depression and apnoea, requiring appropriate countermeasures (ventilation, cardiovascular support).

Benzodiazepine respiratory depressant effects are more serious in patients with severe chronic obstructive airways disease. Severe effects in overdose also include rhabdomyolysis and hypothermia.

Management

Maintain a clear airway and adequate ventilation.

Consider activated charcoal (50g for an adult, 1g/kg for a child) in adults who have taken more than 100mg or children who have taken more than 1mg/kg within one hour, provided they are not too drowsy.

Monitoring level of consciousness, respiratory rate, pulse oximetry and blood pressure in symptomatic patients.

Consider arterial blood gas analysis in patients who have a reduced level of consciousness (GCS < 8; AVPU scale P or U) or have reduced oxygen saturations on pulse oximetry.

Correct hypotension by raising the foot of the bed and by giving an appropriate fluid challenge. Where hypotension is thought mainly due to decreased systemic vascular resistance, drugs with alpha-adrenergic activity such as noradrenaline or high dose dopamine (10-30 micrograms/kg/min) may be beneficial. The dose of inotrope should be titrated against blood pressure.

If severe hypotension persists despite the above measures, then central venous pressure monitoring should be considered.

Supportive measures are indicated depending on the patient's clinical state.

Benzodiazepines are not significantly removed from the body by dialysis.

Flumazenil, a benzodiazepine antagonist, is not advised as a routine diagnostic test in patients with reduced conscious level. It may sometimes be used as an alternative to ventilation in children who are naive to benzodiazepines, or in patients with COPD to avoid the need for ventilation. It is not necessary or appropriate in cases of poisoning to fully reverse the benzodiazepine effect. Flumazenil has a short half-life (about an hour) and in this situation an infusion may therefore be required. Flumazenil is contraindicated when patients have ingested multiple medicines, especially after co-ingestion of a benzodiazepine and a tricyclic antidepressant or any other drug that causes seizures. This is because the benzodiazepine may be suppressing seizures induced by the second drug; its antagonism by flumazenil can reveal severe status epilepticus that is very difficult to control.

Contraindications to the use of flumazenil include features suggestive of a tricyclic antidepressant ingestion including a wide QRS, or large pupils. Use in patients post-cardiac arrest is also contraindicated.

It should be used with caution in patients with a history of seizures, head injury, or chronic benzodiazepine use.

Occasionally a respirator may be required but generally few problems are encountered, although behavioural changes are likely in children.

If excitation occurs, barbiturates should not be used.

Effects of overdose are more severe when taken with centrally-acting drugs, especially alcohol, and in the absence of supportive measures, may prove fatal.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC code: N05B A01

Diazepam is a benzodiazepine tranquilliser with anticonvulsant, sedative, muscle relaxant and amnesic properties.

5.2 Pharmacokinetic Properties

Diazepam is readily and completely absorbed from the GI tract, peak plasma concentrations occurring within about 30-90 minutes of oral administration. Diazepam crosses the blood-brain barrier and is highly lipid soluble. Diazepam has a biphasic half-life with an initial rapid distribution phase followed by a prolonged terminal elimination phase of 1 or 2 days; its action is further prolonged by the even longer half-life of 2-5 days of its principle active metabolite, desmethyldiazepam (nordiazepam), the relative proportion of which increases in the body on long-term administration.

Diazepam is extensively metabolised in the liver and, in addition to desmethyldiazepam, its active metabolites include oxazepam and temazepam. It is excreted in the urine, mainly in the form of its metabolites, either free or in conjugated form. Diazepam is very extensively bound to plasma proteins.

The plasma half-life of diazepam is prolonged in neonates, in the elderly, and in patients with kidney or liver disease. In addition to crossing the blood-brain barrier, diazepam and its metabolites also cross the placental barrier and are excreted in breast milk.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Also contains: lactose, magnesium stearate, maize starch, stearic acid.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Shelf-life

Three years from the date of manufacture.

Shelf-life after dilution/reconstitution

Not applicable.

Shelf-life after first opening

Not applicable.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass containers with screw caps.

The product may also be supplied in blister packs in cartons:

a) Carton: Printed carton manufactured from white folding box board.

b) Blister pack: (i) 250µm white rigid PVC. (ii) Surface printed 20µm hard temper aluminium foil with 5-6g/M² PVC and PVdC compatible heat seal lacquer on the reverse side.

The product may be contained in blister packs which enhance security of the pack increasing resistance to deliberate contamination, pilfering, etc.

Pack size: 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168, 180, 250, 500, 1000.

Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. Bulk packs are included for temporary storage of the finished product before final packaging into the proposed marketing containers.

Maximum size of bulk packs: 50,000.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

Administrative Data

7. Marketing Authorisation Holder

Actavis UK Limited

(Trading style: Actavis)

Whiddon Valley

BARNSTAPLE

N Devon EX32 8NS

8. Marketing Authorisation Number(S)

PL 0142/0087

9. Date Of First Authorisation/Renewal Of The Authorisation

15.7.77

(Renewed: 15.7.82; 15.7.87; 3.9.92)

10. Date Of Revision Of The Text

16/09/2010

Sulmasque

Generic Name: sulfur topical (SULL fur)

Brand Names: Acnotex, Fostril, Liquimat Light, Liquimat Medium, Rezamid, Sulfo-Lo, Sulfoam, Sulforcin, Sulmasque, Sulpho-Lac, Sulpho-Lac Soap

What is Sulmasque (sulfur topical)?

Topical sulfur causes drying and peeling of the skin. This allows excess oil and dirt to be easily washed away.

Sulfur topical is used to treat acne.

Sulfur topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Sulmasque (sulfur topical)?

Do not use sulfur on sunburned, windburned, dry, chapped, or irritated skin or on open wounds.

Avoid abrasive, harsh, or drying soaps and cleansers while using sulfur topical.

Who should not use Sulmasque (sulfur topical)?

Do not use sulfur topical on sunburned, windburned, dry, chapped, or irritated skin. It could make these conditions much worse. Also avoid using sulfur topical on wounds or on areas of eczema. Wait until these conditions have healed before using this medication.

Do not use sulfur topical during treatment with other topical acne products unless otherwise directed with your doctor. The combination could lead to severe skin irritation.

It is not known whether sulfur topical will harm an unborn baby. Do not use sulfur topical without first talking to your doctor if you are pregnant. It is also not known whether sulfur passes into breast milk. Do not use sulfur topical without first talking to your doctor if you are breast-feeding a baby.

How should I use Sulmasque (sulfur topical)?

Use sulfur topical exactly as directed by your doctor, or follow the instructions that accompany the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after applying this medication.

Shake lotions well before using them. Clean and dry the area to which you will apply sulfur topical. Apply the medication to the affected area. When applying sulfur topical, avoid your eyes, the inside of your nose and mouth, your lips, and areas where the skin is broken to prevent excessive irritation. If you get medication in any of these areas, rinse it off with water.

Do not cover the affected area after applying sulfur topical, unless otherwise directed by your doctor. Doing so could cause too much medicine to be absorbed by your body and could be harmful.

Sulfur topical is usually applied one to three times daily.

It may take several weeks or more to see the effects of this drug. Do not stop using sulfur topical if you do not see results immediately.

Apply sulfur topical less often if you experience excessive burning, dryness, or irritation.

Store sulfur topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed and apply only your next regularly scheduled dose.

What happens if I overdose?

An overdose of sulfur topical is unlikely to occur. If you do suspect an overdose, or if sulfur topical has been ingested, call a poison control center or emergency room for advice.

What should I avoid while using Sulmasque (sulfur topical)?

Do not use sulfur topical on sunburned, windburned, dry, chapped, or irritated skin or on open wounds.

Avoid using other topical products on the same area unless otherwise directed to do so by your doctor. They may interfere with the effects or absorption of sulfur topical.

Do not cover the area after applying sulfur topical, unless otherwise directed by your doctor. Doing so could cause too much medicine to be absorbed by your body and could be harmful.

Avoid using harsh, abrasive or irritating cleansers, perfumes or cosmetics on the area you are treating.

Sulmasque (sulfur topical) side effects

Serious side effects are not likely to occur. Stop using sulfur topical and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

You may experience some burning, stinging, tingling, itching, redness, dryness, peeling, or irritation while you are using sulfur topical. If these side effects are excessive, apply sulfur topical less often.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Sulmasque (sulfur topical)?

Do not use other topical preparations unless directed to do so by your doctor. They may interfere with your treatment or increase irritation to your skin.

Avoid using harsh, abrasive or irritating cleansers, perfumes, or cosmetics on the area you are treating.

Drugs other than those listed here may also interact with sulfur topical. Talk to your doctor and pharmacist before taking any prescription or over the counter medicines.

More Sulmasque resources

• Sulmasque Side Effects (in more detail)
• Sulmasque Use in Pregnancy & Breastfeeding
• Sulmasque Drug Interactions
• Sulmasque Support Group
• 0 Reviews for Sulmasque - Add your own review/rating

• Sulmasque Topical Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Sulmasque with other medications

• Acne

Where can I get more information?

• Your pharmacist has additional information about sulfur topical written for health professionals that you may read.

See also: Sulmasque side effects (in more detail)

Soma Compound with Codeine

Generic Name: carisoprodol, aspirin and codeine phosphate

Dosage Form: tablets

SOMA® COMPOUND with CODEINE

(carisoprodol, aspirin and codeine phosphate, USP)

200 mg + aspirin 325 mg + codeine phosphate 16 mg.

Warning: May be habit-forming.

Tablets

CIII

Rx Only

DESCRIPTION- ‘Soma’ Compound with Codeine is a combination product containing carisoprodol, a centrally-acting muscle relaxant, plus aspirin, an analgesic with antipyretic and antiinflammatory properties and codeine phosphate, a centrally-acting narcotic analgesic. It is available as a two-layered, white and yellow, oval-shaped tablet for oral administration. Each tablet contains carisoprodol , USP 200 mg, aspirin 325 mg, and codeine phosphate, USP 16 mg. Chemically, carisoprodol is N-isopropyl-2- methyl-2-propyl-1,3-propanediol dicarbamate. Its empirical formula is C12H24N2O4, with a molecular weight of 260.34. The structural formula is:

Other ingredients: croscarmellose sodium, D&C Yellow #10, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, povidine, sodium metabisulfite, starch, stearic acid.

CLINICAL PHARMACOLOGY- Carisoprodol: Carisoprodol is a centrally acting muscle relaxant that does not directly relax tense skeletal muscles in man. The mode of action of Carisoprodol in relieving acute muscle spasm of local origin has not been clearly identified, but may be related to its sedative properties. In animals, carisoprodol has been shown to produce muscle relaxation by blocking interneuronal activity and depressing transmission of polysynaptic neurons in the spinal cord and in the descending reticular formation of the brain. The onset of action is rapid and lasts four to six hours.

Carisoprodol is metabolized in the liver and is excreted by the kidneys. It is dialyzable by peritoneal and hemodialysis.

Aspirin: Aspirin is a nonnarcotic analgesic with antiinflammatory and antipyretic activity. Inhibition of prostaglandin biosynthesis appears to account for most of its antiinflammatory and for at least part of its analgesic and antipyretic properties.

Aspirin is rapidly absorbed and almost totally hydrolyzed to salicylic acid following oral administration. Although aspirin has a half-life of only about 15 minutes, the apparent biologic half-life of salicylic acid in the therapeutic plasma concentration range is between 6 and 12 hours. Salicylic acid is eliminated by renal excretion and by biotransformation to inactive metabolite. Clearance of salicylic acid in the high-dose range is sensitive to urinary pH (see Drug Interactions) and is reduced by renal dysfunction.

Codeine Phosphate: Codeine phosphate is a centrally acting narcotic-analgesic. Its actions are qualitatively similar to morphine, but its potency is substantially less.

Clinical studies have shown that combining aspirin and codeine produces a significant additive effect in analgesic efficacy.

INDICATIONS AND USAGE- ‘Soma’ Compound with Codeine is indicated as an adjunct to rest, physical therapy, and other measures for the relief of pain, muscle spasm, and limited mobility associated with acute, painful musculoskeletal conditions when the additional action of codeine is desired.

CONTRAINDICATIONS- Acute intermittent porphyria; bleeding disorders; allergic or idiosyncratic reactions to carisoprodol, aspirin, codeine, or related compounds.

WARNINGS- On very rare occasions, the first dose of carisoprodol has been followed by idiosyncratic reactions with symptoms appearing within minutes or hours. These may include extreme weakness, transient quadriplegia, dizziness, ataxia, temporary loss of vision, diplopia, mydriasis, dysarthria, agitation, euphoria, confusion, and disorientation. Although symptoms usually subside over the course of the next several hours, discontinue ‘Soma’ Compound with Codeine and initiate appropriate supportive and symptomatic therapy, which may include epinephrine and/or antihistamines. In severe cases, corticosteroids may be necessary. Severe reactions have been manifested by asthmatic episodes, fever, weakness, dizziness, angioneurotic edema, smarting eyes, hypotension, and anaphylactoid shock.

The effects of carisoprodol with agents such as alcohol, other CNS depressants or psychotropic drugs may be additive. Appropriate caution should be exercised with patients who take one or more of these agents simultaneously with ‘Soma’ Compound with Codeine.

Contains sodium metabisulfate, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

PRECAUTIONS-General: To avoid excessive accumulation of carisoprodol, aspirin, or their metabolites, use ‘Soma’ Compound with Codeine with caution in patients with compromised liver or kidney function, or in elderly or debilitated patients (see CLINICAL PHARMACOLOGY). Use with caution in patients with history of gastritis or peptic ulcer, in patients on anticoagulant therapy, and in addiction-prone individuals.

Ultra-rapid Metabolizers of Codeine

Some individuals may be ultra-rapid metabolizers due to a specific CYP2D6*2x2 genotype. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regiments, individuals who are ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing.

The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1-10% in Caucasians, 3% in African Americans, and 16-28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups.

When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and should inform their patients about these risks and the signs of morphine overdose. (See PRECAUTIONS-Nursing Mothers)

Information for Patients: Caution patients that this drug may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a motor vehicle or operating machinery.

Caution patients with a predisposition for gastrointestinal bleeding that concomitant use of aspirin and alcohol may have an additive effect in this regard.

Caution patients that dosage of medications used for gout, arthritis, or diabetes may have to be adjusted when aspirin is administered or discontinued (see Drug Interactions).

Caution patients that some people have a variation in a liver enzyme and change codeine into morphine more rapidly and completely than other people. These people are ultra-rapid metabolizers and are more likely to have a higher-than-normal levels of morphine in their blood after taking codeine which can result in overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer.

Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby’s doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services).

Drug Interactions: Clinically important interactions may occur when certain drugs are administered concomitantly with aspirin or aspirin–containing drugs.

1.Oral Anticoagulants-By interfering with platelet function or decreasing plasma prothrombin concentration, aspirin enhances the potential for bleeding in patients on anticoagulants.

2. Methotrexate-aspirin enhances the toxic effects of this drug.

3. Probenicid and Sulfinpyrazone-large doses of aspirin reduce the uricosuric effect of both drugs. Renal excretion of salicylate may also be reduced.

4. Oral Antidiabetic Drugs-enhancement of hypoglycemia may occur.

5. Antacids-to the extent that they raise urinary pH, antacids may substantially decrease plasma salicylate concentrations; conversely, their withdrawal can result in a substantial increase.

6. Ammonium Chloride-this and other drugs that acidify a relatively alkaline urine can elevate plasma salicylate concentrations.

7. Ethyl Alcohol-enhanced aspirin –induced fecal blood loss has been reported.

8.Corticosteroids- salicylate plasma levels may be decreased when adrenal corticosteroids are given, and may be increased substantially when they are discontinued.

Carcinogenesis, Mutagenesis, Impairment of Fertility: No long-term studies have been done with ‘Soma’ Compound with Codeine.

Pregnancy-Teratogenic Effects: Pregnancy Category C. Adequate animal reproduction studies have not been conducted with ‘Soma’ Compound with Codeine. It is also not known whether ‘Soma’ Compound with Codeine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ‘Soma’ Compound with Codeine should be given to a pregnant woman only if clearly needed.

Studies in rodents have shown salicylates to be teratogenic when given in early gestation, and embryocidal when given in later gestation in doses considerably greater than usual therapeutic doses in humans. Studies in women who took aspirin during pregnancy have not demonstrated an increased incidence of congenital abnormalities in the offspring.

Labor and Delivery: Ingestion of aspirin near term or prior to delivery may prolong delivery or lead to bleeding in mother, fetus, or neonate.

Nursing Mothers: Carisoprodol is excreted in human milk in concentrations two-to-four times that in maternal plasma. Aspirin is excreted in human milk in moderate amounts and can produce a bleeding tendency in nursing infants. Because of the potential for serious adverse reaction in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.

Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and low dose-dependent. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, some women are ultra-rapid metabolizers of codeine. These women achieve higher-than-expected serum levels of codeine’s active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants.

The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1-10% in Caucasians, 3% in African Americans, and 16-28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups.

The risk of infant exposure to codeine and morphine through breat milk should be weighed against the benefits of breastfeeding for both the mother and baby. Caution should be exercised when codeine is administered to a nursing woman. If a codeine containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding. (See PRECAUTIONS-General- Ultra-rapid Metabolizers of Codeine)

Pediatric Use: Safety and effectiveness in pediatric patients below the age of twelve have not been established.

ADVERSE REACTIONS- If severe reactions occur, discontinue ‘Soma’ Compound with Codeine and initiate appropriate symptomatic and supportive therapy.

The following side effects which have occurred with the administration of the individual ingredients alone may also occur with the combination.

Carisoprodol: Central Nervous System-Drowsiness is the most frequent complaint and along with other CNS effects may require dosage reduction. Observed less frequently are dizziness, vertigo and ataxia. Tremor, agitation, irritability, headache, depressive reactions, syncope, and insomnia have been infrequent or rare.

Idiosyncratic-Idiosyncratic reactions are very rare. They are usually seen within the period of the first to fourth dose in patients having had no previous contact with the drug (see WARNINGS).

Allergic-Skin rash, erythema multiforme, pruritis, eosinophillia, and fixed drug eruptions with cross-reaction to meprobamate have been reported. If allergic reactions occur, discontinue ‘Soma’ Compound with Codeine tablets and treat symptomatically. In evaluating possible allergic reactions, also consider allergy to excipients (information on excipients is available to physicians on request).

Cardiovascular-Tachycardia, postural hypotension, and facial flushing.

Gastrointestinal-Nausea, vomiting, epigastric distress, and hiccup.

Hematologic-No serious blood dyscrasias have been attributed to carisoprodol alone. Leukopenia and pancytopenia have been reported, very rarely, in situations in which other drugs or viral infections may have been responsible.

Aspirin: The most common adverse reactions associated with the use of aspirin have been gastrointestinal, including nausea, vomiting, gastritis, occult bleeding, constipation, and diarrhea. Gastric erosion, angioedema, asthma, rash, pruritus and urticaria have been reported less commonly. Tinnitus is a sign of high serum salicylate levels ( see OVERDOSAGE).

Aspirin Intolerance-Allergic type reactions in aspirin–sensitive individuals may involve the respiratory tract or the skin. Symptoms of the former range from rhinorrhea and shortness of breath to severe asthma and the latter may consist of urticaria, edema, rash, or angioedema (giant hives). These may occur independently or in combination.

Codeine Phosphate: Nausea, vomiting, constipation, miosis, sedation, and dizziness have been reported.

DRUG ABUSE AND DEPENDENCE- Controlled Substance: Schedule C-III (see PRECAUTIONS).

Abuse: In clinical use, has been rare.

Dependence: In clinical use, dependence with ‘Soma’ Compound with Codeine has been rare and there have been no reports of significant abstinence signs. Nevertheless, the following information on the individual ingredients should be kept in mind.

Carisoprodol- In dogs, no withdrawal symptoms occurred after abrupt cessation of carisoprodol from dosages as high as 1 gm/kg/day. In a study of man, abrupt cessation of 100 mg/kg/day (about five times the recommended daily adult dosage) was followed in some subjects by mild withdrawal symptoms such as abdominal cramps, insomnia, chills, headache, and nausea. Delirium and convulsions did not occur (see PRECAUTIONS).

Codeine Phosphate- Drug dependence of the morphine type may result.

OVERDOSAGE- Signs and symptoms: Any of the following which have been reported with the individual ingredients may occur and may be modified to a varying degree by the effects of the ingredients present in ‘Soma’ Compound with Codeine.

Carisoprodol- Stupor, coma, shock, respiratory depression, and, very rarely, death. Overdosage with carisoprodol in combination with alcohol, other CNS depressants, or psychotropic agents can have additive effects, even when one of the agents has been taken in the usually recommended dosage.

Aspirin - Headache, tinnitus, hearing difficulty, dim vision, dizziness, lassitude, hyperpnea, rapid breathing, thirst, nausea, vomiting, sweating, and occasionally diarrhea are characteristic of mild to moderate salicycilate poisoning. Salicylate poisoning should be considered in children with symptoms of vomiting, hyperpnea, and hyperthermia.

Hyperpnea is an early sign of salicylate poisoning, but dyspnea supervenes at plasma levels above 50 mg/dL. These respiratory changes eventually lead to serious acid-base disturbances. Metabolic acidosis is a constant finding in infants but occurs in older children only with severe poisoning; adults usually exhibit respiratory alkalosis initially and acidosis terminally.

Other symptoms of severe salicylate poisoning include hyperthermia, dehydration, delirium, and mental disturbances. Skin eruptions, GI hemorrhage, or pulmonary edema are less common. Early CNS stimulation is replaced by increasing depression, stupor, and coma. Death is usually due to respiratory failure or cardiovascular collapse.

Codeine Phosphate-pinpoint pupils, CNS depression, coma, respiratory depression, and shock.

Treatment: General-Provide symptomatic and supportive treatment, as indicated. Any drug remaining in the stomach should be removed using appropriate procedures and caution to protect the airway and prevent aspiration, especially in the stuporous or comatose patient. Incomplete gastric emptying with delayed absorption of carisoprodol has been reported as a cause for relapse. Should respiration or blood pressure become compromised, respiratory assistance, central nervous system stimulants, and pressor agents should be administered cautiously, as indicated.

Carisoprodol-The following have been used successfully in overdosage with the related drug meprobamate: diuretics, osmotic (mannitol) diuresis, peritoneal dialysis, and hemodialysis (see CLINICAL PHARMACOLOGY). Careful monitoring of urinary output is necessary and caution should be taken to avoid overhydration. Carisoprodol can be measured in biological fluid by gas chromatography (Douglas, J.F.,et al:J Pharm Sci 58:145,1969).

Aspirin-Since there are no specific antidotes for salicylate poisoning, the aim of treatment is to enhance elimination of salicylate and prevent or reduce further absorption; to correct any fluid electrolyte or metabolic imbalance; and to provide general and cardiorespiratory support. If acidosis is present, intravenous sodium bicarbonate must be given, along with adequate hydration, until salicylate levels decrease to within the therapeutic range. To enhance elimination, forced diuresis and alkalinization of urine may be beneficial. The need for hemoperfusion or hemodialysis is rare and should be used only when other measures have failed.

Codeine Phosphate-Narcotic antagonists, such as nalorphine and levallorphan, may be indicated.

DOSAGE AND ADMINISTRATION- Usual Adult Dosage; 1 or 2 tablets, four times daily.

Not recommended for use in children under age twelve.

HOW SUPPLIED

‘Soma’ Compound with Codeine Tablets (carisoprodol 200 mg, aspirin 325 mg, and codeine phosphate, 16 mg) are oval, convex,, two-layered, and inscribed on the white layer with SOMA CC and on the yellow layer with WALLACE 2403. The tablets are available in bottles of 100 (NDC 0037-2403-01).

Store at controlled room temperature 15°-30°C (59°-86°F). Protect from moisture. Dispense in a tight, light-resistant container.

MedPointe Pharmaceuticals

MedPointe Healthcare Inc.

Somerset, NJ 00873

IN-095E2-14

Rev 10/07

Soma Compound with Codeine  carisoprodol, aspirin and codeine phosphate  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0037-2403 Route of Administration ORAL DEA Schedule CIII

INGREDIENTS Name (Active Moiety) Type Strength carisoprodol (carisoprodol) Active 200 MILLIGRAM  In 1 TABLET aspirin (aspirin) Active 325 MILLIGRAM  In 1 TABLET codeine phosphate (codeine) Active 16 MILLIGRAM  In 1 TABLET croscarmellose sodium Inactive   microcrystalline cellulose Inactive   D&C Yellow #10 Inactive   hydroxypropyl methylcellulose Inactive   magnesium stearate Inactive   povidine Inactive   sodium metabisulfite Inactive   starch Inactive   stearic acid Inactive

Product Characteristics Color WHITE, YELLOW Score no score Shape OVAL (OVAL) Size 17mm Flavor Imprint Code SOMA;CC;WALLACE;2403 Contains          Coating false Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 0037-2403-01 100 TABLET In 1 BOTTLE None

Revised: 10/2007MedPointe Pharmaceuticals

More Soma Compound with Codeine resources

• Soma Compound with Codeine Side Effects (in more detail)
• Soma Compound with Codeine Dosage
• Soma Compound with Codeine Use in Pregnancy & Breastfeeding
• Drug Images
• Soma Compound with Codeine Drug Interactions
• 4 Reviews for Soma Compound with Codeine - Add your own review/rating

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• Soma Compound with Codeine MedFacts Consumer Leaflet (Wolters Kluwer)

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