Tiaprizal may be available in the countries listed below.
Tiapride hydrochloride (a derivative of Tiapride) is reported as an ingredient of Tiaprizal in the following countries:
International Drug Name Search
Epaq may be available in the countries listed below.
Metronidazole is reported as an ingredient of Epaq in the following countries:
Salbutamol sulfate (a derivative of Salbutamol) is reported as an ingredient of Epaq in the following countries:
International Drug Name Search
Treating inflammation and itching due to certain skin conditions.
Diflorasone Diacetate Cream is a topical corticosteroid. It works by reducing skin inflammation (redness, swelling, itching, and irritation).
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Diflorasone Diacetate Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Diflorasone Diacetate Cream. Because little, if any, of Diflorasone Diacetate Cream is absorbed into the blood, the risk of it interacting with another medicine is low.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Diflorasone Diacetate Cream 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.
Use Diflorasone Diacetate Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Diflorasone Diacetate Cream.
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:
Dryness; itching.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; burning, cracking, irritation, itching, or peeling not present before you began using Diflorasone Diacetate Cream; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.
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.
See also: Diflorasone Diacetate side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Store Diflorasone Diacetate Cream at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Keep Diflorasone Diacetate Cream out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Diflorasone Diacetate Cream. 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.
Class: 5-alpha-Reductase Inhibitors
VA Class: HS900
Chemical Name: 5α,17β)-N-[2,5-bis(trifluoromethyl)phenyl]-3-oxo-4-azaandrost-1-ene-17-carboxamide
Molecular Formula: C27H30F6N2O2
CAS Number: 164656-23-9
Brands: Avodart
Special Alerts:
[Posted 06/09/2011] ISSUE: FDA notified healthcare professionals that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor (5-ARI) class of drugs has been revised to include new safety information about the increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer).
BACKGROUND: The new safety information is based on FDA’s review of two large, randomized controlled trials––the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial. Finasteride (Proscar), dutasteride (Avodart), and dutasteride in combination with tamsulosin (marketed combination product as Jalyn) are approved to improve symptoms of an enlarged prostate gland (benign prostatic hyperplasia or BPH). Proscar and Avodart are also approved to reduce the risk of urinary retention or surgery related to an enlarged prostate. Finasteride (Propecia) is approved to treat male pattern hair loss.
RECOMMENDATION: Prior to initiating therapy with 5-ARIs, perform appropriate evaluation to rule out other urological conditions, including prostate cancer, that might mimic benign prostatic hyperplasia (BPH). See Drug Safety Communication for a Data Summary and additional information. For more information visit the FDA website at: and .
Selective inhibitor of steroid 5α-reductase isoenzymes, which are necessary for conversion of testosterone to 5α-dihydrotestosterone (DHT).1 4 9
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Treatment of symptomatic BPH1 to improve symptoms and reduce the risk of acute urinary retention and the need for surgery.1 3 Ineffective in patients who do not have evidence of prostatic enlargement.11
Although drug therapy usually is not as effective as surgical therapy, it may provide adequate symptomatic relief with fewer and less serious adverse effects compared with surgery.11
Steroid 5α-reductase inhibitors may be a useful alternative to surgery in patients with obstructive manifestations who are unwilling to undergo surgical correction of BPH;8 may aid those who may be at increased risk from, but not necessarily candidates for, prostate surgery.4 8 10 Also may be considered in patients who have symptomatic prostatic enlargement but whose symptoms are not bothersome (i.e., do not interfere with activities of daily living) in order to prevent progression of the disease.11
May consider combined therapy with an α1-adrenergic blocker and 5α-reductase inhibitor for men with bothersome moderate to severe BPH and demonstrable prostatic enlargement.11 Has been more effective than therapy with either drug alone in preventing long-term BPH symptom progression.11 Men at risk for BPH progression are most likely to benefit from combination therapy.11
Administer orally without regard to meals.1
The capsules should be swallowed whole.1
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Initially and for maintenance therapy, 0.5 mg once daily.1
While early symptomatic improvement (e.g., within 3 months) may occur, ≥6 months of therapy may be necessary to determine clinical benefit.2 Generally, therapy is continued for life.9
No specific dosage recommendations for hepatic impairment.1 (See Hepatic Impairment under Cautions.)
Dosage adjustment not required.1
Dosage adjustment not required.1
Known or suspected pregnancy.1 (See Fetal/Neonatal Morbidity and also Pregnancy under Cautions.)
Use in women or children.1
Known hypersensitivity to dutasteride, other 5α-reductase inhibitors, or any ingredient in the formulation.1
May cause fetal harm; teratogenicity demonstrated in animals.1 Animal studies indicate adverse effects on embryofetal development of male fetuses exposed to the drug during pregnancy (e.g., abnormalities of the external genitalia, decreased prostatic and seminal vesicular weights, distended preputial glands, nipple development).1
Because of the potential for absorption through the skin and the subsequent potential risk to a male fetus, pregnant women or women who may become pregnant should not handle the capsules.1 2
If contact is made with leaking capsules, wash the affected area immediately with soap and water.1 2
To prevent potential fetal exposure, men receiving the drug should not donate blood during dutasteride therapy and for at least 6 months following discontinuance of the drug.1
Seminal drug concentrations not sufficient to warrant the use of condoms to prevent exposure to dutasteride.10
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Evaluate candidates for dutasteride therapy for other urologic conditions that might mimic BPH, such as infection,4 prostate 1 4 or bladder cancer,4 stricture disease,4 uncontrolled diabetes mellitus,4 neurogenic bladder,4 or CHF.4 7
Perform digital rectal examinations, as well as other screening tests for prostate cancer, before initiating therapy and periodically thereafter.1 7 8
Monitor patients with a large residual urinary volume and/or severely diminished urinary flow carefully for obstructive uropathy.4 7 Such patients may not be candidates for dutasteride therapy,1 and may require surgery.4 7
Decreases PSA concentrations; may interfere with interpretation of serum PSA determinations.1 (See Specific Drugs and Laboratory Tests under Interactions.)
Category X.1 (See Fetal/Neonatal Morbidity and also Contraindications under Cautions.)
Not known whether dutasteride is distributed into milk, but use of the drug is contraindicated in women.1 10
Safety and efficacy not established, but the drug is not indicated for use in children.1
No substantial differences in safety and efficacy relative to younger men.1
Not studied in patients with hepatic impairment.1 Increased exposure to the drug is probable.1 Use with caution.1
Impotence, decreased libido, ejaculation disorder, gynecomastia (breast tenderness, enlargement).1
Metabolized by CYP isoenzymes 3A4 and 3A5 to active metabolites; not metabolized by CYP isoenzymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, or 2E1.1
Potential pharmacokinetic interaction with inhibitors of CYP3A4 (decreased clearance and increased serum concentrations of dutasteride).1
Drug or Test | Interaction | Comments |
|---|---|---|
Amlodipine | Pharmacokinetic interaction unlikely1 | |
Cholestyramine | Pharmacokinetic or pharmacodynamic interaction unlikely1 | |
Cimetidine | Decreased clearance and increased serum concentrations of dutasteride1 | Use concomitantly with care |
Ciprofloxacin | Decreased clearance and increased serum concentrations of dutasteride1 | Use concomitantly with care1 |
Digoxin | Pharmacokinetic or pharmacodynamic interaction unlikely1 | |
Diltiazem | Decreased clearance and increased serum concentrations of dutasteride1 | Not considered clinically important1 |
Ketoconazole | Decreased clearance and increased serum concentrations of dutasteride1 | Use concomitantly with care1 |
Ritonavir | Decreased clearance and increased serum concentrations of dutasteride1 | |
Tamsulosin | Pharmacokinetic or pharmacodynamic interaction unlikely1 | |
Terazosin | Pharmacokinetic or pharmacodynamic interaction unlikely1 | |
Test for PSA | 50% decrease in serum PSA concentration after ≥6 months of treatment1 3 6 9 10 No substantial change in ratio of free to total PSA (percentage of free PSA)1 | Establish a new baseline PSA 3–6 months after initiation of treatment1 For clinical interpretation of isolated PSA values in men receiving dutasteride for ≥6 months, double the reported value for PSA for comparison with normal values in men not receiving the drug1 3 No adjustment of reported value of ratio appears to be necessary1 |
Troleandomycin | Decreased clearance and increased serum concentrations of dutasteride1 | |
Verapamil | Decreased clearance and increased serum concentrations of dutasteride1 | Not considered clinically important1 |
Warfarin | Pharmacokinetic or pharmacodynamic interaction unlikely1 |
Absolute bioavailability is approximately 60%.1
Reduces serum and prostatic 5α-dihydroxytestosterone (DHT) concentrations maximally within 1–2 weeks of initiation of therapy.1
Serum drug concentrations are detectable for up to 4–6 months following discontinuance of therapy.1
Decreases peak serum concentrations.1 Not considered clinically important.1
Widely distributed; volume of distribution is 300–500 L.1
Distributes into semen.1
Highly bound to albumin (99%) and α-1 acid glycoprotein (96.6%).1
Metabolized by CYP3A4 and CYP3A5 to active metabolites.1
Excreted in the feces (45%) and urine (<1%) mainly as metabolites; approximately 55% remained unaccounted.1
Terminal half-life is approximately 5 weeks at steady state.1
In patients with hepatic impairment, pharmacokinetics not studied.1 Metabolized extensively in the liver, and increased exposure to the drug is probable in hepatic impairment.1
In adolescents (<18 years of age), pharmacokinetics not studied.1
In patients with renal impairment, pharmacokinetics not studied; however, <0.1% of a dose is excreted in urine in healthy individuals.1
In women, pharmacokinetics not studied; use contraindicated.1
Effects of race on pharmacokinetics not studied.1
25°C (may be exposed to 15–30°C).1
Competitive inhibitor of both the type 1 and type 2 isoenzymes of steroid 5α-reductase.1 9 These enzymes convert testosterone to DHT.1 9
Reduces serum and prostatic DHT concentrations substantially.1 DHT appears to be the principal androgen responsible for initial development and subsequent enlargement of the prostate gland.1 9
Increases serum testosterone (generally remaining within the normal range) and prostatic testosterone concentrations.1 3 9
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Importance of obtaining and reading patient information on dutasteride before initiation of therapy and with each new prescription refill.1
Importance of advising pregnant women or women who may become pregnant to avoid handling the drug.1 (See Pregnancy under Cautions.)
Advise patients that a decrease in the volume of ejaculate may occur but that this does not appear to interfere with normal sexual function.1
Advise patients of the small possibility of impotence and decreased libido.1 10
Advise patients of possibility of developing enlarged or tender breasts.1
Advise patients of possibility of allergic reactions (e.g., rash, pruritus, urticaria, swelling of lips or face).1
Advise patients that ≥6 months of therapy may be required before improvement in BPH symptoms occurs.2
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1
Importance of advising patients of other important precautionary information.1 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Capsules, liquid-filled | 0.5 mg | Avodart | GlaxoSmithKline |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 07/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Avodart 0.5MG Capsules (GLAXO SMITH KLINE): 30/$129.98 or 90/$354.97
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions June 09, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
1. GlaxoSmithKline. Avodart (dutasteride) soft gelatin capsules prescribing information. Research Triangle Park, NC; 2005 May.
2. GlaxoSmithKline. Avodart (dutasteride) soft gelatin capsules patient information. Research Triangle Park, NC; Undated. Available at: . Accessed 2006 Aug 15.
3. Roehrborn CG, Boyle P, Nickel JC et al. Efficacy and safety of a dual inhibitor of 5-alpha-reductase types 1 and 2 (dutasteride) in men with benign prostatic hyperplasia. Urology. 2002 60:434-41.
4. Dull P, Reagan RW, Bahnson RR. Managing benign prostatic hyperplasia. Am Fam Physician. 2002; 66:77-84, 87-8. [IDIS 483339] [PubMed 12126034]
5. Roehrborn CG, McConnell JD, Lieber M et al. Serum prostate-specific antigen concentration is a powerful predictor of acute urinary retenion and need for surgery in men with clinical benign prostatic hyperplasia. PLESS study group. Urology. 1999; 53:473-80. [PubMed 10096369]
6. Potts JM. Prospective identification of National Institutes of Health category IV prostatitis in men with elevated prostate specific antigen. J Urol. 2000; 164:1550-3. [IDIS 455479] [PubMed 11025702]
7. de la Rossette JJ, Alivizatos G, Madersbacher S et al. EAU guidelines on benign prostatic hyperplasia (BPH). Eur Urol. 2001; 40:256-63. [PubMed 11684840]
8. Agency for Health Care Policy and Research. Benign prostatic hyperplasia: diagnosis and treatment. J Am Geriatric Soc. 1998; 46:1163-5.
9. Anon. Dutasteride (avodart) for benign prostatic hyperplasia. Med Lett Drugs Ther. 2002; 44:109-10. [PubMed 12500154]
10. GlaxoSmithKline. Research Triangle Park, NC: Personal communication.
11. American Urological Association. Guideline on the management of benign prostatic hyperplasia (BPH)(2003/updated 2006). Available at: . Accessed 2006 Aug 10.
Mar Plus may be available in the countries listed below.
Dexpanthenol is reported as an ingredient of Mar Plus in the following countries:
International Drug Name Search
In the US, Opana (oxymorphone systemic) is a member of the drug class narcotic analgesics and is used to treat Labor Pain and Pain.
US matches:
Oxymorphone hydrochloride (a derivative of Oxymorphone) is reported as an ingredient of Opana in the following countries:
International Drug Name Search
Atropine Methobromide may be available in the countries listed below.
Atropine Methobromide (BAN, JAN) is known as Atropine in the US.
International Drug Name Search
Glossary
| BAN | British Approved Name |
| JAN | Japanese Accepted Name |
Lorazépam Mylan may be available in the countries listed below.
Lorazepam is reported as an ingredient of Lorazépam Mylan in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Robamox V in the following countries:
International Drug Name Search
Domperidon Mylan may be available in the countries listed below.
Domperidone maleate (a derivative of Domperidone) is reported as an ingredient of Domperidon Mylan in the following countries:
International Drug Name Search
Colipate may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Colistin sulfate (a derivative of Colistin) is reported as an ingredient of Colipate in the following countries:
International Drug Name Search
