Avodart
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
AVODART® (dutasteride) Soft Gelatin Capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
- improve symptoms,
- reduce the risk of acute urinary retention (AUR), and
- reduce the risk of the need for BPH-related surgery.
AVODART in combination with the alpha adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate.
AVODART is not approved for the prevention of prostate cancer.
History
There is currently no drug history available for this drug.
Other Information
AVODART is a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT.
Dutasteride is chemically designated as (5α,17β)-N-{2,5 bis(trifluoromethyl)phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide. The empirical formula of dutasteride is C27H30F6N2O2, representing a molecular weight of 528.5 with the following structural formula:
Dutasteride is a white to pale yellow powder with a melting point of 242° to 250°C. It is soluble in ethanol (44 mg/mL), methanol (64 mg/mL), and polyethylene glycol 400 (3 mg/mL), but it is insoluble in water.
Each AVODART Soft Gelatin Capsule, administered orally, contains 0.5 mg of dutasteride dissolved in a mixture of mono-di-glycerides of caprylic/capric acid and butylated hydroxytoluene. The inactive excipients in the capsule shell are ferric oxide (yellow), gelatin (from certified BSE-free bovine sources), glycerin, and titanium dioxide. The soft gelatin capsules are printed with edible red ink.
Sources
Avodart Manufacturers
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Physicians Total Care, Inc.
![Avodart (Dutasteride) Capsule, Liquid Filled [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Avodart | Physicians Total Care, Inc.
The capsules should be swallowed whole and not chewed or opened, as contact with the capsule contents may result in irritation of the oropharyngeal mucosa. AVODART may be administered with or without food.
2.1 MonotherapyThe recommended dose of AVODART is 1 capsule (0.5 mg) taken once daily.
2.2 Combination With Alpha Adrenergic AntagonistThe recommended dose of AVODART is 1 capsule (0.5 mg) taken once daily and tamsulosin 0.4 mg taken once daily.
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Lake Erie Medical & Surgcial Supply Dba Quality Care Products Llc
Avodart | Lake Erie Medical & Surgcial Supply Dba Quality Care Products Llc
The capsules should be swallowed whole and not chewed or opened, as contact with the capsule contents may result in irritation of the oropharyngeal mucosa. AVODART may be administered with or without food.
2.1 MonotherapyThe recommended dose of AVODART is 1 capsule (0.5 mg) taken once daily.
2.2 Combination With Alpha Adrenergic AntagonistThe recommended dose of AVODART is 1 capsule (0.5 mg) taken once daily and tamsulosin 0.4 mg taken once daily.
-
Glaxosmithkline Llc
Avodart | Glaxosmithkline Llc
The capsules should be swallowed whole and not chewed or opened, as contact with the capsule contents may result in irritation of the oropharyngeal mucosa. AVODART may be administered with or without food.
2.1 MonotherapyThe recommended dose of AVODART is 1 capsule (0.5 mg) taken once daily.
2.2 Combination with Alpha-adrenergic AntagonistThe recommended dose of AVODART is 1 capsule (0.5 mg) taken once daily and tamsulosin 0.4 mg taken once daily.
![Avodart (Dutasteride) Capsule, Liquid Filled [Lake Erie Medical & Surgcial Supply Dba Quality Care Products Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=647540fc-bef5-4aa3-be4c-6b30655f366c&name=Avodart05mgCatalent.jpg)
![Avodart (Dutasteride) Capsule, Liquid Filled [Glaxosmithkline Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=dc330e70-a1d3-400b-3aaf-46067e3fd090&name=7065c13c-25db-4b15-80d6-5fbb30dfeb0f-09.jpg)
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