INDICATIONS
Monotherapy
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.
Combination With Alpha-adrenergic Antagonist
AVODART in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate.
Limitations Of Use
AVODART is not approved for the prevention of prostate cancer.
DOSAGE AND ADMINISTRATION
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.
Monotherapy
The recommended dose of AVODART is 1 capsule (0.5 mg) taken once daily.
Combination With Alpha-adrenergic Antagonist
The recommended dose of AVODART is 1 capsule (0.5 mg) taken once daily and tamsulosin 0.4 mg taken once daily.
OVERDOSE
In volunteer trials, single doses of dutasteride up to 40 mg (80 times the therapeutic dose) for 7 days have been administered without significant safety concerns. In a clinical trial, daily doses of 5 mg (10 times the therapeutic dose) were administered to 60 subjects for 6 months with no additional adverse effects to those seen at therapeutic doses of 0.5 mg.
There is no specific antidote for dutasteride. Therefore, in cases of suspected overdosage, symptomatic and supportive treatment should be given as appropriate, taking the long half-life of dutasteride into consideration.
CONTRAINDICATIONS
AVODART is contraindicated for use in:
- Pregnancy. Dutasteride use is contraindicated in women who are pregnant. In animal reproduction and developmental toxicity studies, dutasteride inhibited development of male fetus external genitalia. Therefore, AVODART may cause fetal harm when administered to a pregnant woman [see WARNINGS AND PRECAUTIONS, Use In Specific Populations].
- Patients with previously demonstrated clinically significant hypersensitivity (e.g., serious skin reactions, angioedema) to AVODART or other 5 alpha-reductase inhibitors [see ADVERSE REACTIONS].
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