Benstat

Benstat

finasteride

Manufacturer:

Biolab

Distributor:

Biopharm
Full Prescribing Info
Contents
Finasteride.
Description
Each tablet contains Finasteride 5 mg.
Action
Finasteride competitively and specifically inhibits 5-alpha-reductase that metabolizes testosterone to dihydrotestosterone (DHT) in the prostate gland, liver and skin. Development of prostate gland is dependent on DHT. Finasteride has no affinity for the androgen receptor and the hypothalamic pituitary-testicular axis does not appear to be affected.
Indications/Uses
For treatment of symptomatic benign prostatic-hyperplasia (BPH). BENSTAT cause regression of the enlarged prostate, improve urinary flow and improve the symptoms associated with BPH.
Dosage/Direction for Use
5 mg once a day. At least six months of therapy may be required to assess clinical response.
No adjustment dosage is required in patients with varying degree of renal insufficiency or on the elderly.
BENSTAT is not indicated for use in women or children.
Contraindications
Patients with hypersensitivity to finasteride.
Pregnancy women who are or may become pregnant.
Special Precautions
Prostate cancer: It is recommended that before initiating therapy with BENSTAT and periodically thereafter, patients should be examined for prostatic cancer by digital rectal examination. Finasteride cause a decrease in serum PSA concentrations; therefore, reduction of serum PSA levels in patients with BPH treated with BENSTAT does not rule out concomitant prostate cancer.
Exposure to finasteride - risk to male fetus: Because of the potential risk of abnormal external genitalia development in male fetuses, a woman who is pregnant or who may become pregnant should not handle crushed finasteride tablets.
Use in Lactation: It is not known whether finasteride is excreted in breast milk. BENSTAT should not be use in nursing mothers.
Use In Pregnancy & Lactation
Use in Pregnancy: Exposure to finasteride - risk to male fetus: Because of the potential risk of abnormal external genitalia development in male fetuses, a woman who is pregnant or who may become pregnant should not handle crushed finasteride tablets.
Use in Lactation: It is not known whether finasteride is excreted in breast milk. BENSTAT should not be use in nursing mothers.
Adverse Reactions
Decreased libido, decreased volume of ejaculate and impotence.
Drug Interactions
No drug interactions of clinical importance have been identified.
Storage
Store at temperature not exceeding 30°C. Protect from light and moisture.
ATC Classification
G04CB01 - finasteride ; Belongs to the class of testosterone-5-alpha reductase inhibitors. Used in the treatment of benign prostatic hypertrophy.
Presentation/Packing
Tab 5 mg x 3 x 10's.
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