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P - Cautioned in pregnancy
L - Contraindicated in lactation
FI - Food *
LI - Lab *
Finasteride is a synthetic antiandrogen that acts by inhibiting type II 5-alpha reductase, the enzyme that converts testosterone to dihydrotestosterone (DHT). It is used as a treatment in benign prostatic hyperplasia (BPH) in low doses, and prostate cancer in higher doses. A May, 2008 study indicates that finasteride reduces the rate of prostate cancer by 30%. It is also indicated for use in combination with doxazosin therapy to reduce the risk for symptomatic progression of BPH. In addition, it is registered in many countries for androgenetic alopecia (male-pattern baldness).
Finasteride was approved initially in 1992 as Proscar, a treatment for enlarged prostate, but the sponsor had studied 1 mg of finasteride and demonstrated hair growth in male pattern hair loss. Merck sells it under the brand name Propecia.
Health organisations and practising clinicians have expressed concerns that Propecia gives rise to persistent side-effects in some men.
Finasteride is a competitive inhibitor of the enzyme 5-α reductase which converts testosterone to dihydrotestosterone (DHT), thus resulting in decreased serum levels of DHT.
Absorbed from the GI tract (oral); peak plasma concentrations after 1-2 hours.
Urine and faeces (as metabolites); <60 yr: 6 hr; >70 year: 8 hours (elimination half-life).
Information Not Available
Gynaecomastia, decreased libido, impotence, reduction in the volume of ejaculate, testicular pain. Hypersensitivity reactions e.g. swelling of lips and face, urticaria, rashes.
Prior to initiating therapy with Finasteride 5 mg tablets, appropriate evaluation should be performed to identify other conditions such as infection, prostate cancer, stricture disease, hypotonic bladder or other neurogenic disorders that might mimic BPH.
Patients with large residual urinary volume and/or severely diminished urinary flow should be carefully monitored for obstructive uropathy. These patients may not be candidates for Finasteride therapy.
Caution should be used in the administration of Finasteride 5 mg tablets in those patients with liver function abnormalities, as Finasteride is metabolized extensively in the liver.
Undiagnosed prostate cancer, liver dysfunction, obstructive uropathy.
None well documented
Food may delay the rate and reduce the extent of oral absorption
Benign prostatic hyperplasia
Adult: 5 mg once daily for ≥6 mth, if necessary.
Male pattern baldness
Adult: 1 mg once daily.
May be taken with or without food
Contraindicated in pregnancy.
Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
Contraindicated in lactation
Safety and efficacy not established
No dosage adjustment is necessary in the elderly.
Children, exposure of pregnant women to finasteride either via direct contact with crushed tab or through semen of male sexual partners who are taking finasteride; pregnancy, lactation.
Store at 15-30°C.
Store at 15-30°C.