Archive for January, 2008

Propecia: Information to Be Provided to the Patients

Monday, January 28th, 2008

Patients should be advised that: finasteride is to be used by men only and should be taken daily as prescribed.

In general, daily use for 3 months or more is necessary before hair growth is increased and/or further hair loss is prevented.

The clinical benefits of finasteride can only be maintained with continuous use of finasteride.

A small number of men may experience less desire to have sex and/or difficulty in achieving an erection. In clinical studies, these side effects disappeared in men who stopped taking finasteride and in most men who continued treatment.

If the patient experiences sustained impairment in sexual function or any other unintended effect, the patient should be advised to consult with the prescribing physician regarding continuation of the medication.

As with all other medications, it is important that any other treating physician(s) be aware of the patient’s use of finasteride.

Women who are or may potentially be pregnant must not use finasteride. They should not handle crushed or broken tablets of finasteride.

Generic Propecia: Drug Interactions

Wednesday, January 16th, 2008

No drug interactions of clinical importance have been identified. Finasteride does not appear to affect significantly the cytochrome P450-linked drug metabolizing enzyme system. Compounds which have been tested in man have included antipyrine, digoxin, glyburide, propranolol, theophylline and warfarin, and no interactions were found. However, patients on medication with narrow therapeutic indices, such as phenytoin, should be carefully monitored when treatment with finasteride is initiated.

Other Concomitant Therapy: Although specific interaction studies were not performed, in clinical studies finasteride doses of 1 mg or more were used concomitantly with ACE inhibitors, acetaminophen, alpha blockers, benzodiazepines, beta blockers, calcium-channel blockers, cardiac nitrates, diuretics, H 2 antagonists, HMG-CoA reductase inhibitors, prostaglandin synthetase inhibitors (NSAIDs), and quinolones, without evidence of clinically significant adverse interactions.

Drug/Laboratory Test Interactions : In clinical studies with finasteride in men 18 to 41 years of age, the mean value of serum prostate-specific antigen (PSA) decreased from 0.7 ng/mL at baseline to 0.5 ng/mL at month 12. When fina-steride is used in older men who have benign prostatic hyperplasia (BPH), PSA levels are decreased by approximately 50%. Until further information is gathered in men >41 years of age without BPH, consideration should be given to doubling the PSA level in men undergoing this test while taking finasteride.

Warnings: Pregnancy and Lactation

Tuesday, January 8th, 2008

Finasteride is not indicated for use in women. Women should not handle crushed or broken finasteride tablets when they are or may potentially be pregnant (see Contraindications). Because of the ability of Type II 5 alpha-reductase inhibitors such as finasteride to inhibit conversion of testosterone to dihydrotestosterone, finasteride may cause abnormalities of the external genitalia of a male fetus when administered to a pregnant woman. It is not known whether finasteride is excreted in human milk.