Product Description:

• Finasteride is a prescription medicine used in men for Male pattern hair loss (androgenetic alopecia): 1 mg tablets help improve hair growth and count by reducing levels of DHT (dihydrotestosterone), the hormone responsible for hair thinning.


• Benign prostatic hyperplasia (BPH): 5 mg tablets shrink an enlarged prostate, improve urinary symptoms, and may delay surgery.


• It works by blocking 5α-reductase, the enzyme that converts testosterone to DHT.


• FDA approvals:


• Proscar (5 mg) – for BPH, approved June 19, 1992


• Propecia (1 mg) – for hair loss, approved Dec 19, 1997


• Both are now available as generics.


• Topical finasteride 0.25% has shown similar hair growth benefits in trials but is not FDA-approved.

Finasteride Side Effects:

Common Finasteride Side Effects

• Common side effects of finasteride 1mg tablets include a decreased interest in sex, erectile dysfunction, and ejaculation disorder. These side effects occurred in 1% or more of patients taking finasteride and greater than the patients treated with placebo in clinical trials.


• Common side effects of finasteride 5 mg tablets may include a failure to have or maintain an erection (impotence), decreased interest in sex, decreased volume of ejaculate, breast enlargement, breast tenderness, and rash. These side effects occurred in 1% or more of patients taking finasteride and greater than the patients treated with placebo in clinical trials.


• The sexual side effects of finasteride may continue after you stop taking this medicine. Talk to your doctor if you have concerns about these side effects.

Serious Finasteride Side Effects

• Get emergency medical help if you have signs of an allergic reaction, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.


• Call your doctor at once if you notice any signs of male breast cancer, such as:


• breast pain or lumps


• nipple discharge; or


• any other breast changes.


• Tell your doctor right away if you have:


• blood in your semen


• pain in your testicles or


• depression.


• It may be harder for you to get a woman pregnant while you are using finasteride.

Dosage:

• Adult Finasteride Dose for Male Pattern Hair Loss:


• Usual dose: 1 mg tablet orally once a day.


• Daily use for 3 months or more is needed before a benefit can be seen. Continued use is recommended to sustain benefits.


• Withdrawal of treatment leads to reversal of effect within 12 months.


• Use: For treatment of male pattern hair loss (androgenetic alopecia) in men only. The safety and efficacy have been demonstrated in men between 18 to 41 years of age with mild to moderate hair loss of the vertex and anterior mid-scalp area.


• Adult Finasteride Dose for Benign Prostatic Hyperplasia:


• Usual dose: 5 mg tablet orally once a day (usual dose)


• Comments:


• Dosing is the same both in monotherapy and in combination therapy.

Warnings:

• Finasteride should never be taken by a woman or a child.


• Finasteride can be absorbed through the skin. Finasteride can cause birth defects if a woman is exposed to it during pregnancy. The tablets should not be handled by a woman who is pregnant or who may become pregnant.


• Using this medicine may increase your risk of developing prostate cancer. Your doctor will perform tests to make sure you do not have other conditions that would prevent you from safely using this medicine.


• Call your doctor at once if you notice any breast lumps, pain, nipple discharge, or other breast changes. These may be signs of male breast cancer.

How should I take finasteride?

• Take a tablet with a full glass of water once a day at the same time each day.


• It may be taken with or without meals.


• Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.


• You may not fully benefit from this medicine for up to 3 months or longer. Use finasteride regularly for the best results.


• Your doctor will need to check your progress on a regular basis.


• For benign prostatic hyperplasia, you will need frequent prostate specific antigen (PSA) tests to check for prostate cancer.


• Tell your doctor if you stop taking finasteride on a regular basis because this could affect your PSA test results.


• Store this medicine at room temperature, away from moisture, heat, and light. When not in use, keep the tablets in the original container, tightly closed.