Propecia is a prescription medicine used to treat the symptoms of benign prostatic hyperplasia (BPH), male pattern hair loss (androgenic alopecia). Propecia may be used alone or with other medications.

Indications and Usage

Propecia prevents the conversion of testosterone to dihydrotestosterone (DHT) in the body. Propecia is used for the treatment of male pattern hair loss on the vertex and the anterior mid-scalp area. Male pattern hair loss is a common condition in which men experience thinning of the hair on the scalp. Often, this results in a receding hairline and/or balding on the top of the head. Propecia is for use by men only and should not be used by women or children. Propecia (finasteride) tablets are film-coated tablets for oral administration. Each tablet contains 1 mg of finasteride and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, magnesium stearate, talc, docusate sodium, yellow ferric oxide, and red ferric oxide.

Dosage and Administration

Take Propecia exactly as prescribed by your doctor. The recommended dose of Propecia is one tablet (1 mg) taken once daily. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label. Take this medicine with a full glass of water. Propecia can be taken with or without food. Take the medicine at the same time each day. It is important to use Propecia regularly to get the most benefit. You may need to take Propecia daily for three months or more before you see a benefit. Propecia can only work over the long term if you continue taking it. If the drug has not worked for you in twelve months, further treatment is unlikely to be of benefit. If you stop taking Propecia, you will likely lose the hair you have gained within 12 months of stopping treatment. You should discuss this with your doctor. To be sure this medication is helping your condition and not causing harmful effects, your blood may need to be tested often. Your doctor will also test your prostate specific antigen (PSA) to check for prostate cancer. Visit your doctor regularly. Store Propecia at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Warnings and Precautions

Propecia is not indicated for use in women. Women should not handle crushed or broken Propecia tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. Propecia tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed.

Contraindications

The following conditions are contraindicated with this drug. Check with your physician if you have any of the following:

Conditions:

• breast cancer in a male patient
• suicidal thoughts
• liver problems
• pregnancy
• a mother who is producing milk and breastfeeding
• high-grade prostate cancer

What are the side effects?

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Chills
• cold sweats
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

Less common

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• breast enlargement and tenderness
• hives or welts, itching, skin rash
• rapid weight gain
• redness of the skin
• swelling of the lips and face
• tingling of the hands or feet
• unusual weight gain or loss

Incidence not known

• Clear or bloody discharge from the nipple
• dimpling of the breast skin
• inverted nipple
• lump in the breast or under the arm
• persistent crusting or scaling of the nipple
• redness or swelling of the breast
• sore on the skin of the breast that does not heal

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Decreased interest in sexual intercourse
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance

Less common

• Runny or stuffy nose
• sleepiness or unusual drowsiness
• sneezing

Less common or rare

• Back pain
• decreased amount of semen
• diarrhea
• dizziness
• headache
• stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.