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The sections below will provide you with more specific information and guidelines related to finasteride and its correct use. Please read them carefully.

FDA Information

Finasteride was approved initially by the US Food and Drug Administration (FDA) in 1992 as Proscar®, a treatment for prostate enlargement, but the sponsor – Merck & Co. – demonstrated in further clinical studied that using 1 mg of finasteride was effective in treating hair growth in male pattern hair loss. As a result, in December 22nd 1997, the FDA approved finasteride (Propecia®) to treat male pattern hair loss.

On June 19th 2006, Merck’s patents on Proscar® and Propecia® expired and the FDA approved a first-time generic formulation for finasteride 5 mg tablets. As a result, Cipla is also manufacturing finasteride (under the brand names Fincar® and Finpecia®), as is Dr. Reddy’s (Finax® and Finast®), Ranbaxy (Finara®), and  Aleppo Pharmaceuticals (Prosteride®).

Please visit the official site of the FDA for further information.

Why is this medication prescribed?

BENIGN PROSTATIC HYPERTROPHY

Finasteride is used alone or in combination with other medications to treat benign prostatic hypertrophy (BPH, enlargement of the prostate gland). The prostate is a part of the male reproductive system that produces a milky fluid for sperm. Over the age of 50, many men develop an enlarged prostate and as the prostate gets bigger it can restrict the flow of urine. Finasteride can help to improve the symptoms caused by BPH, including:

→ a weak or interrupted urine flow
→ a feeling that the bladder is not completely empty
→ a need to pass urine more often (especially at night)
→ an urgent feeling that you must pass urine right away
→ a delay or hesitation when you start to urinate

It also may decrease the chance of needing prostate surgery.

TREATMENT FOR HAIR LOSS

Finasteride is also used for the treatment of certain types of male pattern hair loss, and has a reported 29–68% success rate (against a 17-45% in patients receiving a placebo). However, it is effective only for as long as it is taken, and the hair gained or maintained is lost within 6-12 months of ceasing therapy.

In clinical studies, Propecia®, like minoxidil, was shown to work on both the crown area and the hairline, but is most successful in the crown area. Furthermore, Propecia® has been shown to be ineffective for treating hair loss in women. Despite this, many Propecia® supporters questioned that the study was on post-menopausal women whose hairloss was more likely related to the loss of estrogen versus a sensitivity to testosterone. Other studies have shown that Propecia® is effective for many women with follicular sensitivity to androgens. Many doctors do prescribe it for women, but not without either careful birth control measures or assurance that the woman cannot become pregnant.

Despite the fact that Propecia® must be taken for a lifetime in order to avoid losing hair, future treatments are widely expected by baldness specialists to replace this medication, which would end the need for continued use. In addition, Propecia® is widely considered safe enough to prescribe by health professionals, and is one of the only two FDA-approved baldness treatment products currently on the market.

Other uses for this medicine

This medication has not been prescribed for the treatment of any other symptoms, other than those mentioned in the previous sections.

We strongly recommend that before taking this medication you consult your doctor or pharmacist about the possible risks of using finasteride for your particular condition.

Dosage and using this medicine

Finasteride comes as an orally-administered tablet. The usual prescribed dosage is 5 mg per day for the treatment of BPH, and 1 mg daily for pattern hair loss.

Each dose should be taken with a full glass of water, either with or without food.

Take finasteride at around the same time every day. It is important that you follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. If you require further information, please ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

Continue to take finasteride even if you see rapid improvements, and do not stop taking it without first consulting your doctor. This medication can only work over the long term if you continue taking it, and if you stop taking it you will likely lose any hair you have gained within 12 months of stopping the treatment.

Furthermore, some patients needed to take Propecia® daily for 3 months or more before they began seeing its results. If this medication has not worked for you within 12 months, further treatment is unlikely to be of benefit.

It is very important that you do not take more or less of it or take it more often than prescribed by your doctor. This can cause serious side effects.

Special Notice:

In March 2003, a UC Berkley Wellness letter expressed concern about the unproven long-term safety of Propecia® and recommended cutting a standard 1 milligram dose of this medication into quarters to reduce the cost without reducing its effectiveness. This claim appears to be supported by clinical pharmacological data reviewed by the FDA during Propecia®‘s approval process that suggested that the advantage of taking 1 mg per day over 0.2 mg per day is statisticially small. Some people have unsuccessfully petitioned the FDA to re-examine the approved dosage in light of the statistical evidence and unknown long-term risks. Further to this, the FDA responded and stated that despite the level of DHT found in the scalp was not signifigantly different does not mean there is a correlation with hair loss. A study would have to show that the benefits of using 0.2 mg and 1 mg were not statistically different, and according to the FDA such a study has been performed and a 1 mg dose has a greater benefit.

What special precautions should I follow?

As with any prescription or OTC (over the counter) medications, there are important precautions needed before taking finasteride. Please inform your doctor or pharmacist if you have any of the following conditions:

• an unusual or allergic reaction to finasteride, other medicines, foods, dyes, or preservatives
• kidney disease or infection
• liver disease
• prostate cancer
• blockage of urine flow

Moreover, please inform your doctor and pharmacist any other prescription and non-prescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

You should also know that finasteride is only for use in men. If taken by pregnant women, finasteride can cause abnormalities in the male fetus. Women who are or may be pregnant should not touch broken or crushed finasteride tablets.

This medication is for the treatment of benign prostatic hyperplasia and pattern hair loss in MEN ONLY and should NOT be used by women or children.

Women who are or may potentially be pregnant must not use finasteride and should not handle crushed or broken finasteride tablets because the active ingredient may cause abnormalities of a male baby’s sex organs. If a woman who is pregnant comes into contact with the active ingredient in finasteride, then a doctor should be consulted.

Furthermore, do not donate blood until at least 6 months after your final dose of finasteride. This will prevent giving finasteride to a pregnant female through a blood transfusion.

Additionally, finasteride can interfere with PSA laboratory tests for prostate cancer. If you are scheduled to have a lab test for prostate cancer, tell your prescriber or health care professional that you are taking finasteride.

Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works.

What should I do if I forget a dose?

If you miss a finasteride dose, take it as soon as you remember. However, if you do not remember until the next day and it is time for your next scheduled daily dose, then only take that day’s dose.

It is very important that you do not take double or extra doses to make up for a missed one. This medication will not work faster or more effectively if you take it more than once a day.

What side effects can this medication cause?

Like all prescription products, finasteride may cause side effects. In clinical studies, side effects from finasteride were uncommon and did not affect most men. However, a small number of men experienced certain sexual side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• a decreased libido (less desire for sex)
• impotence (difficulty in achieving or maintaining an erection)
• a decreased volume in the amount of semen

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• changes in the breasts such as lumps, pain, or nipple discharge
• an allergic reactions (including rash, itching, hives and swelling of the lips and face)
• testicular pain

Additionally, finasteride is not indicated for use in women. This medication also falls into the FDA pregnancy category X, which means that it is known to cause birth defects in an unborn baby. Despite this, women who are or who may become pregnant must not handle crushed or broken finasteride tablets, for the medication could be absorbed through the skin. Finasteride is known to cause birth defects in a developing male baby. Exposure to whole tablets should be avoided whenever possible, however exposure to whole tablets is not expected to be harmful as long as the tablets are not swallowed.

Moreover, it is not known whether finasteride passes into breast milk, and thus should not be taken by breastfeeding mothers. However, it appears that finasteride can pass into the semen of men, thus, at certain dosages, caution should be used to avoid ingestion of semen during oral sex if a woman is pregnant or may become pregnant.

Finasteride can also be used to mask steroid abuse, and many professional sports have banned finasteride use for this reason.

If you experience any other serious side effect not mentioned above, you or your doctor may send a report to the FDA’s MedWatch Adverse Event Reporting program online (at http://www.fda.gov/MedWatch/report.htm) or by calling 1-800-332-1088.

What storage conditions are needed for this medicine?

Keep finasteride in the original container it came in, tightly closed, and out of reach of children.

Store in dry place at room temperature between 15 and 30 degrees C (59 and 86 degrees F), and away from excess heat and moisture (not in the bathroom). Protect from light. Finasteride tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed.

Remember to throw away any unused or outdated medication. If you have any questions, please talk to your pharmacist about the proper disposal of your medication.

In case of an emergency/overdose

In the case of a suspected overdose whilst using finasteride, call your local poison control center on 1-800-222-1222.

However, if the victim has collapsed or is not breathing, please call the local emergency services immediately on 911.


Source: http://finasteride.com/


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