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Rogaine ® - Minoxidil
FDA Approves Rogaine ® to Treat Male Pattern Hair Loss in Men
Minoxidil is the active ingredients (pronounced - mi-NOX-i-dil).
Rogaine ® is the brand name.
* Approved by the Food and Drug Administration (FDA) to treat pattern baldness or hair loss, for regrowing hair, a topical solution, which is rubbed into the scalp.
* Topical Rogaine ® has been shown to stimulate hair growth on the bald spot of the back of the head in men. In women, Rogaine ® can increase hair growth in the forehead areas.
* Minoxidil is in a class of drugs called hair growth stimulants.
* In 1990, it cost about $600 a year to use it twice a day. To be effective, minoxidil must be used twice a day. It works better on those who are younger and whose hair loss is recent, according to clinical studies by Pharmacia and Upjohn.
* Effective for only one third of patients.
* Studies show that 26 percent of men between 18 and 49 reported moderate to dense hair regrowth after four months of Rogaine ® treatment. An additional 33 percent had minimal hair regrowth. Almost 20 percent of women between 18 and 45 had moderate regrowth, while an additional 40 percent showed minimal regrowth. A company spokesman said the research accounted for the fully pigmented hair fibers normally seen on the scalp and not vellus hair, which is more like peach fuzz. Many doctors, however, say the number of their patients who have as much success is much lower, and some find that only vellus hair appears. "I have not been that impressed that it helps regrow hair," Kayne says. "I think that occurs in a very small minority."
* Rogaine ® works better in men who fit a certain profile: they've generally been bald for less than ten years, have bald spots on top of the head that are less than four inches in diameter, and they still have fine hairs in their balding areas.
* Rogaine ® treatment must be used for life or any regrown hair will fall out.
* Only those people losing hair on the crown, not in front, are candidates for regrowth.
* Originally approved for hereditary male-pattern baldness in 1988, it was also approved for treating female-pattern hair loss (hair loss or thinning on the scalp in the frontal areas) in August 1991. However, it should not be used by pregnant or nursing women.
* Minoxidil is also available in tablet form to treat severe high blood pressure. Oral minoxidil has a potential for serious side effects and is not approved to treat baldness.
DRUG CLASS AND MECHANISM:
AVAILABILITY: Over-the-counter without a prescription.
APPROXIMATE COST: $25 per month.
INDICATED FOR: Men and women.
DOSING: Rogaine ® has to be applied on the scalp at least twice daily and for at least four months to see results. Rogaine ® works less well in patients that are older, have larger areas of baldness, and have been bald for longer periods of time. Rogaine ® should be applied to a normal dry scalp only and left in place for at least four hours. Rogaine ® must be continued in order to maintain or increase the hair growth achieved. Exceeding the recommended dosage does not produce greater or faster hair growth and may cause increased side effects. You must use minoxidil for at least 4 months, and possibly for up to 1 year, before you see any effect.
DRUG INTERACTIONS: Oral minoxidil can cause a fall in blood pressure, an increase in the heart rate, and weight gain (fluid retention). An increase in the absorption of minoxidil from the scalp can occur in patients with inflamed or abnormal scalps, leading to side effects mentioned above. Patients with heart failure or significant coronary heart disease should avoid Rogaine ® because of these side effects. Rogaine's ® alcohol base can irritate the eyes. Rogaine ® should not be used with other topical medications because they may increase its absorption and side effects. Rogaine ® should be used with caution in those with high blood pressure.
PREGNANCY & NURSING MOTHERS: Rogaine ® should not be used in pregnancy or by nursing women.
SIDE EFFECTS: Skin side effects are seen at times with Rogaine ®, including irritation, itch, contact dermatitis, hives, swelling, and sensitivity. If you experience any of the following symptoms, call your doctor immediately: weight gain, swelling of the face, ankles, hands, or stomach, difficulty breathing (especially when lying down), rapid heartbeat, chest pain, lightheadedness. Minoxidil is highly toxic to cats. Possible side effects other than those listed may occur.
Rogaine ® is marketed by Pharmacia & Upjohn Company.
References:
U.S. Food and Drug Administration - FDA Consumer Magazine - December 1991 - www.cfsan.fda.gov
This summary is a general overview about the topic discussed and does not include all the facts, or include everything there is to know about any medicine and/or products mentioned. Do not use any medicine and/or products without first talking to your doctor. Possible side effects of medications, other than those listed, may occur. Full Disclaimer & General Safety Advisory