Mandatory Propecia® and Rogaine®
PROPECIA®
Is for use by MEN ONLY and should NOT be used by women or children.
Read this Patient Information before you start taking PROPECIA® and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
What is PROPECIA®?
PROPECIA® is a prescription medicine used for the treatment of male pattern hair loss (androgenetic alopecia).
It is not known if PROPECIA® works for a receding hairline on either side of and above your forehead (temporal area).
PROPECIA® is not for use by women and children.
Who should not take PROPECIA®?
Do not take PROPECIA® if you:
• are pregnant or may become pregnant. PROPECIA® may harm your unborn baby. PROPECIA® tablets are coated and will prevent contact with the medicine during handling, as long as the tablets are not broken or crushed. Females who are pregnant or who may become pregnant should not come in contact with broken or crushed PROPECIA® tablets. If a pregnant woman comes in contact with crushed or broken PROPECIA® tablets, wash the contact area right away with soap and water. If a woman who is pregnant comes into contact with the active ingredient in PROPECIA®, a healthcare provider should be consulted.
o If a woman who is pregnant with a male baby swallows or comes in contact with the medicine in PROPECIA®, the male baby may be born with sex organs that are not normal.
• are allergic to any of the ingredients in PROPECIA®. See the end of this leaflet for a complete list of ingredients in PROPECIA®.
What should I tell my healthcare provider before taking PROPECIA®?
Before taking PROPECIA®, tell your healthcare provider if you:
• have any other medical conditions, including problems with your prostate or liver
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take PROPECIA®?
• Take PROPECIA® exactly as your healthcare provider tells you to take it.
• You may take PROPECIA® with or without food.
• If you forget to take PROPECIA® do not take an extra tablet. Just take the next tablet as usual.
PROPECIA will not work faster or better if you take it more than once a day.
What are the possible side effects of PROPECIA®?
• decrease in your blood Prostate Specific Antigen (PSA) levels. PROPECIA® can affect a blood test called PSA (Prostate-Specific Antigen) for the screening of prostate cancer. If you have a PSA test done you should tell your healthcare provider that you are taking PROPECIA® because PROPECIA® decreases PSA levels. Changes in PSA levels will need to be evaluated by your healthcare provider. Any increase in follow-up PSA levels from their lowest point may signal the presence of prostate cancer and should be evaluated, even if the test results are still within the normal range for men not taking PROPECIA. You should also tell your healthcare provider if you have not been taking PROPECIA® as prescribed because this may affect the PSA test results. For more information, talk to your healthcare provider.
• There may be an increased risk of a more serious form of prostate cancer in men taking finasteride at 5 times the dose of PROPECIA®.
The most common side effects of PROPECIA® include:
• decrease in sex drive
• trouble getting or keeping an erection
• a decrease in the amount of semen
The following have been reported in general use with PROPECIA®:
• breast tenderness and enlargement. Tell your healthcare provider about any changes in your breasts such as lumps, pain or nipple discharge.
• depression;
• decrease in sex drive that continued after stopping the medication;
• allergic reactions including rash, itching, hives and swelling of the lips, tongue, throat, and face;
• problems with ejaculation that continued after stopping medication;
• testicular pain;
• difficulty in achieving an erection that continued after stopping the medication;
• male infertility and/or poor quality of semen.
• in rare cases, male breast cancer.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of PROPECIA®. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects.
How should I store PROPECIA®?
• Store PROPECIA® at room temperature between 59˚F to 86˚F (15˚C to 30˚C).
• Keep PROPECIA® in a closed container and keep PROPECIA tablets dry (protect from moisture).
Keep PROPECIA and all medicines out of the reach of children.
General information about the safe and effective use of PROPECIA®.
Medicines are sometimes prescribed for purposes other than those listed in this Patient Information leaflet. Do not use PROPECIA for a condition for which it was not prescribed. Do not give PROPECIA® to other people, even if they have the same symptoms you have. It may harm them.
This Patient Information leaflet summarizes the most important information about PROPECIA. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about PROPECIA® that is written for health professionals.
What are the ingredients in PROPECIA®?
Active ingredient: finasteride.
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.
This Patient Information has been approved by the U.S. Food and Drug Administration.
ROGAINE®
Minoxidil is an antihypertensive vasodilator medication and is used to treat hair loss. It is available as a generic medication and over the counter for the treatment of androgenic alopecia, a form of hair loss, in men and women.
Medical Uses
Minoxidil, applied topically, is widely used for the treatment of hair loss. It is effective in helping promote hair growth in both men and women with androgenic alopecia.[5] About 40% of men experience hair regrowth after 3–6 months.[6] Minoxidil must be used indefinitely for continued support of existing hair follicles and the maintenance of any experienced hair regrowth.[4]. Its effect in people with alopecia areata is unclear
Adverse Effects
Minoxidil is generally well tolerated, but common side effects include burning or irritation of the eye, itching, redness or irritation at the treated area, and unwanted hair growth elsewhere on the body. Exacerbation of hair loss/alopecia has been reported.[8][9] Severe allergic reactions may include rash, hives, itching, difficulty breathing, tightness in the chest, swelling of the mouth, face, lips, or tongue, chest pain, dizziness, fainting, tachycardia, headache, sudden and unexplained weight gain, or swelling of the hands and feet.[10] Temporary hair loss is a common side effect of minoxidil treatment.[11] Manufacturers note that minoxidil-induced hair loss is a common side effect and describe the process as "shedding".
Alcohol and propylene glycol present in some topical preparations may dry the scalp, resulting in dandruff and contact dermatitis.[12]Side effects of oral minoxidil may include swelling of the face and extremities, rapid and irregular heartbeat, lightheadedness, cardiac lesions, and focal necrosis of the papillary muscle and subendocardial areas of the left ventricle.[9] Cases of allergic reactions to minoxidil or the non-active ingredient propylene glycol, which is found in some topical minoxidil formulations, have been reported. Pseudoacromegaly is an extremely rare side effect reported with large doses of oral minoxidil.[13]Minoxidil may cause hirsutism, although is is exceedingly rare and reversible by discontinuation of the drug
Initial Application
Minoxidil was developed in the late 1950s by the Upjohn Company (later became part of Pfizer) to treat ulcers. In trials using dogs, the compound did not cure ulcers, but proved to be a powerful vasodilator. Upjohn synthesized over 200 variations of the compound, including the one it developed in 1963 and named minoxidil.[21] These studies resulted in FDA approving minoxidil (with the trade name 'Loniten') in the form of oral tablets to treat high blood pressure in 1979.[22]
Hair Growth
When Upjohn received permission from the FDA to test the new drug as medicine for hypertension they approached Charles A. Chidsey MD, Associate Professor of Medicine at the University of Colorado School of Medicine.[21] He conducted two studies,[23][24] the second study showing unexpected hair growth. Puzzled by this side-effect, Chidsey consulted Guinter Kahn and discussed the possibility of using minoxidil for treating hair loss.Kahn along with his colleague Paul J. Grant MD obtained a certain amount of the drug and conducted their own research, apparently without notifying Upjohn or Chidsey.[25] The two doctors had been experimenting with a 1% solution of minoxidil mixed with several alcohol-based liquids.[26] They tried to patent the drug for hair loss prevention, but found that Upjohn had already done this. A decade-long trial between Kahn and Upjohn ended with Kahn's name included in a consolidated patent (U.S. #4,596,812 Charles A Chidsey, III and Guinter Kahn) in 1986 and royalties from the company to both Kahn and Grant.[25]Meanwhile the effect of minoxidil on hair loss prevention was so clear that in the 1980s physicians were prescribing Loniten off-label to their balding patients.[22]
In August, 1988, the FDA finally approved the drug for treating baldness in men[22][26] under the trade name 'Rogaine' (FDA rejected Upjohn's first choice, Regain, as misleading[27]). The agency concluded that although "the product will not work for everyone", 39% of the men studied had "moderate to dense hair growth on the crown of the head".[27]
In 1991, Upjohn made the product available for women.[26]
On February 12, 1996, the FDA approved both the over-the-counter sale of the drug and the production of generic formulations of minoxidil.[22] Upjohn replied to that by lowering prices to half the price of the prescription drug[26] and by releasing a prescription 5% formula of Rogaine in 1997.[22]
In 1998, a 5% formulation of minoxidil was approved for nonprescription sale by the FDA.[28]
As of 2014, it was the only topical product that is FDA-approved for androgenic hair loss.[5]
The drug is available over the counter in the United Kingdom[4] and Germany.
