Minoxidil Tablets

Because of the potential for serious adverse effects, minoxidil (minoxidil (minoxidil (minoxidil tablets) tablets) tablets) tablets are indicated only in the treatment of hypertension that is symptomatic or associated with target organ damage and is not manageable with maximum therapeutic doses of a diuretic plus two other antihypertensive drugs. At the present time use in milder degrees of hypertension is not recommended because the benefit-risk relationship in such patients has not been defined. Minoxidil (minoxidil (minoxidil (minoxidil tablets) tablets) tablets) reduced supine diastolic blood pressure by 20 mm Hg or to 90 mm Hg or less in approximately 75% of patients, most of whom had hypertension that could not be controlled by other drugs.

Minoxidil (minoxidil (minoxidil (minoxidil tablets) tablets) tablets) Tablets USP 2.5 mg are 9/32", scored, round, white tablets imprinted "DAN 5642" and "2.5" supplied in bottles of 100 and 500.

Minoxidil (minoxidil (minoxidil (minoxidil tablets) tablets) tablets) Tablets USP 10 mg are 9/32", scored, round, white tablets imprinted "DAN 5643" and "10" supplied in bottles of 100 and 500.

Dispense in a tight container with child-resistant closure.

Store at controlled room temperature 15°-30°C (59°-86°F).

Watson Laboratories, Inc. Corona, CA 92880, USA. Revised: October 2002. FDA Rev date: 6/8/2001

1. Salt and Water Retention (see WARNINGS: Concomitant Use of an Adequate Diuretic is Required)-Temporary edema developed in 7% of patients who were not edematous at the start of therapy.
2. Pericarditis, Pericardial Effusion, and Tamponade (see WARNINGS).
3. Dermatologic-Hypertrichosis-Elongation, thickening, and enhanced pigmentation of fine body hair are seen in about 80% of patients taking minoxidil (minoxidil (minoxidil (minoxidil tablets) tablets) tablets) tablets. This develops within 3 to 6 weeks after starting therapy. It is usually first noticed on the temples, between the eyebrows, between the hairline and the eyebrows, or in the side-burn area of the upper lateral cheek, later extending to the back, arms, legs, and scalp. Upon discontinuation of minoxidil (minoxidil (minoxidil (minoxidil tablets) tablets) tablets) , new hair growth stops, but 1 to 6 months may be required for restoration to pretreatment appearance. No endocrine abnormalities have been found to explain the abnormal hair growth; thus, it is hypertrichosis without virilism. Hair growth is especially disturbing to children and women and such patients should be thoroughly informed about this effect before therapy with minoxidil (minoxidil (minoxidil (minoxidil tablets) tablets) tablets) is begun. Allergic-Rashes have been reported, including rare reports of bullous eruptions, and Stevens-Johnson Syndrome.
4. Hematologic-Thrombocytopenia and leukopenia (WBC < 3000/mm3) have rarely been reported.
5. Gastrointestinal-Nausea and/or vomiting has been reported. In clinical trials the incidence of nausea and vomiting associated with the underlying disease has shown a decrease from pretrial levels.
6. Miscellaneous-Breast tenderness-This developed in less than 1% of patients.
7. Altered Laboratory Findings-(a) ECG changes-Changes in direction and magnitude of the ECG T-waves occur in approximately 60% of patients treated with minoxidil (minoxidil (minoxidil (minoxidil tablets) tablets) tablets) . In rare instances a large negative amplitude of the T-wave may encroach upon the S-T segment, but the S-T segment is not independently altered. These changes usually disappear with continuance of treatment and revert to the pretreatment state if minoxidil (minoxidil (minoxidil (minoxidil tablets) tablets) tablets) is discontinued. No symptoms have been associated with these changes, nor have there been alterations in blood cell counts or in plasma enzymeconcentrations that would suggest myocardial damage. Long-term treatment of patients manifesting such changes has provided no evidence of deteriorating cardiac function. At present the changes appear to be nonspecific and without identifiable clinical significance. (b)-Effects of hemodilution-hematocrit, hemoglobin and erythrocyte count usually fall about 7% initially and then recover to pretreatment levels. (c) Other-Alkaline phosphatase increased varyingly without other evidence of liver or bone abnormality. Serum creatinine increased an average of 6% and BUN slightly more, but later declined to pretreatment levels.

Minoxidil tablets should not be used to promote scalp hair growth.

You should not use this medication if you are allergic to minoxidil, or if you have pheochromocytoma (adrenal gland tumor).

Before using minoxidil, tell your doctor if you are allergic to any drugs, or if you have:

• angina (chest pain);
• congestive heart failure;
• kidney disease (or if you are on dialysis);
• epilepsy or other seizure disorder; or
• if you have recently had a heart attack.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category C. Minoxidil may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Minoxidil can pass into breast milk and may harm a nursing infant. Do not take minoxidil without telling your doctor if you are breast-feeding a baby.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

• Drug Side Effects

© Minoxidil Patient Information is supplied by Cerner Multum, Inc. and Minoxidil Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.