Anwendungsgebiete

Because of the potential for serious adverse effects, minoxidil 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 reduced supine diastolic blood pressure by 20 mm Hg or to 90 mm Hg or less in approximately 75% of patients, most of who had hypertension that could not be controlled by other drugs.

Gegenanzeigen

Minoxidil tablets are contraindicated in pheochromocytoma, because it may stimulate secretion of catecholamines from the tumor through its antihypertensive action. Minoxidil tablets are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Warnhinweise und Vorsichtsmaßnahmen

1. Salt and Water Retention Congestive Heart Failure — concomitant use of an adequate diuretic is required — Minoxidil tablets must usually be administered concomitantly with a diuretic adequate to prevent fluid retention and possible congestive heart failure; a high ceiling (loop) diuretic is almost always required. Body weight should be monitored closely. If minoxidil is used without a diuretic, retention of several hundred milliequivalents of salt and corresponding volumes of water can occur within a few days, leading to increased plasma and interstitial fluid volume and local or generalized edema.

Diuretic treatment alone, or in combination with restricted salt intake, will usually minimize fluid retention, although reversible edema did develop in approximately 10% of nondialysis patients so treated. Ascites has also been reported. Diuretic effectiveness was limited mostly by disease-related impaired renal function. The condition of patients with pre-existing congestive heart failure occasionally deteriorated in association with fluid retention although because of the fall in blood pressure (reduction of afterload), more than twice as many improved than worsened.

Anwendungsgebiete

Minoxidil reduced supine diastolic blood pressure by 20 mm Hg or to 90 mm Hg or less in approximately 75% of patients, most of who had hypertension that could not be controlled by other drugs.

Warnhinweise und Vorsichtsmaßnahmen

Nebenwirkungen

1. Salt and Water Retention (see WARNINGS: Concomitant use of 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 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, 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 is begun. Allergic — Rashes have been reported, including rare reports of bullous eruptions, and Stevens-Johnson Syndrome. 4. Hematologic — Thrombocytopenia and leukopenia (WBC<3000/mm 3 ) 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. 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 is discontinued. No symptoms have been associated with these changes, nor have there been alterations in blood cell counts or in plasma enzyme concentrations 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.

Packung	Code	Status
MINOXIDIL 2.5MG	ANDA071537-001	Discontinued
MINOXIDIL 2.5MG	ANDA071344-001	Prescription
MINOXIDIL 10MG	ANDA071796-001	Discontinued
MINOXIDIL 2.5MG	ANDA071799-001	Discontinued
MINOXIDIL 2.5MG	ANDA071826-001	Prescription
MINOXIDIL 2.5MG	ANDA072709-002	Prescription
MINOXIDIL 10MG	ANDA072709-001	Prescription
MINOXIDIL 10MG	ANDA071839-001	Prescription
MINOXIDIL 10MG	ANDA071345-001	Prescription

Minoxidil

Anwendungsgebiete

Gegenanzeigen

Warnhinweise und Vorsichtsmaßnahmen

Zwei Arzneimittel in einer Frage?

Minoxidil

Anwendungsgebiete

Gegenanzeigen

Warnhinweise und Vorsichtsmaßnahmen

Zwei Arzneimittel in einer Frage?

Wechselwirkungen

Schwangerschaft und Stillzeit

Nebenwirkungen

In anderen Ländern

Packungen

Dokumente

Quellen und Lizenzen

Auf einen Blick