MINOXIDIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

minoxidil (UNII: 5965120SH1) (minoxidil - UNII:5965120SH1)

Available from:

Carilion Materials Management

INN (International Name):

minoxidil

Composition:

minoxidil 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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.

Product summary:

NDC:68151-2031-8 in a CUP of 1 TABLETS Store at 20° to 25°C (68° to 77° F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MINOXIDIL- MINOXIDIL TABLET
CARILION MATERIALS MANAGEMENT
----------
MINOXIDIL TABLETS USP
RX ONLY
WARNING
Minoxidil tablets contain the powerful antihypertensive agent,
minoxidil, which may produce
serious adverse effects. It can cause pericardial effusion,
occasionally progressing to tamponade,
and angina pectoris may be exacerbated. Minoxidil should be reserved
for hypertensive patients
who do not respond adequately to maximum therapeutic doses of a
diuretic and two other
antihypertensive agents.
In experimental animals, minoxidil caused several kinds of myocardial
lesions as well as other
adverse cardiac effects (see ). CARDIAC LESIONS IN ANIMALS
Minoxidil must be administered under close supervision, usually
concomitantly with therapeutic
doses of a beta-adrenergic blocking agent to prevent tachycardia and
increased myocardial
workload. It must also usually be given with a diuretic, frequently
one acting in the ascending limb
of the loop of Henle, to prevent serious fluid accumulation. Patients
with malignant hypertension
and those already receiving guanethidine (see ) should be hospitalized
when minoxidil is first
administered so that they can be monitored to avoid too rapid, or
large orthostatic, decreases in
blood pressure. WARNINGS
DESCRIPTION
Minoxidil tablets contain minoxidil, an antihypertensive peripheral
vasodilator. Minoxidil occurs as a
white to off-white, crystalline powder, soluble in alcohol and
propylene glycol; sparingly soluble in
methanol; slightly soluble in water; practically insoluble in
chloroform, acetone and ethyl acetate. The
chemical name for minoxidil is 2,4-Pyrimidinediamine,
6-(1-piperidinyl)-, 3-oxide. The structural
formula is represented below:
Minoxidil tablets for oral administration contain either 2.5 mg or 10
mg of minoxidil. Inactive
ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium
stearate, microcrystalline
cellulose, and sodium starch glycolate.
CLINICAL PHARMACOLOGY
1. GENERAL PHARMACOLOGIC PROPERTIES
Minoxidil is an orally effective direct acting