MINOXIDIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)

Available from:

Bryant Ranch Prepack

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 mmHg or to 90 mmHg 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 is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Product summary:

Minoxidil Tablets are available as follows: 10 mg : white, round, bisected tablets, debossed “par 257” on one side and “MINOXIDIL 10” on the other side, supplied in bottles of 100 (NDC 63629-9299-1). Store at controlled room temperature 20° to 25°C (68° to 77°F) [See USP]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MINOXIDIL- MINOXIDIL TABLET
BRYANT RANCH PREPACK
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MINOXIDIL
WARNINGS
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 WARNINGS) 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.
DESCRIPTION
Minoxidil tablets contain minoxidil, an antihypertensive peripheral
vasodilator. Minoxidil
occurs as a white to off-white, odorless, crystalline solid that is
soluble in water to the
extent of approximately 2 mg/mL, is readily soluble in propylene
glycol or ethanol, and is
almost insoluble in acetone, chloroform or ethyl acetate. The chemical
name for minoxidil
is 2,4-pyrimidinediamine, 6-(1-piperidinyl)-, 3-oxide. The structural
formula is
represented at right:
C H
N 0 MW 209.25
Minoxidil tablets for oral administration contain either 2.5 mg or 10
mg of minoxidil.
Inactive ingredients include colloidal silicon dioxide, corn starch,
lactose anhydrous,
magnesium stearate and microcrystalline cellulose.
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CLINICAL PHARMACOLOGY
1. GENERAL PHARMACOLOGIC PROPERTIES
Minoxidil is an orally effect