MINOXIDIL tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Sun Pharmaceutical Industries, Inc.

SNN (starptautisko nepatentēto nosaukumu):

minoxidil

Kompozīcija:

minoxidil 2.5 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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.

Produktu pārskats:

Minoxidil tablets are available as follows: Minoxidil tablets 2.5 mg are round, scored, white and debossed on one side and on the reverse side. Bottles of 100 NDC 53489-386-01 Bottles of 250 NDC 53489-386-03 Bottles of 500 NDC 53489-386-05 Bottles of 1000 NDC 53489-386-10 Minoxidil tablets 10 mg are round, scored, white and debossed on one side and on the reverse side. Bottles of 100 NDC 53489-387-01 Bottles of 250 NDC 53489-387-03 Bottles of 500 NDC 53489-387-05 Bottles of 1000 NDC 53489-387-10 Store at 20° to 25°C (68° to 77° F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

MINOXIDIL- MINOXIDIL TABLET
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
MINOXIDIL TABLETS USP
RX ONLY
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, 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 ac