MINOXIDIL tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Actavis Pharma, Inc.

INN (Nama Internasional):

MINOXIDIL

Komposisi:

MINOXIDIL 2.5 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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

Ringkasan produk:

Minoxidil Tablets, USP 2.5 mg are 9/32 ", scored, round, white tablets imprinted “DAN 5642 ” and “2.5 ” supplied in bottles of 100 NDC 0591-5642-01 and 500 NDC 0591-5642-05. Minoxidil Tablets, USP 10 mg are 9/32 ", scored, round, white tablets imprinted “DAN 5643 ” and “10 ” supplied in bottles of 100 NDC 0591-5643-01 and 500 NDC 0591-5643-05. Dispense in a tight container with child-resistant closure. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured In India By:  Watson Pharma Private Limited Verna, Salcette Goa 403 722, India Manufactured For:  Teva Pharmaceuticals Parsippany, NJ 07054 Rev. A 12/2021

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

MINOXIDIL- MINOXIDIL TABLET
ACTAVIS PHARMA, 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, USP contain minoxidil, USP 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, USP
is 2,4-pyrimidinediamine,6-(1-piperidinyl)-, 3-oxide. The structural
formula is represented
below:
C H
N O           M.W. 209.25
9
15
5
Minoxidil tablets, USP for oral administration contain either 2.5 mg
or 10 mg of minoxidil,
USP.
Minoxidil Tablets, USP 2.5 mg and 10 mg contain the following inactive
ingredients:
anhydrous lactose, docusate sodium, magnesium stearate,
microcrystalline cellulose,
sodium be