MINOXIDIL tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

State of Florida DOH Central Pharmacy

INN (Algemene Internationale Benaming):

MINOXIDIL

Samenstelling:

MINOXIDIL 10 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 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 whom 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 samenvatting:

2.5 mg: white, round, bisected tablets, debossed “par 256” on one side and “MINOXIDIL 2 1/2” on the other side. 10 mg: white, round, bisected tablets, debossed “par 257” on one side and “MINOXIDIL 10” on the other side. Store at controlled room temperature 20° to 25°C (68° to 77°F) [See USP]. They are supplied by State of Florida DOH Central Pharmacy as follows:

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

MINOXIDIL - MINOXIDIL TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
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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.
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.
CLINICAL PHARMACOLOGY
1. GENERAL PHARMACOLOGIC PROPERTIES
Minoxidil is an orally effective direct acting peripheral vasodilator
that r