GUANFACINE- guanfacine hydrochloride tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

GUANFACINE HYDROCHLORIDE (UNII: PML56A160O) (GUANFACINE - UNII:30OMY4G3MK)

Tillgänglig från:

Mylan Pharmaceuticals Inc.

INN (International namn):

GUANFACINE HYDROCHLORIDE

Sammansättning:

GUANFACINE 1 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Guanfacine tablets are indicated in the management of hypertension. Guanfacine tablets may be given alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. Guanfacine tablets are contraindicated in patients with known hypersensitivity to guanfacine hydrochloride. No reported abuse or dependence has been associated with the administration of guanfacine tablets.

Produktsammanfattning:

Guanfacine Tablets, USP are available containing guanfacine hydrochloride, USP equivalent to 1 mg or 2 mg of guanfacine. The 1 mg tablets are white, round, unscored tablets debossed with M on one side of the tablet and G4 on the other side. They are available as follows: NDC 0378-1160-77 bottles of 90 tablets NDC 0378-1160-01 bottles of 100 tablets The 2 mg tablets are blue, round, unscored tablets debossed with M on one side of the tablet and G5 on the other side. They are available as follows: NDC 0378-1190-77 bottles of 90 tablets NDC 0378-1190-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 5/2017 GUAN:R7

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

GUANFACINE- GUANFACINE HYDROCHLORIDE TABLET
MYLAN PHARMACEUTICALS INC.
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DESCRIPTION
Guanfacine tablets are a centrally acting antihypertensive with α
-adrenoceptor agonist properties in
tablet form for oral administration.
The chemical name of guanfacine hydrochloride is
N-Amidino-2-(2,6-dichlorophenyl) acetamide
monohydrochloride and its molecular weight is 282.55. Its structural
formula is:
Guanfacine hydrochloride, USP is a white to off-white crystalline
powder; sparingly soluble in water
and alcohol and slightly soluble in acetone.
Each tablet, for oral administration, contains guanfacine
hydrochloride equivalent to 1 mg or 2 mg of
guanfacine and the following inactive ingredients: anhydrous lactose,
colloidal silicon dioxide,
magnesium stearate, microcrystalline cellulose and sodium lauryl
sulfate. In addition, the 2 mg tablets
contain the following ingredient: FD&C Blue No.1 Aluminum Lake.
CLINICAL PHARMACOLOGY
Guanfacine tablets are an orally active antihypertensive agent whose
principal mechanism of action
appears to be stimulation of central α -adrenergic receptors. By
stimulating these receptors, guanfacine
reduces sympathetic nerve impulses from the vasomotor center to the
heart and blood vessels. This
results in a decrease in peripheral vascular resistance and a
reduction in heart rate.
The dose-response relationship for blood pressure and adverse effects
of guanfacine given once a day
as monotherapy has been evaluated in patients with mild to moderate
hypertension. In this study patients
were randomized to placebo or to 0.5 mg, 1 mg, 2 mg, 3 mg or 5 mg of
guanfacine tablets. Results are
shown in the following table. A useful effect was not observed overall
until doses of 2 mg were
reached, although responses in white patients were seen at 1 mg; 24
hour effectiveness of 1 mg to 3 mg
doses was documented using 24 hour ambulatory monitoring. While the 5
mg dose added an increment
of effectiveness, it caused an unacceptable increase in adverse
reactions.
MEAN CHANGES (MM HG) FROM BASELINE IN