GUANFACINE HYDROCHLORIDE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

AvKARE, Inc.

INN (Internationale Bezeichnung):

GUANFACINE HYDROCHLORIDE

Zusammensetzung:

GUANFACINE 1 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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

Produktbesonderheiten:

Guanfacine tablets, USP are available in 2 tablet strengths of guanfacine (as the hydrochloride salt) as follows: 1 mg: white, oval, flat-faced, beveled-edge tablet with “AN” on one side and “711” on the other side. They are available as follows: Bottles of 90: NDC 42291-310-90 2 mg: white, oval, flat-faced, beveled-edge tablet with “AN” on one side and “713” on the other side. They are available as follows: Bottles of 90: NDC 42291-311-90 Store at 20º to 25 ºC (68 º to 77 ºF) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

GUANFACINE HYDROCHLORIDE- GUANFACINE HYDROCHLORIDE TABLET
AVKARE, INC.
----------
GUANFACINE TABLETS, USP
RX ONLY
RX ONLY
FULL PRESCRIBING INFORMATION
DESCRIPTION
Guanfacine hydrochloride, USP is a centrally acting antihypertensive
with α
-adrenoceptor agonist
properties in tablet form for oral administration.
The chemical name of guanfacine hydrochloride, USP is
N-amidino-2-(2,6-dichlorophenyl) acetamide
hydrochloride and its molecular weight is 282.56. Its structural
formula is:
Guanfacine hydrochloride, USP is a white to off-white powder;
sparingly soluble in water and alcohol
and slightly soluble in acetone.
Each tablet, for oral administration, contains guanfacine
hydrochloride, USP equivalent to 1 mg or 2 mg
guanfacine. In addition, each tablet contains the following inactive
ingredients: microcrystalline
cellulose, pregelatinized starch, and stearic acid.
CLINICAL PHARMACOLOGY
Guanfacine hydrochloride is 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. 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 SEATED SYSTOLIC AND
DIASTOLIC BLOOD PRESSURE FO