GUANFACINE HYDROCHLORIDE- guanfacine tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

AvPAK

INN (International namn):

GUANFACINE HYDROCHLORIDE

Sammansättning:

GUANFACINE 2 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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.

Produktsammanfattning:

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. NDC 50268-373-15 (10 tablets per card, 5 cards per carton). 2 mg: white, oval, flat-faced, beveled-edge tablet with “AN” on one side and “713” on the other side. NDC 50268-374-15 (10 tablets per card, 5 cards per carton). Dispensed in Unit Dose Package. For Institutional Use Only. Store at 20º to 25 ºC (68 ºF to 77 ºF) [see USP Controlled Room Temperature]. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 11-2015-00 AV Rev. 10/18 (P) AvPAK

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

GUANFACINE HYDROCHLORIDE- GUANFACINE TABLET
AVPAK
----------
GUANFACINE TABLETS, USP
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 FOR PATIENTS COMPLETING 4 TO 8