GUANFACINE HYDROCHLORIDE tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

TYA Pharmaceuticals

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 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.

Produktsammanfattning:

NDC:64725-0711-1 in a CONTAINER of 15 TABLETS

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

GUANFACINE HYDROCHLORIDE - GUANFACINE HYDROCHLORIDE TABLET
TYA PHARMACEUTICALS
----------
GUANFACINE TABLETS, USP
RX ONLY
FULL PRESCRIBING INFORMATION
DESCRIPTION
Guanfacine hydrochloride is a centrally acting antihypertensive with
α2 -adrenoceptor agonist
properties in tablet form for oral administration.
The chemical name of guanfacine hydrochloride is
N-amidino-2-(2,6-dichlorophenyl) acetamide
hydrochloride and its molecular weight is 282.56. Its structural
formula is:
Guanfacine hydrochloride 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 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 α2 -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 COMPLE