GUANFACINE HYDROCHLORIDE tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Unichem Pharmaceuticals (USA), Inc.

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 hydrochloride.

Tuoteyhteenveto:

Guanfacine tablets, USP are available in the following dosing strengths (expressed in equivalent amounts of guanfacine): 1 mg – White to off white, round, flat-faced, beveled-edge, uncoated tablets debossed with "U" on one side and "45" on the other side. Bottles of 100: 29300-458-01 2 mg – Light blue, mottled, round, flat-faced, beveled-edge, uncoated tablets debossed with "U" on one side and "46" on the other side. Bottles of 100: 29300-459-01 Store at controlled temperature, between 20° and 25°C (68°F and 77°F). [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Please address medical inquiries to Unichem's toll free # 1-866-562-4616. Manufactured by: UNICHEM LABORATORIES LTD. Ind. Area, Meerut Road, Ghaziabad – 201 003, India                                Manufactured for: East Brunswick, NJ 08816 01-R-07/2020 13012677

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

GUANFACINE HYDROCHLORIDE - GUANFACINE HYDROCHLORIDE TABLET
UNICHEM PHARMACEUTICALS (USA), INC.
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GUANFACINE TABLETS, USP
DESCRIPTION
Guanfacine tablets, USP 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 or almost white crystalline
powder; sparingly
soluble in water, methanol and ethanol.
The tablets contain the following inactive ingredients:
1 mg — colloidal silicon dioxide, corn starch, lactose monohydrate
and stearic acid.
2 mg — colloidal silicon dioxide, corn starch, FD & C Blue No. 1
aluminum lake, lactose
monohydrate and stearic acid.
FDA approved dissolution test specifications differ from USP.
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 hydrochloride. 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
2
2
dose added an increment of effectiveness, it caused an unacceptable
increase in
adverse reactions.
MEAN CHANGES (MM HG) FROM BASE