Guanfacine (Guanfacine Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

The recommended initial dose of guanfacine tablets when given alone or in combination with another antihypertensive drug is 1 mg daily given at bedtime to minimize somnolence. If after 3 to 4 weeks of therapy, 1 mg does not give a satisfactory result, a dose of 2 mg may be given, although most of the effect of guanfacine is seen at 1 mg (see CLINICAL PHARMACOLOGY ). Higher daily doses have been used, but adverse reactions increase significantly with doses above 3 mg/day.

The frequency of rebound hypertension is low, but it can occur. When rebound occurs, it does so after 2 to 4 days, which is delayed compared with clonidine hydrochloride. This is consistent with the longer half-life of guanfacine. In most cases, after abrupt withdrawal of guanfacine, blood pressure returns to pretreatment levels slowly (within 2 to 4 days) without ill effects.

HOW SUPPLIED

Guanfacine is available in 2 tablet strengths of guanfacine (as the hydrochloride salt) as follows:

1 mg
white, unscored, oval, flat-faced, bevelled-edge tablet with “G” debossed on one side and “GU 1” debossed on the other side

- in bottles of 100 (NDC 55567-051-18)

- in bottles of 500 (NDC 55567-051-25).

2 mg
white, unscored, oval, flat-faced, bevelled-edge tablet with “G” debossed on one side and “GU 2” debossed on the other side

- in bottles of 100 (NDC 55567-052-18)

- in bottles of 500 (NDC 55567-052-25).

Store at controlled room temperature, between 15°C and 30°C (59°F and 86°F). Dispense in tight, light-resistant container.

Manufactured by:
Genpharm Inc.
Toronto, Ontario
Canada M8Z 2S6
1-800-661-7134

004-282 Rev.#04
December 2002