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 (as the hydrochloride) 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 Tablets, USP equivalent to 1 or 2 mg of guanfacine are supplied as follows:

The 1 mg tablets are white, unscored, round tablets debossed with M on one side and G4 on the other side. They are available as follows:

NDC 0378-1160-01
bottles of 100 tablets

The 2 mg tablets are blue, unscored, round tablets debossed with M on one side and G5 on the other side. They are available as follows:

NDC 0378-1190-01
bottles of 100 tablets

STORE AT CONTROLLED ROOM TEMPERATURE 15°– 30°C (59°– 86°F).

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505

REV APRIL 2003
GUAN:R4