Drug Catalog - Product Detail
GUANFACINE HCL TB 1MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00378-1160-01 | MYLAN | 100 | 1MG | TABLET |
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Description
DESCRIPTION Guanfacine tablets are a centrally acting antihypertensive with α 2 -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 to off-white crystalline 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 of guanfacine and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. In addition, the 2 mg tablets contain the following ingredient: FD&C Blue No.1 Aluminum Lake. Guanfacine Hydrochloride Structural Formula
How Supplied
HOW SUPPLIED Guanfacine Tablets, USP are available containing guanfacine hydrochloride, USP equivalent to 1 mg or 2 mg of guanfacine. The 1 mg tablets are white, round, unscored tablets debossed with M on one side of the tablet and G4 on the other side. They are available as follows: NDC 0378-1160-77 bottles of 90 tablets NDC 0378-1160-01 bottles of 100 tablets The 2 mg tablets are blue, round, unscored tablets debossed with M on one side of the tablet and G5 on the other side. They are available as follows: NDC 0378-1190-77 bottles of 90 tablets NDC 0378-1190-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 5/2017 GUAN:R7
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage and Administration
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 tablets are 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.