Drug Catalog - Product Detail
ACEBUTOLOL HCL CP 400MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00378-1400-01 | MYLAN | 100 | 400MG | CAPSULE |
Generic Name
Substance Name
Product Type
Route
Application Number
Description
DESCRIPTION Acebutolol hydrochloride is a selective, hydrophilic beta-adrenoreceptor blocking agent with mild intrinsic sympathomimetic activity for use in treating patients with hypertension and ventricular arrhythmias. It is marketed in capsule form for oral administration. Acebutolol Hydrochloride Capsules, USP are available in two strengths which contain 200 mg or 400 mg of acebutolol as the hydrochloride salt. The inactive ingredients are povidone, pregelatinized starch and stearic acid. The empty gelatin capsules contain D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. C 18 H 28 N 2 O 4 •HCl M.W. 372.9 Acebutolol hydrochloride, USP is a white or slightly off-white powder freely soluble in water, and less soluble in alcohol. Chemically it is defined as the hydrochloride salt of (±) N-[3-Acetyl-4-[2-hydroxy-3-[(1-methylethyl)amino]propoxy]phenyl] butanamide. Structural Formula
How Supplied
HOW SUPPLIED Acebutolol Hydrochloride Capsules, USP are available containing 200 mg or 400 mg of acebutolol as the hydrochloride salt. The 200 mg capsule is a hard-shell gelatin capsule with a medium orange opaque cap and medium orange opaque body filled with a white powder blend. The capsule is axially printed with MYLAN over 1200 in black ink on both the cap and the body. They are available as follows: NDC 0378-1200-01 bottles of 100 capsules The 400 mg capsule is a hard-shell gelatin capsule with a medium orange opaque cap and medium orange opaque body filled with a white powder blend. The capsule is axially printed with MYLAN over 1400 in black ink on both the cap and the body. They are available as follows: NDC 0378-1400-01 bottles of 100 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Keep container tightly closed. 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 SEPTEMBER 2012 ACEB:R10
Indications & Usage
INDICATIONS AND USAGE Hypertension Acebutolol hydrochloride capsules are indicated for the management of hypertension in adults. They may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. Ventricular Arrhythmias Acebutolol hydrochloride capsules are indicated in the management of ventricular premature beats; it reduces the total number of premature beats, as well as the number of paired and multiform ventricular ectopic beats, and R-on-T beats.
Dosage and Administration
DOSAGE AND ADMINISTRATION Hypertension The initial dosage of acebutolol hydrochloride capsules in uncomplicated mild-to-moderate hypertension is 400 mg. This can be given as a single daily dose, but in occasional patients twice daily dosing may be required for adequate 24-hour blood-pressure control. An optimal response is usually achieved with dosages of 400 to 800 mg/day, although some patients have been maintained on as little as 200 mg/day. Patients with more severe hypertension or who have demonstrated inadequate control may respond to a total of 1200 mg daily (administered b.i.d.), or to the addition of a second antihypertensive agent. Beta-1 selectivity diminishes as dosage is increased. Ventricular Arrhythmia The usual initial dosage of acebutolol hydrochloride capsules is 400 mg daily given as 200 mg b.i.d. Dosage should be increased gradually until an optimal clinical response is obtained, generally at 600 to 1200 mg/day. If treatment is to be discontinued, the dosage should be reduced gradually over a period of about 2 weeks. Use in Older Patients Older patients have an approximately 2-fold increase in bioavailability and may require lower maintenance doses. Doses above 800 mg/day should be avoided in the elderly.