Drug Catalog - Product Detail
PROPRANOLOL HCL ER, USP CP 120MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00228-2780-11 | ACTAVIS PHARMA | 100 | 120MG | CAPSULE |
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Description
DESCRIPTION Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(Its molecular and structural formulae are: C16H21NO2 Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release is formulated to provide a sustained release of propranolol hydrochloride. Propranolol hydrochloride extended-release is available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. The inactive ingredients contained in propranolol hydrochloride extended-release capsules, are: ethylcellulose, gelatin, hydroxypropyl cellulose, povidone, sugar spheres, talc, titanium dioxide. In addition, the 60 mg and 80 mg capsule shells contain yellow iron oxide. The 120 mg capsule shells contain black iron oxide and yellow iron oxide. The 160 mg capsule shells contain black iron oxide. The ink ingredients are common for all strengths: Opacode S-1-8114 or Opacode S-1-8115 black contains: D&C Yellow #10 Aluminum Lake, FD&C blue #1 Aluminum lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, pharmaceutical glaze, propylene glycol, and synthetic black iron oxide. This drug product complies with USP Drug Dissolution Test 1. MM1
How Supplied
HOW SUPPLIED Propranolol hydrochloride extended-release capsules, USP are available as follows: 60 mgEach #3 capsule with white opaque cap and yellow opaque body printed with P and 2778 on the cap and body in black ink contains 60 mg of propranolol hydrochloride, USP. Capsules are supplied in bottles of 100 (NDC 0228-2778-11) with a child-resistant closure and 500 (NDC 0228-2778-50) without a child-resistant closure. 80 mgEach #3 capsule with yellow opaque cap and yellow opaque body printed with P and 2779 on the cap and body in black ink contains 80 mg of propranolol hydrochloride, USP. Capsules are supplied in bottles of 100 (NDC 0228-2779-11) with a child-resistant closure and 500 (NDC 0228-2779-50) without a child-resistant closure. 120 mgEach #2 capsule with gray opaque cap and yellow opaque body printed with P and 2780 on the cap and body in black ink contains 120 mg of propranolol hydrochloride, USP. Capsules are supplied in bottles of 100 (NDC 0228-2780-11) with a child-resistant closure and 500 (NDC 0228-2780-50) without a child-resistant closure. 160 mgEach #1 capsule with gray opaque cap and gray opaque body printed with P and 2781 on the cap and body in black ink contains 160 mg of propranolol hydrochloride, USP. Capsules are supplied in bottles of 100 (NDC 0228-2781-11) with a child-resistant closure and 500 (NDC 0228-2781-50) without a child-resistant closure. Store at 20to 25(68to 77USP Controlled Room Temperature]. Protect from light, moisture, freezing, and excessive heat. Dispense in a tight, light-resistant container as defined in the USP.
Indications & Usage
INDICATIONS & USAGE Hypertension Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules are not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis Propranolol hydrochloride extended-release capsules are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Migraine Propranolol hydrochloride extended-release capsules are indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Hypertrophic Subaortic Stenosis Propranolol hydrochloride extended-release improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis.
Dosage and Administration
DOSAGE & ADMINISTRATION General Propranolol hydrochloride extended-release provides propranolol hydrochloride in a sustained-release capsule for administration once daily. If patients are switched from propranolol hydrochloride tablets to propranolol hydrochloride extended-release capsules, care should be taken to assure that the desired therapeutic effect is maintained. Propranolol hydrochloride extended-release should not be considered a simple mg-for-mg substitute for propranolol hydrochloride. Propranolol hydrochloride extended-release has different kinetics and produces lower blood levels. Retitration may be necessary, especially to maintain effectiveness at the end of the 24-hour dosing interval. Hypertension The usual initial dosage is 80 mg propranolol hydrochloride extended-release once daily, whether used alone or added to a diuretic. The dosage may be increased to 120 mg once daily or higher until adequate blood pressure control is achieved. The usual maintenance dosage is 120 to 160 mg once daily. In some instances a dosage of 640 mg may be required. The time needed for full hypertensive response to a given dosage is variable and may range from a few days to several weeks. Angina Pectoris Starting with 80 mg propranolol hydrochloride extended-release once daily, dosage should be gradually increased at three- to seven-day intervals until optimal response is obtained. Although individual patients may respond at any dosage level, the average optimal dosage appears to be 160 mg once daily. In angina pectoris, the value and safety of dosage exceeding 320 mg per day have not been established. If treatment is to be discontinued, reduce dosage gradually over a period of a few weeks (see WARNINGS ). Migraine The initial oral dose is 80 mg propranolol hydrochloride extended-release once daily. The usual effective dose range is 160 to 240 mg once daily. The dosage may be increased gradually to achieve optimal migraine prophylaxis. If a satisfactory response is not obtained within four to six weeks after reaching the maximal dose, propranolol hydrochloride extended-release therapy should be discontinued. It may be advisable to withdraw the drug gradually over a period of several weeks depending on the patient's age, comorbidity, and dose of propranolol hydrochloride extended-release. Hypertrophic Subaortic Stenosis The usual dosage is 80 to 160 mg propranolol hydrochloride extended-release once daily.