Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Propranolol hydrochloride extended-release capsules, USP are available as follows: 60 mg – Each #3 capsule with white opaque cap and yellow opaque body printed with and 2778 on the cap and body in black ink contains 60 mg of propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol). Capsules are supplied in bottles of 100 (NDC 0228-2778-11). 80 mg – Each #3 capsule with yellow opaque cap and yellow opaque body printed with and 2779 on the cap and body in black ink contains 80 mg of propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol). Capsules are supplied in bottles of 100 (NDC 0228-2779-11). 120 mg – Each #2 capsule with gray opaque cap and yellow opaque body printed with and 2780 on the cap and body in black ink contains 120 mg of propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol). Capsules are supplied in bottles of 100 (NDC 0228-2780-11). 160 mg – Each #1 capsule with gray opaque cap and gray opaque body printed with and 2781 on the cap and body in black ink contains 160 mg of propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol). Capsules are supplied in bottles of 100 (NDC 0228-2781-11). Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Protect from light, moisture, freezing, and excessive heat. Dispense in a tight, light-resistant container as defined in the USP. Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. A 3/2024 2 3 4 5; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0228-2778-11 Propranolol Hydrochloride Extended-Release Capsules, USP 60 mg Rx only 100 Capsules 60; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0228-2779-11 Propranolol Hydrochloride Extended-Release Capsules, USP 80 mg Rx only 100 Capsules 80; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0228-2780-11 Propranolol Hydrochloride Extended-Release Capsules, USP 120 mg Rx only 100 Capsules 120; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0228-2781-11 Propranolol Hydrochloride Extended-Release Capsules, USP 160 mg Rx only 100 Capsules new
- HOW SUPPLIED Propranolol hydrochloride extended-release capsules, USP are available as follows: 60 mg – Each #3 capsule with white opaque cap and yellow opaque body printed with and 2778 on the cap and body in black ink contains 60 mg of propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol). Capsules are supplied in bottles of 100 (NDC 0228-2778-11). 80 mg – Each #3 capsule with yellow opaque cap and yellow opaque body printed with and 2779 on the cap and body in black ink contains 80 mg of propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol). Capsules are supplied in bottles of 100 (NDC 0228-2779-11). 120 mg – Each #2 capsule with gray opaque cap and yellow opaque body printed with and 2780 on the cap and body in black ink contains 120 mg of propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol). Capsules are supplied in bottles of 100 (NDC 0228-2780-11). 160 mg – Each #1 capsule with gray opaque cap and gray opaque body printed with and 2781 on the cap and body in black ink contains 160 mg of propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol). Capsules are supplied in bottles of 100 (NDC 0228-2781-11). Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Protect from light, moisture, freezing, and excessive heat. Dispense in a tight, light-resistant container as defined in the USP. Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. A 3/2024 2 3 4 5
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0228-2778-11 Propranolol Hydrochloride Extended-Release Capsules, USP 60 mg Rx only 100 Capsules 60
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0228-2779-11 Propranolol Hydrochloride Extended-Release Capsules, USP 80 mg Rx only 100 Capsules 80
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0228-2780-11 Propranolol Hydrochloride Extended-Release Capsules, USP 120 mg Rx only 100 Capsules 120
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0228-2781-11 Propranolol Hydrochloride Extended-Release Capsules, USP 160 mg Rx only 100 Capsules new
Overview
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: C 16 H 21 NO 2 ·HCl Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride extended-release capsules, USP are formulated to provide a sustained release of propranolol hydrochloride, USP. Propranolol hydrochloride extended-release capsules, USP are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. Each propranolol hydrochloride extended-release 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol). Each propranolol hydrochloride extended-release 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol). Each propranolol hydrochloride extended-release 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol). Each propranolol hydrochloride extended-release 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol). The inactive ingredients contained in propranolol hydrochloride extended-release capsules are: ethylcellulose, gelatin, hydroxypropyl cellulose, povidone, sugar spheres, talc, and 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. Meets USP Dissolution Test 7. d07a4e7b-figure-01
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 capsules improve NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis.
Dosage & Administration
General Propranolol hydrochloride extended-release capsules provide 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 capsules should not be considered a simple mg-for-mg substitute for propranolol hydrochloride tablets. Propranolol hydrochloride extended-release capsules have 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 capsules 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 capsules 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 capsules 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 capsule 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 capsules. Hypertrophic Subaortic Stenosis The usual dosage is 80 to 160 mg propranolol hydrochloride extended-release capsules once daily.
Warnings & Precautions
WARNINGS Angina Pectoris There have been reports of exacerbation of angina and, in some cases, myocardial infarction, following abrupt discontinuance of propranolol therapy. Therefore, when discontinuance of propranolol is planned, the dosage should be gradually reduced over at least a few weeks, and the patient should be cautioned against interruption or cessation of therapy without the physician's advice. If propranolol therapy is interrupted and exacerbation of angina occurs, it usually is advisable to reinstitute propranolol therapy and take other measures appropriate for the management of unstable angina pectoris. Since coronary artery disease may be unrecognized, it may be prudent to follow the above advice in patients considered at risk of having occult atherosclerotic heart disease who are given propranolol for other indications. Hypersensitivity and Skin Reactions Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions, have been associated with the administration of propranolol (see ADVERSE REACTIONS ). Cutaneous reactions, including Stevens-Johnson Syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme, and urticaria, have been reported with use of propranolol (see ADVERSE REACTIONS ). Cardiac Failure Sympathetic stimulation may be a vital component supporting circulatory function in patients with congestive heart failure, and its inhibition by beta blockade may precipitate more severe failure. Although beta-blockers should be avoided in overt congestive heart failure, some have been shown to be highly beneficial when used with close follow-up in patients with a history of failure who are well compensated and are receiving diuretics as needed. Beta-adrenergic blocking agents do not abolish the inotropic action of digitalis on heart muscle. In Patients without a History of Heart Failure, continued use of beta-blockers can, in some cases, lead to cardiac failure. Nonallergic Bronchospasm (e.g., Chronic Bronchitis, Emphysema) In general, patients with bronchospastic lung disease should not receive beta-blockers. Propranolol should be administered with caution in this setting since it may provoke a bronchial asthmatic attack by blocking bronchodilation produced by endogenous and exogenous catecholamine stimulation of beta-receptors. Major Surgery Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery, however the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures. Hypoglycemia Beta-blockers may prevent early warning signs of hypoglycemia, such as tachycardia, and increase the risk for severe or prolonged hypoglycemia at any time during treatment, especially in patients with diabetes mellitus or children and patients who are fasting (i.e., surgery, not eating regularly, or are vomiting). If severe hypoglycemia occurs, patients should be instructed to seek emergency treatment. Hypoglycemia has been reported in patients taking propranolol after prolonged physical exertion and in patients with renal insufficiency. Thyrotoxicosis Beta-adrenergic blockade may mask certain clinical signs of hyperthyroidism. Therefore, abrupt withdrawal of propranolol may be followed by an exacerbation of symptoms of hyperthyroidism, including thyroid storm. Propranolol may change thyroid-function tests, increasing T 4 and reverse T 3 , and decreasing T 3 . Wolff-Parkinson-White Syndrome Beta-adrenergic blockade in patients with Wolff-Parkinson-White syndrome and tachycardia has been associated with severe bradycardia requiring treatment with a pacemaker. In one case, this result was reported after an initial dose of 5 mg propranolol.
Contraindications
Propranolol is contraindicated in 1) cardiogenic shock; 2) sinus bradycardia and greater than first-degree block; 3) bronchial asthma; and 4) in patients with known hypersensitivity to propranolol hydrochloride.
Adverse Reactions
The following adverse events were observed and have been reported in patients using propranolol. Cardiovascular: Bradycardia; congestive heart failure; intensification of AV block; hypotension; paresthesia of hands; thrombocytopenic purpura; arterial insufficiency, usually of the Raynaud type. Central Nervous System: Light-headedness; mental depression manifested by insomnia, lassitude, weakness, fatigue; catatonia; visual disturbances; hallucinations; vivid dreams; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics. For immediate release formulations, fatigue, lethargy, and vivid dreams appear dose related. Gastrointestinal: Nausea, vomiting, epigastric distress, abdominal cramping, diarrhea, constipation, mesenteric arterial thrombosis, ischemic colitis. Allergic: Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions; pharyngitis and agranulocytosis; erythematous rash; fever combined with aching and sore throat; laryngospasm; respiratory distress. Respiratory: Bronchospasm. Hematologic: Agranulocytosis, nonthrombocytopenic purpura, and thrombocytopenic purpura. Autoimmune: Systemic lupus erythematosus (SLE). Skin and Mucous Membranes: Stevens-Johnson Syndrome, toxic epidermal necrolysis, dry eyes, exfoliative dermatitis, erythema multiforme, urticaria, alopecia, SLE-like reactions, and psoriasisiform rashes. Oculomucocutaneous syndrome involving the skin, serous membranes, and conjunctivae reported for a beta-blocker (practolol) have not been associated with propranolol. Genitourinary: Male impotence; Peyronie's disease. To report SUSPECTED ADVERSE EVENTS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ medwatch.
Drug Interactions
Caution should be exercised when propranolol hydrochloride extended-release capsules are administered with drugs that have an affect on CYP2D6, 1A2, or 2C19 metabolic pathways. Coadministration of such drugs with propranolol may lead to clinically relevant drug interactions and changes on its efficacy and/or toxicity (see Drug Interactions in PHARMACOKINETICS AND DRUG METABOLISM ). Alcohol when used concomitantly with propranolol, may increase plasma levels of propranolol.
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