Propranolol Hydrochloride ER 80 mg/1

propranolol hydrochloride · CAPSULE, EXTENDED RELEASE · ANI Pharmaceuticals, Inc.

No Recall HistoryCurrently in Shortage

Plain English

Propranolol Hydrochloride ER is a capsule, extended release containing propranolol hydrochloride at 80 mg/1, taken oral. Manufactured by ANI Pharmaceuticals, Inc..

Key Facts

Brand Name: Propranolol Hydrochloride ER
Generic Name: propranolol hydrochloride
NDC Code (Product): 62559-531
Manufacturer: ANI Pharmaceuticals, Inc.
Strength: 80 mg/1
Dosage Form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Marketing Status
Application #: NDA018553
Marketing Start: 12/21/2017

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use1,669 reports

drug ineffective1,212 reports

nausea879 reports

product use issue836 reports

product use in unapproved indication817 reports

headache741 reports

fatigue723 reports

toxicity to various agents643 reports

diarrhoea582 reports

drug intolerance572 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Hypertension Propranolol hydrochloride extended-release capsules USP are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules USP are not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis Propranolol hydrochloride extended-release capsules USP are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Migraine Propranolol hydrochloride extended-release capsules USP 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 USP improve NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis.

Dosage & Administration

DOSAGE AND 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 produce 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…

Warnings

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 be…

Contraindications

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.

Drug Interactions

Drug Interactions All drug interaction studies were conducted with propranolol. There are no data on drug interactions with propranolol hydrochloride extended-release capsules. Interactions with Substrates, Inhibitors or Inducers of Cytochrome P-450 Enzymes Because propranolol’s metabolism involves multiple pathways in the Cytochrome P-450 system (CYP2D6, 1A2, 2C19), co-administration with drugs that are metabolized by, or affect the activity (induction or inhibition) of one or more of these pathways may lead to clinically relevant drug interactions (see Drug Interactions under PRECAUTIONS ). Substrates or Inhibitors of CYP2D6 Blood levels and/or toxicity of propranolol may be increased by co-administration with substrates or inhibitors of CYP2D6, such as amiodarone, cimetidine, delavudin, fluoxetine, paroxetine, quinidine, and ritonavir. No interactions were observed with either ranitidine or lansoprazole. Substrates or Inhibitors of CYP1A2 Blood levels and/or toxicity of propranolol may be increased by co-administration with substrates or inhibitors of CYP1A2, such as imipramine, cimetidine, ciprofloxacin, fluvoxamine, isoniazid, ritonavir, theophylline, zileuton, zolmitriptan, a…

Adverse Reactions

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: Agranul…

Frequently Asked Questions

What is Propranolol Hydrochloride ER used for?

Propranolol Hydrochloride ER contains propranolol hydrochloride. It is a capsule, extended release taken oral. Consult your doctor for specific uses.

Is Propranolol Hydrochloride ER a controlled substance?

Propranolol Hydrochloride ER is not classified as a controlled substance by the DEA.

What is the generic name for Propranolol Hydrochloride ER?

The generic name for Propranolol Hydrochloride ER is propranolol hydrochloride. There are 12 other brand versions of propranolol hydrochloride.

What is the NDC code for Propranolol Hydrochloride ER 80 mg/1?

The NDC (National Drug Code) for Propranolol Hydrochloride ER 80 mg/1 is 62559-531, listed by ANI Pharmaceuticals, Inc..

Product NDC

62559-531

Package NDC

62559-531-01

Other Propranolol Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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