Propranolol Hydrochloride 10 mg/1
propranolol hydrochloride · TABLET · Bryant Ranch Prepack
Propranolol Hydrochloride is a tablet containing propranolol hydrochloride at 10 mg/1, taken oral. Manufactured by Bryant Ranch Prepack.
Key Facts
- Brand Name
- Propranolol Hydrochloride
- Generic Name
- propranolol hydrochloride
- NDC Code (Product)
72162-1175- Manufacturer
- Bryant Ranch Prepack
- Strength
- 10 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA070221
- Marketing Start
- 06/21/2010
Recall History
Fresenius Kabi USA, LLC
CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection.
CARDINAL HEALTHCARE
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Teva Pharmaceuticals USA, Inc.
Failed Tablet/Capsule Specification: Teva is recalling certain lots of Propanolol HCl Tablets, 10 mg due to the potential of some tablets not conforming to weight specification.
Upsher Smith Laboratories, Inc.
Failed Dissolution Test Requirements
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Hypertension Propranolol hydrochloride tablets 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 is not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis Propranolol hydrochloride tablets are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation Propranolol hydrochloride tablets are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Myocardial Infarction Propranolol is indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Migraine Propranolol is 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. Essential Tremor Propranolol is indicated in the management of familial or hereditary essential tremo…
Dosage & Administration
DOSAGE AND ADMINISTRATION General Because of the variable bioavailability of propranolol, the dose should be individualized based on response. Hypertension The usual initial dosage is 40 mg propranolol hydrochloride twice daily, whether used alone or added to a diuretic. Dosage may be increased gradually until adequate blood pressure control is achieved. The usual maintenance dosage is 120 mg/day to 240 mg per day. In some instances a dosage of 640 mg a day may be required. The time needed for full antihypertensive response to a given dosage is variable and may range from a few days to several weeks. While twice-daily dosing is effective and can maintain a reduction in blood pressure throughout the day, some patients, especially when lower doses are used, may experience a modest rise in blood pressure toward the end of the 12-hour dosing interval. This can be evaluated by measuring blood pressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day. If control is not adequate, a larger dose, or 3-times-daily therapy may achieve better control. Angina Pectoris Total daily doses of 80 mg to 320 mg propranolol hydrochlori…
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 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 reporte…
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 Caution should be exercised when propranolol is administered with drugs that have an effect on CYP2D6, 1A2, or 2C19 metabolic pathways. Co-administration 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 ). Cardiovascular Drugs Antiarrhythmics Propafenone has negative inotropic and beta-blocking properties that can be additive to those of propranolol. Quinidine increases the concentration of propranolol and produces greater degrees of clinical beta-blockade and may cause postural hypotension. Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with β-blockers such as propranolol. The clearance of lidocaine is reduced with administration of propranolol. Lidocaine toxicity has been reported following co-administration with propranolol. Caution should be exercised when administering propranolol with drugs that slow A-V nodal conduction, e.g. digitalis, lidocaine and calcium channel blockers. Digitalis Glycosides Both digitalis glycosides and beta-blockers slow atrioventricu…
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, and respiratory distress. Respiratory Bronchospasm. Hematologic Agranuloc…
Frequently Asked Questions
What is Propranolol Hydrochloride used for?
Propranolol Hydrochloride contains propranolol hydrochloride. It is a tablet taken oral. Consult your doctor for specific uses.
Is Propranolol Hydrochloride a controlled substance?
Propranolol Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Propranolol Hydrochloride?
The generic name for Propranolol Hydrochloride is propranolol hydrochloride. There are 1 other brand versions of propranolol hydrochloride.
What is the NDC code for Propranolol Hydrochloride 10 mg/1?
The NDC (National Drug Code) for Propranolol Hydrochloride 10 mg/1 is 72162-1175, listed by Bryant Ranch Prepack.
Other Propranolol Hydrochloride Dosages
- Propranolol Hydrochloride60 mg/172162-1178
- Propranolol Hydrochloride80 mg/172162-1179
- Propranolol Hydrochloride40 mg/172789-372
- Propranolol Hydrochloride120 mg/10527-4118
- Propranolol Hydrochloride10 mg/183980-005
- Propranolol Hydrochloride20 mg/150090-7620
- Propranolol Hydrochloride20 mg/151407-236
- Propranolol Hydrochloride20 mg/155154-2646
- Propranolol Hydrochloride10 mg/160687-926
- Propranolol Hydrochloride160 mg/10228-2781
Other Propranolol Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)