Propranolol Hydrochloride (Page 5 of 5)

OVERDOSAGE

Propranolol is not significantly dialyzable. In the event of overdosage or exaggerated response, the following measures should be employed:

General

If ingestion is or may have been recent, evacuate gastric contents, taking care to prevent pulmonary aspiration.

Supportive Therapy

Hypotension and bradycardia have been reported following propranolol overdose and should be treated appropriately. Glucagon can exert potent inotropic and chronotropic effects and may be particularly useful for the treatment of hypotension or depressed myocardial function after a propranolol overdose. Glucagon should be administered as 50-150 mcg/kg intravenously followed by continuous drip of 1-5 mg/hour for positive chronotropic effect. Isoproterenol, dopamine or phosphodiesterase inhibitors may also be useful. Epinephrine, however, may provoke uncontrolled hypertension. Bradycardia can be treated with atropine or isoproterenol. Serious bradycardia may require temporary cardiac pacing.

The electrocardiogram, pulse, blood pressure, neurobehavioral status and intake and output balance must be monitored. Isoproterenol and aminophylline may be used for bronchospasm.

DOSAGE AND ADMINISTRATION

General

Propranolol Hydrochloride Extended-Release Capsules, USP, 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, USP, care should be taken to assure that the desired therapeutic effect is maintained. Propranolol Hydrochloride Extended-Release Capsules, USP, should not be considered a simple mg-for-mg substitute for propranolol hydrochloride tablets. Propranolol Hydrochloride Extended-Release Capsules, USP, 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, USP, 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, USP, 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, USP, 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 Capsules, USP, 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, USP.

Hypertrophic Subaortic Stenosis

The usual dosage is 80 to 160 mg Propranolol Hydrochloride Extended-Release Capsules, USP, once daily.

HOW SUPPLIED

Propranolol Hydrochloride Extended-Release Capsules, USP.

Each white/opaque capsule, imprinted with “60”on cap and “RD203” on body contains 60 mg of propranolol hydrochloride

55700-940-30

Each capsule with white/opaque body and orange/opaque cap, imprinted with “80”on cap and “RD203” on body contains 80 mg of propranolol hydrochloride

Each orange/opaque capsule, imprinted with “120”on cap and “RD203” on body contains 120 mg of propranolol hydrochloride

Each light brown/opaque capsule, imprinted with “160”on cap and “RD203” on body contains 160 mg of propranolol hydrochloride

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.

Propranolol Hydrochloride Extended-Release Capsules, USP, a DIFFUCAPS® drug delivery product, manufactured by Adare Pharmaceuticals, Inc.

You can also ask your doctor or pharmacist for information about Propranolol Hydrochloride Extended-Release Capsules, USP that is written for healthcare professionals. For more information, call 1-800-367-3395 or go to www.bpirx.com.

Distributed by:
Breckenridge Pharmaceutical, Inc.
Berlin, CT 06037

Manufactured by:
Adare Pharmaceuticals, Inc.
Vandalia, OH 45377

Rev. 05/19

PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55700-940(NDC:51991-817) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength propranolol hydrochloride (propranolol) propranolol hydrochloride 60 mg

Inactive Ingredients Ingredient Name Strength ethylcellulose (10 MPA.S) diethyl phthalate titanium dioxide ammonia ferrosoferric oxide GELATIN, UNSPECIFIED POVIDONE K30 potassium hydroxide hypromellose phthalate (24% phthalate, 55 CST) sucrose starch, corn polyethylene glycol 400

Product Characteristics Color WHITE (Opaque) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code 60;RD203 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55700-940-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078703 09/10/2021

Labeler — Quality Care Products, LLC (831276758)

Establishment
Name	Address	ID/FEI	Operations
Quality Care Products, LLC		831276758	repack (55700-940)

Revised: 07/2022 Quality Care Products, LLC