Your browser does not support JavaScript! PROPRANOLOL HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]
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PROPRANOLOL HYDROCHLORIDE tablet
[Dispensing Solutions, Inc.]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

Rx Only

DESCRIPTION

hydrochloride(Propranolol  is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formulae are:

propranololhclusp

Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and in ethanol. Its molecular weight is 295.80.

Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, and 80 mg tablets for oral administration.

The inactive ingredients contained in propranolol hydrochloride tablets, USP are: lactose monohydrate, corn starch, sodium starch glycolate, magnesium stearate, and povidone. In addition, propranolol hydrochloride tablets, USP 10 mg, 40 mg and 80 mg contain  and C yellow No.6 Aluminium Lake and Color D and C Yellow No. 10; propranolol hydrochloride tablets, USP 20 mg and 40mg contain FD and C Blue No.1 and propranolol hydrochloride tablets, USP 60 mg contain D and C Red No. 30 Lake.

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: Lightheadedness, 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: Agranulocytosis, nonthrombocytopenic purpura, 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 psoriasiform 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.

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.

HOW SUPPLIED

Propranolol hydrochloride tablets, USP are supplied as follows:

10mg: Each tablet is an orange colored, round, biconvex tablet, embossed with "P" and "10" on either side of the breakline on one side and plain on the other side.

Each 10 mg tablet contains 10 mg propranolol hydrochloride USP and is supplied in the following packages sizes:

Bottles of 30 tablets                                 NDC 23155-110-03

Bottles of 60 tablets                                  NDC 23155-110-06

Bottles of 100 tablets                                 NDC 23155-110-01

Bottles of 500 tablets                                  NDC 23155-110-05

Bottles of 1000 tablets                                 NDC 23155-110-10

20mg: Each tablet is a blue colored, round, biconvex tablet, embossed with "P" and "20" on either side of the breakline on one side and plain on the other side.

Each 20 mg tablet contains 20 mg of propranolol hydrochloride USP and is supplied in the following package sizes:

Bottles of 30 tablets                                 NDC 23155-111-03

Bottles of 60 tablets                                  NDC 23155-111-06

Bottles of 100 tablets                                  NDC 23155-111-01

Bottles of 500 tablets                                  NDC 23155-111-05

Bottles of 1000 tablets                                 NDC 23155-111-10

40mg: Each tablet is a green colored, round, biconvex tablet, embossed with "P" and "40"on either side of the breakline on one side and plain on the other side.

Each 40 mg tablet contains 40 mg of propranolol hydrochloride USP and is supplied in the following package sizes:

Bottles of 30 tablets                                 NDC 23155-112-03

Bottles of 60 tablets                                  NDC 23155-112-06

Bottles of 100 tablets                                 NDC 23155-112-01

Bottles of 500 tablets                                  NDC 23155-112-05

Bottles of 1000 tablets                                 NDC 23155-112-10

60mg: Each tablet is a pink colored, round, biconvex tablet, embossed with "P" and "60" on either side of the breakline on one side and plain on the other side.

Each 60 mg tablet contains 60 mg of propranolol hydrochloride USP and is supplied in the following package sizes:

Bottles of 30 tablets                                 NDC 23155-113-03

Bottles of 60 tablets                                  NDC 23155-113-06

Bottles of 100 tablets                                 NDC 23155-113-01

Bottles of 500 tablets                                  NDC 23155-113-05

Bottles of 1000 tablets                                 NDC 23155-113-10

80mg: Each tablet is a yellow colored, round, biconvex tablet, embossed with "P" and "80" on either side of the breakline on one side and plain on the other side.

Each 80 mg tablet contains 80 mg of propranolol hydrochloride USP and is supplied in the following package sizes:

Bottles of 30 tablets                                 NDC 23155-114-03

Bottles of 60 tablets                                  NDC 23155-114-06

Bottles of 100 tablets                                 NDC 23155-114-01

Bottles of 500 tablets                                  NDC 23155-114-05

Bottles of 1000 tablets                                 NDC 23155-114-10

Storage: Store at 20°-25°C (68-(°77F); excursions permitted to 15°-30C (59(°-86F) [see USP Controlled Room Temperature]

Protect from light.

Dispense in a well closed, light-resistant container as defined in USP.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Manufactured for:

Heritage Pharmaceuticals Inc.

Edison, NJ 08837

1.866.901.DRUG (3784)

Manufactured by:

Ipca Laboratories Limited

48, Kandivli Ind. Estate,

Mumbai 400 067, India.

propranolol tabs-figure-02

Iss. 0109

PRINCIPAL DISPLAY PANEL


NDC 68258-6010-XX

NDC 68258-6010-XX

NDC 68258-6010-03

NDC 68258-6010-09

PROPRANOLOL HYDROCHLORIDE 
propranolol hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:68258-6010(NDC:23155-111)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL) PROPRANOLOL20 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POVIDONE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STARCH, CORN 
Product Characteristics
ColorblueScore2 pieces
ShapeROUNDSize7mm
FlavorImprint Code P;20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68258-6010-330 in 1 BOTTLE
2NDC:68258-6010-990 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07895510/13/2008
Labeler - Dispensing Solutions, Inc. (066070785)
Registrant - PSS World Medical, Inc. (101822682)
Establishment
NameAddressID/FEIBusiness Operations
Dispensing Solutions, Inc.066070785relabel, repack

Revised: 2/2012
 
Dispensing Solutions, Inc.

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