Propranolol Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Propranolol Hydrochloride

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

PROPRANOLOL HYDROCHLORIDE DESCRIPTION


Propranolol Hydrochloride







CLINICAL PHARMACOLOGY



DOSAGE AND ADMINISTRATION

Mechanism of Action





PHARMACOKINETICS AND DRUG METABOLISM

Absorption



Distribution



Metabolism and Elimination






Enantiomers



USE IN SPECIFIC POPULATIONS

Geriatric



Gender


Race



Renal Insufficiency






Hepatic Insufficiency

PRECAUTIONS

DRUG INTERACTIONS



Interactions with Substrates, Inhibitors or Inducers of Cytochrome P-450 Enzymes
Drug InteractionsPRECAUTIONS

Substrates or Inhibitors of CYP2D6


Substrates or Inhibitors of CYP1A2


Substrates or Inhibitors of CYP2C19


Inducers of Hepatic Drug Metabolism


Cardiovascular Drugs

Antiarrhythmics




Calcium Channel Blockers






Non-Cardiovascular Drugs

Migraine Drugs


Theophylline


Benzodiazepines



Neuroleptic Drugs



Anti-Ulcer Drugs



Lipid Lowering Drugs






PHARMACODYNAMICS AND CLINICAL EFFECTS

Hypertension




Angina Pectoris




Migraine


Hypertrophic Subaortic Stenosis



INDICATIONS & USAGE

Hypertension


Angina Pectoris Due to Coronary Atherosclerosis


Migraine


Hypertrophic Subaortic Stenosis


PROPRANOLOL HYDROCHLORIDE CONTRAINDICATIONS



WARNINGS

Angina Pectoris


Hypersensitivity and Skin Reactions
ADVERSE REACTIONS
ADVERSE REACTIONS

Cardiac Failure



Nonallergic Bronchospasm (e.g., Chronic Bronchitis, Emphysema)


Major Surgery



Diabetes and Hypoglycemia




Thyrotoxicosis


Wolff-Parkinson-White Syndrome


PRECAUTIONS

General



Clinical Laboratory Tests


DRUG INTERACTIONS

Drug InteractionsPHARMACOKINETICS AND DRUG METABOLISM


Cardiovascular Drugs

Antiarrhythmics






Digitalis Glycosides


Calcium Channel Blockers







Alpha Blockers



Reserpine


Inotropic Agents
OVERDOSAGE

Isoproterenol and Dobutamine


Non-Cardiovascular Drugs

Nonsteroidal Anti-Inflammatory Drugs



Antidepressants


Anesthetic Agents


Warfarin


Neuroleptic Drugs


Thyroxine


CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY



PREGNANCY

Pregnancy Category C



NURSING MOTHERS



PEDIATRIC USE




GERIATRIC USE



PROPRANOLOL HYDROCHLORIDE ADVERSE REACTIONS



Cardiovascular:


Central Nervous System:


Gastrointestinal:


Allergic:


Respiratory:


Hematologic:


Autoimmune:


Skin and mucous membranes:


Genitourinary:


OVERDOSAGE





Supportive Therapy:



DOSAGE & ADMINISTRATION





Hypertension


Angina Pectoris

WARNINGS

Migraine


Hypertrophic Subaortic Stenosis


HOW SUPPLIED







STORAGE AND HANDLING











PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Propranolol Hydrochloride

Propranolol Hydrochloride

Propranolol Hydrochloride

Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-420(NDC:0228-2779)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
PROPRANOLOL HYDROCHLORIDE PROPRANOLOL 80 mg

Inactive Ingredients

Ingredient Name Strength
ETHYLCELLULOSES
GELATIN
hydroxypropyl cellulose
povidone
D&C YELLOW NO. 10
talc
titanium dioxide
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
propylene glycol

Product Characteristics

Color Size Imprint Code Shape
yellow 16 mm 2779 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-420-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078494 2011-07-28


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