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

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Diltiazem Hydrochloride

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DILTIAZEM HYDROCHLORIDE DESCRIPTION


Diltiazem Hydrochloride






CLINICAL PHARMACOLOGY



Mechanisms of Action


1. Angina Due to Coronary Artery Spasm


2. Exertional Angina





Hemodynamic and Electrophysiologic Effects





Pharmacokinetics and Metabolism



INDICATIONS & USAGE



DILTIAZEM HYDROCHLORIDE CONTRAINDICATIONS



WARNINGS

WARNINGS

1. Cardiac Conduction
ADVERSE REACTIONS

2. Congestive Heart Failure


3. Hypotension


4. Acute Hepatic Injury
PRECAUTIONS

PRECAUTIONS

General

ADVERSE REACTIONS

DRUG INTERACTIONS

Drug Interactions
WARNINGS
WARNINGS


Beta-Blockers

WARNINGS

Cimetidine


Digitalis
WARNINGS

Anesthetics


Cyclosporine


Carbamazepine


CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

Carcinogenesis, Mutagenesis, Impairment of Fertility


PREGNANCY

Teratogenic Effects

Pregnancy Category C



NURSING MOTHERS



PEDIATRIC USE

Pediatric Use


DILTIAZEM HYDROCHLORIDE ADVERSE REACTIONS

ADVERSE REACTIONS




conduction warning

hepatic warnings





OVERDOSAGE

OVERDOSAGE OR EXAGGERATED RESPONSE












DOSAGE & ADMINISTRATION

Exertional Angina Pectoris Due to Atherosclerotic Coronary Artery Disease or Angina Pectoris at Rest Due to Coronary Artery Spasm


Concomitant Use with Other Cardiovascular Agents


WARNINGSPRECAUTIONS

HOW SUPPLIED





















STORAGE AND HANDLING









INACTIVE INGREDIENT

INACTIVE INGREDIENT
ethylcellulose

hypromellose
lactose monohydrate
magnesium stearate
maltodextrin
polyethylene glycol
sodium lauryl sulfate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Diltiazem Hydrochloride

Diltiazem Hydrochloride

Diltiazem Hydrochloride

Diltiazem Hydrochloride TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-242(NDC:0378-0045)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE DILTIAZEM 60 mg

Inactive Ingredients

Ingredient Name Strength
ETHYLCELLULOSES
HYPROMELLOSES
lactose monohydrate
MAGNESIUM STEARATE
maltodextrin
polyethylene glycol
SODIUM LAURYL SULFATE

Product Characteristics

Color Size Imprint Code Shape
white 10 mm M;45 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-242-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA073186 2011-03-23


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Be sure to consult your doctor before taking any medication!
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