Amlodipine Besylate description, usages, side effects, indications, overdosage, supplying and lots more!

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Amlodipine Besylate

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

AMLODIPINE BESYLATE DESCRIPTION



Amlodipine Besylate



CLINICAL PHARMACOLOGY

Mechanism of Action






PHARMACOKINETICS AND METABOLISM






Pediatric Patients


PHARMACODYNAMICS

Hemodynamics





Electrophysiologic Effects:


CLINICAL STUDIES

Effects in Hypertension

Adult Patients:


Pediatric Patients:


Effects in Chronic Stable Angina:


Effects in Vasospastic Angina:


Studies in Patients with Congestive Heart Failure:



INDICATIONS & USAGE

Hypertension

Chronic Stable Angina

Vasospastic Angina (Prinzmetal's or Variant Angina)


AMLODIPINE BESYLATE CONTRAINDICATIONS



WARNINGS

Increased Angina and/or Myocardial Infarction:


PRECAUTIONS

General:


Use in Patients with Congestive Heart Failure:


Beta-Blocker Withdrawal:


Patients with Hepatic Failure:


DRUG INTERACTIONS



Effect of other agents on amlodipine.





Effect of amlodipine on other agents.






DRUG & OR LABORATORY TEST INTERACTIONS



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY





PREGNANCY

Category C:



NURSING MOTHERS



PEDIATRIC USE



GERIATRIC USE



AMLODIPINE BESYLATE ADVERSE REACTIONS




























OVERDOSAGE





DOSAGE & ADMINISTRATION

Adults:




Children:


Coadministration with Other Antihypertensive and/or Antianginal Drugs:


HOW SUPPLIED




STORAGE AND HANDLING



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Amlodipine Besylate

Amlodipine Besylate

Amlodipine Besylate

Amlodipine Besylate TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-295(NDC:31722-238)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
amlodipine besylate AMLODIPINE 5 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MAGNESIUM STEARATE
cellulose, microcrystalline
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
white 8 mm 238;IG ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-295-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077955 2011-08-22


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Be sure to consult your doctor before taking any medication!
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