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




Exertional Angina


Vasospastic Angina


PHARMACOKINETICS

Pharmacokinetics and Metabolism





Pediatric Patients


PHARMACODYNAMICS

Pharmacodynamics

Hemodynamics





Electrophysiologic Effects


CLINICAL STUDIES

CLINICAL STUDIES

Effects in Hypertension

Adult patients


Pediatric patients


Effects in Chronic Stable Angina


Effects in Vasospastic Angina


Effects in Documented Coronary Artery Disease



Amlodipine Besylate


Amlodipine Besylate





Studies in Patients With Congestive Heart Failure



INDICATIONS & USAGE

1. Hypertension


2. Coronary Artery Disease (CAD)

Chronic Stable Angina






AMLODIPINE BESYLATE CONTRAINDICATIONS

CONTRAINDICATIONS


WARNINGS

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

Drug Interactions


Effect of Other Agents on Amlodipine Besylate Tablets





Effect of Amlodipine Besylate Tablets on Other Agents






DRUG & OR LABORATORY TEST INTERACTIONS

Drug/Laboratory Test Interactions


CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

Carcinogenesis, Mutagenesis, Impairment of Fertility




PREGNANCY

Teratogenic Effects

Pregnancy category C



NURSING MOTHERS

Nursing Mothers


PEDIATRIC USE

Pediatric Use


GERIATRIC USE

Geriatric Use


AMLODIPINE BESYLATE ADVERSE REACTIONS

ADVERSE REACTIONS


























OVERDOSAGE

OVERDOSAGE




DOSAGE & ADMINISTRATION

Adults





Pediatric Patients


Coadministration With Other Antihypertensive and/or Antianginal Drugs


HOW SUPPLIED



2.5 mg Tablets






5 mg Tablets






10 mg Tablets






STORAGE AND HANDLING






SPL PATIENT PACKAGE INSERT














  • ●     ever had heart disease
  • ●     ever had liver problems
  • ●     are pregnant, or plan to become pregnant. Your doctor will decide if amlodipine besylate tablets are the best treatment for you.
  • ●     are breast-feeding. Do not breast-feed while taking amlodipine besylate tablets. You can stop breast-feeding or take a different medicine.

  • ●     Take amlodipine besylate tablets once a day, with or without food. You can take amlodipine besylate tablets with most drinks, including grapefruit juice.
  • ●     It may be easier to take your dose if you do it at the same time every day, such as with breakfast or dinner, or at bedtime. Do not take more than one dose of amlodipine at a time.
  • ●     If you miss a dose, take it as soon as you remember. Do not take amlodipine besylate tablets if it has been more than 12 hours since you missed your last dose. Wait and take the next dose at your regular time.
  • ●     Other medicines: You can use nitroglycerin and amlodipine besylate tablets together. If you take nitroglycerin for angina, don't stop taking it while you are taking amlodipine besylate tablets.
  • ●     While you are taking amlodipine besylate tablets, do not stop taking your other prescription medicines, including any other blood pressure medicines, without talking to your doctor.
  • ●     If you took too much amlodipine besylate tablets, call your doctor or Poison Control Center, or go to the nearest hospital emergency room right away.

  • ●     Do not breast-feed. It is not known if amlodipine will pass through your milk.
  • ●     Do not start any new prescription or non-prescription medicines or supplements, unless you check with your doctor first.


  • ●     headache
  • ●     swelling of your legs or ankles
  • ●     tiredness, extreme sleepiness
  • ●     stomach pain, nausea
  • ●     dizziness
  • ●     flushing (hot or warm feeling in your face)
  • ●     arrhythmia (irregular heartbeat)
  • ●     heart palpitations (very fast heartbeat)











































INACTIVE INGREDIENT

INACTIVE INGREDIENTS:
SILICON DIOXIDE

ANHYDROUS DIBASIC CALCIUM PHOSPHATE
FD&C BLUE NO. 2
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO

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:49349-143(NDC:0378-5208-77)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
amlodipine besylate AMLODIPINE 2.5 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
FD&C BLUE NO. 2
MAGNESIUM STEARATE
cellulose, microcrystalline
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics

Color Size Imprint Code Shape
blue 6 mm M;A8 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-143-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076418 2011-04-08


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Be sure to consult your doctor before taking any medication!
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