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







CLINICAL STUDIES

Effects in Hypertension






Effects in Documented Coronary Artery Disease:





Table 1


Amlodipine Besylate

Amlodipine Besylate







INDICATIONS & USAGE

1. Hypertension


2. Coronary Artery Disease (CAD)
Chronic Stable Angina







AMLODIPINE BESYLATE CONTRAINDICATIONS



WARNINGS

Increased Angina and/or Myocardial Infarction:

PRECAUTIONS

General:

Use in Patients with Congestive Heart Failure:CLINICAL PHARMACOLOGY
Beta-Blocker Withdrawal:
Patients with Hepatic Failure:

DRUG INTERACTIONS


Effect of other agents on amlodipine besylate tablets.




Effect of Amlodipine besylate tablets on other agents.






DRUG & OR LABORATORY TEST INTERACTIONS



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY





PREGNANCY

Category C:



NURSING MOTHERS



PEDIATRIC USE



GERIATRIC USE

DOSAGE AND ADMINISTRATION

AMLODIPINE BESYLATE ADVERSE REACTIONS





Cardiovascular:
Central and Peripheral Nervous System:
Gastrointestinal:
General:
Musculoskeletal System
Psychiatric:
Respiratory System:
Skin and Appendages:

Special Senses:
Urinary System:
Autonomic Nervous System:
Metabolic and Nutritional
Hemopoietic:



CLINICAL PHARMACOLOGYClinical Studies



OVERDOSAGE







DOSAGE & ADMINISTRATION


Adults:


ADVERSE REACTIONS
CLINICAL PHARMACOLOGYClinical Studies
Children:CLINICAL PHARMACOLOGY
Co-administration with Other Antihypertensive and/or Antianginal Drugs:

HOW SUPPLIED

2.5 mg Tablets





5 mg Tablets






10 mg Tablets







STORAGE AND HANDLING




SPL MEDGUIDE

Amlodipine Besylate Tablets


What are amlodipine besylate tablets?



High Blood Pressure (hypertension)


Angina


Who should not use amlodipine besylate tablets?


What should I tell my doctor before taking amlodipine besylate tablets?

  • ●     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.
How should I take amlodipine besylate tablets?
  • ●     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 besylate tablets 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.
What should I avoid while taking amlodipine besylate tablets?
  • ●     Do not breast-feed. It is not known if amlodipine besylate tablets will pass through your milk.
  • ●     Do not start any new prescription or non-prescription medicines or supplements, unless you check with your doctor first.
What are the possible side effects of amlodipine besylate tablets?

  • ●     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)




How do I store amlodipine besylate tablets?


General advice about amlodipine besylate tablets





PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Amlodipine Besylate

Amlodipine Besylate

Amlodipine Besylate TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-510(NDC:64679-422)
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
cellulose, microcrystalline
SODIUM STARCH GLYCOLATE TYPE A POTATO
mannitol
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MAGNESIUM STEARATE
SILICON DIOXIDE

Product Characteristics

Color Size Imprint Code Shape
white 9 mm W;422 BULLET

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-510-19 90 in 1 CANISTER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078500 2011-09-14


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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