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




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 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.

  • ●     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.


  • ●     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)














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:49349-381(NDC:64679-423)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
amlodipine besylate AMLODIPINE 10 mg

Inactive Ingredients

Ingredient Name Strength
SODIUM STARCH GLYCOLATE TYPE A POTATO
mannitol
cellulose, microcrystalline
MAGNESIUM STEARATE
SILICON DIOXIDE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE

Product Characteristics

Color Size Imprint Code Shape
white 11 mm W;423 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-381-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078500 2011-08-22


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Be sure to consult your doctor before taking any medication!
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