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

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Amlodipine Besylate

Lake Erie Medical DBA Quality Care Products LLC

Amlodipine Besylate 5 mg




FULL PRESCRIBING INFORMATION



202525663




in vitro







in vitro

















Ex vivo







Uses




Chronic Stable Angina


Vasospastic Angina (Prinzmetal's or Variant Angina)


Angiographically Documented CAD










2









[see
Adverse Reactions (6)].

[see Clinical Studies (14.4)]

[see Clinical Pharmacology (12.4), Clinical Studies (14.1)]














AMLODIPINE BESYLATE TABLETS 2.5 mg, 5 mg, and 10 mg


What is amlodipine besylate?


High Blood Pressure (hypertension)


Angina


Who should not use amlodipine besylate?


What should I tell my doctor before taking amlodipine besylate?

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

How should I take amlodipine besylate?
  • Take amlodipine besylate tablets once a day, with or without food. You can take amlodipine besylate 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 at a time.
  • If you miss a dose, take it as soon as you remember. Do not take amlodipine besylate 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 together. If you take nitroglycerin for angina, don't stop taking it while you are taking amlodipine besylate.
  • While you are taking amlodipine besylate, 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, 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?
  • Do not breast-feed. It is not known if amlodipine besylate 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?
  • 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





Image of labelAmlodipine Besylate

Amlodipine Besylate

Amlodipine Besylate TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:35356-059(NDC:51991-667)
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
white (off whit) 8 mm 210 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:35356-059-90 90 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078925 2010-11-04


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Be sure to consult your doctor before taking any medication!
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