Rx only

DESCRIPTION

Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker.

CLINICAL PHARMACOLOGY

Clinical Studies
Effects in Hypertension
Adult Patients:   

Pediatric Patients:

Effects in Chronic Stable Angina:

Effects in Vasospastic Angina:

Effects in Documented Coronary Artery Disease:

INDICATIONS AND USAGE

CONTRAINDICATIONS
Amlodipine besylate tablets are contraindicated in patients with known sensitivity to amlodipine.

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: 1/2

Drug Interactions
In vitro

Effect of other agents on amlodipine

®Effect of amlodipine on other agents

Drug/Laboratory Test Interactions

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Pregnancy Category C

Nursing Mothers

Pediatric Use

Geriatric Use

Clinical studies of amlodipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients have decreased clearance of amlodipine with a resulting increase of AUC of approximately 40 to 60%, and a lower initial dose may be required (see DOSAGE AND ADMINISTRATION).

ADVERSE REACTIONS
 

OVERDOSAGE
2 

 DOSAGE AND ADMINISTRATION
Adults:
The recommended dose for chronic stable or vasospastic angina is 5 to10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg for adequate effect. See ADVERSE REACTIONS section for information related to dosage and side effects.
CLINICAL PHARMACOLOGY, Clinical Studies

Children: CLINICAL PHARMACOLOGY

Coadministration with Other Antihypertensive and/or Antianginal Drugs

 HOW SUPPLIED

SPL Patient Package Insert

SUMMARY OF INFORMATION ABOUT

AMLODIPINE BESYLATE TABLETS 2.5 mg, 5 mg and 10 mg

Read this information carefully before you start amlodipine besylate tablets and each time you refill your prescription. There may be new information. This information does not replace talking with your doctor. If you have any questions about amlodipine besylate tablets, ask your doctor. Your doctor will know if amlodipine besylate tablets is right for you.

What is amlodipine besylate?

Amlodipine besylate is a type of medicine known as a calcium channel blocker (CCB). It is used to treat high blood pressure (hypertension) and a type of chest pain called angina. It can be used by itself or with other medicines to treat these conditions.

High Blood Pressure (hypertension)

High blood pressure comes from blood pushing too hard against your blood vessels.

Amlodipine besylate relaxes your blood vessels which lets your blood flow more easily and helps lower your blood pressure. Drugs that lower blood pressure lower your risk of having a stroke or heart attack.

Angina

Angina is a pain or discomfort that keeps coming back when part of your heart does not get enough blood. Angina feels like a pressing or squeezing pain, usually in your chest under the breastbone. Sometimes you can feel it in your shoulders, arms, neck, jaws, or back. Amlodipine besylate can relieve this pain.

Who should not use amlodipine besylate?

Do not use amlodipine besylate if you are allergic to amlodipine, (the active ingredient in amlodipine besylate), or to the inactive ingredients. Your doctor or pharmacist can give you a list of these ingredients.

What should I tell my doctor before taking amlodipine besylate?

Tell your doctor about any prescription and non-prescription medicines you are taking, including natural or herbal remedies.
 

• 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.

• Take amlodipine besylate 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, 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 you 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.

• Do not breastfeed. 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.

• 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?

General advice about amlodipine besylate

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – AMLODIPINE BESYLATE TABLETS 2.5 mg

NDC -51991-666-90
Bottle of 90 tablets
Rx Only

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – AMLODIPINE BESYLATE TABLETS 5 mg

NDC -51991-667-90
Bottle of 90 tablets
Rx Only

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – AMLODIPINE BESYLATE TABLETS 10 mg

NDC -51991-668-90
Bottle of 90 tablets
Rx Only