AMLODIPINE BESYLATE
Amlodipine Besylate Tablets Rx only
FULL PRESCRIBING INFORMATION: CONTENTS*
- AMLODIPINE BESYLATE DESCRIPTION
- CLINICAL PHARMACOLOGY
- AMLODIPINE BESYLATE INDICATIONS AND USAGE
- AMLODIPINE BESYLATE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- AMLODIPINE BESYLATE ADVERSE REACTIONS
- OVERDOSAGE
- AMLODIPINE BESYLATE DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- Amlodipine Besylate Tablets SUMMARY OF INFORMATION ABOUT AMLODIPINE BESYLATE TABLETS
FULL PRESCRIBING INFORMATION
AMLODIPINE BESYLATE DESCRIPTION
Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker.
Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzene-sulphonate. Its molecular formula is C20H25CIN2O5• C6H6O3S, and its structural formula is:
Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets are formulated as white tablets equivalent to 2.5, 5 and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: sodium starch glycolate, mannitol, microcrystalline cellulose, dibasic calcium phosphate anhydrous, colloidal silicon dioxide and magnesium stearate.
CLINICAL PHARMACOLOGY
Mechanism of Action
a2in vitro
Pharmacokinetics and Metabolism
Ex vivo
Pediatric Patients
Pharmacodynamics
Electrophysiologic Effects:
Clinical Studies
Effects in HypertensionAdult Patients:
Pediatric Patients:
ffects in Chronic Stable Angina:
Effects in Vasospastic Angina:
Effects in Documented Coronary Artery Disease:
| Clinical Outcomes N (%) |
Amlodipine (N=663) |
Placebo (N=655) |
Risk Reduction (p-value) |
|---|---|---|---|
| Composite CV Endpoint | 110 (16.6) |
151 (23.1) |
31% (0.003) |
| Hospitalization for Angina* |
51 (7.7) |
84 (12.8) |
42% (0.002) |
| Coronary Revascularization* |
78 (11.8) |
103 (15.7) |
27% (0.033) |
Studies in Patients with Congestive Heart Failure:
AMLODIPINE BESYLATE INDICATIONS AND USAGE
- Hypertension Amlodipine is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
- Coronary Artery Disease (CAD)
Vasospastic Angina (Prinzmetal's or Variant Angina)
Angiographically Documented CAD
AMLODIPINE BESYLATE CONTRAINDICATIONS
Amlodipine is contraindicated in patients with known sensitivity to amlodipine.
WARNINGS
PRECAUTIONS
General
Use in Patients with Congestive Heart Failure
Beta-Blocker Withdrawal
Patients with Hepatic Failure
Drug Interactions
In vitroEffect of other agents on amlodipine.
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Effect of amlodipine on other agents.
Drug/Laboratory Test Interactions
Carcinogenesis, Mutagenesis, Impairment of Fertility
222
Pregnancy Category C
2Nursing Mothers
Pediatric Use
Geriatric Use
AMLODIPINE BESYLATE ADVERSE REACTIONS
Placebo-Controlled Studies
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 PHARMACOLOGY Clinical StudiesStudies in Patients with Coronary Artery Disease
OVERDOSAGE
2AMLODIPINE BESYLATE DOSAGE AND ADMINISTRATION
Adults
ADVERSE REACTIONS
CLINICAL PHARMACOLOGY, Clinical Studies
Children
CLINICAL PHARMACOLOGY.Coadministration with Other Antihypertensive and/or Antianginal Drugs
HOW SUPPLIED
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Amlodipine Besylate Tablets SUMMARY OF INFORMATION ABOUT AMLODIPINE BESYLATE TABLETS
amlodipine amlodipineWhat is amlodipine?
High Blood Pressure (hypertension)
Amlodipine
Angina
Amlodipine
Who should not use amlodipine?
amlodipineamlodipine,amlodipine besylate tablets
What should I tell my doctor before taking amlodipine?
- ever had heart disease
- ever had liver problems
- are pregnant, or plan to become pregnant. Your doctor will decide if amlodipine is the best treatment for you.
- are breast-feeding. Do not breast feed while taking amlodipine. You can stop breastfeeding or take a different medicine.
- Take amlodipine once a day, with or without food. You can take amlodipine 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 at a time.
- If you miss a dose, take it as soon as you remember. Do not take amlodipine 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 together. If you take nitroglycerin for angina, don't stop taking it while you are taking amlodipine.
- While you are taking amlodipine, 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, 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 will pass through your milk.
- Do not start any new prescription or non-prescription medicines or supplements, unless you check with your doctor first.
Amlodipine
- 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)
amlodipine
How do I store amlodipine?
amlodipine besylate tablets amlodipine besylate tablets
amlodipine besylate tablets
amlodipine besylate tablets
General advice about amlodipine
amlodipineamlodipine
amlodipine besylate tabletswww.wockhardtusa.com
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AMLODIPINE BESYLATEAMLODIPINE BESYLATE TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
