Amlodipine Besylate Tablets Rx only
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
Pharmacokinetics and Metabolism
Pediatric Patients
Pharmacodynamics
Clinical Studies
| Composite CV Endpoint | 110(16.6) | 151(23.1) | 31%(0.003) |
| Hospitalization for Angina* | 51(7.7) | 84(12.8) | 42%(0.002) |
| CoronaryRevascularization* | 78(11.8) | 103(15.7) | 27%(0.033) |
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)
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
Drug/Laboratory Test Interactions
Carcinogenesis, Mutagenesis, Impairment of Fertility
Pregnancy Category C
Nursing Mothers
Pediatric Use
Geriatric Use
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
OVERDOSAGE
DOSAGE AND ADMINISTRATION
Adults
Children
Coadministration with Other Antihypertensive and/or Antianginal Drugs
HOW SUPPLIED
Amlodipine Besylate Tablets SUMMARY OF INFORMATION ABOUT AMLODIPINE BESYLATE TABLETS
- 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.