Generic Name
Atorvastatin
Brand Names
Amlodipine Besylate, Amlodipine, Olmesartan Medoxomil, Benazepril, Caduet, Azor, Tribenzor, Atorvaliq, Katerzia, Benicar, Lotrel, Olmesartan Medoxomil Amlodipine, Lipitor, Norliqva, Norvasc, Lotensin
FDA approval date: June 21, 1991
Classification: HMG-CoA Reductase Inhibitor
Form: Tablet, Suspension, Capsule, Solution
What is Amlodipine Besylate (Atorvastatin)?
Atorvastatin calcium tablets are indicated: To reduce the risk of: Myocardial infarction , stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia . As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia . As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia Atorvastatin calcium is an HMG-CoA reductase inhibitor indicated : To reduce the risk of: Myocardial infarction , stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease but without clinically evident CHD. MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia . As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia. As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia.
Approved To Treat
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Brand Information
Amlodipine Besylate (Amlodipine Besylate)
1OVERDOSAGE
Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. In humans, experience with intentional overdosage of amlodipine is limited.
Single oral doses of amlodipine maleate equivalent to 40 mg amlodipine/kg and 100 mg amlodipine/kg in mice and rats, respectively, caused deaths. Single oral amlodipine maleate doses equivalent to 4 or more mg amlodipine/kg or higher in dogs (11 or more times the maximum recommended human dose on a mg/m
If massive overdose should occur, initiate active cardiac and respiratory monitoring. Frequent blood pressure measurements are essential. Should hypotension occur, provide cardiovascular support including elevation of the extremities and the judicious administration of fluids. If hypotension remains unresponsive to these conservative measures, consider administration of vasopressors (such as phenylephrine) with attention to circulating volume and urine output. As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit.
2DESCRIPTION
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, monobenzenesulphonate. Its empirical formula is C
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 USP are formulated as tablets equivalent to 2.5 mg, 5 mg and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: colloidal silicon dioxide, dicalcium phosphate anhydrous, FD & C red no. 40 aluminum lake (only for 2.5 mg strength), magnesium stearate, microcrystalline cellulose and povidone.
Amlodipine besylate tablets USP meet USP Dissolution Test 2.
3PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
AMLODIPINE BESYLATE TABLETS USP
Rx only
2.5 mg
NDC 68180-750-09
90 Tablets
AMLODIPINE BESYLATE TABLETS USP
Rx Only
2.5 mg
NDC 68180-719-09
90 Tablets
AMLODIPINE BESYLATE TABLETS USP
Rx Only
2.5 mg
NDC 68180-233-01
90 Tablets
AMLODIPINE BESYLATE TABLETS USP
Rx Only
2.5 mg
NDC 68180-233-01 (With New Strength Bar Color)
90 Tablets
AMLODIPINE BESYLATE TABLETS USP
Rx Only
5 mg
NDC 68180-751-09
90 Tablets
AMLODIPINE BESYLATE TABLETS USP
Rx Only
5 mg
NDC 68180-720-09
90 Tablets
AMLODIPINE BESYLATE TABLETS USP
Rx Only
5 mg
NDC 68180-455-01
90 Tablets
AMLODIPINE BESYLATE TABLETS USP
Rx Only
5 mg
NDC 68180-455-01 (With New Strength Bar Color)
90 Tablets
AMLODIPINE BESYLATE TABLETS USP
Rx Only
10 mg
NDC 68180-752-09
90 Tablets
AMLODIPINE BESYLATE TABLETS USP
Rx Only
10 mg
NDC 68180-721-09
90 Tablets
