ATV Plus

Each film coated tablet contains Amlodipine (as besilate) 5 mg, Atorvastatin (as calcium) 10 mg.
This tablet combines the long-acting calcium channel blocker amlodipine besilate with the synthetic lipid-lowering agent atorvastatin calcium.

Pharmacology: Pharmacodynamics: Mechanism of Action: It is a combination of two drugs, a dihydropyridine calcium antagonist (calcium-channel blocker) amlodipine (antihypertensive/antianginal agent) and an HMG-CoA reductase inhibitor atorvastatin (cholesterol lowering agent). Amlodipine inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase (statin), the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol.

It is indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate.
Amlodipine: Hypertension.
Coronary Artery Disease (CAD): Chronic Stable Angina; Vasospastic Angina (Prinzmetal's or Variant Angina); Angiographically Documented CAD.
Atorvastatin: Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended, as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD (Coronary Heart Disease) or multiple risk factors for CHD (Coronary Heart Disease), the atorvastatin component can be started simultaneously with diet.
Prevention of Cardiovascular Diseases: In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDLC or a family history of early coronary heart disease, atorvastatin is indicated to: Reduce the risk of myocardial infarction; Reduce the risk of stroke; Reduce the risk for revascularization procedures and angina.
In patients with type 2 diabetes and without clinically evident coronary heart disease but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking or hypertension, it is indicated to: Reduce the risk of myocardial infarction; Reduce the risk of stroke.
In patients with clinically evident coronary heart disease, it is indicated to: Reduce the risk of non-fatal myocardial infarction; Reduce the risk of fatal and non-fatal stroke; Reduce the risk for revascularization procedures; Reduce the risk of hospitalization for CHF (Congestive Heart Failure); Reduce the risk of angina.
Heterozygous Familial and Nonfamilial Hyperlipidaemia: Atorvastatin is indicated as an adjunct to diet to reduce elevated total-C, LDL-C, apo B and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb).
Elevated Serum TG Levels: Atorvastatin is indicated as an adjunct to diet for the treatment of patients with elevated serum TG levels (Fredrickson Type IV).
Primary Dysbetalipoproteinemia: Atorvastatin is indicated for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet.
Homozygous Familial Hypercholesterolemia: Atorvastatin is indicated to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.
Pediatric Patients: Atorvastatin is indicated as an adjunct to diet to reduce total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: a. LDL-C remains ≥190 mg/dL or; b. LDL-C remains ≥160 mg/dL and: There is a positive family history of premature cardiovascular disease or; Two or more other CVD risk factors are present in the pediatric patients.

It must be individualized on the basis of both effectiveness and tolerance for each individual component in the treatment of hypertension/angina and hyperlipidaemia.
Amlodipine (Hypertension or angina): Adults: The usual initial antihypertensive oral dose of amlodipine is 5 mg once daily with a maximum dose of 10 mg once daily. The recommended dose of amlodipine for chronic stable or vasospastic angina is 5-10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. The recommended dose range of amlodipine for patients with coronary artery disease is 5-10 mg once daily.
Children: The effective antihypertensive oral dose of amlodipine in pediatric patients ages 6-17 years is 2.5 mg to 5 mg once daily.
Atorvastatin (Hyperlipidaemia): Hyperlipidaemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Types IIa and IIb): The recommended starting dose of atorvastatin is 10 or 20 mg once daily.
The dosage range of atorvastatin is 10 to 80 mg once daily. Atorvastatin can be administered as a single dose at any time of the day, with or without food.
Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10-17 years of age): The recommended starting dose of atorvastatin is 10 mg/day; the maximum recommended dose is 20 mg/day.
Homozygous Familial Hypercholesterolemia: The dosage of atorvastatin in patients with homozygous FH is 10 to 80 mg daily.

It is contraindicated in patients with active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels, in patients with known hypersensitivity to any component of this medication, women who are pregnant or may become pregnant and nursing mother.

Pregnancy: Pregnancy Category X. Atorvastatin is contraindicated in women who are pregnant or may become pregnant. Atorvastatin may cause fetal harm when administered to a pregnant woman. It should be administered to women of childbearing potential only when such patients are highly unlikely to conceive and have been informed of the potential hazards.
Nursing Mothers: It is not known whether amlodipine is excreted in human milk. It is not known whether atorvastatin excreted in human milk, but a small amount of another drug in this class does pass into breast milk. Women taking this medicine, which includes atorvastatin, should be advised not to nurse their infants.

Common side effects of this medicine include: headache, dizziness, tiredness, extreme sleepiness, stomach pain, nausea, upset stomach, diarrhea, swelling of legs or ankles (edema), hot or warm feeling in face (flushing), irregular heartbeat (arrhythmia), very fast heartbeat (heart palpitations), muscle and joint pain, constipation, flatulence and dyspepsia.

It can potentially interact with several other medications. Some of the medicines that may lead to this drug interactions include: antacids, oral contraceptives, certain antibiotics or anti-fungals, filtrates, grapefruit juice, niacin, protease inhibitors, rifampin, digoxin and spironolactone.

Store at a temperatures not exceeding 30°C. Keep in a dry place away from light and heat.

Calcium Antagonists / Dyslipidaemic Agents

C10BX03 - atorvastatin and amlodipine ; Belongs to the class of HMG CoA reductase inhibitors, other combinations.

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