Amdova

Indications

Patients in whom treatment with Amlodipine and Atorvastatin is appropriate at the dose presented, including: hypertension, chronic stable angina, as an adjunct to diet for hypercholesterolemia, and in hypertensive patients with multiple risk factors for CHD to reduce the risk of nonfatal MI and nonfatal stroke. Amlodipine: hypertension, chronic stable angina, vasospastic angina. Atorvastatin: adjunct to diet to reduce elevated total cholesterol, LDL-cholesterol, apolipoprotein B and triglyceride levels in primary hypercholesterolemia and mixed dyslipidemia.

Pharmacology

It is a combination product containing Amlodipine Besilate (calcium channel blocker) and Atorvastatin calcium (statin/HMG-CoA reductase inhibitor). Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure. Atorvastatin inhibits HMG-CoA reductase, the enzyme catalyzing the conversion of HMG-CoA to mevalonate, an early and rate limiting step in the biosynthesis of cholesterol.

Dosage & Administration

Amlodipine: Usual initial antihypertensive oral dose is 5 mg once daily, maximum 10 mg once daily. Elderly or hepatic insufficiency patients: start on 2.5 mg once daily. For angina: 5-10 mg once daily, lower dose for elderly and hepatic insufficiency. Atorvastatin: Recommended starting dose is 10 mg daily. Dosage range is 10 to 80 mg once daily. Can be administered at any time of day with or without food.

Side Effects

Amlodipine: dizziness, flushing, headache, hypotension, peripheral edema, gastrointestinal disturbances, lethargy. Atorvastatin: constipation, flatulence, dyspepsia, abdominal pain, headache, nausea, myalgia, diarrhea, asthenia, insomnia. Rhabdomyolysis with acute renal failure secondary to myoglobinuria has been reported rarely.

Precautions & Warnings

Liver Dysfunction: HMG-CoA reductase inhibitors have been associated with biochemical abnormalities of liver function. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Amlodipine may increase frequency, duration or severity of angina in patients with severe obstructive coronary artery disease at the start of therapy.

Contraindications

Amlodipine: hypersensitivity to Amlodipine. Atorvastatin: hypersensitivity to any component; active liver disease or unexplained persistent elevations of serum transaminases exceeding three times the upper limit of normal.

Pregnancy & Lactation

Safety in pregnancy has not been established. Use of HMG-CoA reductase inhibitors during breastfeeding is not recommended.

Storage Conditions

Store in a cool and dry place. Protect from light and moisture. Keep all medicines out of the reach of children.

Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always consult your physician or pharmacist before starting any medication.