Amdova

Amlodipine and Atorvastatin
Tablet

1. What Amdova is and what it is used for?
Amdova® is a combination product containing Amlodipine Besilate BP equivalent to 5 mg Amlodipine, a calcium channel blocker and Atorvastatin calcium INN equivalent to 10 mg Atorvastatin, a 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 calcium is a synthetic lipid-lowering agent. It is an inhibitor of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA). This enzyme catalyzes the conversion of HMG-CoA to mevatonate, an early and rate limiting step in the synthesis of cholesterol.

Patients in whom treatment with Amlodipine and Atorvastatin is appropriate at the dose presented, which include hypertension, chronic stable angina, an adjunct to diet for hypercholesterolemia and in hypertensive patient with multiple risk factors for CHD to reduce the risk of non fatal MI and non fatal stroke.

2. Before you take Amdova
Do not take this medicine and tell your doctor if:

Amlodipine is contraindicated in patients with known hypersensitivity to Amlodipine. Atorvastatin is contraindicated in hypersensitivity to any component of this medication. Active liver disease or unexplained persistent elevations of serum transaminases exceeding three times the upper limit of normal. Do not take this medicine if the above applies to you. If you are not sure, talk to your doctor before taking Amdova.

Take special care with Amdova
Since the vasodilatation induced by Amlodipine is gradual in onset, acute hypotension has rarely been reported after oral administration of Amlodipine. Nonetheless, caution should be exercised when administering Amlodipine as with any other peripheral vasodilator particularly in patients with severe aortic stenosis. Use in Patients with Congestive Heart Failure: Although hemodynamic studies and a controlled trial in Class-II-III heart failure patients have shown that amlodipine did not lead to clinical deterioration as measured by exercise tolerance, left ventricular ejection fraction, and clinical symptoms. In general, all calcium channel blockers should be used with caution in patients with heart failure. Rhabdomyolysis with acute renal failure secondary to myoglobinuria has been reported with other drugs in the statin class. Atorvastatin may cause an elevation in serum creatine phosphokinase levels. This should be considered in the differential diagnosis of chest pain in patients on therapy with Atorvastatin. Uncomplicated myalgia has been reported in Atorvastatin-treated patients. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.

Taking other medicines
Caution should be exercised when administering Amlodipine as with any other peripheral vasodilator particularly in patients with severe aortic stenosis.

Pregnancy and breast-feeding
Safety in pregnancy has not been established.

3. How to take Amdova?
Amlodipine: The usual initial antihypertensive oral dose is 5 mg once daily with a maximum dose of 10 mg once daily. Elderly individuals or patients with hepatic insufficiency may be started on 2.5 mg once daily dose and this dose may be used when adding Amlodipine to other antihypertensive therapy. Dosage should be adjusted according to each patient's need. The recommended dose for chronic stable or vasospastic angina is 5-10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency.
Atorvastatin: Adults: The patient should be placed on a standard cholesterol-lowering diet before receiving Atorvastatin and should continue on this diet during treatment with Atorvastatin Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Types IIa and IIb): The recommended starting dose of Atorvastatin is 10 mg daily. The dosage range 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. Homozygous Familial Hypercholesterolemia: The dosage of Atorvastatin in patients with homozygous FH is 10 to 80 mg daily. Patients with renal insufficiency: Renal disease has no influence on the plasma concentrations or lipid effects of Atorvastatin; thus no adjustment of dose is required. Hemodialysis is not expected to significantly enhance the clearance of Atorvastatin since the drug is extensively bound to plasma proteins. Patients with hepatic dysfunction: In patients with moderate to severe hepatic dysfunction, the therapeutic response to Atorvastatin is unaffected but exposure to the drug is greatly increased.

If you take more Amdova than you should
In humans, experience with intentional overdosage of Amlodipine & Atorvastatin is limited. If massive overdosage occurs, active cardiac and respiratory monitoring should be instituted. Frequent blood pressure measurements are essential.

If you forget to take Amdova
If you forget to take a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose

If you stop taking Amdova
Do not stop taking this medicine without talking to your doctor. You should not stop taking Amdova just because you feel better. This is because the problem may come back or get worse again.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Amdova can cause side effects, although not everybody gets them.

Amlodipine: General: Since the vasodilatation induced by Amlodipine is gradual in onset, acute hypotension has rarely been reported after oral administration of Amlodipine. Nonetheless, caution should be exercised when administering Amlodipine as with any other peripheral vasodilator particularly in patients with severe aortic stenosis. Use in Patients with Congestive Heart Failure: Although hemodynamic studies and a controlled trial in Class-II-III heart failure patients have shown that Amlodipine did not lead to clinical deterioration as measured by exercise tolerance, left ventricular ejection fraction, and clinical symptoms. In general, all calcium channel blockers should be used with caution in patients with heart failure. Beta-blocker Rhabdomyolysis with acute renal failure secondary to myoglobinuria has been reported with other drugs in this class. Atorvastatin: Atorvastatin may cause an elevation in serum creatine phosphokinase levels. This should be considered in the differential diagnosis of chest pain in patients on therapy with Atorvastatin. Uncomplicated myalgia has been reported in Atorvastatin-treated patients. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Side effects: Atorvastatin is generally well tolerated. Adverse effects reported commonly include constipation, flatulence, dyspepsia, abdominal pain, headache, nausea, myalgia, diarrhea, asthenia and insomnia.
Tell your doctor if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet

5. How to store Amdova?
Store in cool & dry place, away from children.


Amdova Prescribing Information

Located in: Cardiovascular