SB-Amloator Tablet

It 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-CoAto mevatonate, an early and rate limiting step in the synthesis of cholesterol.

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:

• 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.

Drug interaction with atorvastatin: The risk of myopathy during treatment with drugs of this class is increased with concurrent administration of cyclosporine, fibric acid derivatives, niacin (nicotinic acid), erythromycin, azole antifungals. When atorvastatin and antacid suspension containing magnesium and aluminum hydroxide were co administered, plasma concentrations of atorvastatin decreased approximately 35%. However, LDL-C reduction was not altered. Plasma concentrations of atorvastatin decreased approximately 25% when colestipol and atorvastatin were co administered. However, LDL-C reduction was greater when atorvastatin and colestipol were co-administered than when either drug was given alone. When multiple doses of atorvastatin and digoxin were co-administered, steady state plasma digoxin concentrations increased by approximately 20%. Patients taking digoxin should be monitored appropriately. In healthy individuals, plasma concentrations of atorvastatin increased approximately 40% with co- administration of atorvastatin and erythromycin. Co- administration of atorvastatin and an oral contraceptive increased AUC values for norethindrone and ethinylestradiol by approximately 30% and 20%. These increases should be considered when selecting an oral contraceptive for a woman taking atorvastatin.
 
Drug interaction with amlodipine: Amlodipine may potentiate the effect of other antihypertensive (e.g.Beta-blockers, ACE inhibitors, Alpha-1-blockers and Diuretics). In clinical interaction studies, Amlodipine did not affect the pharmacokinetics of Atorvastatin, Digoxin, Warfarin or Cyclosporine.

Amlodipine: Amlodipine is contraindicated in patients with known hypersensitivity to Amlodipine. Atorvastatin: Contraindicated in hypersensitivity to any component of this medication. Active liver disease or unexplained persistent elevations of serum transaminases exceed three times the upper limit of normal.

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.

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

Warning: Increased Angina and/or Myocardial Infarction Rarely, patients, particularly those with severe obstructive coronary artery disease, have developed documented increased frequency, duration and/or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase. The mechanism of this effect has not been elucidated. Liver Dysfunction. HMG-CoA reductase inhibitors, like some other lipid-lowering therapies, have been associated with biochemical abnormalities of liver function. Precaution

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.

Atorvastatin: Rhabdomyolysis with acute renal failure secondary to myoglobinuria has been reported with other drugs in this 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.

Pediatrics: Safety and efficacy of Atorvastatin have not been established in children.

Geriatrics: Efficacy and safety in older patients using recommended doses is similar to that seen in the general population.

Anti-anginal & lipid lowering drugs

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