Taven 10

Generic

Atorvastatin Calcium

 

Indications

Atorvastatin is indicated as an adjunct to diet for the reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in patients with- Primary hypercholesterolemia- heterozygous familial and non-familial hypercholesterolemia and mixed dyslipidemia (Fredrickson types IIa and IIb) Elevated serum TG levels (Fredrickson type IV) Primary dysbetalipoproteinemia (Fredrickson type III) who do not respond adequately to diet. Homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (LDL apheresis) or if such treatments are unavailable.

 

Pharmacology

Atorvastatin may be a specific inhibitor of HMG-CoA reductase. This chemical is the rate limiting protein mindful for the transformation of HMG-CoA to mevalonate, a forerunner of sterols, counting cholesterol. Atorvastatin brings down plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol union within the liver and increments the number of hepatic LDL receptors on the cell surface for improved take-up and catabolism of LDL.

 

Dosage & Administration

Patients should be placed on a standard cholesterol-lowering diet before receiving Taven 10 should continue on this diet during treatment with Atorvastatin. The usual starting dose for all the indications is 10mg once daily. The doses range is 10 to 80 mg once daily. Doses should be individualized according to tobaseline LDL-C levels, the goal of therapy, and patient response. Adjustment of dosage should be made at intervals of 4 weeks or more. Doses may be given at any time of day with or without food.

 

Interaction

Taven 10 is indicated as an adjunct to diet for the reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in patients with- Primary hypercholesterolemia- heterozygous familial and non-familial hypercholesterolemia and mixed dyslipidemia (Fredrickson types IIa and IIb) Elevated serum TG levels (Fredrickson type IV) Primary dysbetalipoproteinemia (Fredrickson type III) who do not respond adequately to diet. Homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (LDL apheresis) or if such treatments are unavailable.

 

Contraindications

Taven 10 is contraindicated in patients with hypersensitivity to any component of this medication, active liver disease or unexplained persistent elevations of serum transaminases, during pregnancy, while breastfeeding, and in women of child-bearing potential not using appropriate contraceptive measures.

 

Side Effects

Taven 10 is generally well tolerated. Adverse reactions have usually been mild and transient. Reversible myositis is a rare but significant side effect of statins. The statins also cause headache, altered liver function tests, and gastrointestinal effects including abdominal pain, flatulence, diarrhea, nausea, and vomiting. Thrombocytopenia, rash, and hypersensitivity reactions have been reported rarely. Other side effects are reported with Taven 10 therapy include insomnia, angioedema, anorexia, asthenia, paraesthesia, peripheral neuropathy, alopecia, pruritus, rash, impotence, chest pain, hypoglycemia and hyperglycemia.

 

Pregnancy & Lactation

Taven 10 is contraindicated in pregnancy and while breastfeeding. Women of childbearing potential should use appropriate contraceptive measures. If the woman becomes pregnant while taking Taven 10, it should be discontinued.

 

Precautions & Warnings

Liver effects: Liver function tests should be performed before the initiation of treatment and periodically thereafter. Should an increase in ALT or AST of greater than 3 times the upper limit of normal persist, reduction of dose or withdrawal of Atorvastatin is recommended Taven 10 should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease? Skeletal muscle effects: 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. Should significant increases in CPK persist, reduction of dose or withdrawal of Atorvastatin is recommended Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with Atorvastatin and with other drugs in this class. Use in Special Populations Children: Treatment experience in a pediatric population with a dose of Atorvastatin up to 80 mg/day is limited. Geriatric (>70 years): The safety and efficacy of Atorvastatin in this population is as similar as < 70 years of age patients with the dose up to 80 mg/day. Renal Insufficiency: No dosage adjustment is required.

 

Therapeutic Class

Other Anti-anginal & Anti-ischaemic drugs, Statins Pharmacology Atorvastatin is a synthetic lipid-lowering agent. It is a selective, competitive inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.

 

Storage Conditions

Store in a cool dry place protected from light. Keep out of reach of children.

 

Pharmaceutical Name

Renata Limited

 

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