Anzitor 10

Generic

Atorvastatin Calcium

 

Indications

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

 

Pharmacology

Anzitor ® is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme responsible for the conversion of 3- hydroxy- 3- methyl- glutaryl- coenzyme A to mevalonate, a precursor of sterols, including cholesterol. Triglycerides (TG) and cholesterol in the liver are incorporated into VLDL and released into the plasma for delivery to peripheral tissues. Low-density lipoprotein (LDL) is formed from VLDL and is catabolised primarily through the high affinity LDL receptor.

Anzitor ® lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL. Anzitor ® reduces LDL production and the number of LDL particles. Anzitor ® produces a profound and sustained increase in LDL receptor activity coupled with a beneficial change in the quality of circulating LDL particles.

 

Dosage & Administration

Patients should be placed on a standard cholesterol-lowering diet before receiving Anzitor ® and should continue on this diet during treatment with Anzitor ®. The usual starting dose for all the indications is 10 mg once daily. The doses range is 10 to 80 mg once daily. Doses should be individualised according to baseline 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 anytime of day with or without food.

Children:

• Treatment experience in a paediatric population with dose of Anzitor® up to 80 mg/day is limited.

Geriatric (>70 years) use:

• The safety and efficacy of Anzitor ® in this population is as similar as < 70 years of age patients with the dose upto 80 mg/day.
  In patients with Renal Insufficiency: No dosage adjustment is required.

 

Interaction

The risk of myopathy during treatment with atorvastatin increases with the simultaneous administration of cyclosporine, fibric acid derivatives, erythromycin, azole antifungals and niacin. When atorvastatin was used in combination with antihypertensive or hypoglycaemic drugs, no clinically significant interactions were observed. If atorvastatin is added to digoxin, erythromycin, oral contraceptives, colestipol, antacids, and warfarin, the patient should be closely monitored.

 

Contraindications

Atorvastatin 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 breast-feeding, and in women of child-bearing potential not using appropriate contraceptive measures.

 

Side Effects

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

 

Pregnancy & Lactation

Atorvastatin is contraindicated in pregnancy and while breast-feeding. Women of child bearing potential should use appropriate contraceptive measures. If the woman become pregnant while taking Atorvastatin, it should be discontinued.

 

Precautions & Warnings

Hepatic Effects: Liver function tests should be performed before starting treatment and regular check-ups thereafter. Patients who drink a lot of alcohol or have a history of liver disease should use atorvastatin with caution. If there is a significant increase in CPK levels or myopathy is diagnosed or suspected, treatment with atorvastatin should be discontinued.

 

Therapeutic Class

Other Anti-anginal & Anti-ischaemic drugs, Statins.

 

Storage Conditions

Store below 250 C. Protect from light and moisture. Keep all medicines out of the reach of children.

 

Pharmaceutical Name

Square Pharmaceuticals Ltd.

 

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