Atorvastatin

Visa No.: 893110151225

Product: Zoamco 40mg

API: Atorvastatin

Product Category: Cardiovascular & Metabolism

Version approved leaflet: 76/QĐ-QLD_09/02/2015_149

INDICATIONS

• Atorvastatin is indicated as an adjunct to diet to reduce total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides, and to increase HDL cholesterol in patients with primary hypercholesterolaemia.
• Patients with dysbetalipoproteinaemia who do not respond adequately to dietary measures.
• Atorvastatin is also indicated to reduce total cholesterol and LDL-cholesterol in patients with homozygous familial hypercholesterolaemia, as an adjunct to diet and other non-pharmacological treatments when these measures do not provide an adequate response.
   

DOSAGE AND ADMINISTRATION

Atorvastatin may be administered at any time of day, with or without food.
Primary hypercholesterolaemia (heterozygous familial and non-familial) and mixed dyslipidaemia: Recommended starting dose: 10–20 mg once daily. Patients requiring a greater reduction in LDL-cholesterol (>45%) may start at 40 mg once daily. Therapeutic dose range: 10–80 mg once daily.
After initiation of therapy and/or following dose adjustment, lipid levels should be assessed within 2–4 weeks to allow appropriate dose titration.
Homozygous familial hypercholesterolaemia: 10–80 mg once daily. Atorvastatin should be used as an adjunct to other lipid-lowering treatments.
Combination therapy: Atorvastatin may be co-administered with bile acid sequestrants (resins) to enhance lipid-lowering efficacy. When co-administered with the following medicinal products or combinations: amiodarone, fosamprenavir, darunavir/ritonavir, fosamprenavir/ritonavir, or saquinavir/ritonavir, the maximum dose of atorvastatin should not exceed 20 mg per day.
Renal impairment: No dose adjustment is required in patients with renal impairment.
Treatment should be initiated at the lowest effective dose. If necessary, the dose may be adjusted according to inpidual needs and response, with dose increases at intervals of no less than 4 weeks. Patients should be monitored for adverse reactions, particularly those involving the skeletal muscle.
 

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients.
Active liver disease or persistent unexplained elevations of serum transaminases.
Pregnancy and breastfeeding.
 

WARNINGS AND PRECAUTIONS

This medicine is for prescription use only. Read the instructions for use carefully before taking this medicine. If you need further information, consult your physician or pharmacist. Keep out of the reach of children.