Avas EZ 40 mg+10 mg (Tablet)

Indications

• Reduction of elevated total cholesterol
• Reduction of low density lipoprotein cholesterol (LDL-C)
• Reduction of apolipoprotein B (Apo B)
• Reduction of triglycerides (TG)
• Increase in high-density lipoprotein cholesterol (HDL-C)
• Treatment for primary hyperlipidemia
• Treatment for mixed hyperlipidemia
• Treatment for homozygous familial hypercholesterolemia (HoFH)

Pharmacology

• Mechanism of action of Atorvastatin
• Mechanism of action of Ezetimibe
• Inhibition of HMG-CoA reductase
• Inhibition of cholesterol absorption by small intestine
• Role of NPC1L1 in cholesterol absorption
• Effects on plasma concentrations of fat-soluble vitamins

Dosage & Administration

• Dosage range of 10/10 mg to 80/20 mg daily
• Recommended starting dose of 10/10 mg or 20/10 mg daily
• Administration as a single dose at any time of the day
• Dosage adjustment based on lipid levels analysis
• Specific dosage for patients with Homozygous Familial Hypercholesterolemia
• Contradictions in patients with hepatic impairment
• Monitoring for skeletal muscle effects in patients with renal impairment

Interaction

• Increased risk of myopathy with concurrent administration of fibric acid derivatives
• Risk of myopathy/rhabdomyolysis with gemfibrozil
• Enhanced risk of skeletal muscle effects with niacin
• Monitoring of patients taking digoxin or oral contraceptives with Avas EZ
• Caution when prescribing Avas EZ with colchicine or warfarin

Contraindications

• Active liver disease
• Unexplained persistent elevations of hepatic transaminase levels
• Hypersensitivity to any component of the preparation

Side Effects

• Rhabdomyolysis
• Myopathy
• Liver enzyme abnormalities
• Myalgia
• Abdominal pain

Pregnancy & Lactation

• Pregnancy Category X
• Contraindicated in pregnant women
• Increase in serum cholesterol and triglycerides during pregnancy
• Excretion in human milk

Precautions & Warnings

• Cases of myopathy, including rhabdomyolysis
• Temporary withholding or discontinuation in patients with acute, serious condition suggestive of myopathy
• Recommendation for liver enzyme tests prior to initiating therapy
• Caution when administered concomitantly with drugs affecting endocrine function

Use in Special Populations

• Safety and effectiveness not established in pediatric patients
• No dosage adjustment necessary in geriatric patients

Overdose Effects

• No specific recommended treatment
• Symptomatic treatment
• Supportive measures

Therapeutic Class

• Other lipid regulating drugs

Storage Conditions

• Storage temperature not above 30°C
• Dry storage
• Protection from light
• Keep out of the reach of children

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