Divastin E 10 mg+10 mg (Tablet)

Indications

• Reduction of elevated total cholesterol
• Lowers low density lipoprotein cholesterol (LDL-C)
• Reduces Apolipoprotein B (Apo B)
• Decreases triglycerides (TG)
• Increases high-density lipoprotein cholesterol (HDL-C)
• Treatment for primary hyperlipidemia
• Treatment for homozygous familial hypercholesterolemia (HoFH)

Pharmacology

• Lowers plasma cholesterol levels
• Inhibits HMG-CoA reductase
• Increases hepatic LDL receptors
• Reduces LDL production
• Inhibits absorption of cholesterol by small intestine
• Reduces blood cholesterol levels
• Inhibits intestinal cholesterol absorption

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
• Recommended starting dose for patients requiring larger LDL-C reduction
• Dosage for patients with homozygous familial hypercholesterolemia
• Contraindicated in patients with active liver disease
• No dosage adjustment necessary in patients with renal impairment

Interaction

• Increased risk of myopathy with concurrent administration of fibric acid derivatives
• Coadministration with cyclosporine should be avoided
• Caution with concomitant use of niacin
• Monitoring required for patients taking digoxin

Contraindications

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

Side Effects

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

Pregnancy & Lactation

• Contraindicated in pregnant women
• Serum cholesterol and triglycerides increase during normal pregnancy
• Not known if excreted in human milk

Precautions & Warnings

• Cases of myopathy reported
• Caution with colchicine coadministration
• Liver enzyme tests recommended prior to therapy initiation
• Caution with drugs that may decrease endogenous steroid hormones

Use in Special Populations

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

Overdose Effects

• Symptomatic treatment recommended

Therapeutic Class

• Other lipid regulating drugs

Storage Conditions

• Do not store above 30°C
• Keep in a dry place
• Protect from light
• Keep out of the reach of children

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