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Simvoget

Simvoget

simvastatin

Manufacturer:

Getz Pharma

Distributor:

Getz Bros
Concise Prescribing Info
Contents
Simvastatin
Indications/Uses
Primary hypercholesterolemia, heterozygous & homozygous familial hypercholesterolemia or combined (mixed) hyperlipidemia in patients who have not responded adequately to diet & other appropriate measures. Prevention of coronary events. Reduce LDL-cholesterol, apolipoprotein B & triglycerides & increase HDL-cholesterol in the treatment of hyperlipidemias including hypercholesterolemia & combined hyperlipidemia (type IIA & IIB). Adjunct therapy to patients w/ homozygous familial hypercholesterolemias who have some LDL-receptor function. Prophylaxis of hypercholesterolemic patients w/ ischemic heart disease.
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Dosage/Direction for Use
Dose range: 5-80 mg/day. Starting dose: 20-40 mg once daily in the evening. Reductions in risk of CHD mortality & CV events 40 mg/day. Patient w/ homozygous familial hypercholesterolemia 40 mg/day in the evening or 80 mg/day in 3 divided doses of 20 mg, 20 mg & an evening dose of 40 mg. Patient w/ heterozygous familial hypercholesterolemia Adolescent 10-17 yr Start on 10 mg once daily in the evening. Recommended dosing range is 10-40 mg/day. Max: 40 mg/day. Adjust the dose at intervals of ≥4 wk. Concomitant lipid-lowering therapy Max: 10 mg/day. Patient taking cyclosporine or danazol Start w/ 5 mg/day. Max: 10 mg/day. Patient taking amiodarone or verapamil Max: 20 mg/day. Patient w/ renal insufficiency Start at 5 mg/day.
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Administration
May be taken with or without food: Avoid excessive consumption (>1 L/day) of grapefruit juice.
Contraindications
Active liver disease or unexplained persistent elevations of serum transaminases. Cytochrome P450 3A4 including itraconazole, ketoconazole, HIV PIs, erythromycin, clarithromycin, telithromycin & nefazodone. Pregnancy & lactation.
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Special Precautions
Severe renal insufficiency. Patients w/ predisposing factors for rhabdomyolysis. Monitor CK levels & liver function test. Stop the therapy prior to elective major surgery. Childn <10 yr & pre-menarchal girls.
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Adverse Reactions
Constipation, diarrhea, fatigue, gas, heartburn & headache. Abdominal pain or cramps, blurred vision, dizziness, easy bruising or bleeding, itching, muscle pain or cramps, rash & yellowing of the skin or eyes.
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Drug Interactions
Alcohol, diltiazem, grapefruit juice, oral anticoagulants. Cytochrome P450 3A4 including itraconazole, ketoconazole, HIV PIs, erythromycin, clarithromycin, telithromycin & nefazodone.
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Storage
View Simvoget storage conditions for details to ensure optimal shelf-life.
Description
View Simvoget description for details of the chemical structure and excipients (inactive components).
Action
View Simvoget mechanism of action for pharmacodynamics and pharmacokinetics details.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA01 - simvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Simvoget FC tab 20 mg
Packing/Price
10's (P9.3/film-coated tab)
Form
Simvoget FC tab 40 mg
Packing/Price
10's (P15/film-coated tab)
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