Medicine Information

Lipex

Name: Lipex
Brand: Lipex
Rating: 4.5 (117 reviews)

Tablet10 mgLipid-modifying agents (statins)ATC: C10AA01

Generic Name

Simvastatin

Manufacturer

Square Pharmaceuticals Ltd.

Country

Bangladesh

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Price Details

Current market pricing information

Variant	Unit Price	Strip Price
lipex 10 mg tablet	৳ 10.00	৳ 100.00

Description

Overview of the medicine

Simvastatin is a statin medication used to lower cholesterol and triglycerides in the blood. It reduces the risk of heart attack, stroke, and other heart complications in people with heart disease or at high risk for it.

Uses & Indications

Primary hypercholesterolemia (including heterozygous familial hypercholesterolemia) or mixed dyslipidemia.

Homozygous familial hypercholesterolemia.

Cardiovascular risk reduction in patients with atherosclerotic cardiovascular disease or diabetes.

Dosage

Adults

Initially 10-20 mg once daily in the evening. Doses range from 5-80 mg daily. Max 40 mg daily for most patients due to increased risk of myopathy with 80 mg.

Elderly

Similar to adults, but cautious titration recommended.

Renal_impairment

Moderate (CrCl 30-60 mL/min): No dose adjustment. Severe (CrCl < 30 mL/min): Doses >10 mg/day should be carefully considered and if necessary, closely monitored.

How to Take

Oral, once daily in the evening, with or without food.

Mechanism of Action

Simvastatin is a selective competitive inhibitor of HMG-CoA reductase, an enzyme that catalyzes the rate-limiting step in cholesterol biosynthesis. This inhibition reduces cholesterol production in the liver, leading to an upregulation of LDL receptors and increased clearance of LDL cholesterol from the blood.

Pharmacokinetics

Onset

Lipid-lowering effects typically observed within 2 weeks, maximal by 4-6 weeks.

Excretion

Primarily via bile and feces (approximately 60%), with some renal excretion (approximately 13%).

Half life

Active metabolite has a plasma half-life of approximately 2 hours.

Absorption

Well absorbed, but undergoes extensive first-pass metabolism. Bioavailability of active metabolites is less than 5%.

Metabolism

Extensively metabolized in the liver, primarily by CYP3A4, to active and inactive metabolites.

Side Effects

Contraindications

Active liver disease or unexplained persistent elevations of serum transaminases.
Pregnancy and lactation.
Concomitant use with strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin, HIV protease inhibitors, nefazodone).
Concomitant use with gemfibrozil, cyclosporine, or danazol.

Drug Interactions

Warfarin

May slightly enhance anticoagulant effect. INR monitoring recommended.

Niacin (≥1 g/day)

Increased risk of myopathy/rhabdomyolysis. Max simvastatin dose 20 mg/day.

Gemfibrozil, Cyclosporine, Danazol

Increase risk of myopathy/rhabdomyolysis. Concomitant use contraindicated.

Amiodarone, Amlodipine, Diltiazem, Verapamil

Max simvastatin dose 20 mg/day.

Strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin, HIV protease inhibitors)

Significantly increase simvastatin levels, leading to increased risk of myopathy/rhabdomyolysis. Concomitant use contraindicated.

Storage

Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.

Overdose

No specific antidote. Symptomatic and supportive measures should be taken. Dialysis is unlikely to be beneficial.

Pregnancy & Lactation

Contraindicated in pregnancy and lactation due to potential for fetal harm (cholesterol is essential for fetal development) and excretion into breast milk.

Frequently Asked Questions

Common questions about this medicine

Pack Sizes

10 tablets30 tablets50 tablets

Shelf Life

Typically 2-3 years, depending on manufacturer.

Availability

Pharmacies, hospitals

Approval Status

Generally approved by major regulatory bodies (e.g., FDA, EMA)

Patent Status

Off-patent (generic versions available)

WHO Essential Medicine

Yes

Clinical Trials

Extensive clinical trials have demonstrated the efficacy and safety of simvastatin in reducing lipid levels and cardiovascular events, such as the Scandinavian Simvastatin Survival Study (4S) and Heart Protection Study (HPS).

Lab Monitoring

Liver function tests (ALT/AST) before starting treatment, at 12 weeks after starting or dose increase, and periodically thereafter.
Lipid panel (total cholesterol, LDL-C, HDL-C, triglycerides) before and during treatment to assess efficacy.
Creatine kinase (CK) levels if muscle symptoms occur.

Doctor Notes

Emphasize lifestyle modifications alongside drug therapy.
Monitor LFTs at baseline, at 12 weeks, and periodically.
Counsel patients on reporting muscle symptoms promptly.
Review all concomitant medications to avoid harmful drug interactions.

Patient Guidelines

Take the medication as prescribed, preferably in the evening.
Report any unexplained muscle pain, tenderness, or weakness immediately.
Avoid grapefruit juice.
Inform your doctor about all other medications and supplements you are taking.
Maintain a healthy diet and regular exercise.

Missed Dose Advice

Take the missed dose as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose.

Driving Precautions

Simvastatin usually does not affect the ability to drive or operate machinery. However, if you experience dizziness or visual disturbances, you should avoid such activities.