Simvastatin 10mg Film Coated Tablet

Prescription MedicinesPrescription required

PHILSTAT

Product details

Generic Name:Simvastatin

Category:Prescription Medicines

Brand:PHILSTAT

Strength:10mg

Dosage Form:Tablet

Indications

Used together with appropriate diet and lifestyle measures for the treatment of primary hypercholesterolemia, mixed dyslipidemia, and certain inherited lipid disorders. It may also be used in appropriate patients to reduce the risk of major cardiovascular events associated with atherosclerotic cardiovascular disease.

Contraindications

Hypersensitivity or allergy to simvastatin or any component of the formulation.
Active liver disease or unexplained persistent elevations of serum transaminases.
Pregnancy.
Breastfeeding.
Concomitant use with strong CYP3A4 inhibitors such as certain azole antifungals, macrolide antibiotics, HIV protease inhibitors, or other medicines specifically contraindicated with simvastatin.
Concomitant use with gemfibrozil, ciclosporin, or danazol may be contraindicated depending on current product labeling.

Warnings and Precautions

Simvastatin can cause muscle-related adverse effects ranging from myalgia to rare but serious myopathy and rhabdomyolysis. Seek medical attention for unexplained muscle pain, tenderness, weakness, or dark-colored urine.
The risk of muscle toxicity increases with higher doses, advanced age, kidney impairment, untreated hypothyroidism, and certain interacting medicines.
Liver function should be assessed as clinically appropriate, particularly if symptoms of liver injury such as unusual fatigue, loss of appetite, dark urine, or jaundice develop.
Use with caution in patients with significant liver disease or substantial alcohol consumption.
Grapefruit and grapefruit juice can increase simvastatin exposure and the risk of muscle toxicity and should be avoided or limited according to the specific product information.
Simvastatin has numerous clinically important drug interactions. Concomitant medicines should be reviewed before starting or changing therapy.
Statins may cause small increases in blood glucose and may contribute to new-onset diabetes in susceptible patients.
Stop treatment and seek medical advice if pregnancy occurs.
Treatment should be used together with appropriate dietary and lifestyle measures and should not be stopped or changed without medical advice.

Product details

Indications

Contraindications

Warnings and Precautions

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