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Cardiovascular Agents

Simvastatin STADA 10 mg/20 mg

Pack size:

Box of 3 blisters x 10 film-coated tablets.

 

Compositon:

Each film-coated tablet contains simvastatin 10 mg.
Each film-coated tablet contains simvastatin 20 mg.

 

Shelf-life:

24 months from the date of manufacturing.

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet.
  • Treatment of homozygous familial hypercholesterolaemia.
  • Treatment of hypertriglyceridemia.

Reduction of cardiovascular mortality and morbidity in patients with manifest atherosclerotic cardiovascular disease or diabetes mellitus.

Dosage:

  • Hypercholesterolaemia

Starting with 10 - 20 mg/day. Patients with LDL-C more than 45 % may start at 20 - 40 mg/day.

  • Homozygous familial hypercholesterolaemia

Start with 40 mg/day. In patients taking lomitapide concomitantly with simvastatin, the maximum dose of simvastatin is 40 mg/day.

  • Cardiovascular prevention

The usual dose is 20 to 40 mg/day in patients at high risk of coronary heart disease (CHD, with or without hyperlipidaemia).

  • Concomitant therapy

In patients taking simvastatin concomitantly with fibrates, verapamil, diltiazem, dronedarone, the maximum dose of simvastatin is 10 mg/day.

In patients taking amiodarone, amlodipine, verapamil, diltiazem, ranolazine concomitantly with simvastatin, the maximum dose of simvastatin is 20 mg/day.

  • Children and adolescents with heterozygous familial hypercholesterolaemia, the starting dose is 10 mg once a day in the evening; the maximum recommended dose is 40 mg/day. The experience of simvastatin in prepubertal children is limited.

Adjustments of dosage, if required, should be made at intervals of not less than 4 weeks, to a maximum of 80 mg/day.

Usage:

Simvastatin STADA 10 / 20mg is administered orally, can be administered as a single dose in the evening. Dosing of Simvastatin STADA 10 / 20mg should occur either at least 2 hours before or 4 hours after administration of a bile acid sequestrant.

Known hypersensitivity to any of the active substance or excipients.

Active liver disease or unexplained persistent elevations of serum transaminases.

Pregnancy and lactation.

Anaemia; headache, paresthesia, dizziness, peripheral neuropathy; constipation, abdominal pain, flatulence, dyspepsia, diarrhoea, nausea, vomiting, pancreatitis; hepatitis/jaundice; rash, pruritus, alopecia; myopathy (including myositis), rhabdomyolysis with or without renal failure, myalgia, muscle cramps; asthenia; an apparent hypersensitivity syndrome; increases in serum transaminases, elevated alkaline phosphatase; increase in serum CK levels; increases in Hba1c and fasting serum glucose levels.

Liver enzyme tests should be performed before starting statin therapy and as clinically indicated thereafter.

Simvastatin may cause elevation of creatine kinase and transaminase levels. This should be considered in the differential diagnosis of chest pain in patients on therapy with simvastatin.

Lipid determinations should be performed periodically at intervals of not less than 4 weeks and the dosage adjusted according to the patient's response.

Pediatric patients: Safety and efficacy of simvastatin have not been evaluated in prepubertal girls or in children younger than 10 years of age.

Use with caution in patients who consume substantial amounts of alcohol and/or have a history of liver disease, renal impairment, hypothyroidism, personal or familial history of hereditary muscular disorders, previous history of muscular toxicity with a statin or fibrate, previous history of liver disease and/or where substantial quantities of alcohol are consumed, in elderly (age > 70 years) with the presence of other predisposing factors for rhabdomyolysis: If CK > 5 times upper limit of normal at baseline, treatment should not be started. If muscular pain, weakness or cramps occur, CK levels should be measured.

Simvastatin therapy should be temporarily withheld or discontinued in any patients with an acute, serious condition suggestive of a myopathy or having a risk factor predisposing to the development of renal failure secondary to rhabdomyolysis.

Patients should be aware of how they react to drug before driving or operating machinery.

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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