Nhà máy Stada
Stada
stada
stada
Cardiovascular Agents

Simvastatin STADA® 10 mg

 

Pack size:

Box of 3 blisters x 10 film-coated tablets.

 

Compositon:

Each film-coated tablet contains simvastatin 10 mg.
 

Shelf-life:

24 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Do not store above 30oC.

 

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

  • Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (such as: exercise, weight reduction) is inadequate.
  • Treatment of homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are not appropriate.
  • Treatment of hypertriglyceridemia.
  • Reduction of cardiovascular mortality and morbidity in patients with manifest atherosclerotic cardiovascular disease or diabetes mellitus, with either normal or increased cholesterol levels.
     
  • Administered orally as a single dose in the evening.
     
  • The dosage range is 5 - 80 mg/day given orally as a single dose in the evening. Adjustments of dosage, if required, should be made at intervals of not less than 4 weeks, to a maximum of 80 mg/day given as a single dose in the evening. The 80 mg dose is only recommended in patients with severe hypercholesterolaemia and high risk for cardiovascular complications, who have not achieved their treatment goals on lower doses and when the benefits are expected to outweigh the potential risks.
  • Hypercholesterolaemia
    The patient should be placed on a standard cholesterol-lowering diet, and should continue on this diet during treatment with simvastatin. The usual starting dose is 10 - 20 mg/day given as a single dose in the evening. Patients who require a large reduction in LDL-C (more than 45 %) may be started at 20 - 40 mg/day given as a single dose in the evening. Adjustments of dosage, if required, should be made as specified above.
  • Homozygous familial hypercholesterolaemia
    Based on the results of a controlled clinical study, the recommended dosage is simvastatin 40 mg/day in the evening. Simvastatin should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable. In patients taking lomitapide concomitantly with simvastatin, the dose of simvastatin must not exceed 40 mg/day.
  • Cardiovascular prevention
    The usual dose of simvastatin is 20 to 40 mg/day given as a single dose in the evening in patients at high risk of coronary heart disease (CHD, with or without hyperlipidaemia). Drug therapy can be initiated simultaneously with diet and exercise. Adjustments of dosage, if required, should be made as specified above.
  • Concomitant therapy
    Simvastatin is effective alone or in combination with bile acid sequestrants. Dosing should occur either > 2 hours before or > 4 hours after administration of a bile acid sequestrant. In patients taking simvastatin concomitantly with fibrates, other than gemfibrozil or fenofibrate the dose of simvastatin should not exceed 10 mg/day. In patients taking amiodarone, amlodipine, verapamil or diltiazem concomitantly with simvastatin, the dose of simvastatin should not exceed 20 mg/day.
  • Patients with renal impairment
    No modification of dosage should be necessary in patients with moderate renal insufficiency. In patients with severe renal insufficiency (creatinine clearance < 30 ml/min), dosages above 10 mg/day should be carefully considered and, if deemed necessary, implemented cautiously.
  • Older people
    No dosage adjustment is necessary.
  • Paediatric population
    For children and adolescents (boys Tanner Stage II and above and girls who are at least one year post-menarche, 10 - 17 years of age) with heterozygous familial hypercholesterolaemia, the recommended usual starting dose is 10 mg once a day in the evening. Children and adolescents should be placed on a standard cholesterol-lowering diet before simvastatin treatment initiation; this diet should be continued during simvastatin treatment. The recommended dosing range is 10 - 40 mg/day; the maximum recommended dose is 40 mg/day. Doses should be individualized according to the recommended goal of therapy as recommended by the paediatric treatment recommendations. Adjustments should be made at intervals of 4 weeks or more. The experience of simvastatin in pre-pubertal children is limited.
     

Or as prescribed by physicians.

 

  • Hypersensitivity to simvastatin or any ingredient of the drug.
  • Active liver disease or unexplained persistent elevations of serum transaminases.
  • Pregnancy and lactation.
  • Do not exceed 10 mg simvastatin daily with: Verapamil, diltiazem, dronedarone. These drugs are contraindicated with ≥ 20 mg of simvastatin.
  • Do not exceed 20 mg simvastatin daily with: Amiodarone, amlodipine, ranolazine.

     

Rare

  • 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.

Very rare:

  • Insomnia.
  • Memory impairment.
  • Fatal and non-fatal hepatic failure.

Not known

  • Depression.
  • Interstitial lung disease.
  • Immune-mediated necrotizing myopathy, tendinopathy, sometimes complicated by rupture.
  • Erectile dysfunction.

An apparent hypersensitivity syndrome has been reported rarely which has included some of the following features: Angioedema, lupus-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, thrombocytopenia, eosinophilia, ESR increased, arthritis and arthralgia, urticaria, photosensitivity, fever, flushing, dyspnoea and malaise.

Investigations:
Rare: Increases in serum transaminases (alanine aminotransferase, aspartate aminotransferase, γ-glutamyl transpeptidase), elevated alkaline phosphatase; increase in serum CK levels.
Increases in HbA1c and fasting serum glucose levels have been reported with statins, including simvastatin.
There have been rare post-marketing reports of cognitive impairment (e.g. memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use, including simvastatin. The reports are generally non serious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).

The following additional adverse events have been reported with some statins:

  • Sleep disturbances, including nightmares.
  • Sexual dysfunction.
  • Diabetes mellitus: Frequency will depend on the presence or absence of risk factors (fasting blood glucose ≥ 5.6 mmol/L, BMI > 30 kg/m2, raised triglycerides, history of hypertension).

     

  • 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.
  • A creatine kinase (CK) level should be measured before starting treatment in the following situations: 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), the necessity of such measurement should be considered, according to the presence of other predisposing factors for rhabdomyolysis, the potential for drug interactions and in special populations. In such situations, the risk of treatment should be considered in relation to possible benefit and clinical monitoring is recommended. If CK levels are significantly elevated > 5 times upper limit of normal at baseline, treatment should not be started.
  • If muscular pain, weakness or cramps occur whilst a patient is receiving treatment with a statin, their CK levels should be measured.
  • Before and during treatment with statins, the cholesterol control should be combined with diet, weight loss, exercise, and treatment of the diseases causing hyperlipidemia. Lipid determinations should be performed periodically at intervals of not less than 4 weeks and the dosage adjusted according to the patient's response. The goal of treatment is to reduce LDL cholesterol, so depending on  LDL cholesterol concentration to begin treatment and evaluate the response to the treatment.  Only when LDL cholesterol is not tested, total cholesterol is used for monitoring the treatment.
  • Suspend or discontinue any use of statins in patients with manifestation of severe myopathy or risk factors for acute renal failure due to rhabdomyolysis, such as severe acute infection, hypotension, major surgery and trauma, abnormalities of metabolism, endocrine, and electrolyte or uncontrolled seizures.
  • Geriatric patients: Because geriatric patients frequently have decreased renal function, particular attention should be paid to evaluating renal function prior to initiation of simvastatin and subsequently thereafter in this age group.
  • Pediatric patients: Safety and efficacy of simvastatin have not been evaluated in prepubertal girls or in children younger than 10 years of age.
  • Pregnancy: Safety in pregnant women has not been established. Because simvastatin decreases the synthesis of cholesterol and possibly other products of the cholesterol biosynthetic pathway, simvastatin may cause fetal harm when administered to pregnant women. Therefore, simvastatin is contraindicated during pregnancy.
  • Lactation: It is not known whether simvastatin or its metabolites are excreted in human milk. Because of the potential for serious adverse reactions from simvastatin in nursing infants, the drug is contraindicated in nursing women.
  • Simvastatin has no or negligible influence on the ability to drive and use machines.

     

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



Visitors Counter

Online
23
Total