KARDAK 40 FILM-COATED TABLETS 40 MG [SIN14454P]

Product Info

KARDAK 40 FILM-COATED TABLETS 40 MG

[SIN14454P]

Therapeutic indications

Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when the response to diet and other nonpharmacological measures alone has been inadequate.

PATIENTS AT HIGH RISK OF CORONARY HEART DISEASE (CHD) OR WITH EXISTING CHD

In patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, Simvastatin Tablets is indicated to:

• Reduce the risk of total mortality by reducing CHD deaths;

• Reduce the risk of non-fatal myocardial infarction and stroke;

• Reduce the need for coronary and non-coronary revascularization procedures.

In hypercholesterolemic patients with coronary heart disease, Simvastatin Tablets slows the progression of coronary atherosclerosis, including reducing the development of new lesions and new total occlusions.

PATIENTS WITH HYPERLIPIDEMIA

• Simvastatin Tablets is indicated as an adjunct to diet to reduce elevated total-C, LDL-C, TG, and apolipoprotein B (apo B), and to increase HDL-C in patients with primary hypercholesterolemia including heterozygous familial hypercholesterolemia (Fredrickson type IIa), or combined (mixed) hyperlipidemia (Fredrickson type IIb), when response to diet and other nonpharmacological measures is inadequate. Simvastatin Tablets, therefore, lowers LDL- C/HDL-C and total- C/HDL C ratios. Simvastatin Tablets is also indicated as an adjunct to diet and other non-dietary measures for the treatment of patients with homozygous familial hypercholesterolemia to reduce elevated total-C, LDL-C and apo B.

Posology and method of administration

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. Due to the increased risk of myopathy, including rhabdomyolysis, particularly during the first year of treatment, use of the 80-mg dose of simvastatin should be restricted to patients who have been taking simvastatin 80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity. Patients unable to achieve their LDL-C goal utilizing the 40-mg dose of simvastatin should not be titrated to the 80-mg dose, but should be placed on alternative LDL-C-lowering treatment(s) that provides greater LDL-C lowering.

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 10–20mg/day given as a single dose in the evening. Patients who require a large reduction in LDLC (more than 45 %) may be started at 20–40 mg/ day given as a single dose in the evening. Patients who require a large reduction in LDLC (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
The recommended dosage is Simvastatin 40 mg/day in the evening or 80 mg/day in 3 divided doses of 20 mg and an evening dose of 40 mg. 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.

Cardiovascular prevention
Patients with coronary heart disease can be treated with a starting dose of 20mg/day given as a single dose in the evening. Patients at high risk for a CHD event due to existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease have been shown to benefit from 40mg/day and can be started at this dose.

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 (see CONTRAINDICATIONS) or fenofibrate the dose of Simvastatin should not exceed 10mg/day. In patients taking amiodarone, verapamil, diltiazem, or products containing elbasvir or grazoprevir concomitantly with Simvastatin, the dose of Simvastatin should not exceed 20mg/day. In patients taking amlodipine concomitantly with Simvastatin, the dose of Simvastatin should not exceed 40mg/day.

Dosage in renal insufficiency
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.

Use in the elderly
For patients over the age of 65 years who received simvastatin in controlled clinical studies, efficacy, as assessed by reduction in total-C and LDL-C, appeared similar to that seen in the population as a whole, and there was no apparent increase in the overall frequency of clinical or laboratory adverse findings. However, in a clinical trial of patients treated with simvastatin 80 mg/day, patients ≥ 65 years of age had an increased risk of myopathy compared to patients <65 years of age.

Use in children and adolescents
Simvastatin is not recommended for paediatric use.

Contraindications

Hypersensitivity to Simvastatin or to any of the excipients.
Active liver disease or unexplained persistent elevation of serum transaminase values.
Porphyria.
Myopathy.
Concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone, and drugs containing cobicistat), gemfibrozil, cyclosporine, danazol, delaviridine and amiodarone.
Pregnancy and lactation.
Women of child-bearing potential, unless adequate contraception is used.