Posology : מינונים

4.2 Posology and method of administration

Posology
Recommended Dosing
The usual dosage range is 5 to 40 mg/day. In patients with CHD, Simvastatin Teva can be started simultaneously with diet. The recommended usual starting dose is 10 or 20 mg once a day in the evening. Lipid determinations should be performed after 4 weeks of therapy and periodically thereafter.

Restricted Dosing for 80 mg

Due to the increased risk of myopathy, including rhabdomyolysis, particularly during the first year of treatment, use of the 80-mg dose of Simvastatin Teva 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 [see Special Warnings and Precautions for use (4.4)].

Patients who are currently tolerating the 80-mg dose of Simvastatin Teva who need to be initiated on an interacting drug that is contraindicated or is associated with a dose cap for simvastatin should be switched to an alternative statin with less potential for the drug-drug interaction.

Due to the increased risk of myopathy, including rhabdomyolysis, associated with the 80-mg dose of Simvastatin Teva, patients unable to achieve their LDL-C goal utilizing the 40-mg dose of Simvastatin Teva 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.

Co-administration with Other Drugs

Patients taking Verapamil, Diltiazem or Dronedarone
The dose of Simvastatin Teva should not exceed 10 mg/day [see Special Warnings and Precautions for use (4.4), Interaction with other medical products and other forms of interaction (4.5), and Pharmacokinetic properties (5.2)].

Patients taking Amiodarone, Amlodipine or Ranolazine
The dose of Simvastatin Teva should not exceed 20 mg/day [see Special Warnings and Precautions for use (4.5), Interaction with other medical products and other forms of interaction (4.5), and Pharmacokinetic properties (5.2)].

Patients taking Bile Acid Sequestrants
Simvastatin Teva 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.

Patients with Homozygous Familial Hypercholesterolemia
The recommended dosage is 40 mg/day in the evening [see Dosage and Administration, Restricted Dosing for 80 mg (4.2)]. Simvastatin Teva should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.

Simvastatin exposure is approximately doubled with concomitant use of lomitapide; therefore, the dose of Simvastatin Teva should be reduced by 50% if initiating lomitapide. Simvastatin Teva dosage should not exceed 20 mg/day (or 40 mg/day for patients who have previously taken Simvastatin Teva 80 mg/day chronically, e.g., for 12 months or more, without evidence of muscle toxicity) while taking lomitapide.

Patients with Renal Impairment

Because Simvastatin Teva does not undergo significant renal excretion, modification of dosage should not be necessary in patients with mild to moderate renal impairment.
However, caution should be exercised when Simvastatin Teva is administered to patients with severe renal impairment; such patients should be started at 5 mg/day and be closely monitored [see Interaction with other medical products and other forms of interaction (4.5) and Pharmacokinetic properties (5.2)].

Chinese Patients Taking Lipid-Modifying Doses (≥1 g/day Niacin) of Niacin- Containing Products
Because of an increased risk for myopathy in Chinese patients taking simvastatin 40 mg co-administered with lipid-modifying doses (≥1 g/day niacin) of niacin-containing products, caution should be used when treating Chinese patients with simvastatin doses exceeding 20 mg/day co-administered with lipid-modifying doses of niacin- containing products. Because the risk for myopathy is dose-related, Chinese patients should not receive simvastatin 80 mg co-administered with lipid-modifying doses of niacin-containing products. The cause of the increased risk of myopathy is not known.
It is also unknown if the risk for myopathy with co-administration of simvastatin with lipid-modifying doses of niacin-containing products observed in Chinese patients applies to other Asian patients. [Interaction with other medical products and other forms of interaction (4.5).]