Zenon Dosage/Direction for Use

Posology: The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with ZENON.
ZENON is not suitable for initial therapy. Treatment initiation or dose adjustment if necessary should only be done with the monocomponents and after setting the appropriate doses the switch to the fixed dose combination of the appropriate strength is possible.
Patient should use the strength corresponding to their previous treatment.
The recommended dose is one ZENON tablet daily.
The dose of 5/10 mg can be met by using a single product of each of the approved active substance which marketed in Indonesia, which are rosuvastatin 5 mg and ezetimibe 10 mg. For patients who need higher LDL cholesterol reduction, dosage can be adjusted. After initiation or dosage titration of ZENON, lipid level should be analysis after 4 weeks or more, then dosage can be adjusted according to those analysis result.
Co-administration with bile acid sequestrants: Dosing of ZENON should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant (see Interactions).
Paediatric population: The safety and efficacy of ZENON in children below the age of 18 years have not yet been established.
Elderly: A start dose of 5 mg rosuvastatin is recommended in patients >70 years (see Precautions). The combination is not suitable for initial therapy. Treatment initiation or dose adjustment if necessary should only be done with the monocomponents and after setting the appropriate doses the switch to the fixed dose combination of the appropriate strength is possible.
Hepatic impairment: No dosage adjustment is required in patients with mild hepatic impairment (Child Pugh score 5 to 6). Treatment with ZENON is not recommended in patients with moderate (Child Pugh score 7 to 9) or severe (Child Pugh score>9) liver dysfunction (see Precautions and Pharmacology: Pharmacokinetics under Actions). ZENON is contraindicated in patients with active liver disease (see Contraindications).
Renal impairment: No dose adjustment is necessary in patients with mild renal impairment.
The recommended start dose is rosuvastatin 5 mg in patients with moderate renal impairment (creatinine clearance <60 ml/min).
The 40 mg/10 mg dose (not available in the Indonesia) is contraindicated in patients with moderate renal impairment.
The use of ZENON in patients with severe renal impairment is contraindicated for all doses (see Contraindications and Pharmacology: Pharmacokinetics under Actions).
Race: Increased systemic exposure of rosuvastatin has been seen in Asian subjects (see Precautions and Pharmacology: Pharmacokinetics under Actions). The recommended start dose is rosuvastatin 5 mg for patients of Asian ancestry. The fixed dose combination is not suitable for initial therapy. Monocomponent preparations should be used to start the treatment or to modify the dose. Combination of 40 mg/10 mg film-coated tablets (not available in the Indonesia) are contraindicated in these patients.
Genetic polymorphisms: Specific types of genetic polymorphisms are known that can lead to increased rosuvastatin exposure (see Pharmacology: Pharmacokinetics under Actions). For patients who are known to have such specific types of polymorphisms, a lower daily dose of ZENON is recommended.
Dosage in patients with pre-disposing factors to myopathy: The recommended start dose is rosuvastatin 5 mg in patients with pre-disposing factors to myopathy (see Precautions). The fixed dose combination is not suitable for initial therapy.
Monocomponent preparations should be used to start the treatment or to modify the dose.
Concomitant therapy: Rosuvastatin is a substrate of various transporter proteins (e.g. OATP1B1 and BCRP). The risk of myopathy (including rhabdomyolysis) is increased when ZENON is administered concomitantly with certain medicinal products that may increase the plasma concentration of rosuvastatin due to interactions with these transporter proteins (e.g. ciclosporin and certain protease inhibitors including combinations of ritonavir with atazanavir, lopinavir, and/or tipranavir; see Precautions and Interactions).
Whenever possible, alternative medications should be considered, and, if necessary, consider temporarily discontinuing ZENON therapy. In situations where co-administration of these medicinal products with ZENON is unavoidable, the benefit and the risk of concurrent treatment and rosuvastatin dosing adjustments should be carefully considered (see Interactions).
Method of administration: Route of administration is oral. ZENON can be administered at any time of the day, with or without food. The tablet should be swallowed whole with a drink of water.