LIPITRIN 40/10 7 TAB; simvastatin, ezetimibe, cardiovascular agents .
ACTIVE-INGREDIENT OF LIPITRIN 40/10 7 TAB
Each tablet contains 10 mg ezetimibe and 40 mg of simvastatin.
INDICATION OF LIPITRIN 40/10 7 TAB
Hypercholesterolaemia LIPITRIN is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familail) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate: patients not appropriately controlled with a statin alone, patients already treated with a statin and ezetimibe. LIPITRIN contains ezetimibe and simvastatin. Simvastatin (20-40 mg) has been shown to reduce the frequency of cardiovascular events. A beneficial effect of LIPITRIN or ezetimibe on cardiovascular morbidity and mortality has not yet been demonstrated. Homozygous familial hypercholesterolaemia (HoFH) : LIPITRIN is indicated as adjunctive therapy to diet for use in patients with HoFH. Patients may also receive adjunctive treatments (e.g., low-density lipoprotein [LDL] apheresis).
DOSAGE OF LIPITRIN 40/10 7 TAB
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
recommended dosage range is 5 to 40 mg/day . In patients with CHD . Simvastattin can be started simultaneously with diet . The recommended usual starting dose is 10 -20 mg once a day in the eveneing . For at hifgh risk for a CHD event due to existing CHD diabetes , peripheral vessel disease , history of stroke or other cerebrovascular disease , the recommended starting dose is 40 mg/day . lipid determinations should be performed after 4 weeks of therapy and periodically thereafter . hypercholesterolaemia : the patient should be on an appropriate lipid lowerinig diet and should continue on this diet during treatment with lipitrin . route of administration is oral . the dosage range of lipitrin is 10/10 mg/day through given as a single dose in the evening . the patient’s low-density lipoprotein cholestrol (LDL C ) level , coronatry heart disease risk status , and response to current cholestrol -lowering therapy should be considered when restarting therapy or adjusing the dose . the dose of lipitrin should be individualised based on the known efficacy of the various dose strengths of lipitrin and the response to the current cholestrol – lowering therapy . adjustments of dosage , if required , should be made at intervals of not less than 4 weeks . lipitrin can be administered with or without food . the tablet should not be split . dosage in patients with homozygous famitial hypercholestrolesterolaemia : the recommended dosage for patients with homozygous familial hyperlesterolemia is lipitrin 10/40 mg/day in the evening . lipitrin should be used as an adjunct to other lipid-lowering treatments ( e.g. , LDL apherosis ) in these patients or if such treatments are available . coadministration with other medicines : patients taking arniodarone , verapamil , or diltiazem . the dose of SIMVASTATIN should not exceed 10 mg /day . patients taking amlodipine or ranolazine . the dose of SIMVASTATIN should not exceed 20 mg /day . dosing of lipitrin should occur either ≥ 2 hours before or ≥ 4 hours after administration of abile acid sequestrant . in patients taking diltiazem or arnlodipine conomitantly with lipitrin the dose of lipitrin should not exceed 10/40 mg/day . in patients taking amiodarone or veraparnil concomitantly with lipitrin , the dose of lipitrin should not exceed 10/20 mg/day . in patients taking lipid-lowering doses ( 1 g/day “) of niacin concomitantly with lipitrin , the dose of lipitrin should not exceed 10/20 mg/day . in patients taking ciclosporin or danazol concomitantly with lipitrin , the dose of lipitrin should not exceed 10/10 mg/day . use in elderly : no dosage adjustment is required for elderly patients . use in children and adolescents : lipitrin is not recommended for use in children due to a lack of data on safety and efficacy . use in hepatic impairments : no dosage adjustment is required in patients with mild hepatic insufficiency ( child pugh score 5 to 6 ) treatment with lipitrin is not recommended in patients with moderate ( child pugh score 7 to 9 ) or severe ( child pugh score > 9 )” liver dysfunction . use in renal impairment : no modification of dosage should be necessary in patients with moderate renal insufficienxccy . if treatment in patients with severe renal insufficiency ( creatinine clearance OVER-DOSAGE OF LIPITRIN 40/10 7 TAB
LIPITRIN in the event of overdose, symptomatic and supportive measures should be employed. Coadministration of ezetimibe (1000 mg/kg) and simvastatin (1000 mg/kg) was well-tolerated in acute, oral toxicity studies in mice and rats. No clinical signs of toxicity were observed in these animals. The estimated oral L D50 for both species was ezetimibe ≥1000 mg/kg simvastatin ≥1000 mg/kg. Ezetimibe: In clinical studies, administration of ezetimibe, 50 mg/kg to 15 healthy subjects for up to 14 days, or 40 mg/day to 18 patients with primary hypercholesterolemia for up to 56 days, was generally well tolerated. A few cases of overdosage have been reported; most have not been associated with adverse experiences. Reported adverse experiences have not been serious. In animals, no toxicity was observed after single oral doses of 5000 mg/kg of ezetimibe in rats and mice and 3000 mg/kg in dogs. Simvastatin: A few cases of overdosage have been reported; the maximum dose taken was 3.6 g. All patients recovered without sequelae.
CONTRA-INDICATION OF LIPITRIN 40/10 7 TAB
Hypersensitivity to ezetimibe, simvastatin, or to any of the excipients. Pregnancy and lactation. Active liver disease or unexplained persistent elevations in serum transaminases, Concomitant administration of potent CYP3A4 inhibitors ( e.g. itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors and nefazodone).
STORAGE OF LIPITRIN 40/10 7 TAB
Store in a dry place at a temperature not exceeding 30 ° C.
PACK OF LIPITRIN 40/10 7 TAB
Carton box containing 1, 2 or 3 (AL/AL) strips each of 7 tablets & pamphlet.
LIPITRIN 40/10 7 TAB MANUFACTURED BY
Chemipharm pharmaceutical industries 6 October city – Egypt.