ROTORLIP 10

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COMPOSITION:
Rosuvastatin calcium ........................................... equivalent to 10 mg of rosuvastatin
Excipients q.s .............................................................................................. 1 tablet
(Microcrystalline cellulose M101, lactose monohydrate, crospovidone, PVP K30, magnesium stearate, HPMC 606, HPMC 615, PEG 6000, titanium dioxide, red ferric oxide, talc).
DOSAGE FORM: Film coated tablets.
PRESENTATION: Box of 3 blisters x 10 tablets.
PHARMACODYNAMICS: Rotorlip contains rosuvastatin, which is a competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts HMG-CoA to mevalonate, a precursor of cholesterol. Rosuvastatin inhibits cholesterol biosynthesis, lowers hepatocellular cholesterol, stimulates LDL (Low Density Lipoprotein) receptor synthesis, and thereby increasing transportation of LDL from blood. The final result is reduction of plasma cholesterol concentration.
Rosuvastatin reduces LDL effectively. It also increases the HDL (High Density Lipoprotein) cholesterol and consequently lowers LDL/HDL and total cholesterol/HDL. Rosuvastatin also reduces the plasma triglyceride by increasing the clearance of surplus VLDL (Very Low-Density Lipoprotein) by LDL receptor.
Clinical studies, evidences have showed that statins remarkably reduce the rate of coronary events, every early cardiovascular events, and total of death in patients with coronary arterial disease.
PHARMACOKINETICS:
Peak plasma concentrations of rosuvastatin were reached 3 to 5 hours following oral dosing; the absolute bioavailability of rosuvastatin is approximately 20%. Both absorption and concentration increased in approximate proportion to rosuvastatin dose. Administration of rosuvastatin with food did not affect the concentration of rosuvastatin. Following oral administration, rosuvastatin is primarily excreted in the feces (90%). The elimination half-life of rosuvastatin is approximately 19 hours.
INDICATIONS: Rosuvastatin is indicated as an adjunct to diet in cases: primary hypercholesterolemia (Type IIa including heterozygous familial hypercholesterolemia), and mixed dyslipidemia (Type IIb), primary dysbetalipoproteinemia, hypertriglyceridemia, slowing of the progression of atherosclerosis.
Homozygous familial hypercholesterolemia: as adjunctive therapy to other lipid lowering treatments or if such treatments are unavailable. Primary prevention of cardiovascular disease (reduce the risk of stroke, myocardial infarction, arterial revascularization procedures) in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease.
CONTRAINDICATIONS: Hypersensitivity to any components of the drug. In patients with active liver disease or with unexplained persistent elevations of serum transaminases. Severe renal failure. Myopathy. Receiving concomitant cyclosporin.
PRECAUTIONS:
Before starting on the rosuvastatin treatment, blood cholesterol should be coordinately controlled by diet, weight loss, exercise, treatment of diseases associated with elevated lipid. Lipid assay should be periodically tested and the dosage can be adjusted according to patient’s response to the drug. Using LDL-C concentration to start treatment and assess treatment response.
It is recommended that liver enzyme tests be performed before the initiation of rosuvastatin and as clinically indicated. Creatine kinase (CK) should be carefully considered to monitor in cases of:
+ Before treatment: CK test should be carried out in cases of impaired renal function, hypothyroidism, personal or family history of hereditary muscular disorders, previous history of muscular toxicity with statin or fibrate, history of hepatic disease and/or alcohol abuse, elderly patients (>70 years of old) with a risk factory of rhabdomyolysis, possibility of drug interactions and some special patient subjects. In such patients the risk of treatment should be considered in relation to possible benefit and clinical monitoring is recommended. If CK levels are significantly elevated at baseline (>5xULN) treatment should not be started.
+ Whilst on treatment, patients should be asked to report muscle pain, weakness or cramps immediately. CK levels should be measured in these patients.
Statins therapy should be temporarily withheld or discontinued in any patient with an acute, serious condition suggestive of a myopathy or having a risk factor predisposing to the development of renal failure secondary to rhabdomyolysis. Rosuvastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive and when patients suffer from very high hypercholesterolemia without response with other drugs.
PREGNANCY AND LACTATION:
The drug is contraindicated in pregnant women and nursing mothers. 
VEHICLE DRIVERS AND MACHINERY OPERATORS: Cautions should be taken when driving vehicles and operating machinery because the drug may cause dizziness.
INTERACTIONS:
The risk of myopathy may be increased by concomitant administration of rosuvastatin and gemfibrozil, blood cholesterol-lowering agents of other fibrates, high-dose niacin (> 1 g/day), colchicine, cyclosporin, itraconazole, ketoconazole.
The interactions between drugs for human immunodeficiency virus (HIV) or hepatitis C virus (HCV) and certain cholesterol-lowering drugs known as statins may increase the risk for muscle injury (myopathy). The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney failure, which can be fatal.
Rosuvastatin may increase the effect of warfarin and the bioavailability of oral contraceptive when they are co-administered.
The simultaneous dosing of Rotorlip with an antacid suspension containing aluminum hydroxide and magnesium hydroxide or with erythromycin resulted in a decrease in rosuvastatin bioavailability. This effect was mitigated when the antacid was dosed 2 hours after Rotorlip.
ADVERSE EFFECTS: Frequently observed: Diarrhoea, constipation, flatulence, colic, nausea. Headache, dizziness, caligo, insomnia, asthenia. Muscular-arthral pains.
Infrequently observed: muscular weakening, rash, rhinitis, sinusitis, pharyngitis, and cough.
Rarely observed: myositis, rhabdomyolysis leading to secondary acute renal impairment due to myoglobulinuria.
Other adverse effects: cognitive impairment (e.g. memory loss, forgetfulness,... ), increase in blood glucose levels, elevated HbA1c.
Inform your physician about any adverse effects occur during the treatment.
OVERDOSAGE: There is no specific treatment for rosuvastatin overdosage. In the event of an overdose, the patient should be treated symptomatically and supportive measures instituted as required. Hemodialysis is not expected to significantly enhance rosuvastatin clearance.
DOSAGE & ADMINISTRATION:
Before treatment initiation the patient should be placed on a standard cholesterol-lowering diet that should continue during treatment
The recommended start dose is 5 or 10 mg orally once daily, at any time of day, with or without food. A dose adjustment to the next dose level can be made after 4 weeks, if necessary. The recommended maximum dose is 40 mg/ time/ day; a closed monitor should be advised in those taking the dose of 40 mg.
According to a pharmacokinetic study on Asians in the US, the ability to absorb rosuvastatin in Asians was in 2-fold increase compared with whites; so the recommended start dose is 5 mg for patients of Asian ancestry
Children (10 - 17 years of age): 5 - 20 mg/ day, maximum of 20 mg/ day.
Patients who are receiving atazanavir, atazanavir + ritonavir, lopinavir + ritonavir: maximum dose 10 mg/ time/ day.
For patients with severe renal impairment (CLcr < 30 ml/ min) not on hemodialysis: dosing of Rotorlip should be started at 5 mg once daily and not exceed 10 mg once daily.
Or as directed by the physician.
Read the directions carefully before use. 
Consult the physician for more information. 
This drug is for prescription only.  
Shelf-life: 24 months from the manufacturing date.
Storage conditions: Store in dry places, not exceeding 30oC, protect from light.
Specifications: Manufacturer's.

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