COMPOSITION :

Each f/c tablet contains: Rosuvastatin calcium equivalent to Rosuvastatin 5 mg, 10mg and 20mg.

DESCRIPTION :

Liparoze (Rosuvastatin) is anti-hypercholesterolaemia drug that belongs to a group called statin. It works on reducing the plasma lipids

leading to reduce cardiovascular diseases.

Rosuvastatin inhibits HMG-coA reductase which is involved in cholesterol synthesis in hepatocytes as well it inhibits the synthesis of

VLDL. Liparoze also it increases the number of hepatic LDL receptors on the cell-surface, enhancing the uptake and catabolism of LDL

from the blood circulation thereby decreasing LDL & VLDL levels in the blood which are the low density lipoprotein which are bad type

of cholesterol that precipitates in the blood vessels.

Rosuvastatin also increases HDL quantity in the blood "which is the high density lipoprotein considered as good type of cholesterol"; it

takes the excess amount of lipids from the blood to the liver for catabolism.

Rosuvastatin is the most potent statin for lowering bad cholesterol (LDL) and doesn't interfere as much with other drugs because it

minimally involved with CYP450 enzyme. It has fewer muscle and nervous system side effects because it has tendency to dissolve or

combine with water (hydrophilic ).

INDICATIONS:

- Treatment of Hypercholesterolaemia as an adjunct to diet when the response to diet and other non-medical treatment (e.g. exercise,

weight reduction) is inadequate for controlling hypercholesterolaemia.

- Prevention of cardiovascular diseases.

- Prevention of cardiovascular diseases.

DOSAGE & ADMINISTRATION:

- Before starting treatment you should be in standard cholesterol-lowering diet and the diet should be continued during treatment.

- Liparoze dose could be taken at any time of day, with or without food.

- Treatment of hypercholesterolaemia :

* Adults recommended starting dose is: 5 or 10 mg orally once daily. If necessary, the dose can be adjusted after 4 weeks.

* The maximum usual dose is 20 mg daily but in patients with severe hyperchloesterolaemia at high cardiovascular risk and the treatment

goal is not achieved on 20 mg only in this situation, the dose 40mg to be given as a maximum dose.

*Children and adolescents 6 to 9 years with heterozygous familial hypercholesterolaemia: The usual dose is 5-10 mg once daily.

*Children and adolescents 10 to 17 years with heterozygous familial hypercholesterolaemia: The usual dose is 5-20 mg once daily.

*Children and adolescents 6 to 17 years with homozygous familial hypercholesterolaemia: The usual start dose is 5-10 mg once daily

depend on age and body weight. And the maximum daily dose is 20 mg once daily.

* Elderly >70 years, patients with mild to moderate renal impairment, patients with Asian ancestry (Japanese, Chinese, Filipino,

Vietnamese, Koreans or Indians) or Patients with predisposing factors to myopathy should consult their doctor and the recommended

daily dose is 5 mg.

- Prevention of cardiovascular disease risk the usual dose is: 20 mg daily.

RESTRICTIONS ON USE :

Contraindications

- Hypersensitivity to Rosuvastatin. - Patients with active liver disease.

- Patients with myopathy. - Patient with sever renal impairment (Cr.Cl<30ml/min).

The dose 40mg is contraindicated in patient with:

- Moderate renal impairment. - Hypothyroidism - Myopathy. - Asian patient -

Concomitant use with fibrates. - Previous history of muscle toxicity with HMG-CoA inhibitor drugs or with fibrate

Precautions

- Renal impairment , hypothyroidism or Age > 70 years.

- Patient with Renal impairment or patient with hypothyroidism or patient > 70 years.

- History of hereditary muscular disorders or pervious history of muscular toxicity with fibrate or another HMG-CoA reductase inhibitor.

- The drug affects the liver so if transaminase is three times greater than the UNL the patient should consult the doctor.

- Patient at high risk of future diabetes (fasting blood glucose >5.6 mmol/L, BMI >30, kg/m2, raised triglycerides, history of

hypertension) the usage of liparoze may produce an increase in glucose level, so a formal diabetes care is appropriate.

Use in Pregnancy & Lactation

If you are pregnant or there is probability to be pregnant or during breastfeeding do not take liparoze.

Effects on the capacity to drive vehicles or use machines

Liparoze may cause dizziness for some patients, so caution should be taken during driving.

DRUG INSTRATCTIONS :

Ciclosporin, Protease inhibitors, Gemfibrozil and another lipid lowering drugs cause increase risk of myopathy.

- Vitamin K antagonists interact with liparoze so the dose of them should be adjusted according to INR ratio and the ratio should be

monitoring periodically .

- Erythromycin, Antacids containing aluminum and magnesium hydroxide resulted in a decrease in Rosuvastatin plasma concentration so

antacids must be taken after two hours from taking Liparoze.

- Concomitant use of liparoze with Oral contraceptives leads to increase the contraceptive concentration in plasma so the dose should

been adjusted.

ADVERSE EFFECTS:

Some of the side effects will happen to some patients not all patients will suffer from side effect like Headache, Dizziness, Constipation,

Nausea, Abdominal pain, Myalgia, Asthenia, Pruritus, Rash and Urticaria.

OVERDOSAGE :

There is no specific treatment in case of overdose; the patient should be treated symptomatically and supportively. Liver function and CK

levels should be monitored.

STORAGE INSTRUCTIONS:

Store below 30oC, in a dry place.

PRESENTATION :

Liparoze 5mg,10mg , 20mg Tablets : pack of 30 tablets, and hospital p