Crestor 5 5mg. 10mg. 20mg. 40mg Tablet

To reduce the risk of cardiovascular events: In adult patients with an increased risk of atherosclerotic cardiovascular disease based on the presence of cardiovascular disease risk markers such as an elevated high-sensitivity C-reactive protein (hsCRP) level, age, hypertension, low HDL-C, smoking or a family history of premature coronary heart disease, CRESTOR is indicated to reduce the risk of non-fatal stroke, non-fatal MI, and the need for arterial revascularisation.

In adult patients with hypercholesterolaemia:

• CRESTOR is indicated for patients with primary hypercholesterolaemia, mixed dyslipidaemia and isolated hypertriglyceridaemia (including Fredrickson Type IIa, IIb and IV; and heterozygous familial and non-familial hypercholesterolaemia) as an adjunct to diet when response to diet and exercise is inadequate.
• CRESTOR is indicated to treat patients with primary dysbetalipoproteinaemia (Fredrickson Type III hyperlipoproteinaemia).
• CRESTOR is also indicated to reduce Total Cholesterol and LDL - C in patients with homozygous familial hypercholesterolaemia, either alone or as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis). CRESTOR 40 mg should only be considered in patients with severe hypercholesterolaemia and high cardiovascular risk who do not achieve their treatment goal on 20 mg of CRESTOR or alternative therapy. Specialist supervision is recommended when the 40 mg dose is initiated.

Children and adolescents 10-17 years of age: CRESTOR is indicated to reduce the Total Cholesterol, LDL-C and Apo B in patients with heterozygous familial hypercholesterolaemia (HeFH).

The dose range for CRESTOR is 5-40 mg orally once a day. The recommended start dose is 5 mg once a day. The dosage of CRESTOR should be individualised according to the goal of therapy and patient response. The majority of patients are controlled at the 10 mg dose. However, if necessary, dose adjustment can be made at 2-4 week intervals. CRESTOR may be given at any time of the day, with or without food.

Adults: Primary hypercholesterolaemia (including heterozygous familial hypercholesterolaemia), mixed dyslipidaemia, dysbetalipoproteinaemia (Fredrickson Type III hyperlipoproteinaemia), and isolated hypertriglyceridaemia: The recommended start dose is 5 mg once a day. A 5 mg starting dose is recommended for patients of Asian ancestry, and for patients requiring a smaller reduction in LDL-C to achieve treatment target. For patients with severe hypercholesterolaemia (including heterozygous familial hypercholesterolaemia), a start dose of 20 mg may be considered.

Homozygous familial hypercholesterolaemia: For patients with homozygous familial hypercholesterolaemia a start dose of 20 mg once a day is recommended.

Children and adolescents 10-17 years of age: In children and adolescents with heterozygous familial hypercholesterolaemia the usual dose range is 5-20 mg orally once daily. The dose should be appropriately titrated to achieve treatment goal. Safety and efficacy of doses greater than 20 mg have not been studied in this population. In children and adolescents with homozygous familial hypercholesterolaemia experience is limited to a small number of patients (aged 8 years and above).

Special populations: Use in the elderly: The usual dose range applies. Dosage in patients with renal insufficiency: The starting dose applies in patients with mild to moderate renal impairment. For patients with severe renal impairment the dose of CRESTOR should not exceed 10 mg once daily. Dosage in patients with hepatic insufficiency: The usual starting dose applies in patients with mild to moderate hepatic impairment. Patients with severe hepatic impairment should start therapy with CRESTOR 5 mg. Increased systemic exposure to rosuvastatin has been observed in these patients, therefore the use of doses above CRESTOR 10 mg should be carefully considered.

Race: A 5 mg starting dose of CRESTOR should be considered for Asian patients. Increased plasma concentration of rosuvastatin has been seen in Asian subjects.

CRESTOR is contraindicated in:

• patients with hypersensitivity to any component of this product
• patients with active liver disease
• concomitant use with ciclosporin
• patients with myopathy

Safety in pregnancy and lactation has not been established.

CRESTOR should be used with caution in patients who consume excessive quantities of alcohol and/or have a history of liver disease. An assessment of renal function should be considered during routine follow-up of patients treated with a dose of 40 mg.

Effects on skeletal muscle e.g. uncomplicated myalgia, myopathy and rhabdomyolysis, have been reported in patients treated with rosuvastatin. As with other HMG-CoA reductase inhibitors, the reporting rate for rhabdomyolysis in post-marketing use is higher at the highest marketed dose. Patients who develop any signs or symptoms suggestive of myopathy should have their Creatine kinase (CK) levels measured. CRESTOR therapy should be discontinued if myopathy is diagnosed or suspected. An increase in the incidence of myositis and myopathy has been seen in patients receiving other HMG-CoA reductase inhibitors together with ciclosporin, fibric acid derivatives, including gemfibrozil, nicotinic acid, azole antifungals and macrolide antibiotics. CRESTOR should be prescribed with caution in patients with pre-disposing factors for myopathy, such as renal impairment, advanced age and hypothyroidism, or situations where an increase in plasma levels may occur.

CRESTOR should be temporarily withheld in any patient with an acute serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g. sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders; or uncontrolled seizures).

CRESTOR should be used with caution in patients taking various protease inhibitors in combination with ritonavir as pharmacokinetic studies have shown an increase in the AUC and C max of rosuvastatin.

Interaction with other medicinal products and other forms of interaction:

Warfarin: The pharmacokinetics of warfarin are not significantly affected following co-administration with CRESTOR. However, as with other HMG-CoA reductase inhibitors, co-administration of CRESTOR and warfarin may result in a rise in INR compared to warfarin alone. In patients taking warfarin monitoring of INR is recommended both at initiation or cessation of therapy with CRESTOR or following dose adjustment.

Ciclosporin: Co-administration of CRESTOR with ciclosporin resulted in no significant changes in ciclosporin plasma concentration. However, rosuvastatin steady state AUC (0-t) increased up to 7-fold over that seen in healthy volunteers.

Gemfibrozil: Concomitant use of CRESTOR and gemfibrozil resulted in a 2-fold increase in rosuvastatin C max and AUC (0-t).

Protease inhibitors: Increased systemic exposure to rosuvastatin has been observed in subjects in pharmacokinetic studies receiving CRESTOR with various protease inhibitors in combination with ritonavir. The lowest dose of CRESTOR that provides therapeutic benefit to the patient should be used, and close monitoring of adverse events is indicated.

Antacids: The simultaneous dosing of CRESTOR with an antacid suspension containing aluminium and magnesium hydroxide resulted in a decrease in rosuvastatin plasma concentration of approximately 50 %. This effect was mitigated when the antacid was dosed 2 hours after CRESTOR. The clinical relevance of this interaction has not been studied.

Cytochrome P450 enzymes: In vitro and in vivo data indicate that rosuvastatin has no clinically significant cytochrome P450 interactions (as a substrate, inhibitor or inducer). Other medications: There were no clinically significant interactions with an oral contraceptive, digoxin, ezetimibe or fenofibrate.

The safety of CRESTOR during pregnancy and whilst breastfeeding has not been established. Women of child-bearing potential should use appropriate contraceptive measures.

Pharmacology testing revealed no evidence of a sedative effect of CRESTOR. From the safety profile, CRESTOR is not expected to adversely affect the ability to drive or use machines.

In controlled clinical trials less than 4 % of CRESTOR treated patients were withdrawn due to adverse events. The frequencies of adverse events are ranked according to the following: Common ( u22651/100, < 1/10); Uncommon (u2265 1/1 000, < 1/100); Rare (u2265 1/10 000, < 1/1 000); Very rare (<1/10 000).

Clinical trials:

• Nervous system disorders: Common: headache, dizziness
• Gastrointestinal disorders: Common: constipation, nausea, abdominal pain; Rare: pancreatitis
• Musculoskeletal, connective tissue and bone disorders: Common: myalgia; Rare: myopathy (including myositis), rhabdomyolysis
• General disorders: Common: asthenia
• Skin disorders: Uncommon: pruritus, rash, urticaria; Rare: hypersensitivity reactions including angio-oedema

Post marketing experience: In addition to the above, the following adverse events have been reported during post marketing experience for CRESTOR: Hepatobiliary disorders: Jaundice, hepatitis, increased hepatic transaminases. Musculoskeletal disorders: Arthralgia. The reporting rate for rhabdomyolysis in post-marketing use is higher at the highest marketed dose.

The incidence of adverse drug reactions tends to increase with increasing dose. Skeletal muscle effects: Rhabdomyolysis, which may occasionally be associated with impairment of renal function, has been reported with rosuvastatin. Renal effects: Proteinuria (see: u201c Laboratory effects u201d). Nervous system disorders: Memory loss. Laboratory effects: A dose-related increase in liver transaminases and Creatine kinase (CK) has been observed in patients taking rosuvastatin. Abnormal urinalysis testing (dipstick-positive proteinuria with haematuria) has been seen in patients taking CRESTOR. The protein detected was mostly tubular in origin. In most cases, proteinuria decreases or disappears spontaneously on continued therapy, and is not predictive of acute or progressive renal disease.

There is no specific treatment in the event of overdose. In the event of overdose, the patient should be treated symptomatically and supportive measures instituted as required. Haemodialysis is unlikely to be of benefit.