Rostat CV 10,20mg

Class: HMG-CoA reductase inhibitors (statins), antiplatelet

Manufacturer: Atoz Pharmaceuticals Pvt. Ltd, No. 12, Balaji Nagar, Ambattur, Chennai – 600 053 India

Dosage Form: Capsule, Tablet

Similar Brands:

Uses:

Rosuvastatin and clopidogrel, which prevents heart attack and stroke. Rosuvastatin is a lipid lowering medication that blocks the body’s ability to produce “bad” cholesterol (LDL) and improves the level of “good” cholesterol “HDL”. Clopidogrel is an antiplatelet medication. It prevents the platelets from sticking together and decreases the formation of harmful blood clots.

Dosage:

A single dose is recommended or as directed by physician.

Method of administration: oral

Not recommended for children below 18 years.

Paediatric population: rosuvastatin and clopidogrel should not be used in children

Side Effects:

Thrombocytopenia, hypersensitivity reactions including angioedema, diabetes mellitus, depression, headache, dizziness, cough, dyspoea, nausea, serum sickness, anaphylactoid reactions, hallucinations, confusion, taste disturbances, ageusia and serious hemorrhage, hemorrhage of operative wound, vasculitis, hypotension.

Warnings & Precautions:

Rosuvastatin: Rosuvastatin as with other HMG-CoA reductase inhibitors, should be prescribed with caution in patients with pre-disposing factors for myopathy/rhabdomyolysis. Patients should be asked to report inexplicable muscle pain, weakness or cramps immediately, particularly if associated with malaise of fever. CK levels should be measured in these patients. Rosuvastatin must not be co-administered with systemic formulations of fusidic acid or within 7 days of stopping fusidic acid treatment.

Clopidogrel: Due to the risk of bleeding and haematological adverse reactions, blood cell count determination and/or other appropriate testing should be promptly considered whenever clinical symptoms suggestive of bleeding arise during the course of treatment. Patients should be told that it might take longer than usual to stop bleeding when they take clopidogrel (alone or in combination with ASA), and that they should report any unusual bleeding (site or duration) to their physician. Caution is required in patients treated concomintantly with clopidogrel and CYP2C8 subtrate medicinal products.

Pregnancy & Lactation:

Rosuvastatin is contraindicated in pregnancy and lactation.

Women of child bearing potential should use appropriate contraceptive measures. As no clinical data on exposure to clopidogrel during pregnancy are available, it is preferable not to use clopidogrel during pregnancy as a precautionary measure. It is unknown whether clopidogrel is excreted in human breast milk.

Drug Interactions:

Rosuvastatin is a substrate for certain transporter proteins including the hepatic uptake transporter OATP181 and efflux transporter BCRP. Concomitant administration of rosuvastatin with medicinal products that are inhibitors of these transporter proteins may result in increased rosuvastatin plasma concentrations and an increased risk of myopathy. Rosuvastatin is contraindicated in patients receiving concomitant ciclosporin. Concomitant administration did not affect plasma concentrations of ciclosporin. Concomitant use of rosuvastatin and gemifibrozil resulted in a 2-fold increased in rosuvastatin Cmax and AUC. Oral anticoagulants: the concomitant administration of clopidogrel with oral anticoagulants is not recommended since it may increase the intensity of bleedings. Co-administration of heparin had no effect on the inhibition of platelet aggregation induced by clopidogrel.

 

Contraindications:

Rosuvastatin is contraindicated in patients with hypersensitivity to the active substance or to any of the exipients listed. Contraindication of clopidogrel is severe hepatic impairment. Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.

Price: Ksh 2,210

Notes:

Pack Size: 30s

Overdose

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. Liver function and CK levels should be monitored. Haemodialysis is unlikely to be of benefit. Overdose following clopidogrel administration may lead to prolonged bleeding time and subsequent bleeding complications. Appropriate therapy should be considered if bleeding are observed. No antidote to the pharmacological activity of clopidogrel has been found. If prompt correction of prolonged bleeding time is required, platelet transfusion may reverse the effects of clopidogrel.

Date of publication/review: 18 January 2021 (PIKE157)

Manufactured by:

Atoz Pharmaceuticals Pvt. Ltd, No. 12, Balaji Nagar, Ambattur, Chennai – 600 053 India

Marketed by:

Innocia Lifesciences Pvt. Ltd