Brand Name: Nexirozova Tablet.
Composition:
Each Nexirozova 20mg Film tablet contains: Rosuvastatin .............................................. 20 mg
Each Nexirozova 10mg Film tablet contains: Rosuvastatin ............................................... 10 mg
Each Nexirozova 5mg Film tablet contains: Rosuvastatin .................................................. 5 mg
Therapeutic Indications:
- Treatment of hypercholesterolemia.
- Prevention of Cardiovascular Events.
Dosage and Administration:
- Treatment of hypercholesterolemia
○ The recommended start dose is 5 or 10 mg orally once daily in both statin naïve or patients switched from another HMG CoA reductase inhibitor. who do not achieve their treatment goal on 20 mg, and in whom routine follow-up will be performed. Specialist supervision is recommended when the 40 mg dose is initiated.
- Prevention of cardiovascular events
○ In the cardiovascular events risk reduction study, the dose used was 20 mg daily
Contraindications:
- in patients with hypersensitivity to rosuvastatin or to any of the excipients.
- in patients with active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding 3 times the upper limit of normal (ULN).
- in patients with severe renal impairment (creatinine clearance <30 ml/min).
- in patients with myopathy.
- in patients receiving a concomitant combination of sofosbuvir/velpatasvir/voxilaprevir
- in patients receiving concomitant ciclosporin.
- during pregnancy and lactation and in women of childbearing potential not using appropriate contraceptive measures.
- The 40 mg dose is contraindicated in patients with predisposing factors for myopathy/rhabdomyolysis. Such factors include:
○ moderate renal impairment (creatinine clearance < 60 ml/min)
○ Hypothyroidism
○ personal or family history of hereditary muscular disorders
○ previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate
○ alcohol abuse
○ situations where an increase in plasma levels may occur
○ Asian patients
○ concomitant use of fibrates
Warnings and precautions:
- Renal Effects
- Skeletal Muscle Effects
- Creatine Kinase Measurement.
- Liver Effects
- Lactose Intolerance
- Protease Inhibitors
Undesirable Effects:
- Headache ● Dizziness ● Constipation ● Nausea
- Abdominal pain
- Myalgia
Pharmacological Properties:
Nexirozova is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor for cholesterol. The primary site of action of rosuvastatin is the liver, the target organ for cholesterol lowering.
Rosuvastatin increases the number of hepatic LDL receptors on the cell surface, enhancing uptake and catabolism of LDL and it inhibits the hepatic synthesis of VLDL, thereby reducing the total number of VLDL and LDL particles belong to the proton pump inhibitor group is a medication that reduces stomach acid
Packaging:
Nexirozova 20mg Tables; box containing 2 blisters of 7 tablets each.
Nexirozova 10mg Tables; box containing 2 blisters of 7 tablets each.
Nexirozova 5mg Tables; box containing 2 blisters of 7 tablets each.
