ROVISTA 10MG TABLET 30S

Rosuvastatin lowers cholesterol by blocking an enzyme HMG Co-A reductase in the liver that’s needed to make cholesterol. When this enzyme is blocked, the liver makes less cholesterol and pulls more cholesterol out of the blood. This reduces the levels of LDL cholesterol in the bloodstream, helping to prevent heart attacks and strokes.

Statin

This medication is used for:

• LDL cholesterol reduction
• HDL cholesterol increase
• Cardiovascular risk reduction

Rosuvastatin drug dosage recommendations are:

• Hypercholesterolaemia, Mixed dyslipidaemia - Adult - Initially, 5 or 10 mg once daily. Usual Max - 20 mg once daily. Max of 40 mg once daily may be used for severe hypercholesterolaemia. Patients with homozygous familial hypercholesterolaemia may start on 20 mg once daily. Dosage may be increased at intervals of 2-4 weeks.
• Hypercholesterolaemia, Mixed dyslipidaemia - Elderly - >70 years Initially, 5 mg once daily.
• Hypercholesterolaemia, Mixed dyslipidaemia - Child - Heterozygous familial hypercholesterolaemia - Initially, 5 mg once daily. Usual dose range - 6-9 years 5-10 mg once daily. 10-17 years 5-20 mg once daily. Familial homozygous hypercholesterolaemia - 6-17 years Initially, 5 or 10 mg once daily. May titrate up to Max of 20 mg once daily according to response and tolerability.
• Prophylaxis of cardiovascular events in high-risk patients - Adult - 20 mg once daily.
• Prophylaxis of cardiovascular events in high-risk patients - Elderly - >70 years Initially, 5 mg once daily.

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

If you miss a dose, take it as soon as you remember. If it is close to the next dose, skip the missed dose. Do not take double doses.

Take tablet/tablets as directed by your healthcare provider. Follow the dosage instructions provided.

Rosuvastatin is contraindicated in:

• Patients with hypersensitivity to rosuvastatin or any of the excipients
• 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)
• Patients with severe renal impairment (creatinine clearance <30 ml/min)
• Patients with myopathy
• Patients receiving concomitant cyclosporin
• Pregnancy and lactation, and in women of childbearing potential not using appropriate contraceptive measures
• Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

The side effects of Rosuvastatin tablets are as follows:

• Gastrointestinal discomfort
• Headache
• Dizziness
• Allergic reactions
• Fatigue

Patients should be aware of these precautions and warnings before using this medication:

• Use with caution if you have hypothyroidism, a history of hereditary muscular disorders, or have experienced muscular toxicity with another HMG-CoA reductase inhibitor or fibrates.
• Avoid use if you consume excessive amounts of alcohol, have a history of liver disease, or are experiencing severe respiratory failure.
• Use with caution if you are of Asian ancestry, have predisposing factors for myopathy, or are taking concomitant medications such as ciclosporin, gemfibrozil, atazanavir/ritonavir, lopinavir/ritonavir, or simeprevir.
• Consider genetic testing if you have SLCO1B1 and ABCG2 polymorphisms.
• Use with caution in patients with moderate renal impairment (creatinine clearance 30-60 mL/min), as well as in children and the elderly.

Drug interactions with rosuvastatin include:

• CYP2C19 inhibitors (e.g., fluconazole) (may increase rosuvastatin levels)
• CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) (generally less interaction as rosuvastatin is minimally metabolized by CYP3A4, but monitor for potential effects)
• CYP2C9 inhibitors (e.g., warfarin) (may increase rosuvastatin levels)
• Antacids (e.g., magnesium hydroxide, aluminum hydroxide) (may decrease rosuvastatin absorption)
• Gemfibrozil (may significantly increase rosuvastatin levels and risk of myopathy)
• Ezetimibe (may enhance the cholesterol-lowering effects)
• Warfarin (may enhance the anticoagulant effect)

Store at room temperature in a tightly closed container. Dispose of unused or expired medication by returning it to a pharmacy for safe disposal.