Rosuvastatin BSS

Rosuvastatin Sandoz 10/20/40 mg film-coated tablets.  Formulation: Each coated tablet contains 10, 20 or 40 mg of rosuvastatin. Indications: Treatment of hypercholesterolaemia, prevention of cardiovascular events. Dose: Treatment of hypercholesterolemia. Recommended initial dose, 5 or 10 mg orally once a day. Prevention of cardiac events. Doses of 20 mg per day were used in studies. Pediatric population between 6 and 17 years old (Tanner Stage <II-V). Usual starting dose is 5mg per day. In children 6 to 9 years of age with heterozygous familial hypercholesterolaemia, the usual dose range is 5-10 mg orally once daily. Safety and efficacy of doses greater than 10 mg have not been studied in this population. In children 10 to 17 years of age with heterozygous familial hypercholesterolaemia, the usual dose range is 5-20 mg orally once daily. Safety and efficacy of doses greater than 20 mg have not been studied in this population. The safety and efficacy of use in children younger than 6 years has not been studied. A start dose of 5 mg is recommended in patients >70 years. Contraindications: Hypersensitivity to rosuvastatin or to any of the other components of the product; Active hepatic disease including unexplained elevations of serum transaminases, severe renal insufficiency, myopathy, patients receiving concomitant cyclosporine, during pregnancy and breastfeeding and in women of childbearing age that do not use adequate birth control measures. Precautions for use: Proteinuria has been seen in patients with higher doses of rosuvastatin. Myalgia, myopathy, rhabdomyolysis with doses above 20 mg. Caution in patients with risk of rhabdomyolysis. Use with caution in patients who consume excessive amounts of alcohol and/or have a history of hepatic disease. With some statins exceptional cases of interstitial lung disease have been reported. Some evidences suggest that statins as a class of medication increase blood glucose, and in some patients, who are in a future high risk of displaying diabetes, can produce a level of hyperglycemia for which it would be appropriate to establish an appropriate diabetes formal care. Adverse Events. Common side effects: headache, dizziness, constipation, giddiness, stomach pain, muscle weakness, weakness feeling, increase in the amount of protein in the urine. These effects usually disappear and the normal state spontaneously returns without having to suspend the usage of tablets. Uncommon side effects: itching, rash, or other skin reaction (hives) and increase in the amount of protein in the urine.  CDS May 2019.