Following is information on contraindications to the use of rosuvastatin in general, pregnancy & breastfeeding and children. Please note that the contraindications may vary depending on the dosage form of a drug (eg tablet, syringe, ointment).
When should Rosuvastatin not be used?
Rosuvastatin should not be used with
- Hypersensitivity to the active substance
- existing liver disease, including an unexplained and persistent increase in typical laboratory values (transaminases in the blood and any increase in transaminase levels more than three times normal)
- severe renal impairment (creatinine clearance below 30 milliliters / minute)
- muscle diseases.
Rosuvastatin should be given only after careful consideration of the benefit-risk by a physician and under his control at
- moderate renal impairment (creatinine clearance below 60 milliliters / minute)
- hereditary muscle diseases in personal or family history
- muscle-damaging effects of previous use of fibrates or other statins
- Alcohol Abuse
- Situations in which increased plasma concentrations of rosuvastatin may be present (for example, kidney problems and age over 70 years)
- of Asian descent.
In all these cases, the dosage of rosuvastatin should not reach 40 milligrams a day.
What should you watch out for during pregnancy and lactation?
Rosuvastatin should not be used during pregnancy or breast-feeding. Women of childbearing potential must use appropriate contraception during treatment. Since cholesterol and other products of the body’s cholesterol production are necessary for the development of the unborn child, the risk posed by the drug outweighs the benefits of treatment during pregnancy. If a patient becomes pregnant during treatment, treatment must be stopped immediately.
Rosuvastatin is excreted in the milk of rats. There are no findings from the studies on the transition from rosuvastatin to human milk.
What should be considered in children?
The active substance is approved for the treatment of children over the age of ten years. However, in this age group more than in adults, abnormal muscle values in the blood (CK value) as well as muscle complaints after exercise and increased physical activity can occur.
Warnings and Precautions
- Unexplained muscle aches, muscle weakness or muscle spasm should be reported to a physician immediately, especially if they are accompanied by discomfort or fever.
- Pregnancy must be reliably prevented during treatment.
- Acid-binding agents should only be taken at least two hours apart from the drug.
- If a patient already has risk factors for the development of diabetes, the blood sugar must be checked regularly during treatment.
- Dizziness can occur during treatment, making driving and operating machines dangerous.
Sometimes medications release allergic reactions.
If you notice any signs of allergic reaction, tell your doctor or pharmacist immediately.