Rovaterol Tablet 5 mg (Rosuvastatin Calcium)

Adult dosage

For primary hypercholesterolemia and related conditions, the initial dose is 5 mg once daily, administered at any time of the day irrespective of meals. If more LDL cholesterol reduction is required, the maintenance dose can be adjusted to 10 mg once daily, and can be increased up to a maximum of 20 mg once daily at intervals of 4 weeks or more based on treatment goals and patient response.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), administer once daily in the range of 5 mg to 20 mg. The dosage should be adjusted according to treatment goals with intervals of 4 weeks or longer.

This medication should not be used in certain patients. For example, patients with allergies to any of its components, those with severe liver dysfunction, patients with muscle diseases, those taking certain medications, patients with severe kidney dysfunction, pregnant or breastfeeding women, and patients with specific genetic diseases should not take this medication. Additionally, liver function and muscle condition should be monitored periodically while taking this medication. Special caution is required when consuming alcohol heavily or having a history of liver disease, hypothyroidism, impaired kidney function, a history of muscle issues, elderly patients, and when taking certain medications together. This medication can cause muscle pain, muscle weakness, and rarely serious muscle damage, so if muscle pain, weakness, or cramps occur, the doctor should be notified immediately. Side effects such as abnormal liver function, increased blood sugar, gastrointestinal symptoms, headache, dizziness, skin rashes, etc., may occur, so if these symptoms arise, consult a healthcare professional. This medication has not been established as safe for use in pregnant or breastfeeding women and should not be taken during these periods; women who may become pregnant must use appropriate contraception. Furthermore, since this medication can interact with other drugs, it is important to inform healthcare providers about other medications being taken, especially when combined with certain antiviral drugs, immunosuppressants, antibiotics, and fibrate class medications. In the case of overdose, there is no specific antidote, treatment will depend on symptoms, and monitoring liver function and muscle enzyme levels is necessary. Finally, this medication is known not to significantly affect driving or machine operation, but caution is advised as dizziness may occur.

Serious side effects

Urticaria, angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, tightness in the chest, difficulty breathing, dyspnea, asthma attack, jaundice, hepatitis, fatal and non-fatal hepatic failure, severe edema, acute renal failure, oliguria, severe allergic reactions, serious skin adverse reactions, severe neurological symptoms, immune-mediated necrotizing myopathy, rhabdomyolysis, severe muscle weakness, ophthalmoplegia.

Mild side effects

• Headache
• dizziness
• constipation
• nausea
• abdominal pain
• itching
• muscle pain
• weakness
• hematuria
• diarrhea

This medication should be stored in a tightly closed container to protect it from air and moisture. It is best to keep it at room temperature between 1°C and 30°C.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets (15 tablets/PTP X 2)