Allstatin Tablet 10 mg (Rosuvastatin Calcium)

Adult dose

It can be taken at any time during the day, regardless of meals. The initial dose is 5 mg once daily, and if a greater reduction in LDL cholesterol levels is required, the maintenance dose can be adjusted. The maintenance dose is 10 mg once daily, adjusted according to LDL cholesterol levels, treatment goals, and the patient's response at intervals of 4 weeks or more. The maximum daily dosage can be increased to 20 mg.

Child dose

The usual dosage range is 5 mg to 20 mg once daily. The dosage is adjusted according to the individual patient's treatment goals, with adjustments made at intervals of 4 weeks or more. Safety and efficacy in children under 10 years have not been established.

This medication should not be administered to certain patients. For example, patients who are allergic to this drug, those with severely impaired liver function, those with muscle diseases, and those with severe kidney impairment should not use it. Special caution is required when administering this drug to women who are pregnant, breastfeeding, or of childbearing potential without adequate contraception. If a woman of childbearing potential is considered unlikely to be pregnant, and the risks to the fetus are adequately explained, it may be administered. Patients at high risk for muscle-related side effects, such as those with moderate or severe kidney impairment, hypothyroidism, a family history of hereditary muscle disorders, those with alcohol dependency, Asian patients, and those taking certain drugs in combination should have their dosage adjusted or use of the drug contraindicated. This drug contains lactose and should not be given to patients with lactose intolerance or related genetic disorders. While taking this medication, liver function tests should be regularly conducted to monitor for abnormal increases in liver enzyme levels, particularly in patients with a history of excessive alcohol consumption or liver disease. If symptoms such as muscle pain, weakness, or cramps occur, notify medical staff immediately, and if necessary, check creatine kinase levels to assess for significant muscle damage. This drug may increase blood concentration, heightening the risk of muscle damage when taken with other specific medications, so always discuss with medical personnel about other medications being taken. If pregnant or breastfeeding, this drug should not be used, and women of childbearing potential must use appropriate contraception. In the case of overdose, there is no specific antidote; therefore, treatment should be symptom-based, and monitoring for liver function and muscle damage indicators is essential. Lastly, this drug is not known to significantly impair driving or operating machinery, but caution is advised as dizziness may occur.

Serious side effects

• Allergic reactions including urticaria and angioedema
• Severe allergic reactions
• Pancreatitis
• Myopathy (including myositis), rhabdomyolysis
• Immune-mediated necrotizing myopathy
• Severe muscle weakness, ophthalmoplegia
• Stevens-Johnson syndrome
• Eosinophilia and systemic symptoms associated drug reaction (DRESS)
• Lupus-like syndrome
• Renal failure, acute renal failure, oliguria

Mild side effects

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

This medication must be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain storage temperature between 1 degree Celsius and 30 degrees Celsius at room temperature. Proper storage will help ensure drug efficacy.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle