Subaroadi Tablet 10mg (Rosuvastatin Calcium (Unmicronized))

Adult dose

This medication is an oral disintegrating tablet that should be placed on the tongue and allowed to dissolve, taken without water. It can be administered at any time of the day regardless of meals. The initial dosage is 5 mg once daily, while the maintenance dosage is 10 mg once daily. The dosage should be adjusted every 4 weeks or more, and can be increased to a maximum of 20 mg daily.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), 5 mg to 20 mg is administered once daily. The dosage should be adjusted individually every 4 weeks or more.

This medication should not be used in certain patients. For example, individuals with allergies to its ingredients, active liver disease, muscle disorders, severe renal impairment, women who are pregnant or breastfeeding, and women of childbearing age who do not use adequate contraception should not be administered this medication. Additionally, in cases where there is susceptibility to myopathy or rhabdomyolysis, particularly high doses (40mg) are prohibited. Such conditions include moderate or severe renal impairment, hypothyroidism, family or personal history of muscle disorders, alcoholism, and concomitant use of certain medications. When administering this medication, liver function and muscle status should be periodically evaluated. If there is an abnormal elevation in liver enzyme levels or symptoms such as muscle pain, muscle weakness, or muscle cramps, the healthcare provider should be notified immediately. In particular, if the blood creatine kinase (CK) level is significantly elevated, administration should be stopped. This medication should be used with caution in patients who consume large amounts of alcohol or have a history of liver disease, and those with hypothyroidism or nephrotic syndrome should be treated for those conditions before starting this treatment. Additionally, there may be interactions when used with other medications, so it is essential to inform the healthcare provider of any current medications. Co-administration with some drugs may increase the blood concentration of this medication, raising the risk of muscle-related side effects. Women who are pregnant or breastfeeding should not use this medication, and women of childbearing potential should use adequate contraception. This medication may pose a risk to the fetus, and there may be adverse effects for the baby if breastfeeding. In the case of overdose, there are no specific antidotes, so immediate medical attention should be sought for symptom-specific treatment, and liver function and muscle status should be checked periodically. Finally, while this medication does not significantly affect the ability to drive or operate machinery, dizziness and other symptoms may occur, so caution should be exercised.

Serious side effects

Allergic reactions including urticaria and angioedema, Stevens-Johnson syndrome, chest tightness, difficulty breathing, respiratory distress, ocular muscle weakness, myopathy, rhabdomyolysis, immune-mediated necrotizing myopathy, severe edema, oliguria, acute renal failure, jaundice, hepatitis, fatal and non-fatal hepatic failure, severe allergic reactions, severe skin reactions, breathing problems, liver dysfunction (jaundice), severe edema or urination abnormalities, severe muscle symptoms

Mild side effects

• Headache
• dizziness
• constipation
• nausea
• abdominal pain
• itching
• myalgia
• weakness
• diarrhea
• arthralgia

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is recommended to maintain storage temperatures between 1 to 30 degrees Celsius.

Appearance

White to pale yellow round oral disintegrating tablet

Package unit

30 tablets/box [10 tablets/PTP × 3], 10 tablets/box [10 tablets/PTP × 1]