Rosuvastatin Calcium (unmodified) 20 mg Dispersible Tablets

Adult dose

This medication is to be taken as an orally disintegrating tablet placed on the tongue and allowed to dissolve without water. The initial dosage is 5 mg once daily, and in cases requiring greater reductions in LDL-cholesterol levels, the maintenance dose can be adjusted accordingly. The maintenance dose is generally 10 mg once daily, which is sufficient for most patients to control. The maintenance dose should be adjusted according to LDL-cholesterol levels, treatment goals, and patient response, and can be increased up to a maximum of 20 mg per day with intervals of at least 4 weeks or longer.

Child dose

This medication is to be taken as an orally disintegrating tablet placed on the tongue and allowed to dissolve without water. The usual dosage for pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia is once daily 5 mg up to 20 mg.

This medication should not be used in certain patients. For example, it should not be given to patients who are allergic to it, those with severely impaired liver function, patients with myopathy, those taking certain immunosuppressants, severely impaired renal function patients, and women who are pregnant or breastfeeding. It should be used with caution in individuals with diminished liver function or those consuming large amounts of alcohol. Liver function tests should be conducted several times before and during treatment; if the patient has hypothyroidism or nephrotic syndrome, these conditions should be treated before starting this medication. Muscle-related side effects such as myalgia, muscle weakness, and in severe cases, rhabdomyolysis have been reported, thus if any symptoms of muscle pain or weakness occur, the patient should notify the doctor immediately and undergo evaluation. Patients at higher risk of muscle damage should be particularly vigilant and may need to discontinue the medication as necessary. This medication may affect the kidneys when taken at high doses, so it is advisable to perform regular kidney function tests. Asian patients may display higher blood concentrations of this medication, potentially necessitating dose adjustments. This medication is also used in children and adolescents, but while major impacts on growth and sexual characteristics were not observed after 1 year of observation, the safety of long-term use has not been fully established. During treatment, side effects such as rare headaches, dizziness, constipation, nausea, abdominal pain, skin rash, pruritus, myalgia, asthenia, hematuria, cough, diarrhea, arthralgia, fatigue, numbness, paresthesia, chest discomfort, loss of appetite, abdominal distension, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, depression, sleep disorders (including insomnia and nightmares), sexual dysfunction, gynecomastia, memory impairment, amnesia, memory loss, memory disturbances, and confusion may occasionally occur. This medication may affect liver function, so if symptoms of liver damage (for example, jaundice, severe fatigue) occur, the patient should discontinue use immediately and consult a physician. It may interact with other medications; hence, patients must inform their doctor or pharmacist of any other medications they are taking, particularly those from specific antiviral agents, immunosuppressants, antifungals, antibiotics, or fibrate drug classes. Women who are pregnant or may become pregnant should be cautious as this medication may pose risks to the fetus, thus appropriate contraception should be utilized, and if planning a pregnancy or if pregnancy is confirmed, treatment should be discontinued immediately. In case of overdose, there is no specific antidote, so one should seek immediate medical attention and undergo tests for liver function and muscle damage. This medication does not significantly impair the ability to drive or operate machinery, but due to the possibility of dizziness, caution is advised.

Serious side effects

Hypersensitivity reactions including urticaria and angioedema, pancreatitis, myopathy, rhabdomyolysis, severe muscle weakness, ocular muscle weakness, thrombocytopenia, jaundice, hepatitis, Stevens-Johnson syndrome, immune-mediated necrotizing myopathy, acute renal failure, oliguria, significant increases in CK levels (more than five times the upper limit of normal), severe allergic reactions, severe skin reactions, dyspnea, liver abnormalities (jaundice), severe neurological symptoms, and severe adverse reactions.

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, pruritus, rash, myalgia, asthenia, hematuria, cough, diarrhea, arthralgia, fatigue, numbness, paresthesia, chest discomfort, loss of appetite, abdominal distension, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, depression, sleep disturbances (including insomnia and nightmares), sexual dysfunction, gynecomastia, memory impairment, amnesia, memory loss, memory disturbances, and confusion.

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. Furthermore, it is best kept in a cool place, specifically at room temperature between 1 degree and 30 degrees Celsius.

Appearance

White to pale yellow circular orally disintegrating tablets

Package unit

28 tablets/box [14 tablets/PTP × 2]