Rocasta 10mg (Rosuvastatin Calcium)

Adult dose

1. Primary hypercholesterolemia (type IIa, including heterozygous familial hypercholesterolemia), mixed dyslipidemia (type IIb), primary dysbetalipoproteinemia (type III), and homozygous familial hypercholesterolemia Patients should follow a standard cholesterol-lowering diet before and during treatment with this medicine and continue it throughout the treatment period. This medicine may be taken at any time of day, with or without food. The initial dose is 5 mg once daily. If a greater reduction in LDL cholesterol is required, the dose may be adjusted as a maintenance dose. The maintenance dose is 10 mg once daily, which controls the condition in most patients. The maintenance dose should be adjusted appropriately at intervals of 4 weeks or more, according to LDL cholesterol levels, the treatment goal, and the patient's response. The dose may be increased to a maximum of 20 mg once daily. 3. Elderly patients : No dosage adjustment is necessary. 4. Patients with renal impairment : No dosage adjustment is necessary in patients with mild or moderate renal impairment. This medicine should not be administered to patients with severe renal impairment. Particular caution is required when administering 20 mg of this medicine to patients with moderate renal impairment. 5. Patients with hepatic impairment : No increase in systemic exposure to rosuvastatin was observed in patients with a Child-Pugh score of 7 or less, but an increase was observed in patients with a Child-Pugh score of 8 or 9. Renal function testing should be considered in these patients. There is no experience with administration to patients with a Child-Pugh score above 9. This medicine should not be administered to patients with active liver disease. 6. Race : Because systemic exposure to this medicine is increased in Asian patients, the recommended initial dose is 5 mg. Administration of the 40 mg dose is contraindicated. 7. Patients predisposed to myopathy : The recommended initial dose for patients predisposed to myopathy is 5 mg. Administration of the 40 mg dose of this medicine is contraindicated in some of these patients.

Child dose

2. Pediatric patients with heterozygous familial hypercholesterolemia (ages 10 years to 17 years) The usual dosage range is 5 mg to 20 mg once daily. (There are no clinical data on doses higher than 20 mg in pediatric patients.) The dose should be adjusted individually according to the recommended treatment goal for each patient. The dose should be adjusted at intervals of 4 weeks or longer. Children under 10 years of age: Safety and efficacy have not been established.

This medication should not be administered to certain patients. Firstly, individuals allergic to any of the ingredients of this medication should not take it. Patients with severely impaired liver function or persistent unexplained elevations in liver enzymes should also avoid this drug. Those with muscle disorders or muscle weakness, as well as patients taking the specific drug cyclosporine, should refrain from using it. Individuals with significantly reduced kidney function and women who are pregnant, breastfeeding, or of childbearing potential without appropriate contraception should not use this medication. In particular, patients at high risk for muscle disorders are prohibited from taking high doses. Additionally, this medication contains lactose, so those with lactose intolerance or related genetic disorders should not take it. When taking this medication, caution is necessary. Individuals who consume large amounts of alcohol or have a history of liver disease should undergo regular liver function tests, and those with hypothyroidism or nephrotic syndrome should treat those conditions first. If symptoms such as muscle pain, weakness, or cramps occur, notify the medical staff immediately, and if necessary, undergo muscle enzyme tests. Particularly, individuals at high risk for muscle damage should be carefully monitored before and after treatment. In cases of acute severe conditions, the use of this medication must be discontinued, and if severe muscle weakness occurs, administration must be stopped immediately. This medication may interact with other drugs, so it is important to inform your doctor about any medications currently being taken. Co-administration with certain antiviral medications, immunosuppressants, antifungals, some antibiotics, and fibrate medications may increase the risk of muscle damage, so caution is warranted. Especially when taking high doses, regular kidney function tests are recommended. The drug concentration may be higher in Asians; therefore, dosage adjustments may be necessary. Generally, the side effects of this medication are mild and temporary, but muscle pain, headaches, digestive disorders, and skin rashes may occur. Rarely, liver function abnormalities, severe skin reactions, or kidney abnormalities have been reported, so if unusual symptoms arise, immediately consult with medical personnel. Additionally, this medication is contraindicated during pregnancy; women planning to become pregnant should consult a doctor before taking it. In cases of overdose, as there is no specific antidote, treatment according to symptoms and monitoring of liver function and muscle enzyme levels are necessary. The effects of this medication on driving or operating machinery are not clearly defined, but it may cause dizziness, so caution is advised. Finally, long-term use of this medication may lead to rare side effects such as interstitial lung disease, so if symptoms such as shortness of breath or persistent cough occur, treatment should be discontinued immediately, and medical consultation is necessary.

Hypersensitivity reactions including angioedema, diabetes, headache, dizziness, constipation, nausea, abdominal pain, pancreatitis, pruritus, rash, urticaria, myalgia, myopathy, rhabdomyolysis, asthenia, polyneuropathy, amnesia, peripheral neuropathy, myasthenia gravis, cough, dyspnea, diarrhea, ocular myasthenia, thrombocytopenia, jaundice, hepatitis, increased transaminases, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, lichenoid drug eruption, lupus-like syndrome, muscle rupture, arthralgia, immune-mediated necrotizing myopathy, hematuria, edema, depression, sleep disorders, interstitial lung disease, sexual dysfunction, gynecomastia, fatal and non-fatal liver failure, cognitive impairment, increased ALT, chest pain, muscle cramps, gout, erectile dysfunction, numbness, dysesthesia, chest discomfort, loss of appetite, abdominal distention, syncope, widespread pain, fatigue

This medication should be stored in a sealed container to protect it from air and moisture, and it is best kept at room temperature between 1 and 30 degrees Celsius. Storing it this way can help maintain the medication's effectiveness and prevent deterioration.

Appearance

Pink round film-coated tablet

Package unit

28 tablets (14 tablets/PTP x 2)