Rosuvastatin Calcium 5 mg Oral Disintegrating Tablet

Adult dose

This medication is taken as an orodispersible tablet placed on the tongue and allowed to dissolve without water. The initial dosage is 5 mg once daily, and most patients are adjusted to a maintenance dose of 10 mg once daily. The maintenance dosage should be appropriately adjusted according to LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, and can be increased up to a maximum of 20 mg per day, depending on dietary intake.

Child dose

The usual dosage range is 5 mg to 20 mg once daily. The dosage should be adjusted individually according to the recommended therapeutic goals for each patient. The dose must be adjusted at intervals of 4 weeks or more.

This medication should not be administered to certain patients. For instance, it should not be used in patients who are allergic to its components, those with liver function issues, muscle disease patients, those taking specific medications, patients with severe renal impairment, and pregnant or nursing women. Additionally, women of childbearing potential should only take this medication if they are highly unlikely to be pregnant and fully aware of the potential risks to the fetus. High-dose administration is prohibited in patients at high risk for muscle-related disorders, such as those with moderately to severely reduced kidney function, hypothyroid patients, those with a family history of muscle disorders, and patients with alcohol dependence. This medication can affect liver function; thus, patients with a history of liver disease or excessive alcohol consumption should undergo repeat liver function tests before and during treatment. If symptoms such as myalgia, muscle weakness, or cramps occur, patients should immediately inform their doctor, undergo blood tests, and discontinue medication if necessary. Patients with acute severe conditions or specific endocrine disorders should cease using this medication. Rarely, severe muscle weakness or ocular muscle weakness can occur as a side effect, so use should be discontinued immediately if such symptoms arise. It may interact with various medications, so patients taking other medications should inform their doctor or pharmacist, especially concerning certain antiviral agents, immunosuppressants, antibiotics, and fibrate drugs. This medication may also affect kidney function, so kidney function tests should be considered at high doses. For Asian patients, drug concentrations may be higher; therefore, dose adjustments may be necessary. Pediatric and adolescent patients should be evaluated for potential effects on growth and maturation, and it exhibits a safety profile similar to that of adults. Rarely, it may cause interstitial lung disease or severe liver damage; thus, if symptoms such as dyspnea or jaundice occur, it should be discontinued immediately. Patients at risk for diabetes should regularly monitor blood glucose levels, as the risk of developing diabetes may increase; however, it is advisable to continue treatment due to the larger benefits in preventing cardiovascular diseases. Genetic factors may alter drug response, necessitating ongoing observation of treatment efficacy and side effects for dose adjustment. In case of overdose, there is no specific antidote, and symptomatic treatment and tests of liver function and muscle enzymes should be performed. Caution is advised when driving or operating machinery, as dizziness may occur.

Serious side effects

Allergic reactions including urticaria and angioedema, pancreatitis, myopathy (including myositis), rhabdomyolysis, thrombocytopenia, jaundice, hepatitis, Stevens-Johnson syndrome, immune-mediated necrotizing myopathy, edema, polyneuropathy, amnesia, peripheral neuropathy, severe muscle weakness, dyspnea, ocular muscle weakness, fatal and non-fatal liver failure, acute renal failure, oliguria, elevated serum creatinine, severe muscle weakness or ocular muscle weakness

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, pruritus, rash, myalgia, weakness, diarrhea, hematuria, fatigue, numbness, paresthesia, chest discomfort, anorexia, abdominal distension, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, depression, sleep disturbances (including insomnia and nightmares), sexual dysfunction, gynecomastia, memory decline, forgetfulness, amnesia, memory impairment, confusion

This medication should be stored in an airtight container to protect from air and moisture. It is recommended to maintain a storage temperature between 1°C and 30°C. This will help preserve the medication's efficacy and safety for a longer duration.

Appearance

White to pale yellow round orodispersible tablet

Package unit

28 tablets/box [14 tablets/PTP × 2]