Daewoong Rosuvastatin Tablet 20 Milligrams (Rosuvastatin Calcium (Unmodified))

Adult dose

For adult patients with primary hypercholesterolemia, start with an initial dose of 5 milligrams once daily. The maintenance dose is 10 milligrams once daily, adjusted according to LDL cholesterol levels and the patient's response at intervals of 4 weeks or more. A maximum dose of 20 milligrams per day can be administered. The recommended initial dose for Asian patients and those prone to myopathy is 5 milligrams. A dose of 40 milligrams is contraindicated.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), administer a dose of 5 milligrams to 20 milligrams once daily. Adjust the dosage according to the individual patient's treatment goals at intervals of 4 weeks or more.

This medication should not be used in certain patients. For instance, it is contraindicated in patients allergic to this medication, those with severe liver dysfunction, patients with muscle diseases, patients taking certain immunosuppressants, patients with severe kidney dysfunction, pregnant or breastfeeding women, or fertile women who do not use appropriate contraceptives. In addition, caution is needed in patients with a high risk of muscle disease or a history of certain genetic muscle disorders, alcoholics, and when used in combination with certain medications. This drug contains lactose and should not be used in patients with lactose intolerance or related genetic diseases. Patients with a history of liver disease or high alcohol intake should undergo regular liver function tests before and during treatment with this medication, and underlying conditions such as hypothyroidism or nephrotic syndrome should be treated first. This medication may cause muscle-related side effects, such as myalgia, myopathy, or rarely rhabdomyolysis, so any symptoms of muscle pain, weakness, or cramps should be immediately reported to a healthcare provider for evaluation. Particularly, if muscle enzyme levels significantly increase, discontinuation of the medication may be necessary. In cases of acute severe illness, administration of this drug should be discontinued, and if severe muscular weakness or oculomotor weakness occurs or worsens, use should be stopped. This medication can interact with other drugs, particularly when used with fibrate drugs, certain antibiotics, antifungals, and immunosuppressants, which may increase the risk of muscle-related side effects, hence caution is required. Moreover, this drug may affect kidney function, so regular kidney function tests are recommended. Patients of Asian descent may require dose adjustments as this medication may show higher plasma concentrations. While on this drug, interstitial lung disease or significant liver injury symptoms may occur, so if symptoms such as shortness of breath, cough, or jaundice appear, treatment should be discontinued immediately and consulted with a healthcare provider. Patients at risk for diabetes should regularly monitor blood glucose levels and receive appropriate treatment if glucose control is needed. Women of childbearing potential should use appropriate contraception and should not take this medication during pregnancy. It is also not recommended during breastfeeding. In cases of overdose, there is no specific antidote, so treatment should be symptom-based, alongside checking liver function and muscle enzymes. Dizziness may occur when driving or operating machinery, so caution is required. Finally, if symptoms of skin rash, severe allergic reactions, or severe skin disease occur during treatment, the medication should be discontinued immediately and reported to a healthcare provider.

Serious side effects

• Allergic reactions
• including urticaria and angioedema
• severe swelling
• chest tightness
• difficulty breathing
• severe muscle weakness
• oculomotor weakness
• Stevens-Johnson syndrome
• jaundice
• liver failure

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, diabetes, itching, myalgia, weakness, hematuria, diarrhea, chest discomfort, loss of appetite, abdominal distension, abnormal liver function tests, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, joint pain, fatigue, numbness, sensory changes, cough, memory loss, peripheral neuropathy, thrombocytopenia, hepatitis, increased transaminases, eosinophilia, and drug reaction with eosinophilia and systemic symptoms, lupus.

This drug may be sensitive to air and moisture, so it should be stored in a tightly closed container. It is best to maintain a storage temperature between 1°C and 30°C at room temperature. Storing it this way helps to preserve the medication's effectiveness and safety for a long time.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle