Medication info
Rovajet Tablet 10/10 mg

Rovajet Tablet 10/10 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
에이치케이이노엔(주)
Appearance
Yellow, biconvex, egg-shaped film-coated tablet
Packaging
30 tablets
Approval status
Active

MFDS item code 201601195 · Approved 2016.02.29 · Insurance code 640006950

Summary

Main use
Improvement of hyperlipidemia (dyslipidemia) and inhibition of the risk of atherosclerotic vascular diseases
Who takes it
Adults
Adult dose
This medication is administered once daily without regard to meals. For primary hypercholesterolemia, the dosage may be from 10/5 mg to 10/20 mg daily, with an initial recommended dose of 10/5 mg. Patients requiring further LDL cholesterol reduction can adjust the dose, with checks on lipid levels spaced at intervals of more than 4 weeks to adjust the dosage accordingly. The maximum daily dose is 10/20 mg.

Ingredients

Manufacturer
에이치케이이노엔(주)

Efficacy & effects

Improvement of hyperlipidemia (dyslipidemia) and inhibition of the risk of atherosclerotic vascular diseases

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • increased LDL cholesterol
  • increased Apo B protein
  • increased triglycerides
  • increased non-HDL cholesterol
  • increased risk of atherosclerotic vascular diseases due to hypercholesterolemia
  • dyslipidemia
  • diabetes
View approved original text

This medication is used as an adjunct to diet to lower elevated total cholesterol, LDL-cholesterol, Apo B, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and to increase HDL cholesterol, which is considered good cholesterol. It should be administered when non-pharmacological treatments, such as dietary restrictions on saturated fat and cholesterol intake, are not sufficient. It also aids in achieving appropriate lipid control for patients at high risk of atherosclerotic vascular diseases due to hypercholesterolemia. Before treatment, secondary causes of dyslipidemia, such as diabetes and hypothyroidism, should be identified and treated if necessary, and lipid levels should be monitored accurately. This helps to effectively control blood lipid levels and improve cardiovascular health.

How to take

Adult dose

This medication is administered once daily without regard to meals. For primary hypercholesterolemia, the dosage may be from 10/5 mg to 10/20 mg daily, with an initial recommended dose of 10/5 mg. Patients requiring further LDL cholesterol reduction can adjust the dose, with checks on lipid levels spaced at intervals of more than 4 weeks to adjust the dosage accordingly. The maximum daily dose is 10/20 mg.

Precautions

This medication carries a risk of rhabdomyolysis, a rare side effect that can cause muscle problems. If serious muscle pain or muscle weakness occurs, notify a doctor immediately. This medication can affect liver function, therefore it should not be used in patients with liver disease or elevated liver enzymes. Regular liver function tests should be conducted during treatment. Patients with impaired kidney function or severe renal failure should consult a physician before taking this medication, and in some cases, its use should be avoided. This medication is not recommended for women who are pregnant or may become pregnant, or for breastfeeding women. If planning to become pregnant or confirmation of pregnancy occurs, discontinue use immediately. Patients with a history of alcohol abuse or liver disease should exercise caution when using this medication, and elderly patients also have a risk of muscle-related side effects. This medication may not be suitable for patients with certain genetic problems (e.g., lactose intolerance). Interactions may occur if taken with other medications, so it is important to inform healthcare providers of all drugs being taken. Particular caution should be taken when used with fibrates or certain antibiotics and immunosuppressants. During treatment, if symptoms such as muscle pain, fatigue, or fever develop, medical attention should be sought immediately, and if necessary, blood tests should be done to assess muscle damage. Additionally, this medication does not have sufficient safety and efficacy established in children, and is not recommended for them. Care should also be taken when driving or operating machinery, as symptoms such as dizziness may occur. Finally, this medication should be kept out of reach of children and should not be transferred to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain, difficulty breathing or shortness of breath, asthma attacks, respiratory distress with cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headaches, thunderclap headaches, seizures, confusion, visual disturbances, paralysis, urination changes

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, nasopharyngitis, elevated ALT, elevated AST, elevated ALP, abnormal liver function tests, fatigue, myalgia, allergic reactions including rash and angioedema, pruritus, urticaria, muscle pain, weakness, arthralgia, chest discomfort, sweating, dermatitis, burning sensation in the skin, alopecia, cough, dyspnea, oropharyngeal pain, nasal congestion, depression, sensory disturbances, tremors, diarrhea, indigestion, vomiting

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained at room temperature between 1°C and 30°C. Proper storage ensures the medication's effectiveness.

Appearance and packaging

Appearance

Yellow, biconvex, egg-shaped film-coated tablet

Package unit

30 tablets

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.