Medication info
Rotib Tablet 10/5 Milligrams

Rotib Tablet 10/5 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
동화약품(주)
Appearance
Pink rectangular film-coated tablets
Packaging
30 tablets/box [10 tablets/PTP × 3], 30 tablets/bottle
Approval status
Active

MFDS item code 202004599 · Approved 2020.06.23 · Insurance code 642706990

Summary

Main use
Improvement of hypercholesterolemia (primary and mixed) and inhibition of the risk of atherosclerotic vascular disease
Who takes it
Adults
Adult dose
This medication is administered once daily regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg per day is recommended. For patients requiring greater reductions in LDL cholesterol, the dose may be adjusted, with a maximum of 10/20 mg per day. After initiating treatment or adjusting the dosage, blood lipid levels should be checked at intervals of 4 weeks or more to adjust the dosage accordingly.

Ingredients

Manufacturer
동화약품(주)

Efficacy & effects

Improvement of hypercholesterolemia (primary and mixed) and inhibition of the risk of atherosclerotic vascular disease

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

This medication is used as an adjunct to diet for the reduction of total cholesterol, LDL cholesterol, apolipoprotein B, triglycerides, and non-HDL cholesterol levels, and for increasing HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It is administered alongside appropriate dietary adjustments and non-pharmacologic methods in patients at high risk of atherosclerotic vascular disease, used when dietary changes alone are insufficient. Additionally, it's necessary to check for other conditions or medications causing dyslipidemia and to treat them if needed. Treatment efficacy should be monitored through blood lipid level measurements, and it is also referenced in patients with acute coronary events. This medication effectively improves blood lipid disorders related to hypercholesterolemia.

How to take

Adult dose

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg per day is recommended. For patients requiring greater reductions in LDL cholesterol, the dose may be adjusted, with a maximum of 10/20 mg per day. After initiating treatment or adjusting the dosage, blood lipid levels should be checked at intervals of 4 weeks or more to adjust the dosage accordingly.

Precautions

This medication can rarely cause the destruction of muscle tissue leading to serious kidney damage; therefore, if symptoms of severe muscle pain or weakness occur, the doctor should be informed immediately. In cases where there are risk factors such as severe infections, hypotension, major surgery, trauma, severe metabolic disturbances, or uncontrolled seizures, the use of this drug may need to be temporarily suspended or discontinued. Individuals with allergies to the active ingredient or any component of this medication should not use it, nor should it be administered to individuals with severe liver dysfunction or persistent elevations in liver enzymes of unknown origin. Individuals with muscle diseases or taking cyclosporine, those with significantly impaired kidney function, pregnant or potentially pregnant women, and nursing mothers should not use this medication. Additionally, high doses of this medication should be avoided in patients at risk of myopathy or rhabdomyolysis, those with hypothyroidism or a family history thereof, individuals with alcoholism, and those taking specific medications concurrently. Patients with genetic lactose intolerance should also avoid this medication. Patients with a history of alcohol abuse or liver disease should use this medication cautiously, and it is not recommended for patients with moderate to severe liver dysfunction. Elderly patients, those with impaired kidney function, and individuals with risk factors for myopathy should also exercise caution when using this medication. Liver function and muscle condition should be regularly checked during treatment, and if symptoms such as muscle pain, muscle weakness, fatigue, or fever occur, a doctor should be consulted immediately. Pregnant women or those planning to become pregnant should not take this medication and should use appropriate contraceptive methods. Safety in children and adolescents has not been sufficiently established, so its use is not recommended. When taken in combination with other drugs, interactions may occur; therefore, consultation with a doctor or pharmacist is essential. In the event of an overdose, there is no specific antidote; therefore, treatment based on symptoms and liver function, as well as muscle enzyme testing, is required. 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

Allergic reactions including hives, angioedema, facial swelling, chest tightness, chest discomfort, difficulty breathing, cold sweat, pallor, rashes and hives, symptoms indicating severe dermatological adverse reactions (severe rash, blistering, skin peeling, pain in oral/ocular mucosa), severe allergic reactions, respiratory issues, liver abnormalities (jaundice), yellowing of the skin or eyes, sudden and very severe headache, thunderclap headache, seizures,

Mild side effects

Headache, dizziness, indigestion, dry mouth, increased liver enzymes, elevated blood lactate dehydrogenase levels, pruritus, weakness, arthralgia, fatigue, numbness, paresthesia, nausea, abdominal pain, diarrhea, loss of appetite, abdominal bloating, cough, sputum, nasal congestion, pelvic pain, breast cysts, eyelid droop, diabetic retinopathy, ear discomfort, elevated blood sugar, hives, rash, itching, cold sweat, hair loss, sweating, drowsiness, lethargy

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. Additionally, it is important to maintain a room temperature between 1 and 30 degrees Celsius when storing the medication. This helps to ensure the effectiveness of the drug.

Appearance and packaging

Appearance

Pink rectangular film-coated tablets

Package unit

30 tablets/box [10 tablets/PTP × 3], 30 tablets/bottle

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.

Questions about this medicine

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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.