Medication info
Rotiget Tablets 10/20 mg

Rotiget Tablets 10/20 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)씨엠지제약
Appearance
Pink oval film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 202004589 · Approved 2020.06.23 · Insurance code 648604120

Summary

Main use
Improvement of dyslipidemia and suppression of the risk of atherosclerotic vascular diseases in patients with hyperlipidemia (primary, mixed type)
Who takes it
Adults
Adult dose
This medication is administered once daily irrespective of meals. For primary hypercholesterolemia, the dosage range is 10/5 mg to 10/20 mg daily. A starting dose of 10/5 mg daily is recommended. For patients requiring a more significant reduction in LDL-cholesterol, the dosage may be adjusted accordingly. Blood lipid levels should be checked at least 4 weeks after starting treatment or adjusting dosage, followed by dosage adjustments as necessary.

Ingredients

Manufacturer
(주)씨엠지제약

Efficacy & effects

Improvement of dyslipidemia and suppression of the risk of atherosclerotic vascular diseases in patients with hyperlipidemia (primary, mixed type)

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • elevated LDL-cholesterol
  • elevated Apo B protein
  • elevated triglycerides
  • elevated non-HDL cholesterol
View approved original text

This medication helps lower blood cholesterol and triglycerides in patients with primary hypercholesterolemia and mixed dyslipidemia, and increases good cholesterol (HDL). It is particularly effective for those at high risk of atherosclerotic vascular diseases and should be used in conjunction with dietary measures. Before starting drug therapy, it is necessary to check for other causes such as diabetes or hypothyroidism and treat them. Regular checks of blood lipid levels are performed to assess treatment effectiveness, and in high-risk patients, lipid levels are measured even during hospitalization. This management is used to reduce the risk of cardiovascular diseases and improve health status.

How to take

Adult dose

This medication is administered once daily irrespective of meals. For primary hypercholesterolemia, the dosage range is 10/5 mg to 10/20 mg daily. A starting dose of 10/5 mg daily is recommended. For patients requiring a more significant reduction in LDL-cholesterol, the dosage may be adjusted accordingly. Blood lipid levels should be checked at least 4 weeks after starting treatment or adjusting dosage, followed by dosage adjustments as necessary.

Precautions

This medication can rarely cause muscle damage leading to serious kidney problems; therefore, if severe muscle pain or weakness occurs, the doctor must be notified immediately. Patients with allergies to any components of this medication, severely impaired liver function, muscle disease, certain kidney dysfunctions, or women who are pregnant or breastfeeding should not take this medication. Caution should be exercised if there is a history of muscle disease or liver disease, in elderly individuals, alcoholics, or if taken in combination with certain medications, requiring regular blood tests and monitoring by a physician. During treatment with this medication, if symptoms such as muscle pain, cramps, weakness, fatigue, or fever occur, the patient must consult a doctor immediately and may need to undergo testing for muscle damage indicators (CPK) in the blood. Liver function abnormalities may occur, so liver function tests should be done before starting this medication, and if signs of liver damage occur during treatment, tests should be repeated. Women who are pregnant or planning to become pregnant should avoid taking this medication, and if pregnancy is confirmed during treatment, it must be stopped immediately. The safety and efficacy of this medication in children and adolescents have not been adequately established; therefore, it is not recommended for pediatric use. This medication may interact with other drugs, so if other medications are being taken, the patient must inform their doctor or pharmacist. In cases of overdose, there is no specific antidote, and treatment according to symptoms and monitoring of liver function and muscle damage indicators are necessary. Keep out of reach of children and do not transfer to other containers. While driving or operating machinery, dizziness may occur; caution is advised. Severe skin adverse reactions may arise, so symptoms like rash, itching, or swelling require immediate consultation with medical staff.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, cold sweats, difficulty breathing, severe allergic reactions, severe rash, blistering, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attack, respiratory distress associated with cough and fever, jaundice (yellowing of skin or eyes), profound malaise, liver abnormalities (jaundice), sudden and severe headaches, migraines, vertigo

Mild side effects

  • Nasopharyngitis
  • dyspepsia
  • headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • dry mouth
  • increased liver enzymes
  • abnormal liver function tests
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  • increased blood lactate dehydrogenase
  • pruritus
  • edema
  • myalgia
  • increased blood sugar
  • elevated CPK in blood
  • upper respiratory infection
  • bronchitis
  • rhinitis
  • cystitis
  • dermatophyte infection of nails
  • soft tissue infection
  • dermatitis
  • skin burning sensation
  • alopecia
  • oropharyngeal pain
  • nasal congestion
  • pelvic pain
  • breast cysts
  • eyelid drooping

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 air and moisture ingress, and the storage temperature should remain between 1°C and 30°C at room temperature. This storage method helps maintain the drug's effectiveness for a long period and prevents deterioration.

Appearance and packaging

Appearance

Pink oval film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP x 3]

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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.