Medication info
Ozget 10/40 mg Tablets

Ozget 10/40 mg Tablets

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›43.4mg / 1 tablet
Manufacturer / importer
제이더블유중외제약(주)
Appearance
White, oval film-coated tablet
Packaging
30 tablets/box [(10 tablets/PTP packaging (Alu-Alu) x3)]
Approval status
Active

MFDS item code 202101607 · Approved 2021.02.18

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia (total cholesterol, LDL-C, etc.)
Who uses it
Adults
Adult dosage
This medication should be taken once daily regardless of meals. The dosage range is 10/10 mg to 10/80 mg per day. For the initial dose, 10/10 mg or 10/20 mg once daily is recommended. For patients requiring greater LDL cholesterol reduction (more than 55%), 10/40 mg once daily is recommended as the initial dose. After starting the treatment or adjusting the dosage, blood lipid levels should be tested at intervals of at least 2 weeks.

Ingredients

Manufacturer
제이더블유중외제약(주)

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia (total cholesterol, LDL-C, etc.)

  • Primary hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dyslipidemia
  • atherosclerotic vascular disease due to hypercholesterolemia
View approved original text

This medication is used as an adjunct to diet to lower total cholesterol, LDL cholesterol, apo B, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and to raise HDL cholesterol levels. Additionally, in patients with homozygous familial hypercholesterolemia, it is used as an adjunct treatment in conjunction with other therapies such as LDL apheresis or when other treatments are ineffective. When treating dyslipidemia, it should be used with appropriate dietary measures, and it is important to first identify and treat any secondary causes such as diabetes or hypothyroidism. This medication is utilized to help control lipids in patients at risk for atherosclerotic vascular disease and should be administered considering regular blood lipid tests and risk factors based on the patient's condition. Therefore, this medication is effectively used in the treatment of hypercholesterolemia and dyslipidemia.

Dosage and Administration

Adult dosage

This medication should be taken once daily regardless of meals. The dosage range is 10/10 mg to 10/80 mg per day. For the initial dose, 10/10 mg or 10/20 mg once daily is recommended. For patients requiring greater LDL cholesterol reduction (more than 55%), 10/40 mg once daily is recommended as the initial dose. After starting the treatment or adjusting the dosage, blood lipid levels should be tested at intervals of at least 2 weeks.

Precautions

This medication can rarely cause damage to muscle tissue, resulting in muscle pain or weakness, and in severe cases, may lead to kidney function issues. Therefore, if muscle pain or weakness is severe or persistent, the patient must inform their physician immediately. This medication may affect liver function, requiring liver function tests before and during treatment, and if abnormalities are found, treatment should be discontinued or the dosage adjusted. This medication is not prescribed to patients with certain liver diseases or those with abnormally high liver enzyme levels. Pregnant or potentially pregnant women and breastfeeding women should not take this medication, and fertile women should use appropriate contraceptive methods while taking it. Patients with a history of alcohol dependence or liver disease, those with impaired kidney function, patients with hypothyroidism, and the elderly should take this medication with caution and follow their doctor's advice. When taken with other medications, drug interactions may increase the risk of side effects from this medication, so patients should inform their physician or pharmacist of all medications they are taking. This medication contains lactose, therefore, patients with lactose intolerance should not take it. Dizziness, muscle pain, and gastrointestinal disorders may occur as side effects, so caution is advised when driving or operating machinery. In cases of overdose, there is no specific antidote, and appropriate treatment should be provided according to symptoms while monitoring liver function and muscle condition. Safety and efficacy in children have not been established, hence it is not recommended.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash accompanied by high fever, blisters, skin peeling, pain of mucous membranes in the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, cough with fever accompanied by respiratory abnormalities, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning-like headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Muscle pain
  • abdominal pain
  • headache
  • dizziness
  • cough
  • nausea
  • diarrhea
  • musculoskeletal pain
  • joint pain
  • hyperkalemia
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  • bronchitis
  • sinusitis
  • flushing
  • fatigue
  • malaise
  • chest pain
  • chest discomfort
  • edema
  • weakness
  • fever
  • dry mouth
  • epigastric discomfort
  • belching
  • gastrointestinal disturbance
  • pharyngitis
  • urticaria
  • skin rash
  • itching
  • hair loss
  • angioedema
  • erythema multiforme
  • pruritus
  • rash
  • hyperhidrosis
  • thrombocytopenia
  • insomnia
  • nightmares

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

Storage

This medication should be stored tightly closed in a container to avoid exposure to air or moisture. It is best to maintain a storage temperature between 1 to 30 degrees Celsius. This will help preserve the medication's effectiveness over time.

Appearance and packaging

Appearance

White, oval film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP packaging (Alu-Alu) x3)]

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.