Medication info
Ozget Tablet 10/20 mg

Ozget Tablet 10/20 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›21.7mg / 1 tablet
Manufacturer / importer
제이더블유중외제약(주)
Appearance
White oblong film-coated tablet
Packaging
30 tablets/box [(10 tablets/PTP packaging (Alu-Alu)x3)]
Approval status
Active

MFDS item code 202101605 · 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 is administered once daily, regardless of meals. For primary hypercholesterolemia, it is administered within the dosage range of 10/10 mg to 10/80 mg daily. A starting dose of 10/10 mg or 10/20 mg daily is recommended, and for patients requiring a greater reduction in LDL cholesterol, a daily dose of 10/40 mg is recommended. After starting treatment or adjusting the dosage, blood lipid levels should be checked at intervals of more than 2 weeks.

Ingredients

Manufacturer
제이더블유중외제약(주)

Efficacy & effects

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

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
View approved original text

This medication is used in conjunction with a dietary regimen to lower total cholesterol, LDL-cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol levels in patients with primary hypercholesterolemia, particularly those with heterozygous familial and non-familial hypercholesterolemia. It also helps increase levels of HDL-cholesterol, known as good cholesterol. Additionally, it is used in patients with homozygous familial hypercholesterolemia when alternative treatments are not feasible. This medication is an important adjunctive therapy to reduce the risk of cardiovascular disease due to dyslipidemia and should be considered adequately along with a dietary regimen and non-drug therapies. Before treatment, it is necessary to identify and manage any secondary causes like diabetes or hypothyroidism, and regular lipid level testing is recommended. This medication contributes to improving cholesterol and lipid levels in patients and enhances cardiovascular health.

Dosage and Administration

Adult dosage

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, it is administered within the dosage range of 10/10 mg to 10/80 mg daily. A starting dose of 10/10 mg or 10/20 mg daily is recommended, and for patients requiring a greater reduction in LDL cholesterol, a daily dose of 10/40 mg is recommended. After starting treatment or adjusting the dosage, blood lipid levels should be checked at intervals of more than 2 weeks.

Precautions

This medication has been reported to cause a rare side effect called rhabdomyolysis, which can lead to serious muscle damage and kidney function issues. Therefore, if severe muscle pain or weakness symptoms arise, consult a physician immediately. Additionally, if there are risk factors for muscle damage such as severe acute infections, hypotension, major surgeries, trauma, or severe metabolic disorders, it may be necessary to temporarily discontinue the use of this medication. This medication should not be used in persons who have allergies to the active substance or any other components, serious liver dysfunction, muscle diseases, women who are pregnant or may become pregnant, nursing mothers, individuals taking certain antiviral medications, or those with lactose intolerance. Caution should be exercised in patients with a history of alcohol abuse or liver disease, patients with severe liver dysfunction, those with impaired kidney function, those with hypothyroidism, a family history of muscle diseases, and elderly patients who have a high risk of myopathy, although dosage adjustment is generally not required. Patients with liver disease should confirm their liver function status before using this medcation and should not use it if liver function is serious. Patients with impaired kidney function also need careful observation for muscle toxicity. In case of overdose, since there is no specific antidote, appropriate treatment and supportive therapy should be provided according to symptoms, and liver function and muscle damage should be examined. During the course of treatment with this medication, if muscle pain, muscle weakness, fatigue, fever, or other symptoms develop, inform healthcare personnel immediately and get tested. Furthermore, this medication may interact with other drugs, so if you are taking other medications, it is important to inform your doctor or pharmacist.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory distress accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, vision disturbances, paralysis, urinary problems.

Mild side effects

  • Muscle pain
  • abdominal pain
  • nausea
  • diarrhea
  • dizziness
  • joint pain
  • muscle weakness
  • musculoskeletal pain
  • hyperkalemia
  • bronchitis
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  • sinusitis
  • flushing
  • increased ALT
  • increased AST
  • headache
  • fatigue
  • constipation
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • appetite loss
  • indigestion
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal and laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • altered perception
  • sensory loss
  • altered taste
  • memory loss
  • peripheral neuropathy
  • muscle cramps
  • vigilance.

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 or moisture from entering. Additionally, it is safe to store the medication at room temperature, between 1 degree and 30 degrees Celsius, which is neither too hot nor too cold.

Appearance and packaging

Appearance

White oblong 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.