Medication info
Ozhet Tablet 10/10 mg

Ozhet Tablet 10/10 mg

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tabletAtorvastatin Calcium Trihydrate›10.85mg / 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 202101606 · Approved 2021.02.18

Summary

Main use
Improvement of lipids through reduction of cholesterol and increase of HDL in hypercholesterolemia and dyslipidemia
Who uses it
Adults
Adult dosage
This medication is administered once daily regardless of food. The dosage range is from 10/10 mg to 10/80 mg per day. A starting dose of 10/10 mg or 10/20 mg per day is recommended. If significant reduction of LDL cholesterol is required, a starting dose of 10/40 mg per day is recommended. Blood lipid levels should be checked at least two weeks after starting therapy or adjusting dosage and the dosage should be adjusted accordingly.

Ingredients

Manufacturer
제이더블유중외제약(주)

Efficacy & effects

Improvement of lipids through reduction of cholesterol and increase of HDL in hypercholesterolemia and dyslipidemia

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

This medication helps to lower elevated 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 or mixed dyslipidemia, and to increase levels of good cholesterol, HDL cholesterol. Additionally, in patients with homozygous familial hypercholesterolemia, it can be used as an adjunct to other lipid-lowering therapies or as a replacement if other treatments are ineffective. This medication is used in conjunction with appropriate dietary therapy and contributes to the treatment of various types of dyslipidemia. It is important to identify and treat any secondary causes, such as diabetes or hypothyroidism, before starting this medication. It helps reduce the risk of cardiovascular diseases associated with hypercholesterolemia, improving overall health.

Dosage and Administration

Adult dosage

This medication is administered once daily regardless of food. The dosage range is from 10/10 mg to 10/80 mg per day. A starting dose of 10/10 mg or 10/20 mg per day is recommended. If significant reduction of LDL cholesterol is required, a starting dose of 10/40 mg per day is recommended. Blood lipid levels should be checked at least two weeks after starting therapy or adjusting dosage and the dosage should be adjusted accordingly.

Precautions

This medication is used to lower blood cholesterol levels, with the active ingredients being atorvastatin and ezetimibe. Rarely, this medication may cause serious damage to muscle tissue, leading to muscle pain, weakness, and rhabdomyolysis, which can result in kidney dysfunction. Patients showing serious myopathy symptoms or with risk factors such as severe infection, hypotension, major surgery, trauma, or metabolic disorders should temporarily discontinue or stop this medication. Patients with an allergy to active ingredients or components of this medication, those with active liver disease or consistently elevated liver function tests, patients with muscular disorders, pregnant or potentially pregnant women, nursing mothers, and those taking certain antiviral medications should not take this medication. Additionally, patients with lactose intolerance or related genetic disorders should avoid this medication. Patients with a history of alcohol abuse or liver disease, severe liver dysfunction, kidney dysfunction or hypothyroidism, or a family history of muscular disorders need to exercise caution while taking this medication, and should consult a doctor promptly if muscle pain or unusual symptoms occur. This medication may affect liver function, so regular liver function tests should be conducted before and during treatment, and the medication should be discontinued immediately if symptoms such as hepatitis or jaundice arise. During medication, side effects such as dizziness, muscle pain, abdominal pain, nausea, fatigue, constipation, indigestion, vomiting, belching, hyperglycemia, hypoglycemia, weight gain, anorexia, throat and laryngeal pain, nosebleeds, insomnia, nightmares, sensory disturbances, paresthesia, taste abnormalities, memory loss, peripheral neuropathy, muscle cramps, joint swelling, back pain, neck pain, muscle fatigue, lupus-like syndrome, and thrombocytopenia may occur, so caution is advised. This medication may interact with other drugs, particularly with CYP3A4 inhibitors, cyclosporine, some antibiotics, antiviral drugs, and fibrate-class medications, increasing the risk of muscle injury, so it should be taken after consulting a doctor. Women of childbearing age should use appropriate contraception to prevent pregnancy while taking this medication, and if pregnancy is confirmed, the medication should be discontinued immediately. This medication is not recommended for children as safety and efficacy have not been established. Elderly patients are at a higher risk of myopathy, so caution is needed while taking this medication, but dose adjustment is typically not required. In the case of overdose, there is no specific antidote, so symptomatic treatment and supportive care should be initiated, and liver function and muscle enzyme levels should be monitored. This medication should be stored out of reach of children, and care should be taken not to transfer it to another container, as this may compromise quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash accompanied by high fever, blisters, peeling skin, pain in the mucous membranes of the mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory issues accompanying cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, vision disturbances, paralysis, urination issues

Mild side effects

  • Muscle pain
  • abdominal pain
  • nausea
  • diarrhea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
  • dizziness
  • cough
  • pharyngitis
Show 26 more
  • fatigue
  • headache
  • constipation
  • indigestion
  • vomiting
  • belching
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
  • throat and laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • sensory anomalies
  • paresthesia
  • taste abnormalities
  • memory loss
  • peripheral neuropathy
  • muscle cramps
  • joint swelling
  • back pain
  • neck pain
  • muscle fatigue
  • lupus-like syndrome
  • thrombocytopenia

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

Storage

This medication must be stored in a tightly closed container to prevent exposure to air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. Proper storage will ensure the medication's effectiveness is safely maintained.

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.