Medication info
Genewon Azev Tablets 10/40 mg

Genewon Azev Tablets 10/40 mg

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›43.4mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
주식회사제뉴원사이언스
Appearance
White to light white, biconvex, rectangular film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 202101734 · Approved 2021.02.22

Summary

Main use
Effects of lipid control through reduction of cholesterol and increase of HDL in hypercholesterolemia (primary, homozygous familial) and dyslipidemia.
Who uses it
Adults
Adult dosage
This medication is administered once daily regardless of meals. For primary hypercholesterolemia, an initial dose of 10/10 mg or 10/20 mg is recommended. For patients requiring greater reductions in LDL cholesterol (more than 55%), an initial dose of 10/40 mg is recommended. Dose adjustments should be made based on blood lipid levels checked at intervals of more than 2 weeks. Homozygous familial hypercholesterolemia

Ingredients

Manufacturer
주식회사제뉴원사이언스

Efficacy & effects

Effects of lipid control through reduction of cholesterol and increase of HDL in hypercholesterolemia (primary, homozygous familial) and dyslipidemia.

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

This medication aids in lowering total cholesterol, LDL-cholesterol, apo B protein, triglycerides, and non-HDL cholesterol levels, while increasing good cholesterol, HDL-cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia. Particularly, it is used in patients with homozygous familial hypercholesterolemia when other lipid-lowering treatments are ineffective or when adjunctive therapy is needed. This medication is to be administered alongside dietary therapy, and secondary causes of dyslipidemia due to other health conditions or medications must also be identified and managed. Additionally, for patients with acute coronary events, lipid testing should be performed during hospitalization or within 24 hours post-hospitalization for treatment reference. Overall, this medication contributes to the prevention and treatment of cardiovascular diseases by regulating blood lipid levels.

Dosage and Administration

Adult dosage

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, an initial dose of 10/10 mg or 10/20 mg is recommended. For patients requiring greater reductions in LDL cholesterol (more than 55%), an initial dose of 10/40 mg is recommended. Dose adjustments should be made based on blood lipid levels checked at intervals of more than 2 weeks. Homozygous familial hypercholesterolemia

Precautions

This medication is primarily used to lower blood cholesterol levels. Serious muscle problems may arise while taking this medication, so if symptoms such as muscle pain or weakness occur, the doctor must be notified immediately. In cases where kidney function is at risk of being weakened due to acute infections, hypotension, major surgery or trauma, or severe endocrine disorders, it may be necessary to temporarily stop this medication. Individuals allergic to the active or inactive ingredients of this medication, those with severely impaired liver function, individuals with muscle disorders, pregnant or breastfeeding women, those taking certain antiviral medications, or individuals with lactose intolerance should not take this medication. Caution is especially necessary for individuals with alcohol dependence or a history of liver disease, those with reduced kidney function, hypothyroidism, the elderly, etc., as they may have an increased risk of myopathy and require regular monitoring based on the physician's instructions. This medication may elevate liver enzyme levels, so liver function tests should be performed before use, and periodic checks for liver abnormalities should be conducted during use. This medication may interact with other drugs, so patients taking other medications must inform their doctor or pharmacist, particularly when used concurrently with certain antibiotics, antivirals, immunosuppressants, antihypertensives, or antidiabetic agents. Women who may become pregnant while taking this medication should utilize appropriate contraception, and if pregnancy is confirmed, the medication should be stopped immediately. Symptoms such as dizziness may occur, necessitating caution while driving or operating machinery. This medication has not been established as safe and effective in children and is not recommended. In cases of overdose, there is no specific antidote, so appropriate treatment and supportive therapy according to symptoms are necessary, and monitoring of liver function and muscle enzyme levels should be conducted. This medication should be kept out of the reach of children and should not be transferred to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with high fever, blistering, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, cough accompanied by fever and respiratory abnormalities, jaundice (yellowing of the skin or eyes), extreme fatigue, sudden and severe headache, lightning headache, seizure, consciousness confusion, visual disturbance, paralysis, urine

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevation of liver enzymes
  • dizziness
  • cough
  • nausea
  • diarrhea
  • musculoskeletal pain
  • joint pain
  • muscle weakness
Show 28 more
  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • headache
  • fatigue
  • constipation
  • pharyngitis
  • sinusitis
  • upper respiratory tract infection
  • low back pain
  • muscle cramps
  • itching
  • rash
  • hair loss
  • urticaria
  • thrombocytopenia
  • hepatitis
  • blurred vision
  • tinnitus
  • vomiting
  • gallstones
  • cholecystitis
  • respiratory difficulty
  • asthma
  • insomnia
  • nightmares
  • sensory abnormalities

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly closed container. Additionally, it should be kept at room temperature between 1 and 30 degrees Celsius, avoiding excessively hot or cold locations.

Appearance and packaging

Appearance

White to light white, biconvex, rectangular 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.