Medication info

Anapher jeyjeong 5/160/20 mg

Prescription medicationApproval withdrawn
Ingredient · strength
Amlodipine Besylate›Strength being verifiedValsartan›Strength being verifiedAtorvastatin Calcium Hydrate›Strength being verified
Manufacturer / importer
아주약품(주)
Appearance
Light pink oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202105302 · Approved 2021.07.12

This product's status changed to Approval withdrawn on 2023.09.14. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of hypertension and dyslipidemia, reduction of risk of myocardial infarction and stroke
Who uses it
Adults
Adult dosage
This medication is taken as 1 tablet once daily with water. It is recommended to take it at the same time each day (e.g., in the morning) if possible. The dosage should be individualized based on the efficacy and tolerability of the amlodipine/valsartan combination and atorvastatin in each patient. For the amlodipine/valsartan combination: - 5/80 mg: Patients so far not adequately controlled on amlodipine 5 mg or valsartan 80 mg monotherapy

Ingredients

Manufacturer
아주약품(주)

Efficacy & effects

Improvement of hypertension and dyslipidemia, reduction of risk of myocardial infarction and stroke

  • Essential hypertension
  • hypercholesterolemia
  • dyslipidemia
  • primary hypercholesterolemia
  • mixed dyslipidemia
  • primary Hyper beta-lipoproteinemia
  • elevated serum triglycerides
  • homozygous familial hypercholesterolemia
View approved original text

This medication is used for patients with chronic hypertension where blood pressure is not adequately controlled with monotherapy, using the combination of amlodipine and valsartan. Additionally, atorvastatin reduces the risk of myocardial infarction, stroke, and complications after vascular procedures in adults at high risk for cardiovascular disease and in patients with type 2 diabetes. Furthermore, it effectively reduces cholesterol and triglyceride levels in patients with dyslipidemia and plays a role in increasing good cholesterol (HDL) levels. This drug is very useful in managing hypertension and cardiovascular disease risks, as well as dyslipidemia simultaneously. Therefore, it is used to improve the health condition of patients with dyslipidemia accompanied by hypertension and cardiovascular disease risk.

Dosage and Administration

Adult dosage

This medication is taken as 1 tablet once daily with water. It is recommended to take it at the same time each day (e.g., in the morning) if possible. The dosage should be individualized based on the efficacy and tolerability of the amlodipine/valsartan combination and atorvastatin in each patient. For the amlodipine/valsartan combination: - 5/80 mg: Patients so far not adequately controlled on amlodipine 5 mg or valsartan 80 mg monotherapy

Precautions

This medication can cause serious harm to the fetus and newborn during the second and third trimesters of pregnancy; therefore, it should be discontinued immediately upon confirmation of pregnancy. If there are muscle-related disorders or elevated muscle enzyme levels, the use of this medication should be stopped or done with caution as there is a risk of severe muscle damage affecting kidney function. Patients with allergies to any ingredients contained in this medication, those who are pregnant or breastfeeding, and patients with severe liver or kidney disease should not take it. In cases of certain health conditions such as hypotension, hypovolemia, hyperkalemia, renal artery stenosis, angioedema, heart failure, or myocardial infarction, this medication should be used cautiously under close supervision by healthcare professionals. While taking this medication, dizziness or fatigue may occur, so caution should be exercised while driving or operating machinery. Patients with impaired liver function should adjust the dosage and report any symptoms of liver dysfunction to their healthcare provider immediately. This medication can interact with other drugs, so it is essential to inform healthcare providers of other medications being taken, particularly specific antibiotics, antiviral agents, antacids, contraceptives, etc. Adverse reactions such as muscle pain, liver function abnormalities, and gastrointestinal issues may occur due to the atorvastatin component. If symptoms such as muscle pain, weakness, or fever arise, healthcare professionals should be informed immediately. This medication has not established safety and efficacy in children; therefore, it should not be administered to those under 18 years of age. Elderly patients may be more sensitive to this medication, so it is advisable to start with a lower dose and gradually increase it. Regular blood tests and kidney and liver function assessments should be conducted to ensure safety during treatment.

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 fever, blisters, peeling skin, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Visual disturbances
  • dry eyes
  • nausea
  • headache
  • dizziness
  • drowsiness
  • orthostatic dizziness
  • sensory abnormalities
  • light-headedness
  • tinnitus
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  • tachycardia
  • palpitations
  • fainting
  • orthostatic hypotension
  • hypotension
  • cough
  • oropharyngeal and laryngeal pain
  • diarrhea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • itching
  • muscle cramps
  • lethargy
  • polyuria
  • diabetes insipidus
  • erectile dysfunction
  • edema
  • facial swelling
  • peripheral edema
  • fatigue
  • flushing
  • asthenia
  • facial flushing

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is recommended to maintain the storage temperature between 1 degree and 30 degrees at room temperature.

Appearance and packaging

Appearance

Light pink oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle

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.