Medication info

Anapergia Tablet 5/80/20 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Prescription medicationApproval withdrawn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 orange oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202105304 · 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This product's status changed to Approval withdrawn on 2023.09.14.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
Treatment of essential hypertension and dyslipidemia, reduction of risk of myocardial infarction and stroke
Who uses it
Adults
Adult dosage
Take one tablet once daily with water. It is recommended to take it at the same time each day (e.g., in the morning). The dosage of the amlodipine/valsartan combination should be individualized for each patient. - 5/80 mg: Administered to patients whose blood pressure is not controlled with amlodipine 5 mg or valsartan 80 mg monotherapy. - 5/160 mg: Administered to patients whose blood pressure is not controlled with amlodipine 5 mg or valsartan 160 mg.

Ingredients

Manufacturer
아주약품(주)

Efficacy & effects

Treatment of essential hypertension and dyslipidemia, reduction of risk of myocardial infarction and stroke

  • Essential hypertension
  • myocardial infarction
  • stroke
  • vascular surgery
  • chronic stable angina
  • retinopathy
  • albuminuria
  • congestive heart failure
  • angina
  • dyslipidemia
  • hypercholesterolemia
  • abnormal beta-lipoproteinemia
View approved original text

This medication is used in patients with essential hypertension whose blood pressure is not adequately controlled while taking a combination of amlodipine and valsartan, and in patients who require atorvastatin. The amlodipine/valsartan combination primarily lowers blood pressure effectively to manage hypertension. Atorvastatin helps reduce the risk of myocardial infarction, stroke, and complications after vascular surgeries in adults with multiple cardiovascular risk factors and in diabetic patients. Additionally, it decreases the risk of hospitalization due to angina or congestive heart failure. Atorvastatin is also used for the treatment of dyslipidemia and helps normalize blood lipid levels by improving hypercholesterolemia and various types of lipid abnormalities. Thus, this medication is effectively used to manage hypertension, cardiovascular diseases, and dyslipidemia.

Dosage and Administration

Adult dosage

Take one tablet once daily with water. It is recommended to take it at the same time each day (e.g., in the morning). The dosage of the amlodipine/valsartan combination should be individualized for each patient. - 5/80 mg: Administered to patients whose blood pressure is not controlled with amlodipine 5 mg or valsartan 80 mg monotherapy. - 5/160 mg: Administered to patients whose blood pressure is not controlled with amlodipine 5 mg or valsartan 160 mg.

Precautions

This medication can cause serious harm to the fetus and newborn if taken during pregnancy, especially in the second and third trimesters, so it should be discontinued immediately if pregnancy is confirmed. If there are abnormalities in the muscles or significant increases in muscle-related test values, this medication should be discontinued. This medication should be avoided in patients with certain diseases or conditions, such as severe liver dysfunction, kidney impairment, pregnant or potentially pregnant women, or anyone with specific allergic reactions. Patients with body sodium or fluid deficiency, patients with hyperkalemia, patients with kidney issues, and patients after heart failure or myocardial infarction need special caution when taking this medication and should be closely monitored by a physician. This medication can cause various adverse reactions, with common symptoms including headache, dizziness, swelling, and gastrointestinal disturbances; rarely, severe myopathy, liver dysfunction, or allergic reactions may occur. Caution is advised as dizziness or fatigue may occur when driving or operating machinery. This medication can interact with other drugs, so it is essential to inform the physician or pharmacist if you are taking other medications, especially when used concurrently with certain antibiotics, antifungals, or other blood pressure medications. Pregnant or breastfeeding women should not take this medication, and women of childbearing age should use appropriate contraceptive methods. It is advisable not to use this medication in children under 18 years of age, as safety and efficacy have not been established. Elderly patients may be more sensitive to this medication, so starting with a low dose and gradually increasing it is advisable. It is crucial to regularly monitor health status through blood tests or liver function tests while taking this medication.

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, peeling skin, pain in oral/ocular mucosa, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by coughing and fever, jaundice (yellowing of skin or eyes), profound fatigue, liver problems (jaundice), sudden and severe headache, thunderclap headache, seizures

Mild side effects

  • Eye abnormalities
  • dryness of eyes
  • nausea
  • headache
  • visual disturbances
  • anxiety
  • dizziness
  • drowsiness
  • orthostatic dizziness
  • sensory abnormalities
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  • vertigo
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
  • hypotension
  • cough
  • throat and laryngeal pain
  • diarrhea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • itching
  • muscle cramps
  • weakness
  • polyuria
  • excessive urination
  • erectile dysfunction
  • edema
  • anasarca
  • facial swelling
  • peripheral edema
  • fatigue

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, and the storage temperature should be maintained between 1 degree and 30 degrees Celsius at room temperature. Storing it this way will help preserve the efficacy and prevent degradation of the medication.

Appearance and packaging

Appearance

Light orange 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.