Medication info

Anaphrg 5/80/10 mg Tablet

Prescription medicationApproval withdrawn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Approval withdrawn

MFDS item code 202105305 · 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This product's status changed to Approval withdrawn on 2023.09.14.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
Reduction of essential hypertension and cardiovascular disease risk, improvement of dyslipidemia
Who uses it
Adults
Adult dosage
Take one tablet daily with water. If possible, it is recommended to take it at the same time daily (e.g., in the morning). Dosage adjustment of the amlodipine/valsartan combination should be individualized for each patient. Example dosages for the amlodipine/valsartan combination are as follows: - 5/80 mg: Administered to patients whose blood pressure is not adequately controlled with either amlodipine 5 mg or valsartan 80 mg monotherapy.

Ingredients

Manufacturer
아주약품(주)

Efficacy & effects

Reduction of essential hypertension and cardiovascular disease risk, improvement of dyslipidemia

  • Essential hypertension
  • hypertension
  • low HDL cholesterol levels
  • family history of early coronary heart disease
  • myocardial infarction
  • stroke
  • chronic stable angina
  • retinopathy
  • albuminuria
  • type 2 diabetes
  • congestive heart failure
  • angina
View approved original text

This drug is used for patients with essential hypertension whose blood pressure is difficult to control with amlodipine and valsartan monotherapy, and for patients requiring the effects of atorvastatin. The amlodipine/valsartan combination reduces cardiovascular burden by controlling blood pressure. Atorvastatin improves hypercholesterolemia and dyslipidemia, and reduces the risk of myocardial infarction and stroke in adults at high risk for coronary heart disease and diabetes. It also decreases the risk of hospitalization due to vascular interventions, angina, and congestive heart failure, thereby improving overall heart health. This medication is effectively used for the prevention of cardiovascular disease and management of hypertension.

Dosage and Administration

Adult dosage

Take one tablet daily with water. If possible, it is recommended to take it at the same time daily (e.g., in the morning). Dosage adjustment of the amlodipine/valsartan combination should be individualized for each patient. Example dosages for the amlodipine/valsartan combination are as follows: - 5/80 mg: Administered to patients whose blood pressure is not adequately controlled with either amlodipine 5 mg or valsartan 80 mg monotherapy.

Precautions

This medication should not be used in patients with known allergies to certain ingredients or those with severely impaired liver or kidney function. Pregnant or nursing women should not take this medication, and caution is advised for those planning to become pregnant. Patients with hypotension or volume depletion should stabilize their condition before taking this medication and should do so under medical supervision. Care should also be taken in patients with high potassium levels or impaired kidney function, and regular blood tests are recommended. Patients with heart disease or muscle disorders should consult their physician before taking this medication. Caution is also needed when driving or operating machinery, as dizziness or fatigue may occur. Regular liver and kidney function tests are recommended while taking this medication. Additionally, potential drug interactions may occur when taken together with other medications, so it is essential to inform healthcare providers of all current medications. The safety and efficacy of this drug have not been established in children; hence, it should not be administered to individuals under 18 years of age. Elderly patients may respond more sensitively to this medication, and starting with a lower dose followed by gradual increases is advisable.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attack, abnormal breathing with cough and fever, yellowing of skin or eyes, profound lethargy, sudden severe headache, thunderclap headache, seizure, confusion, visual disturbances, paralysis, significantly reduced urine output

Mild side effects

  • Abnormal vision
  • dry eyes
  • nausea
  • headache
  • visual disturbances
  • anxiety
  • dizziness
  • drowsiness
  • orthostatic dizziness
  • paresthesia
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  • lightheadedness
  • tinnitus
  • tachycardia
  • palpitations
  • fainting
  • orthostatic hypotension
  • hypotension
  • cough
  • throat and laryngeal pain
  • diarrhea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • back pain
  • arthritis
  • muscle cramps
  • weakness
  • polyuria
  • nocturia
  • erectile dysfunction
  • edema
  • dependent edema

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. This helps preserve the effectiveness and safety of the drug for an extended period.

Appearance and packaging

Appearance

White 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.