Medication info
Amifoprazine 10/160 mg

Amifoprazine 10/160 mg

Prescription medicationTablet경구
Ingredient · strength
Valsartan›160mg / 1 tabletAmlodipine Besylate›13.87mg / 1 tablet
Manufacturer / importer
아이큐어(주)
Appearance
Bright yellow oval film-coated tablet
Packaging
28 tablets
Approval status
Active

MFDS item code 201602313 · Approved 2016.04.25

Summary

Main use
Improvement in blood pressure control in essential hypertension through the combination of amlodipine and valsartan
Who takes it
Adults · Children
Adult dose
The recommended dosage of this medication is one tablet once daily, taken with water regardless of meals. It is advised to take it at the same time every day (e.g., in the morning). 5/80 mg is administered to patients whose blood pressure is inadequately controlled by amlodipine 5 mg or valsartan 80 mg monotherapy. 5/160 mg is administered to patients whose blood pressure is inadequately controlled by amlodipine 5 mg or valsartan 160 mg monotherapy.
Child dose
Safety and efficacy have not been established for pediatric patients under 18 years old, so the administration of this medication is not recommended.

Ingredients

Manufacturer
아이큐어(주)

Efficacy & effects

Improvement in blood pressure control in essential hypertension through the combination of amlodipine and valsartan

  • Essential hypertension
View approved original text

This medication is used to effectively lower blood pressure in patients with essential hypertension whose blood pressure is inadequately controlled by monotherapy with amlodipine or valsartan.

How to take

Adult dose

The recommended dosage of this medication is one tablet once daily, taken with water regardless of meals. It is advised to take it at the same time every day (e.g., in the morning). 5/80 mg is administered to patients whose blood pressure is inadequately controlled by amlodipine 5 mg or valsartan 80 mg monotherapy. 5/160 mg is administered to patients whose blood pressure is inadequately controlled by amlodipine 5 mg or valsartan 160 mg monotherapy.

Child dose

Safety and efficacy have not been established for pediatric patients under 18 years old, so the administration of this medication is not recommended.

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 must be discontinued immediately upon confirmation of pregnancy. This medication should not be used by patients who are allergic to its active ingredients or similar class medications, women who are pregnant or breastfeeding, and patients with severe renal or hepatic dysfunction. Patients with low sodium or fluid levels in the body may experience hypotension, so their status should be well assessed before taking the medication and should be closely monitored at the start of treatment. Patients with high potassium levels or those taking other medications that may increase potassium should frequently monitor their potassium levels. Patients with renal artery stenosis or those who have undergone kidney transplantation need cautious use and monitoring due to the risk of renal function deterioration. If symptoms of angioedema occur, the medication should be stopped immediately and should not be resumed. For patients with heart failure or after myocardial infarction, careful observation of renal function changes is necessary, and considerations for potential angina exacerbation should be made in acute myocardial infarction patients. Caution is required as dizziness or fatigue may occur when driving or operating machinery. This medication may interact with other antihypertensives, potassium supplements, diuretics, and specific anti-inflammatory agents, so other medications being taken must be disclosed to the doctor or pharmacist. Women who are pregnant or planning to become pregnant should not use this medication, and breastfeeding women are also advised to avoid taking it. It is not recommended for patients under 18 years of age, as safety and efficacy have not been sufficiently established. In case of overdose, symptoms such as hypotension, dizziness, and cardiac arrhythmias may occur, so it is essential to adhere to the prescribed dosage, and if any abnormal symptoms manifest, immediate medical attention should be sought. It is important to regularly check blood pressure, renal function, and electrolyte levels during the course of treatment to ensure no abnormalities are present.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary retention.

Mild side effects

  • Nasopharyngitis
  • influenza
  • hypersensitivity
  • visual disturbances
  • anxiety
  • headache
  • dizziness
  • drowsiness
  • orthostatic dizziness
  • paraesthesia
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  • vertigo
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
  • hypotension
  • cough
  • pain in the pharynx and larynx
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • dry mouth
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • lumbago
  • arthritis
  • muscle cramps
  • fatigue
  • polyuria
  • diuresis
  • erectile dysfunction
  • edema.

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

Storage

This medication can be sensitive to air and moisture, so it should be stored in a tightly closed container. It is advisable to maintain the storage temperature between 1 and 30 degrees Celsius. Proper storage will help retain the medication's efficacy and safety over time.

Appearance and packaging

Appearance

Bright yellow oval film-coated tablet

Package unit

28 tablets

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

No questions yet.

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.