Medication info
Exforge 5/160mg (Amlodipine Besilate, Valsartan)

Exforge 5/160mg (Amlodipine Besilate, Valsartan)

Prescription medicationTablet경구
Ingredient · strength
Valsartan›160mg / 1 tabletAmlodipine Besylate›6.94mg / 1 tablet
Manufacturer / importer
한국노바티스(주)
Appearance
Dark yellow oval film-coated tablet
Packaging
28 tablets (14 tablets/PTP packaging X 2), 28 tablets (7 tablets/PTP packaging X 4)
Approval status
Active

MFDS item code 200703803 · Approved 2007.04.03 · Insurance code 653600850

Summary

Main use
Improves blood pressure control in essential hypertension with the combination of amlodipine and valsartan
Who takes it
Adults · Children
Adult dose
The recommended dosage of this medication is 1 tablet once daily, to be taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., morning). If blood pressure is not controlled, consideration can be given to using the 5/80mg dosage for patients whose blood pressure remains uncontrolled with monotherapy using 5mg amlodipine or 80mg valsartan. Separate monotherapy dosages include 5mg amlodipine or 160mg valsartan.
Child dose
Safety and efficacy in pediatric patients under 18 years of age have not been established; therefore, the use of this medication is not recommended.

Ingredients

Importer
한국노바티스(주)

Efficacy & effects

Improves blood pressure control in essential hypertension with the combination of amlodipine and valsartan

  • Essential hypertension
View approved original text

This medication is used to control blood pressure in patients with essential hypertension whose blood pressure is not adequately controlled with monotherapy using amlodipine or valsartan.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet once daily, to be taken with water regardless of meals. It is advisable to take it at the same time each day (e.g., morning). If blood pressure is not controlled, consideration can be given to using the 5/80mg dosage for patients whose blood pressure remains uncontrolled with monotherapy using 5mg amlodipine or 80mg valsartan. Separate monotherapy dosages include 5mg amlodipine or 160mg valsartan.

Child dose

Safety and efficacy in pediatric patients under 18 years of age have not been established; therefore, the use of this medication is not recommended.

Precautions

This medication can cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy; therefore, use should be discontinued immediately if pregnancy is confirmed. Patients with allergies to any of the active ingredients or related medications, pregnant or breastfeeding women, and those with severe renal or liver dysfunction should not use this medication. Patients with low sodium or fluid levels in the body should carefully check their condition before taking this medication, and during use, blood pressure and condition should be monitored closely. Patients with high potassium levels should frequently check their potassium levels when taking this medication with potassium-increasing medications. Patients with kidney problems or those who have received a kidney transplant should closely monitor kidney function when taking this medication, and should discontinue use immediately if symptoms of angioedema appear. Patients recovering from heart failure or myocardial infarction should carefully monitor changes in kidney function while taking this medication and be prepared for potential heart failure worsening. This medication lowers blood pressure, so an overdose can lead to dizziness or severe hypotension, which may require immediate medical attention. Dizziness or fatigue may occur while driving or operating machinery, so caution is advised. There may be interactions if taken with other medications, especially potassium supplements, diuretics, and anti-inflammatory drugs, so it is advisable to consult a doctor or pharmacist before taking them together. It is safest for women who are pregnant or planning to become pregnant, as well as breastfeeding women, to avoid using this medication. This medication is not recommended for children under 18 years of age, as its safety and efficacy have not been adequately established.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, oral/eye mucosal pain, shortness of breath or difficulty breathing, asthma attack, respiratory distress with cough and fever, jaundice (yellowing of the skin or eyes), profound fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • paresthesia
  • vertigo
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
Show 28 more
  • hypotension
  • cough
  • throat and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • dry mouth
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • back pain
  • arthritis
  • muscle cramps
  • fatigue
  • polyuria
  • nocturia
  • erectile dysfunction
  • edema
  • peripheral edema
  • facial edema
  • fatigue
  • flushing
  • weakness
  • facial flushing
  • nasal congestion

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

Storage

This medication should be stored in a closed container to protect it from air and moisture. It is recommended to maintain storage temperature between 1 degree Celsius and 30 degrees Celsius.

Appearance and packaging

Appearance

Dark yellow oval film-coated tablet

Package unit

28 tablets (14 tablets/PTP packaging X 2), 28 tablets (7 tablets/PTP packaging X 4)

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.