Medication info
Exforge 5/80 mg (Amlodipine Besylate, Valsartan)

Exforge 5/80 mg (Amlodipine Besylate, Valsartan)

Prescription medicationTablet경구
Ingredient · strength
Valsartan›80mg / 1 tabletAmlodipine Besylate›6.94mg / 1 tablet
Manufacturer / importer
한국노바티스(주)
Appearance
Dark yellow round film-coated tablet
Packaging
28 tablets (14 tablets/PTP packaging x 2)
Approval status
Active

MFDS item code 200703804 · Approved 2007.04.03 · Insurance code 653600860

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dose of this medication is 1 tablet once daily, to be taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). The dosages of 5/80 mg, 5/160 mg, and 10/160 mg should be adjusted according to blood pressure control status. Patients with renal or hepatic impairment need to be cautious regarding dosage adjustments or limits. Caution should be exercised when increasing the dose in patients aged 65 and over.
Child dose
Safety and efficacy for pediatric patients under 18 years of age have not been established, and the use of this medication is not recommended.

Ingredients

Importer
한국노바티스(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication is used for essential hypertension that is not appropriately controlled with Amlodipine or Valsartan monotherapy.

How to take

Adult dose

The recommended dose of this medication is 1 tablet once daily, to be taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). The dosages of 5/80 mg, 5/160 mg, and 10/160 mg should be adjusted according to blood pressure control status. Patients with renal or hepatic impairment need to be cautious regarding dosage adjustments or limits. Caution should be exercised when increasing the dose in patients aged 65 and over.

Child dose

Safety and efficacy for pediatric patients under 18 years of age have not been established, and 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, it should be discontinued immediately upon confirmation of pregnancy. Patients with allergies to the ingredients of this medication, those who are pregnant or breastfeeding, patients with severe kidney or liver disease, and those with certain heart conditions should not take this medication. Patients with low sodium or fluid levels in their body may experience hypotension, so their status should be checked before taking the medication and monitored closely. Patients with high potassium levels should have their potassium levels checked frequently if taking this medication with other potassium-increasing drugs. Patients with kidney vascular issues or kidney transplant recipients should monitor kidney function closely when taking this medication. If symptoms of angioedema occur, discontinue the medication immediately and do not reuse it. Patients with heart failure or those recovering from a myocardial infarction should frequently check their kidney function and blood pressure while taking this medication, as there may be potential for worsening heart failure. Patients with acute myocardial infarction should be cautious as this medication may worsen angina or myocardial infarction symptoms. This medication may interact with other blood pressure-lowering medications, so it should be taken after consulting a physician. Dizziness or fatigue may occur when driving or operating machinery, so caution is advised. Overdose of this medication can lead to severe hypotension or shock, thus immediate medical attention is required. Safety for children or patients under 18 years of age has not been established, so it is not recommended for them. Elderly patients may be given the same dosage as adults, but their condition should be monitored closely. Women who are pregnant or planning to become pregnant should not take this medication, and nursing mothers are also advised to avoid it.

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 fever, blisters, skin peeling, pain in the mucous membranes of the 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 malaise, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • sensory disturbances
  • lightheadedness
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
Show 29 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
  • frequent urination
  • polyuria
  • erectile dysfunction
  • edema
  • dependent edema
  • facial edema
  • peripheral edema
  • tiredness
  • flushing
  • weakness
  • facial flushing
  • diplopia

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

Storage

This medication should be stored in a tightly sealed container to protect against air and moisture. Storage temperature should be kept between 1 to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Dark yellow round film-coated tablet

Package unit

28 tablets (14 tablets/PTP packaging x 2)

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.

Related searches

Search tags

Suggested searches

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.