Medication info

Valsartan/Amlodipine Tablet 5/80 mg

Prescription medicationExpired
Ingredient · strength
Amlodipine Besylate›Strength being verifiedValsartan›Strength being verified
Manufacturer / importer
동화약품(주)
Appearance
Dark yellow round film-coated tablet
Packaging
28 tablets (14 tablets/Alu-AluX2)
Approval status
Expired

MFDS item code 201308536 · Approved 2013.07.30

This product's status changed to Expired on 2023.07.30. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of blood pressure control in essential hypertension
Who uses it
Adults · Children
Adult dosage
Take 1 tablet once daily with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning) if possible. Administer 5/80 mg for patients whose blood pressure is not controlled with monotherapy of amlodipine 5 mg or valsartan 80 mg. Administer 5/160 mg for patients whose blood pressure is not controlled with monotherapy of amlodipine 5 mg or valsartan 160 mg.
Children's dosage
Safety and efficacy have not been established for pediatric patients under 18 years of age, and administration is not recommended.

Ingredients

Manufacturer
동화약품(주)

Efficacy & effects

Improvement of blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

This medication is used for patients with essential hypertension who have difficulty controlling blood pressure with either amlodipine or valsartan monotherapy alone. Maintaining blood pressure within the normal range is important for essential hypertension, and this medication effectively lowers blood pressure, helping to reduce the risk of cardiovascular disease. Therefore, this medication assists in the management of hypertension and improves blood pressure control.

Dosage and Administration

Adult dosage

Take 1 tablet once daily with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning) if possible. Administer 5/80 mg for patients whose blood pressure is not controlled with monotherapy of amlodipine 5 mg or valsartan 80 mg. Administer 5/160 mg for patients whose blood pressure is not controlled with monotherapy of amlodipine 5 mg or valsartan 160 mg.

Children's dosage

Safety and efficacy have not been established for pediatric patients under 18 years of age, and administration is not recommended.

Precautions

This medication can cause serious harm to the fetus if taken during pregnancy, especially in the second and third trimesters, so it should be discontinued immediately upon confirmation of pregnancy. It should not be used in patients with allergies to any of the active ingredients or similar classes of drugs, as well as in pregnant or breastfeeding women and patients with severe kidney or liver disorders. Patients who are sodium or fluid depleted may experience hypotension, so their condition should be carefully checked before starting the medication, and blood pressure and symptoms should be closely monitored during use. Patients with high potassium levels or taking medications that can raise potassium levels should have their potassium levels frequently checked and monitored. Patients with renal vascular problems or those who have had a kidney transplant should also use this medication cautiously as kidney function may worsen. If angioedema occurs while taking this medication, it should be discontinued immediately, and it should not be restarted. Patients with heart failure or those recovering from a myocardial infarction should use this medication cautiously according to a doctor's advice due to the risk of changes in kidney function and hypotension. Dizziness or fatigue may occur while taking this medication, so caution is needed when driving or operating machinery. Interactions may occur when taken with other antihypertensive medications, potassium supplements, diuretics, or non-steroidal anti-inflammatory drugs (NSAIDs), so consultation with a physician or pharmacist is recommended. It is not recommended for children as safety and effectiveness 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 fever, blisters, peeling skin, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities combined with cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary retention.

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • paresthesia
  • lightheadedness
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
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  • hypotension
  • cough
  • throat and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • back pain
  • arthritis
  • muscle spasms
  • weakness
  • frequent urination
  • polyuria
  • erectile dysfunction
  • edema
  • localized swelling
  • facial swelling
  • peripheral edema
  • fatigue
  • flushing
  • asthenia
  • facial flushing
  • nasal inflammation.

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

Storage

This medication should be stored tightly closed in a container that prevents air or moisture from entering. A storage temperature of 1 to 30 degrees Celsius at room temperature is recommended.

Appearance and packaging

Appearance

Dark yellow round film-coated tablet

Package unit

28 tablets (14 tablets/Alu-AluX2)

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.