Medication info

Valsartan 5/160 mg Tablet

Prescription medicationExpired
Ingredient · strength
Amlodipine Besylate›Strength being verifiedValsartan›Strength being verified
Manufacturer / importer
동화약품(주)
Appearance
Dark yellow oval film-coated tablet
Packaging
28 tablets (14 tablets/Alu-Alu X2)
Approval status
Expired

MFDS item code 201308535 · 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 in blood pressure control in essential hypertension
Who uses it
Adults · Children
Adult dosage
The recommended dosage for this medication is 1 tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time each day (for example, in the morning). 5/80 mg: Administered to patients whose blood pressure is not adequately controlled with monotherapy of amlodipine 5 mg or valsartan 80 mg. 5/160 mg: Administered to patients whose blood pressure is not adequately controlled with monotherapy of amlodipine 5 mg or valsartan 160 mg.
Children's dosage
Safety and efficacy of this medication in pediatric patients under 18 years of age have not been established, and its use is not recommended.

Ingredients

Manufacturer
동화약품(주)

Efficacy & effects

Improvement in blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

This medication is used for the treatment of essential hypertension that is uncontrolled by monotherapy with amlodipine or valsartan. Essential hypertension is a condition characterized by abnormally high blood pressure, and this medication effectively lowers blood pressure to reduce the risk of cardiovascular diseases, thereby assisting in the improvement of the patient's health status.

Dosage and Administration

Adult dosage

The recommended dosage for this medication is 1 tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time each day (for example, in the morning). 5/80 mg: Administered to patients whose blood pressure is not adequately controlled with monotherapy of amlodipine 5 mg or valsartan 80 mg. 5/160 mg: Administered to patients whose blood pressure is not adequately controlled with monotherapy of amlodipine 5 mg or valsartan 160 mg.

Children's dosage

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

Precautions

This medication can cause serious harm to the fetus if taken during the second and third trimesters of pregnancy, so it should be discontinued immediately if pregnancy is confirmed. It should not be used by individuals with allergies to this medicine or similar medications, pregnant or nursing women, or patients with severe kidney or liver dysfunction. Patients who are sodium or fluid depleted, have hyperkalemia, renal artery stenosis, have recently undergone kidney transplantation, have a history of angioedema, or suffer from heart failure or have had a myocardial infarction, should use this medication with special caution. Side effects may include dizziness, headache, swelling, low blood pressure, palpitations, cough, dyspepsia, skin rash, and others; consult a doctor immediately if any atypical symptoms occur. Caution is advised while driving or operating machinery as dizziness or fatigue may occur. This medication may interact with other antihypertensive medications, potassium supplements, diuretics, certain antibiotics, grapefruit juice, etc., so inform your doctor about any other medications you are taking. Women who are pregnant or planning to become pregnant should not use this medication, and nursing women are also advised to avoid it. Safety and effectiveness in children under 18 years of age have not been sufficiently established, so its use in this age group is not recommended. In cases of overdose, there is a risk of severe hypotension or tachycardia; therefore, it is crucial to adhere to the prescribed dosage, and if an overdose is suspected, seek immediate medical attention.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in oral/nasal mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urine

Mild side effects

  • Nasopharyngitis
  • influenza
  • anxiety
  • headache
  • dizziness
  • drowsiness
  • orthostatic dizziness
  • paresthesia
  • vertigo
  • tinnitus
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  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
  • hypotension
  • cough
  • throat and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • back pain
  • arthritis
  • muscle cramps
  • weakness
  • polyuria
  • nocturia
  • erectile dysfunction
  • swelling
  • localized swelling
  • facial swelling

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 advisable to maintain storage temperature between 1 to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Dark yellow oval film-coated tablet

Package unit

28 tablets (14 tablets/Alu-Alu X2)

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.