Medication info

Valsartan/Amlodipine Tablets 10/160 mg

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

MFDS item code 201308534 · 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
The recommended dose of this medication is 1 tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). The dosage should be adjusted based on the patient's condition using either amlodipine or valsartan alone, and if blood pressure is not controlled, a switch to this medication may be considered. For patients with renal impairment, no dosage adjustment is needed for mild to moderate cases, but in severe renal impairment and dialysis, this medication should not be used.
Children's dosage
Safety and efficacy in pediatric patients under 18 years have not been established, so this medication is not recommended for use.

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 whose blood pressure is not adequately controlled with either amlodipine or valsartan alone.

Dosage and Administration

Adult dosage

The recommended dose of this medication is 1 tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). The dosage should be adjusted based on the patient's condition using either amlodipine or valsartan alone, and if blood pressure is not controlled, a switch to this medication may be considered. For patients with renal impairment, no dosage adjustment is needed for mild to moderate cases, but in severe renal impairment and dialysis, this medication should not be used.

Children's dosage

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

Precautions

This medication may cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy, and should be discontinued immediately upon confirmation of pregnancy. It is also safe not to take this medication if you have an allergy to its ingredients, are pregnant or breastfeeding, have severe kidney or liver disease, or specific heart disease. Patients with low sodium or fluid levels in the body may experience low blood pressure, so their condition should be carefully checked before taking the medication, and if symptoms of low blood pressure occur, the patient should be laid down and necessary measures taken. Patients with high potassium levels or those taking medications that may increase potassium levels should frequently monitor their potassium levels for safety. Patients who have issues with renal blood vessels or have recently undergone kidney transplantation should use this medication carefully as it may affect kidney function. Symptoms of angioedema, such as swelling of the face, lips, and tongue, may occur, and if these symptoms appear, the medication should be discontinued immediately. Patients with heart failure or after a myocardial infarction should closely monitor changes in kidney function while taking this medication, and specific heart disease patients need to exercise caution when using it. This medication, when used in combination with other antihypertensive drugs, may increase the risk of low blood pressure, worsening kidney function, and hyperkalemia, so blood pressure and kidney function should be monitored regularly per medical advice. Caution is advised due to possible dizziness or fatigue when driving or operating machinery. In the case of overdose, severe low blood pressure or heart problems may occur; if an overdose is suspected, medical assistance should be sought immediately. The safety of this medication has not been fully established in children, so it is not recommended, and elderly patients should use the same dose as adults but with careful monitoring.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory distress accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme general lethargy, sudden and severe headaches, thunderclap headaches, seizures, confusion, visual disturbances, paralysis, urinary issues.

Mild side effects

  • Nasopharyngitis
  • influenza
  • hypersensitivity
  • visual disturbances
  • anxiety
  • headache
  • dizziness
  • drowsiness
  • orthostatic dizziness
  • sensory disturbances
Show 28 more
  • vertigo
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
  • hypotension
  • cough
  • pharyngeal and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • dry mouth
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • low back pain
  • arthritis
  • muscle cramps
  • lethargy
  • polyuria
  • nocturia
  • erectile dysfunction
  • edema
  • etc.

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 exposure to air or moisture. Additionally, it is best stored at a normal indoor temperature between 1 and 30 degrees Celsius, avoiding extremes of heat or cold.

Appearance and packaging

Appearance

Bright yellow oval film-coated tablets

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

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.