Medication info

Amlodipine/Valsartan Tablet 10/160 mg

Prescription medicationTablet경구Expired
Ingredient · strength
Valsartan›160mg / 1 tabletAmlodipine Besylate›13.87mg / 1 tablet
Manufacturer / importer
동국제약(주)
Appearance
Bright yellow oblong film-coated tablet
Packaging
28 tablets (14 tablets/Alu-Alu X 2), 30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 201902050 · Approved 2019.04.04

This product's status changed to Expired on 2024.04.04. 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 through the combination of amlodipine and valsartan
Who takes it
Adults · Children
Adult dose
The recommended dosage of this medicine is 1 tablet once a day, taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). If blood pressure is not controlled after dose adjustment with individual components, it can be administered as follows: - 5/80 mg: for patients whose blood pressure is not controlled by amlodipine 5 mg or valsartan 80 mg alone. - 5/160.
Child dose
Safety and efficacy in pediatric patients under 18 years of age have not been established, and use is not recommended.

Ingredients

Manufacturer
동국제약(주)

Efficacy & effects

Improvement of blood pressure control in essential hypertension through the combination of amlodipine and valsartan

  • Essential hypertension
View approved original text

This medicine is used in patients with essential hypertension whose blood pressure is not sufficiently controlled by using amlodipine or valsartan alone. It helps to lower blood pressure more effectively, protecting heart and vascular health, and reducing the risk of complications due to hypertension.

How to take

Adult dose

The recommended dosage of this medicine is 1 tablet once a day, taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). If blood pressure is not controlled after dose adjustment with individual components, it can be administered as follows: - 5/80 mg: for patients whose blood pressure is not controlled by amlodipine 5 mg or valsartan 80 mg alone. - 5/160.

Child dose

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

Precautions

This medicine can cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. Patients who are allergic to this medicine or have hypersensitivity to its ingredients should not use it. Patients with severe renal impairment or liver dysfunction, as well as pregnant or breastfeeding women, should not take this medicine. Caution should be exercised when administering this medicine to patients with excessively low blood pressure or sodium or fluid depletion, and immediate action is needed if symptoms of hypotension occur during use. Patients with high potassium levels or those taking potassium supplements should have their potassium levels checked frequently. Patients with renal vascular issues or those who have undergone kidney transplantation should also be cautious when using this medicine. A serious allergic reaction called angioedema may occur, so if swelling of the face, lips, tongue, etc., occurs, treatment should be stopped immediately. Patients with certain heart conditions, such as heart failure or post-myocardial infarction, or aortic stenosis should take special care when taking this medicine. There may be an increased risk of hypotension, hyperkalemia, and worsening kidney function when this medicine is taken with other specific antihypertensive medications, so either combination should be avoided or taken under strict medical supervision. Dizziness or fatigue may occur during driving or operating machinery, so caution is necessary. In case of overdose, severe hypotension or tachycardia may occur, and the patient should visit a medical institution immediately. Use in children is not recommended as safety and efficacy have not been sufficiently established, while elderly patients may use the same dosage as adults. It is advisable to regularly check liver and kidney function during treatment with this medicine. This medicine should not be used by pregnant women or women planning to become pregnant, and breastfeeding women should also avoid taking it.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/eye mucous membranes, shortness of breath or difficulty breathing, asthma attack, respiratory problems accompanied by cough + fever, yellowing of the skin or eyes (jaundice), feeling very lethargic all over, sudden and severe headache, lightning headache, seizures, confusion, vision abnormalities, paralysis, urinary issues.

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • altered sensation
  • vertigo
  • tinnitus
  • tachycardia
  • palpitations
  • fainting
  • orthostatic hypotension
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  • hypotension
  • cough
  • throat and larynx pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • dry mouth
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • low back pain
  • arthritis
  • muscle cramps
  • weakness
  • increased urinary frequency
  • polyuria
  • erectile dysfunction
  • edema
  • periorbital swelling
  • facial swelling
  • peripheral edema
  • fatigue
  • flushing
  • weakness
  • facial flushing
  • nasal congestion.

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

Storage

This medicine may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is recommended to keep the storage temperature between 1 and 30 degrees Celsius to safely maintain the medication's effectiveness.

Appearance and packaging

Appearance

Bright yellow oblong film-coated tablet

Package unit

28 tablets (14 tablets/Alu-Alu X 2), 30 tablets/bottle, 100 tablets/bottle

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.