Medication info
Amlodipine/Valsartan Tablets 5/80 mg

Amlodipine/Valsartan Tablets 5/80 mg

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

MFDS item code 201403382 · Approved 2014.07.25 · Insurance code 653402990

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dose 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). 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.
Child dose
Safety and efficacy in pediatric patients under 18 years have not been established; therefore, use of this medication is not recommended.

Ingredients

Manufacturer
동국제약(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication is used to effectively lower blood pressure in patients with essential hypertension who do not achieve adequate blood pressure control with monotherapy of amlodipine or valsartan.

How to take

Adult dose

The recommended dose 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). 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.

Child dose

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

Precautions

This medication can cause serious harm to the fetus and newborn when taken during the second and third trimesters of pregnancy; therefore, it should be discontinued immediately upon confirmation of pregnancy. It is safe not to take this medication if you are allergic to its components or similar classes of medications, pregnant or breastfeeding, or have severe kidney or liver disease. Patients with insufficient sodium or fluids in the body may experience hypotension, so it is essential to check their condition before taking the medication, and blood pressure and health should be monitored carefully during treatment. Patients with high potassium levels should exercise caution when taking this medication with potassium-rich drugs or supplements and should regularly check their potassium levels through blood tests. Patients with issues related to renal blood vessels or those who have received a kidney transplant may experience worsening kidney function while taking this medication, thus requiring careful monitoring by a physician. If symptoms of angioedema occur, this medication should be discontinued immediately and not restarted. Patients with heart conditions, such as heart failure or after a myocardial infarction, or those with aortic stenosis should take this medication with caution. When taken with other blood pressure medications, this drug can increase the risk of hypotension, kidney dysfunction, and hyperkalemia; therefore, when co-administered, blood pressure, kidney function, and electrolyte status must be thoroughly checked. Dizziness or fatigue may occur when driving or operating machinery, so caution is needed. Overdosage may present symptoms such as hypotension and reflex tachycardia; in such cases, immediate medical attention should be sought for appropriate treatment. This medication is not recommended for children under 18 years of age as its safety and efficacy have not been established in this population. In elderly patients, the normal dosage is recommended, but it should be taken with caution considering their physical condition. If there are any abnormal symptoms or discomfort during treatment, it is crucial to consult a healthcare professional, and regular examinations to monitor physical status are important.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory issues accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizure, confusion, visual disturbances,

Mild side effects

  • Nasopharyngitis
  • influenza
  • anxiety
  • headache
  • dizziness
  • drowsiness
  • orthostatic dizziness
  • paresthesia
  • dizziness
  • 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
  • low back pain
  • arthritis
  • muscle cramps
  • weakness
  • frequency of urination
  • polyuria
  • erectile dysfunction
  • edema
  • local edema
  • facial edema

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

Storage

This medication should be stored in a tightly sealed container to keep it away from air and moisture. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius.

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

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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.