Medication info
Exroton Tablet 5/160 mg

Exroton Tablet 5/160 mg

Prescription medicationTablet경구
Ingredient · strength
Valsartan›160mg / 1 tabletAmlodipine Besylate›6.94mg / 1 tablet
Manufacturer / importer
(주)넥스팜코리아
Appearance
Dark yellow oval film-coated tablet
Packaging
PTP - 28 tablets/box [28 tablets (14 tablets/Alu-Alu) X 2]
Approval status
Active

MFDS item code 201603220 · Approved 2016.06.07 · Insurance code 662503500

Summary

Main use
Improvement of blood pressure control in essential hypertension through combination of amlodipine and valsartan
Who takes it
Adults · Children
Adult dose
The recommended dosage of this medication is 1 tablet once a day, to be 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 adequately controlled, the dosage may be adjusted in comparison to monotherapy with amlodipine or valsartan at each respective dose. In patients with mild to moderate renal impairment, no dosage adjustment is necessary; however, patients with severe renal impairment or those on dialysis should not be administered this medication.
Child dose
The safety and efficacy in pediatric patients under 18 years have not been established, so administration of this medication is not recommended.

Ingredients

Manufacturer
(주)넥스팜코리아

Efficacy & effects

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

  • Essential hypertension
View approved original text

This medication helps effectively lower blood pressure in patients with essential hypertension who do not achieve adequate blood pressure control with monotherapy using either amlodipine or valsartan. It is used to manage blood pressure stably and reduce the risk of cardiovascular disease.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet once a day, to be 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 adequately controlled, the dosage may be adjusted in comparison to monotherapy with amlodipine or valsartan at each respective dose. In patients with mild to moderate renal impairment, no dosage adjustment is necessary; however, patients with severe renal impairment or those on dialysis should not be administered this medication.

Child dose

The safety and efficacy in pediatric patients under 18 years have not been established, so administration of this medication is not recommended.

Precautions

This medication can cause severe 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. Persons with allergies to the main ingredient or similar ingredients, pregnant or breastfeeding women, and individuals with severe kidney or liver disease should not use this medication. Patients with sodium or fluid depletion or hyperkalemia should closely monitor blood pressure and potassium levels during treatment and take appropriate measures if necessary. Patients with kidney issues or those who have undergone kidney transplantation, as well as patients with a history of angioedema, should use this medication with caution. Patients with heart-related conditions such as heart failure, post-myocardial infarction, acute myocardial infarction, or aortic stenosis should consult with healthcare providers before taking this medication. This medication can rarely cause side effects such as headache, dizziness, edema, hypotension, cough, gastrointestinal disturbances, skin rashes, etc., and any unusual symptoms should be reported to healthcare professionals immediately. Caution should be taken when driving or operating machinery, as dizziness or fatigue may occur. This medication may interact with other antihypertensives, potassium supplements, certain diuretics, and anti-inflammatory drugs (NSAIDs), so it is important to inform healthcare providers of any other medications being taken. Pregnant women or those planning to become pregnant should not use this medication, and breastfeeding women are also advised to avoid taking it. Use in patients under 18 years is not recommended as safety and efficacy have not been established.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • severe swelling (edema)
  • angioedema
  • vasculitis
  • severe allergic reactions
  • severe cutaneous adverse reactions
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • jaundice
  • hepatitis
Show 9 more
  • liver dysfunction (jaundice)
  • serious neurological symptoms
  • syncope
  • thrombocytopenia
  • leukopenia
  • acute kidney failure
  • renal impairment
  • exacerbation of heart failure
  • and pulmonary edema.

Mild side effects

  • Pharyngitis
  • influenza
  • visual disturbances
  • anxiety
  • headache
  • dizziness
  • drowsiness
  • orthostatic dizziness
  • paresthesia
  • vertigo
Show 27 more
  • tinnitus
  • 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
  • lethargy
  • polyuria
  • nocturia
  • erectile dysfunction
  • edema
  • and angioedema.

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

Storage

Store this medication in a tightly closed container to protect it from air and moisture. It is advisable to keep it at room temperature between 1 degree and 30 degrees.

Appearance and packaging

Appearance

Dark yellow oval film-coated tablet

Package unit

PTP - 28 tablets/box [28 tablets (14 tablets/Alu-Alu) 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.