Medication info
Exvy Tablet 10/160 Milligrams

Exvy Tablet 10/160 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Valsartan›160mg / 1 tabletAmlodipine Besylate›13.87mg / 1 tablet
Manufacturer / importer
광동제약(주)
Appearance
Bright yellow rectangular film-coated tablet
Packaging
28 tablets (14 tablets/PTP×2)
Approval status
Active

MFDS item code 201308474 · Approved 2013.07.30 · Insurance code 641805540

Summary

Main use
Improvement of blood pressure control in essential hypertension with 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 every day (e.g., in the morning). This medication is to be administered to those whose blood pressure is not controlled with monotherapy of Amlodipine or Valsartan. Patients with renal impairment do not need dosage adjustment in mild to moderate cases but should not receive this medication in severe cases or those on dialysis. Hepatic impairment patients should not exceed a daily dose of 80 mg of Valsartan.
Child dose
Safety and efficacy in pediatric patients under 18 years of age have not been established, therefore, use of this medication is not recommended.

Ingredients

Manufacturer
광동제약(주)

Efficacy & effects

Improvement of blood pressure control in essential hypertension with combination of Amlodipine and Valsartan

  • Essential hypertension
View approved original text

This medication is used for patients with essential hypertension whose blood pressure is not adequately controlled with monotherapy of Amlodipine or Valsartan. It effectively lowers blood pressure and helps in the prevention of complications such as heart disease and stroke. It is a suitable treatment for those struggling with blood pressure control.

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 every day (e.g., in the morning). This medication is to be administered to those whose blood pressure is not controlled with monotherapy of Amlodipine or Valsartan. Patients with renal impairment do not need dosage adjustment in mild to moderate cases but should not receive this medication in severe cases or those on dialysis. Hepatic impairment patients should not exceed a daily dose of 80 mg of Valsartan.

Child dose

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

Precautions

This medication may cause serious harm to the fetus if taken during the second and third trimesters of pregnancy; it should be discontinued immediately if pregnancy is confirmed. Patients with allergies to the active ingredients or similar class medications, women who are pregnant or breastfeeding, patients with severe kidney or liver disease, and those with a history of specific heart diseases or angioedema should avoid this medication. Patients with insufficient sodium or fluids in the body may experience hypotension, so it is crucial to verify their condition before starting the medication and monitor closely during treatment. Patients with high potassium levels or taking medications that may raise potassium levels should have their potassium levels checked frequently. Patients with reduced kidney function or those who have received a kidney transplant should be cautious as kidney function may deteriorate. If symptoms of angioedema occur, immediate discontinuation is necessary, and retaking should not occur. Patients with heart failure or post-myocardial infarction should have their kidney function periodically assessed while on the medication. The risk of hypotension, worsening kidney function, and hyperkalemia may increase when this medication is used in conjunction with other blood pressure medications, so careful monitoring of blood pressure and kidney function according to a doctor's advice is necessary. Dizziness or fatigue may occur while driving or operating machinery, so caution is advised. In case of overdose, severe hypotension or cardiac arrhythmias may occur; thus, the dosage must be strictly adhered to, and if any abnormal symptoms arise, immediate medical attention should be sought. This medication is not recommended for use in children under 18 years of age, as safety and efficacy have not been sufficiently established. In elderly patients, it can be taken at dosages similar to those used in adults, but care must be taken based on individual physical conditions.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (including angioedema), difficulty breathing, chest tightness, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, jaundice, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, significantly reduced urine output, severe generalized swelling, elevated blood pressure, hypersensitivity including serum sickness, vasculitis, renal failure, renal damage, serum sickness

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • sensory disturbances
  • vertigo
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
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  • hypotension
  • cough
  • pharyngeal and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • low back pain
  • arthritis
  • muscle cramps
  • weakness
  • frequent urination
  • polyuria
  • erectile dysfunction
  • edema
  • limb swelling
  • facial swelling
  • peripheral edema
  • fatigue
  • flushing
  • weakness
  • facial flushing
  • rhinitis

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

Storage

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

Appearance and packaging

Appearance

Bright yellow rectangular film-coated tablet

Package unit

28 tablets (14 tablets/PTP×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.