Medication info
Exvalsa Tablets 10/160mg

Exvalsa Tablets 10/160mg

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›13.87mg / 1 tabletValsartan›160mg / 1 tablet
Manufacturer / importer
대원바이오텍주식회사
Appearance
Bright yellow oval film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP X 3]
Approval status
Active

MFDS item code 201907959 · Approved 2019.11.18 · Insurance code 057600390

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage of this medication is one tablet once daily, taken with water regardless of meals. It is advised to take it at the same time each day (e.g., in the morning). For patients with renal impairment: Patients with mild to moderate renal impairment (creatinine clearance greater than 10 mL/min) do not require dosage adjustment. Patients with severe renal impairment (creatinine clearance less than 10 mL/min)
Child dose
Safety and efficacy have not been established in pediatric patients under 18 years old, and administration of this medication is not recommended.

Ingredients

Manufacturer
대원바이오텍주식회사

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication helps effectively lower blood pressure in patients with essential hypertension for whom control is difficult with either amlodipine or valsartan alone. By combining the mechanisms of action of the two drugs, it assists in the stable management of blood pressure. This contributes to reducing the risk of cardiovascular complications and improving overall health. This medication is used for the treatment of essential hypertension.

How to take

Adult dose

The recommended dosage of this medication is one tablet once daily, taken with water regardless of meals. It is advised to take it at the same time each day (e.g., in the morning). For patients with renal impairment: Patients with mild to moderate renal impairment (creatinine clearance greater than 10 mL/min) do not require dosage adjustment. Patients with severe renal impairment (creatinine clearance less than 10 mL/min)

Child dose

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

Precautions

This medication 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. People who are allergic to any of the active ingredients or similar drugs, pregnant or breastfeeding women, patients with severe kidney or liver diseases, and those with a history of specific heart diseases or angioedema should not take this medication. Patients who have deficiencies in body sodium or fluids must correct their condition before taking this medication. If symptoms of low blood pressure occur during treatment, the patient should rest immediately by lying down and seek medical help if necessary. Patients with high potassium levels in the blood or those taking other medications that can increase potassium levels should have their potassium levels monitored frequently. Patients with problems in renal blood vessels or those who have recently undergone kidney transplantation may be affected in kidney function when taking this medication, necessitating caution. This medication may cause changes in kidney function in patients with heart failure or after myocardial infarction, so regular kidney function tests are recommended during treatment. Caution is advised during driving or operating machinery, as dizziness or fatigue may occur. Overdosing on this medication may lead to severe hypotension or heart problems, so the dosage must be strictly adhered to, and any unusual symptoms should be reported to healthcare professionals immediately. Additionally, this medication may interact with other specific drugs, so patients should inform their healthcare provider if they are taking other medications. This medication is not recommended for children under the age of 18, and similar doses can be given to elderly patients as to the general adult population. Breastfeeding women should avoid taking this medication, and women who are planning to become pregnant or may become pregnant should not use 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 high fever, blisters, peeling skin, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough and fever, jaundice (yellowing of skin or eyes), extreme fatigue, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Nasopharyngitis
  • influenza
  • visual disturbances
  • anxiety
  • headache
  • dizziness
  • drowsiness
  • orthostatic dizziness
  • paresthesia
  • tinnitus
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  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
  • hypotension
  • cough
  • pharyngeal and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • dry mouth
  • rash
  • erythema
  • diaphoresis
  • pruritus
  • joint swelling
  • lumbago
  • arthritis
  • muscle cramps
  • lethargy
  • polyuria
  • diuresis
  • erectile dysfunction
  • edema
  • generalized edema

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is also important to maintain a room temperature between 1 degree and 30 degrees Celsius when storing the medication. This ensures the safety of its effectiveness.

Appearance and packaging

Appearance

Bright yellow oval film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP X 3]

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.