Medication info
Exrotan Tablets 5/80 mg

Exrotan Tablets 5/80 mg

Prescription medicationTablet경구
Ingredient · strength
Valsartan›80mg / 1 tabletAmlodipine Besylate›6.94mg / 1 tablet
Manufacturer / importer
(주)넥스팜코리아
Appearance
Dark yellow round film-coated tablet
Packaging
28 tablets/box[((14 tablets/Alu-Alu)×2))]
Approval status
Active

MFDS item code 201603219 · Approved 2016.06.07 · Insurance code 662503480

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage for this medication is 1 tablet once daily, to be taken with water regardless of meals. It is advisable to take it at the same time every day (e.g., in the morning). Dosage may vary according to blood pressure control status for the 5/80mg, 5/160mg, and 10/160mg formulations. Patients with renal impairment, liver impairment, or elderly individuals require dosage adjustment and caution.
Child dose
The safety and efficacy of this medication in pediatric patients under 18 years have not been established; therefore, its use is not recommended.

Ingredients

Manufacturer
(주)넥스팜코리아

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication is used when blood pressure is not adequately controlled with amlodipine or valsartan monotherapy in the treatment of essential hypertension. The combination of the two components effectively lowers blood pressure, reduces cardiovascular burden, and helps prevent complications. It supports safe and effective blood pressure control in patients with hypertension.

How to take

Adult dose

The recommended dosage for this medication is 1 tablet once daily, to be taken with water regardless of meals. It is advisable to take it at the same time every day (e.g., in the morning). Dosage may vary according to blood pressure control status for the 5/80mg, 5/160mg, and 10/160mg formulations. Patients with renal impairment, liver impairment, or elderly individuals require dosage adjustment and caution.

Child dose

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

Precautions

This medication can cause serious harm or death to the fetus and newborn if taken during the second and third trimesters of pregnancy; therefore, it should be discontinued immediately upon confirmation of pregnancy. Patients should not take this medication if they are allergic to the active ingredients or similar medications, are pregnant or breastfeeding, have severe kidney or liver dysfunction, or certain heart conditions. Patients with low sodium or fluid levels may experience hypotension, so it is important to check their condition before taking the medication, and to monitor blood pressure and status carefully during treatment. Patients with high potassium levels should be cautious when taking this medication with potassium supplements or other medications that increase potassium levels, and should frequently check their potassium concentration. Patients with kidney issues or kidney transplant recipients may need special attention due to possible changes in kidney function while using this medication. If signs of angioedema (swelling of the face, lips, tongue, throat) appear during treatment with this medication, it should be discontinued immediately and not taken again. Patients with heart failure or myocardial infarction may experience changes in kidney function and hypotension during treatment, necessitating regular kidney function tests. This medication may cause dizziness or fatigue while driving or operating machinery; therefore, caution is advised. In the case of an overdose, symptoms such as hypotension, dizziness, and increased heart rate may appear, and in severe instances, emergency treatment may be required. This medication may interact with other antihypertensives, potassium-sparing diuretics, NSAIDs, and some antibiotics, so patients should consult with their physician or pharmacist before using it in combination with other drugs. Breastfeeding women are not advised to take this medication, and use in children or adolescents under 18 years of age is not recommended due to insufficient evidence of safety and efficacy. Elderly patients may be prescribed the same dosage as adults, but caution is necessary according to individual conditions. It is recommended to undergo regular liver and kidney function tests during treatment with this medication, and to inform healthcare providers immediately if any abnormal symptoms occur.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, severe swelling, chest tightness, difficulty breathing, cold sweats, paleness, severe rash accompanied by high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme drowsiness, sudden severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis.

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • orthostatic dizziness
  • sensory disturbance
  • vertigo
  • tinnitus
  • tachycardia
  • palpitations
  • fainting
Show 28 more
  • 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
  • polyuria
  • nocturia
  • erectile dysfunction
  • edema
  • local edema
  • facial swelling
  • peripheral edema
  • fatigue
  • flushing
  • weakness

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is best kept at room temperature between 1 and 30 degrees Celsius. By maintaining appropriate temperature and environment, the effectiveness and safety of the medication can be preserved for a long time.

Appearance and packaging

Appearance

Dark yellow round film-coated tablet

Package unit

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