Medication info
Excombi Tablet 10/160 mg

Excombi Tablet 10/160 mg

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›13.87mg / 1 tabletValsartan›160mg / 1 tablet
Manufacturer / importer
대원제약(주)
Appearance
Bright yellow oval film-coated tablet
Packaging
For domestic use: 30 tablets (10 tablets/PTP X 3), for export: 30 tablets (10 tablets/PTP X 3)
Approval status
Active

MFDS item code 201309092 · Approved 2013.08.30 · Insurance code 671805610

Summary

Main use
Improvement in blood pressure control for essential hypertension with the combination of amlodipine and valsartan
Who takes it
Adults · Children
Adult dose
The recommended dose for adults is 1 tablet once daily, to be taken with water regardless of meals. It is advised to take it at the same time every day (e.g., in the morning). For patients with mild to moderate renal impairment, dose adjustment is not necessary. For patients with mild to moderate liver impairment, the daily dosage of valsartan should not exceed 80 mg. For patients with severe renal impairment and dialysis patients, and for patients with severe liver impairment, this medication should not be administered.
Child dose
The safety and efficacy of this medication have not been established in pediatric patients under 18 years of age, so its use is not recommended.

Ingredients

Manufacturer
대원제약(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension with the combination of amlodipine and valsartan

  • Essential hypertension
View approved original text

This medication is used to effectively lower blood pressure in patients with essential hypertension whose blood pressure is not sufficiently controlled with monotherapy of amlodipine or valsartan.

How to take

Adult dose

The recommended dose for adults is 1 tablet once daily, to be taken with water regardless of meals. It is advised to take it at the same time every day (e.g., in the morning). For patients with mild to moderate renal impairment, dose adjustment is not necessary. For patients with mild to moderate liver impairment, the daily dosage of valsartan should not exceed 80 mg. For patients with severe renal impairment and dialysis patients, and for patients with severe liver impairment, this medication should not be administered.

Child dose

The safety and efficacy of this medication have not been established in pediatric patients under 18 years of age, so its use 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 if pregnancy is confirmed. Patients with allergies to the active ingredient or similar compounds, women who are pregnant or breastfeeding, and patients with severe kidney or liver disease should not take this medication. Patients with sodium or fluid depletion, patients with hyperkalemia, patients with renal artery stenosis, and patients who have recently undergone kidney transplantation require special caution when taking this medication, and close monitoring by healthcare professionals is necessary. Since this medication lowers blood pressure, emergency measures are required if symptoms of hypotension occur, such as laying the patient down and administering saline if necessary. This medication may cause side effects such as headache, dizziness, swelling, fatigue, and skin rash, and if symptoms are severe or persistent, patients should consult their healthcare provider. Caution is needed when driving or operating machinery as dizziness or fatigue may occur. This medication can interact with other antihypertensive drugs, potassium supplements, diuretics, and certain anti-inflammatory drugs (NSAIDs), so patients should inform their healthcare provider of any other medications they are taking. Women who are pregnant or planning to become pregnant should not take this medication, and breastfeeding women are also advised to avoid it. It is not recommended for children under 18 years of age as the safety and efficacy of this medication have not been adequately established in pediatric patients. Severe hypotension or cardiac dysfunction may occur in cases of overdose, so it is crucial to adhere to the prescribed dosage and inform the healthcare provider of any unusual symptoms.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • severe swelling (edema)
  • angioedema
  • vasculitis
  • Stevens-Johnson syndrome
  • renal failure
  • kidney damage
  • elevated serum creatinine
  • increased liver function levels
  • jaundice
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  • severe allergic reactions
  • severe skin adverse reactions
  • shortness of breath
  • difficulty breathing
  • pulmonary edema
  • acute heart failure exacerbation
  • chest discomfort
  • breathing difficulty
  • seizures
  • altered consciousness
  • visual disturbances
  • paralysis
  • elevated blood pressure
  • severe edema
  • hematuria
  • intestinal vascular edema.

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • postural dizziness
  • sensory disturbances
  • lightheadedness
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
Show 28 more
  • orthostatic hypotension
  • hypotension
  • cough
  • throat and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • dry mouth
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • low back pain
  • arthritis
  • muscle cramps
  • weakness
  • polyuria
  • nocturia
  • erectile dysfunction
  • swelling
  • pituitary swelling
  • facial swelling
  • peripheral edema
  • fatigue
  • flushing
  • and asthenia.

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

Storage

This medication is susceptible to air and moisture, so it should be stored in a tightly sealed container. It is recommended to maintain the storage temperature between 1 and 30 degrees Celsius to safely preserve the effectiveness of the medication.

Appearance and packaging

Appearance

Bright yellow oval film-coated tablet

Package unit

For domestic use: 30 tablets (10 tablets/PTP X 3), for export: 30 tablets (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.