Medication info
Olmesartan Medoxomil/Hydrochlorothiazide/Amlodipine Besilate 5/40/12.5mg Tablet

Olmesartan Medoxomil/Hydrochlorothiazide/Amlodipine Besilate 5/40/12.5mg Tablet

Prescription medicationTablet경구
Ingredient · strength
Olmesartan Medoxomil›40mg / 1 tabletHydrochlorothiazide›12.5mg / 1 tabletS-Amlodipine Besylate Dihydrate›7.38mg / 1 tablet
Manufacturer / importer
동국제약(주)
Appearance
Round film-coated tablets in reddish color
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 202401352 · Approved 2024.05.31 · Insurance code 653405740

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
This medication should be taken once daily with water, regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). The maximum dosage is 5/40/25mg of Amlodipine/Olmesartan Medoxomil/Hydrochlorothiazide. Dosing adjustments should be made considering the blood pressure response at intervals of more than 2 weeks. The recommended doses are as follows: - 2.5/20/12.5mg: for patients whose blood pressure is not adequately controlled
Child dose
The safety and efficacy of this medication in pediatric patients under 18 years have not been established, and therefore its use is not recommended.

Ingredients

Manufacturer
동국제약(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

The combination therapy of Amlodipine and Olmesartan Medoxomil is a helpful treatment for patients with essential hypertension who find it difficult to control blood pressure. This medication lowers blood pressure, reduces cardiovascular burden, and contributes to the prevention of stroke or heart disease. It is used to dilate blood vessels and maintain stable blood pressure, thereby reducing the risk of complications. This medication helps achieve effective blood pressure management.

How to take

Adult dose

This medication should be taken once daily with water, regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). The maximum dosage is 5/40/25mg of Amlodipine/Olmesartan Medoxomil/Hydrochlorothiazide. Dosing adjustments should be made considering the blood pressure response at intervals of more than 2 weeks. The recommended doses are as follows: - 2.5/20/12.5mg: for patients whose blood pressure is not adequately controlled

Child dose

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

Precautions

This medication may cause severe harm to the fetus and newborn if taken during the second and third trimesters of pregnancy, thus it should be discontinued immediately upon confirmation of pregnancy. Patients with allergies or hypersensitivity to this drug or its components, pregnant or breastfeeding women, those with severe hypotension, and patients with serious heart, kidney, or liver problems should not take this medication. Patients with low blood volume or electrolyte imbalance may experience hypotension when starting this drug, thus they should be monitored closely, and appropriate treatment should be provided if hypotension occurs. This medication can affect kidney function, so patients with weak kidney function should have regular blood tests, and those with severe kidney impairment should avoid taking this medication. Patients with impaired liver function should also use caution while taking this medication, and it is safer not to take it if there is severe liver disease. This medication has a blood pressure-lowering effect; therefore, caution is advised when performing activities that require concentration, such as driving or operating machinery, as dizziness or drowsiness may occur. While taking this medication, the skin may become sensitive to sunlight; therefore, it is recommended to use sunscreen and protect the skin when going outside. Elderly patients or those with a history of diabetes or gout should carefully monitor for electrolyte imbalances or changes in kidney function while taking this medication. Overdose of this medication may lead to severe hypotension, palpitations, and electrolyte imbalances, so it is essential to adhere to the prescribed dosage and regimen. If symptoms such as severe diarrhea, difficulty breathing, severe allergic reactions, visual disturbances, or severe swelling occur during treatment, consult a doctor immediately. This medication may interact with other antihypertensive drugs, diuretics, lithium, and non-steroidal anti-inflammatory drugs (NSAIDs). Therefore, it is essential to inform healthcare providers of any other medications being taken. If breastfeeding, since this medication may be transmitted through breast milk to the baby, patients should consult with their doctor regarding whether to continue breastfeeding. The safety and efficacy of this medication have not been established in children under 18 years old, and therefore it is not recommended for use in this age group. This medication should be stored in a tightly sealed container, protected from moisture and heat, and kept out of reach of children. Transferring it to another container should be avoided.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • severe swelling (edema)
  • anaphylactic reactions
  • acute renal failure
  • acute respiratory distress syndrome
  • difficulty breathing
  • pulmonary edema
  • jaundice
  • hepatitis
  • acute cholecystitis
Show 13 more
  • altered consciousness
  • syncope
  • seizures
  • paralysis
  • visual disturbances
  • thrombosis
  • embolism
  • vasculitis
  • Stevens-Johnson syndrome
  • angioedema
  • acute eosinophilic pneumonia
  • thrombocytopenia
  • leukopenia

Mild side effects

  • Peripheral edema
  • headache
  • dizziness
  • upper respiratory infection
  • rhinitis
  • urinary tract infection
  • sialadenitis
  • leukopenia
  • thrombocytopenia
  • bone marrow suppression
Show 17 more
  • neutropenia/agranulocytosis
  • hemolytic anemia
  • aplastic anemia
  • drug hypersensitivity reactions
  • hyperkalemia
  • hypokalemia
  • anorexia
  • diabetes
  • hypercalcemia
  • hyperglycemia
  • hypomagnesemia
  • hyponatremia
  • hypochloremia
  • hypertriglyceridemia
  • hypercholesterolemia
  • hyperuricemia
  • hypochloremic metabolic alkalosis

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. Furthermore, it should be stored at room temperature, avoiding extremes of heat or cold, specifically between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Round film-coated tablets in reddish color

Package unit

30 tablets/bottle, 300 tablets/bottle

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.