Medication info
Olmesartan Medoxomil/Amlodipine Besilate/Hydrochlorothiazide Tablet 10/40/12.5 mg

Olmesartan Medoxomil/Amlodipine Besilate/Hydrochlorothiazide Tablet 10/40/12.5 mg

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›13.888mg / 1 tabletOlmesartan Medoxomil›40mg / 1 tabletHydrochlorothiazide›12.5mg / 1 tablet
Manufacturer / importer
제이더블유중외제약(주)
Appearance
Red-brown round film-coated tablets
Packaging
28 tablets (14 tablets/PTP X 2)/carton
Approval status
Active

MFDS item code 201805227 · Approved 2018.12.21 · Insurance code 644914620

Summary

Main use
Improvement in blood pressure control in essential hypertension
Who takes it
Adults · Children
Adult dose
Take one tablet once daily, regardless of meals, with water. It is recommended to take it at the same time every day (e.g., in the morning). Recommended dosages are as follows: - 5/20/12.5mg: Administered to patients whose blood pressure is not adequately controlled with combination therapy of amlodipine/olmesartan medoxomil 5/20mg. - 5/40/12.5mg: Amlodipine/olmesartan medoxomil 5/40mg.
Child dose
The safety and efficacy in pediatric patients under 18 years of age have not been established, hence its use is not recommended.

Ingredients

Manufacturer
제이더블유중외제약(주)

Efficacy & effects

Improvement in blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

This medication is an effective treatment for patients with essential hypertension whose blood pressure is not adequately controlled even with the combination therapy of amlodipine and olmesartan medoxomil. This medicine lowers blood pressure by dilating blood vessels and reducing the burden on the heart. It targets multiple mechanisms of action simultaneously through combination therapy, making it useful for situations where blood pressure control is difficult. Regular use can lead to stable management of blood pressure, reducing the risk of complications. Due to these characteristics, it is widely used for the treatment of essential hypertension.

How to take

Adult dose

Take one tablet once daily, regardless of meals, with water. It is recommended to take it at the same time every day (e.g., in the morning). Recommended dosages are as follows: - 5/20/12.5mg: Administered to patients whose blood pressure is not adequately controlled with combination therapy of amlodipine/olmesartan medoxomil 5/20mg. - 5/40/12.5mg: Amlodipine/olmesartan medoxomil 5/40mg.

Child dose

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

Precautions

This medication can cause serious harm to the fetus and newborn in the second and third trimesters of pregnancy; therefore, it should be discontinued immediately upon confirmation of pregnancy. Do not use this medication if you are allergic to it or any of its components, or if you have certain heart and kidney diseases, hypotension, liver dysfunction, electrolyte abnormalities, etc. Patients with reduced blood volume or impaired kidney function may experience symptoms of hypotension at the beginning of treatment, so careful monitoring is necessary. This medication can affect kidney function, and patients with poor kidney function should undergo regular blood tests and electrolyte monitoring. Patients with liver or heart diseases should also be cautious when taking this medication, and particularly patients with liver cirrhosis should adjust the dose accordingly. This medication can cause skin hypersensitivity or photosensitivity, so care should be taken to avoid sun exposure, and if skin abnormalities occur, medical consultation should be sought immediately. Dizziness or drowsiness may occur while taking this medication, so it is advisable to avoid driving or operating hazardous machinery. This medication may interact with other blood pressure medications or specific drugs; therefore, if you are taking other medications, be sure to inform your physician or pharmacist. In case of overdose, severe hypotension or heart rhythm abnormalities may occur, necessitating immediate hospital treatment. The safety and effectiveness in children and adolescents under 18 years of age have not been established, hence its use is not recommended. Elderly patients may have reduced kidney and liver function; therefore, it is best to start at a lower dose and take it with caution. Store in a place out of reach of children and avoid moisture, heat, and direct sunlight.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, peeling skin, pain in the oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, cough and fever accompanied breathing difficulties, jaundice (yellowing of the skin or eyes), extreme malaise, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, reduced urination

Mild side effects

  • Peripheral edema
  • headache
  • dizziness
  • upper respiratory tract infection
  • rhinitis
  • urinary tract infection
  • sialadenitis
  • leukopenia
  • thrombocytopenia
  • bone marrow suppression
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  • neutropenia/agranulocytosis
  • hemolytic anemia
  • aplastic anemia
  • drug hypersensitivity
  • hyperkalemia
  • hypokalemia
  • loss of appetite
  • 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 should be stored in a sealed container to protect it from air or moisture, preferably at room temperature between 1 and 30 degrees Celsius. Proper storage will maintain the medication's efficacy and safety.

Appearance and packaging

Appearance

Red-brown round film-coated tablets

Package unit

28 tablets (14 tablets/PTP X 2)/carton

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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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.