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

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

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.944mg / 1 tabletOlmesartan Medoxomil›40mg / 1 tabletHydrochlorothiazide›12.5mg / 1 tablet
Manufacturer / importer
제이더블유중외제약(주)
Appearance
Light yellow round film-coated tablet
Packaging
28 tablets (14 tablets/PTP X 2)/carton
Approval status
Active

MFDS item code 201805228 · Approved 2018.12.21 · Insurance code 644914600

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 one tablet at any time, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). The maximum dosage is Amlodipine/Olmesartan Medoxomil/Hydrochlorothiazide of 10/40/25 mg. Adjust doses with intervals of more than 2 weeks considering blood pressure responses. Recommended dosages include 5/20/12.5 mg, 5/40/12.5 mg, 5/40/25 mg.
Child dose
Safety and efficacy in pediatric patients under 18 years have not been established, and the use of this medication is not recommended.

Ingredients

Manufacturer
제이더블유중외제약(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

In cases where blood pressure is not adequately controlled due to essential hypertension, the combination therapy of Amlodipine and Olmesartan Medoxomil can effectively lower and control blood pressure. These two drugs help expand blood vessels and suppress blood pressure rises, thereby reducing the burden on the cardiovascular system. Regular use of this medication can help decrease the risk of complications due to hypertension. Therefore, this drug is used to treat essential hypertension.

How to take

Adult dose

This medication should be taken once daily, with one tablet at any time, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). The maximum dosage is Amlodipine/Olmesartan Medoxomil/Hydrochlorothiazide of 10/40/25 mg. Adjust doses with intervals of more than 2 weeks considering blood pressure responses. Recommended dosages include 5/20/12.5 mg, 5/40/12.5 mg, 5/40/25 mg.

Child dose

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

Precautions

This medication should not be used during the second and third trimesters of pregnancy. Taking it during pregnancy may cause serious harm to the fetus or newborn, so usage must be stopped immediately upon confirmation of pregnancy. Patients with a history of allergy or hypersensitivity to any components of this medication or similar drugs, pregnant or nursing women, patients with severe hypotension or heart valve diseases, and those with unstable heart failure following acute myocardial infarction should not be administered this drug. Patients with severely impaired kidney or liver function, hyponatremia, hypokalemia, hypercalcemia, gout, and certain other conditions should use this medication carefully and frequently monitor blood pressure, kidney function, and electrolyte levels before and during treatment. Since this drug has a blood pressure-lowering effect, it may cause low blood pressure leading to dizziness or orthostatic hypotension. If these symptoms occur, notify healthcare professionals immediately, and be cautious when driving or operating hazardous machinery. This drug can interact with other antihypertensive medications, diuretics, lithium, non-steroidal anti-inflammatory drugs (NSAIDs), so inform healthcare professionals of any other medications being taken. During treatment, regular blood tests to monitor kidney function, electrolytes, blood glucose, and cholesterol levels are necessary, and consult a doctor if any unusual symptoms occur. This medication is not recommended for nursing women, and if necessary, breastfeeding should be discontinued or alternative treatment options considered. In cases of overdose, severe hypotension, palpitations, bradycardia, and electrolyte imbalances may occur, requiring immediate medical attention at a hospital. This medication should be stored in a tightly sealed container, away from direct sunlight and moisture, out of reach of children, and should not be transferred to different containers.

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, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue throughout the body, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, very low urine output.

Mild side effects

  • Peripheral edema
  • headache
  • dizziness
  • upper respiratory infection
  • nasopharyngitis
  • urinary tract infection
  • sialadenitis
  • leukopenia
  • thrombocytopenia
  • bone marrow suppression
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  • neutropenia/agranulocytosis
  • hemolytic anemia
  • aplastic anemia
  • drug hypersensitivity reactions
  • 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

Store this medication in a tightly sealed container to prevent air or moisture ingress, at a temperature between 1 to 30 degrees Celsius room temperature. This storage method will help maintain the drug's efficacy for a longer period.

Appearance and packaging

Appearance

Light yellow round film-coated tablet

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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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.