Medication info

Olmesartan Medoxomil and Hydrochlorothiazide Tablets 20/12.5 mg

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Olmesartan Medoxomil›20mg / 1 tabletHydrochlorothiazide›12.5mg / 1 tablet
Manufacturer / importer
한국다이이찌산쿄(주)
Appearance
Round, yellowish-orange film-coated tablets
Packaging
28 tablets (14 tablets/PTP X 2)/carton
Approval status
Approval withdrawn

MFDS item code 201305039 · Approved 2013.02.15 · Insurance code 680900140

This product's status changed to Approval withdrawn on 2025.12.16. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment for control of essential hypertension
Who takes it
Adults · Children
Adult dose
This medication is administered as one tablet once daily, regardless of meals, if adequate blood pressure control is not achieved after adjusting doses of either Olmesartan Medoxomil or Hydrochlorothiazide alone. The dose should be adjusted at intervals of 2 to 4 weeks based on the patient's blood pressure response. Elderly patients should start at the lowest dose, and the dosage should be adjusted considering renal function, cardiac function, comorbid conditions, and concomitant medications. In patients with mild and moderate renal failure (creatinine clearance >30 mL/min), Olmesartan Medoxomil and Hydrochlorothiazide should typically be administered. For patients with more severe renal failure, loop diuretics are preferable to thiazide diuretics, so this medication should not be administered.
Child dose
Safety and efficacy in pediatric patients have not been established.

Ingredients

Importer
한국다이이찌산쿄(주)

Efficacy & effects

Treatment for control of essential hypertension

  • Essential hypertension
View approved original text

This medication combines Olmesartan Medoxomil and Hydrochlorothiazide and is used to effectively lower blood pressure in patients with essential hypertension who find it difficult to control blood pressure with monotherapy. The two components act together to dilate blood vessels and help the body eliminate excess salt and water, thereby controlling blood pressure steadily. This helps reduce the risk of cardiovascular complications and improves the patient's health. Regular use will be of great help in managing hypertension.

How to take

Adult dose

This medication is administered as one tablet once daily, regardless of meals, if adequate blood pressure control is not achieved after adjusting doses of either Olmesartan Medoxomil or Hydrochlorothiazide alone. The dose should be adjusted at intervals of 2 to 4 weeks based on the patient's blood pressure response. Elderly patients should start at the lowest dose, and the dosage should be adjusted considering renal function, cardiac function, comorbid conditions, and concomitant medications. In patients with mild and moderate renal failure (creatinine clearance >30 mL/min), Olmesartan Medoxomil and Hydrochlorothiazide should typically be administered. For patients with more severe renal failure, loop diuretics are preferable to thiazide diuretics, so this medication should not be administered.

Child dose

Safety and efficacy in pediatric patients have not been established.

Precautions

This medication can cause serious harm or death to the fetus and newborn during the second and third trimesters of pregnancy, so it must be discontinued immediately upon confirmation of pregnancy. Patients who have allergies to the ingredients in this medication or hypersensitivity to certain diuretics, those with acute kidney disease or severe liver disease, and patients with certain genetic metabolic disorders should not take this medication. Patients with low blood volume or low sodium may experience hypotension, so their condition should be checked carefully before taking the medication, and appropriate measures should be taken if necessary. Patients with impaired kidney function, kidney transplant patients, renal artery stenosis patients, liver disease patients, etc. should use caution as their kidney or liver function may be affected by this medication. This medication can affect electrolyte balance, especially potassium, sodium, calcium, and magnesium levels, so regular blood tests are necessary. Various side effects, including dizziness, nausea, headaches, rashes, and low blood pressure may occur; if symptoms are severe, consultation with healthcare professionals is advised. This medication may interact with other antihypertensives, diuretics, lithium, non-steroidal anti-inflammatory drugs, etc., so patients must inform their doctors about any other medications they are taking. Pregnant or breastfeeding women should decide whether to take this medication based on their doctor’s instructions as it may affect the fetus or infant. The elderly should start at the lowest dose due to the potential for decreased kidney and liver function and should take the medication cautiously. In case of overdose, symptoms such as hypotension, electrolyte abnormalities, and dehydration may appear, and immediate medical attention should be sought for appropriate treatment. During treatment with this medication, care must be taken to avoid excessive exposure to sunlight, and if any skin abnormalities occur, consultation with a doctor should be sought immediately.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rashes with fever, blisters, skin peeling, oral/eye mucosal pain, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanying cough and fever, jaundice (skin or eyes turning yellow), profound lethargy, liver abnormalities (jaundice), sudden onset

Mild side effects

  • Nausea
  • hyperuricemia
  • dizziness
  • upper respiratory tract infection
  • headache
  • urinary tract infection
  • chest pain
  • back pain
  • peripheral edema
  • abdominal pain
Show 25 more
  • dyspepsia
  • gastroenteritis
  • diarrhea
  • increased AST
  • increased GGT
  • increased ALT
  • hyperlipidemia
  • increased creatine phosphokinase
  • hyperglycemia
  • arthritis
  • arthralgia
  • myalgia
  • cough
  • rash
  • hematuria
  • facial swelling
  • weakness
  • vomiting
  • alopecia
  • pruritus
  • urticaria
  • dizziness
  • headache
  • palpitations
  • increased blood pressure

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

Storage

This medication can be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is best to maintain storage temperatures between 1 and 25 degrees Celsius to preserve the effectiveness and safety of the medication over time.

Appearance and packaging

Appearance

Round, yellowish-orange 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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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.