Medication info

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

Prescription medicationTablet경구Expired
Ingredient · strength
Olmesartan Medoxomil›40mg / 1 tabletAmlodipine Besylate›6.944mg / 1 tabletHydrochlorothiazide›12.5mg / 1 tablet
Manufacturer / importer
오스틴제약(주)
Appearance
Pale yellow round film-coated tablet
Packaging
30 tablets/box [10 tablets/Alu-Alu × 3]
Approval status
Expired

MFDS item code 202003535 · Approved 2020.05.15

This product's status changed to Expired on 2025.05.15. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement in blood pressure control in essential hypertension
Who takes it
Adults · Children
Adult dose
Take one tablet 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 recommended dosing is as follows: - 5/20/12.5mg: Administered to patients whose blood pressure is not adequately controlled with the combination therapy of amlodipine/olmesartan medoxomil 5/20mg. - 5/40/12.5mg: Administered to patients whose blood pressure is not adequately controlled with the combination therapy of amlodipine/olmesartan medoxomil 5/40mg.
Child dose
The safety and efficacy of this medication in pediatric patients under 18 years have not been established, and its use is not recommended.

Ingredients

Manufacturer
오스틴제약(주)

Efficacy & effects

Improvement in blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

This combination therapy of amlodipine and olmesartan medoxomil is used in patients whose blood pressure is hard to control due to essential hypertension. These medications work together to dilate blood vessels and lower blood pressure, helping to control blood pressure and reduce the risk of complications. It is effectively used for essential hypertension, resulting in stable blood pressure improvement.

How to take

Adult dose

Take one tablet 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 recommended dosing is as follows: - 5/20/12.5mg: Administered to patients whose blood pressure is not adequately controlled with the combination therapy of amlodipine/olmesartan medoxomil 5/20mg. - 5/40/12.5mg: Administered to patients whose blood pressure is not adequately controlled with the combination therapy of amlodipine/olmesartan medoxomil 5/40mg.

Child dose

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

Precautions

This medication can cause serious harm to the fetus and newborn during the second and third trimesters of pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. Patients allergic to any components of this medication or related drugs, pregnant or breastfeeding women, patients with severe hypotension, and those with significant cardiac, renal, or liver problems should not take this medication. Patients with low blood volume or salt deficiency may experience hypotension upon initial dosing, so caution is necessary; such cases should start treatment while closely monitoring the condition. This medication can affect renal function, so patients with compromised renal function should have regular blood tests to monitor their condition. Patients with impaired liver function or specific heart diseases should also exercise caution when taking this medication. This drug may interact with other antihypertensive drugs, certain diuretics, lithium, and non-steroidal anti-inflammatory drugs (NSAIDs), so if any other medications are being taken, it is essential to consult a doctor or pharmacist. Side effects such as dizziness or drowsiness may occur during treatment, so driving or operating dangerous machinery should be avoided. Prolonged use of this medication may lead to electrolyte imbalance, hence regular blood tests should be conducted to monitor electrolyte status. Skin may become sensitive to sunlight, so precautions for UV protection should be taken when going outdoors. This medication is not recommended for children under 18 years of age as its safety and efficacy have not been established. In the elderly, the drug's effects and side effects may vary due to decreased renal or liver function, so they should start at a lower dose and take it cautiously. In case of overdose, severe hypotension or heart side effects may occur, and immediate medical attention should be sought for appropriate treatment. Store this medication out of the reach of children, and keep it in a place away from moisture, heat, and direct sunlight.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash accompanied by high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, difficulty catching breath or shortness of breath, asthma attacks, respiratory difficulties with cough and fever, jaundice (yellowing of the skin or eyes), extreme malaise, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis

Mild side effects

  • Peripheral edema
  • headache
  • dizziness
  • upper respiratory infection
  • nasopharyngitis
  • urinary tract infection
  • sialadenitis
  • leukopenia
  • thrombocytopenia
  • bone marrow suppression
Show 18 more
  • neutropenia
  • agranulocytosis
  • hemolytic anemia
  • aplastic anemia
  • drug hypersensitivity
  • 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

Store this medication in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain the storage temperature between 1 and 30 degrees Celsius to preserve the drug's effectiveness.

Appearance and packaging

Appearance

Pale yellow round film-coated tablet

Package unit

30 tablets/box [10 tablets/Alu-Alu × 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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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.