Medication info
Oldifil 5/40/12.5 mg

Oldifil 5/40/12.5 mg

Prescription medicationTablet경구
Ingredient · strength
Olmesartan Medoxomil›40mg / 1 tabletAmlodipine Besylate›6.944mg / 1 tabletHydrochlorothiazide›12.5mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
Light yellow round film-coated tablet
Packaging
30 tablets (10 tablets/Alu-Alu X 3)
Approval status
Active

MFDS item code 201903159 · Approved 2019.05.15 · Insurance code 693903000

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
This medication is taken once daily as one tablet, with or without food. It is recommended to take it at the same time each day, preferably in the morning. The recommended dosages are as follows: - 5/20/12.5 mg: For patients whose blood pressure is not adequately controlled with Amlodipine/Olmesartan Medoxomil 5/20 mg combination therapy. - 5/40/12.5 mg: For patients whose blood pressure is not adequately controlled with Amlodipine/Olmesartan Medoxomil 5/40 mg combination therapy.
Child dose
The safety and efficacy of this medication in pediatric patients under 18 years of age have not been established, hence its use is not recommended.

Ingredients

Manufacturer
(주)셀트리온제약

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This is a combination therapy with Amlodipine and Olmesartan Medoxomil for the treatment of difficult-to-treat essential hypertension. Essential hypertension refers to the condition where blood pressure is elevated without a specific cause. In this case, Amlodipine helps lower blood pressure by dilating blood vessels, while Olmesartan Medoxomil helps manage blood pressure by inhibiting the action of hormones that cause blood pressure elevation. However, there may be instances where blood pressure is not adequately controlled even with the combination therapy of these two medications. In such cases, additional treatment methods or changes in medications may be necessary. These drugs are used to effectively manage blood pressure in patients with essential hypertension.

How to take

Adult dose

This medication is taken once daily as one tablet, with or without food. It is recommended to take it at the same time each day, preferably in the morning. The recommended dosages are as follows: - 5/20/12.5 mg: For patients whose blood pressure is not adequately controlled with Amlodipine/Olmesartan Medoxomil 5/20 mg combination therapy. - 5/40/12.5 mg: For patients whose blood pressure is not adequately controlled with Amlodipine/Olmesartan Medoxomil 5/40 mg combination therapy.

Child dose

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

Precautions

This medication should not be taken during the second and third trimesters of pregnancy as it can cause serious harm to the fetus and newborn. If pregnancy is confirmed, this medication should be discontinued immediately. Patients who are allergic or hypersensitive to this medication or any of its components, pregnant or breastfeeding women, patients with severe hypotension, and patients with significant renal or hepatic impairment should not receive this medication. Patients with decreased blood volume, impaired renal function, liver disease, and heart valve disease should use this medication with caution and monitor closely for symptoms such as hypotension or worsening renal function. Since this medication lowers blood pressure, it may cause dizziness or orthostatic hypotension, so caution is advised when driving or operating machinery. During treatment with this medication, regular tests should be conducted to monitor electrolyte levels and renal function, particularly considering the risk of elevated or decreased potassium levels. This medication can interact with other drugs, so especially when used in combination with lithium, non-steroidal anti-inflammatory drugs (NSAIDs), and other antihypertensives, consultation with a physician or pharmacist is necessary. The hydrochlorothiazide component can make the skin more sensitive to sunlight, so caution should be taken regarding UV protection during treatment, and if symptoms of photosensitivity occur, the medication should be discontinued immediately and advice should be sought from a specialist. This medication is not recommended for pediatric patients under 18 years of age as its safety and efficacy have not been established. In the elderly, the body's response to the medication may vary due to decreased renal and hepatic function, so treatment should start at lower doses and dose adjustments should be made cautiously. In cases of overdose, severe hypotension and heart dysfunction may occur, necessitating immediate medical attention for appropriate treatment. This medication should be stored out of reach of children and kept protected from direct sunlight and moisture.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • anaphylactic reaction
  • palpitations
  • heart failure
  • myocardial infarction
  • arrhythmia
  • angina
  • hypotension
  • orthostatic hypotension
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  • vasculitis
  • thrombosis
  • embolism
  • dyspnea
  • acute interstitial pneumonia
  • respiratory distress syndrome
  • pulmonary edema
  • jaundice
  • acute renal failure
  • acute cholecystitis
  • autoimmune hepatitis
  • angioedema
  • Quincke edema
  • toxic skin necrosis
  • Stevens-Johnson syndrome
  • seizures
  • fainting
  • acute respiratory distress syndrome

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
  • loss of appetite
  • diabetes
  • hypercalcemia
  • hyperglycemia
  • hypomagnesemia
  • hyponatremia
  • hypochloremia
  • hypertriglyceridemia
  • hypercholesterolemia
  • hyperuricemia
  • hypochloremic alkalosis

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to maintain room temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Light yellow round film-coated tablet

Package unit

30 tablets (10 tablets/Alu-Alu X 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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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.