Medication info
Ozatran Plus Tablet 100/12.5 mg

Ozatran Plus Tablet 100/12.5 mg

Prescription medicationTablet경구
Ingredient · strength
Losartan Potassium›100mg / 1 tabletHydrochlorothiazide›12.5mg / 1 tablet
Manufacturer / importer
한미약품(주)
Appearance
White to grayish oval coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 200710606 · Notified 2007.09.18 · Insurance code 643502000

Summary

Main use
Improvement in blood pressure control in cases of uncontrolled hypertension with monotherapy
Who takes it
Adults · Children
Adult dose
The usual dosage for adults is 50 mg of Losartan Potassium / 12.5 mg of Hydrochlorothiazide, taken once daily as one tablet. Doses exceeding 100 mg of Losartan Potassium / 25 mg of Hydrochlorothiazide daily are not desirable. For patients whose blood pressure is not controlled using losartan or hydrochlorothiazide monotherapy, treatment can be initiated with 50 mg of Losartan Potassium / 12.5 mg of Hydrochlorothiazide, taken once daily as one tablet.
Child dose
There is no experience in using this combination of losartan and hydrochlorothiazide in children and adolescents; therefore, it should not be administered to these age groups.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

Improvement in blood pressure control in cases of uncontrolled hypertension with monotherapy

  • Hypertension
View approved original text

This medication is used to manage blood pressure effectively in patients with hypertension who find it difficult to control blood pressure with monotherapy.

How to take

Adult dose

The usual dosage for adults is 50 mg of Losartan Potassium / 12.5 mg of Hydrochlorothiazide, taken once daily as one tablet. Doses exceeding 100 mg of Losartan Potassium / 25 mg of Hydrochlorothiazide daily are not desirable. For patients whose blood pressure is not controlled using losartan or hydrochlorothiazide monotherapy, treatment can be initiated with 50 mg of Losartan Potassium / 12.5 mg of Hydrochlorothiazide, taken once daily as one tablet.

Child dose

There is no experience in using this combination of losartan and hydrochlorothiazide in children and adolescents; therefore, it should not be administered to these age groups.

Precautions

This medication can cause serious harm to the fetus and newborn, especially during pregnancy; therefore, it should not be used by women who are pregnant or may become pregnant. This medication may pose risks when administered to patients with certain diseases or conditions, such as those with anuria, electrolyte imbalance, severe liver impairment, severe renal impairment, patients on dialysis, or those with specific genetic metabolic disorders, among others. Patients with significantly low blood pressure or existing renal function issues, patients with a history of liver impairment, patients with hyperuricemia or gout, and elderly patients should exercise particular caution when using this medication. The hydrochlorothiazide component can cause electrolyte imbalance, so regular blood tests should be conducted to monitor electrolyte levels, and any symptoms that arise should prompt immediate consultation with a physician. This medication may cause side effects such as skin rash, angioedema, dizziness, cough, abdominal pain, and rarely, serious allergic reactions or liver dysfunction and worsening renal function. Due to potential drug interactions, especially with potassium-sparing diuretics, potassium supplements, certain antihypertensives, nonsteroidal anti-inflammatory drugs, and lithium preparations, patients should consult their physician if taking such medications together. While taking this medication, sudden onset of symptoms indicating low blood pressure or dizziness may occur, so caution is needed when driving or operating machinery. Women who are pregnant or planning to become pregnant must consult their physician before taking this medication and must immediately discontinue use if pregnancy is confirmed, as well as consider stopping breastfeeding if applicable. This medication is not recommended for use in children and adolescents due to a lack of established safety and efficacy. Elderly patients may have a higher risk of experiencing side effects and should be closely monitored when administered this medication. In case of overdose, symptoms such as hypotension, tachycardia, and electrolyte imbalance may occur, so the prescribed dosage should be strictly adhered to; if any unusual symptoms occur, immediate contact with a healthcare facility is necessary. This medication should be kept out of reach of children and stored in its original container to avoid misuse or quality degradation.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin shedding, pain in mouth/eyes mucosa, shortness of breath or breathing difficulties, asthma attacks, respiratory issues along with cough and fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances,

Mild side effects

  • Abdominal pain
  • edema/swelling
  • palpitations
  • back pain
  • dizziness
  • cough
  • sinusitis
  • upper respiratory infection
  • weakness/fatigue
  • diarrhea
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  • nausea
  • headache
  • bronchitis
  • pharyngitis
  • chest pain
  • facial swelling
  • fever
  • orthostatic hypotension
  • fainting
  • angina
  • arrhythmia
  • hypotension
  • myocardial infarction
  • secondary atrioventricular block
  • loss of appetite
  • constipation
  • toothache
  • dry mouth
  • dyspepsia
  • flatulence
  • gastric inflammation
  • vomiting
  • malaise
  • anemia
  • gout
  • arm pain
  • joint pain
  • arthritis
  • fibromyalgia

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

Storage

This medication is sensitive to light and should be stored in a securely closed container that blocks light. It is important to maintain a storage temperature between 1°C and 30°C at room temperature.

Appearance and packaging

Appearance

White to grayish oval coated tablet

Package unit

30 tablets/bottle

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.