Medication info
Rosatek Plus Tablet

Rosatek Plus Tablet

Prescription medicationTablet경구
Ingredient · strength
Losartan Potassium›50mg / 1 tabletHydrochlorothiazide›12.5mg / 1 tablet
Manufacturer / importer
대원바이오텍주식회사
Appearance
Yellow oval film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201906383 · Approved 2019.09.10 · Insurance code 057600180

Summary

Main use
Improves blood pressure control in cases of insufficient single-agent treatment for hypertension
Who takes it
Adults · Children
Adult dose
The usual dose 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 per day are not recommended. For patients whose blood pressure is not controlled by monotherapy, the treatment should start with 50 mg of losartan potassium / 12.5 mg of hydrochlorothiazide taken once daily as one tablet, and after three weeks, if blood pressure is still uncontrolled, it can be adjusted up to the maximum dose of 100 mg of losartan potassium / 25 mg of hydrochlorothiazide once daily as one tablet.
Child dose
Experience using this medication in children and adolescents (under 18 years) has not been established, so the losartan-hydrochlorothiazide combination is not to be administered to them.

Ingredients

Manufacturer
대원바이오텍주식회사

Efficacy & effects

Improves blood pressure control in cases of insufficient single-agent treatment for hypertension

  • Hypertension
View approved original text

This medication is used as an add-on to effectively lower blood pressure in patients with hypertension whose blood pressure is not adequately controlled with monotherapy.

How to take

Adult dose

The usual dose 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 per day are not recommended. For patients whose blood pressure is not controlled by monotherapy, the treatment should start with 50 mg of losartan potassium / 12.5 mg of hydrochlorothiazide taken once daily as one tablet, and after three weeks, if blood pressure is still uncontrolled, it can be adjusted up to the maximum dose of 100 mg of losartan potassium / 25 mg of hydrochlorothiazide once daily as one tablet.

Child dose

Experience using this medication in children and adolescents (under 18 years) has not been established, so the losartan-hydrochlorothiazide combination is not to be administered to them.

Precautions

This medication can cause serious harm to the fetus if taken during pregnancy, especially in the second and third trimesters; therefore, it should be discontinued immediately upon confirmation of pregnancy. It is safe to avoid administering this medication to patients with certain conditions, such as anuria, severe liver impairment, severe renal impairment, and pregnant women. Caution should be exercised when using this medication in specific patient populations, including those with hypotension, renal function abnormalities, liver impairment, electrolyte imbalances, and the elderly. This medication has a blood pressure-lowering effect, which may result in dizziness or drowsiness during the initial doses; caution is advised when driving or operating machinery. While taking this medication, patients should not use potassium supplements or salt substitutes containing potassium without consulting a physician, and they should be cautious of changes in serum potassium levels. Some patients may experience side effects such as rash, cough, dizziness, and edema, so medical consultation is necessary if any unusual symptoms occur. While taking this medication, it is important to regularly monitor renal function and electrolyte status through blood tests. Particularly, the hydrochlorothiazide component may increase sensitivity to sunlight and raise the risk of skin cancer, so sun exposure should be limited, and protective measures taken. This medication may interact with other drugs; therefore, patients should inform healthcare professionals of any currently taken medications, and it is advisable to avoid grapefruit juice consumption. The safety and efficacy of this medication have not been established in children or adolescents.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme malaise, sudden and severe headache, thunderclap headache, seizures, confusion, visual abnormalities, paralysis, urination issues

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
  • rash
  • chest pain
  • facial swelling
  • fever
  • orthostatic hypotension
  • fainting
  • angina
  • arrhythmia
  • cerebrovascular accident
  • hypotension
  • myocardial infarction
  • secondary AV block
  • loss of appetite
  • constipation
  • toothache
  • dry mouth
  • dyspepsia
  • flatulence
  • gastritis
  • vomiting
  • malaise
  • anemia
  • gout
  • arm pain
  • joint pain

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

Storage

This medication should be stored in a tightly sealed container that protects it from light and kept at room temperature between 1°C and 30°C. Proper storage helps maintain the drug's effectiveness and prevents degradation.

Appearance and packaging

Appearance

Yellow oval film-coated tablet

Package unit

30 tablets/bottle, 300 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.