Medication info
Rosaplus-EF Tablet

Rosaplus-EF Tablet

Prescription medicationTablet경구
Ingredient · strength
Losartan Potassium›100mg / 1 tabletHydrochlorothiazide›25mg / 1 tablet
Manufacturer / importer
(주)한국파비스제약
Appearance
Pale yellow oval film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 200607942 · Notified 2006.07.27 · Insurance code 621802090

Summary

Main use
Improved blood pressure control when monotherapy is insufficient for hypertension
Who takes it
Adults · Children
Adult dose
The usual dosage is 50 mg of losartan potassium/12.5 mg of hydrochlorothiazide, taken once a day with one tablet. A dose exceeding 100 mg of losartan potassium/25 mg of hydrochlorothiazide per day is not advisable. If blood pressure is not controlled, therapy should start with 50 mg of losartan potassium/12.5 mg of hydrochlorothiazide once daily, and if blood pressure remains uncontrolled after 3 weeks, the dose can be increased to a maximum of 100 mg of losartan potassium/25 mg of hydrochlorothiazide once daily.
Child dose
Experience with the use of this medication in children and adolescents (under 18 years old) is lacking, therefore the Losartan-hydrochlorothiazide combination should not be administered.

Ingredients

Manufacturer
(주)한국파비스제약

Efficacy & effects

Improved blood pressure control when monotherapy is insufficient for hypertension

  • Hypertension
View approved original text

This medication is used for patients with hypertension that is not adequately controlled with monotherapy.

How to take

Adult dose

The usual dosage is 50 mg of losartan potassium/12.5 mg of hydrochlorothiazide, taken once a day with one tablet. A dose exceeding 100 mg of losartan potassium/25 mg of hydrochlorothiazide per day is not advisable. If blood pressure is not controlled, therapy should start with 50 mg of losartan potassium/12.5 mg of hydrochlorothiazide once daily, and if blood pressure remains uncontrolled after 3 weeks, the dose can be increased to a maximum of 100 mg of losartan potassium/25 mg of hydrochlorothiazide once daily.

Child dose

Experience with the use of this medication in children and adolescents (under 18 years old) is lacking, therefore the Losartan-hydrochlorothiazide combination should not be administered.

Precautions

This medication can cause serious harm to the fetus when taken during pregnancy, especially in the second and third trimesters, so it should be discontinued immediately if pregnancy is confirmed. Patients with allergies to this drug or its components, certain kidney diseases, liver diseases, or electrolyte imbalances should not take this medication. Patients with specific diseases or conditions such as hypotension, kidney impairment, liver impairment, hyperuricemia, diabetes, or the elderly should exercise special caution when taking this medication. During treatment, blood pressure, kidney function, and electrolyte levels should be monitored regularly to check for abnormal signs, with particular attention to hypokalemia or hyperkalemia. This drug has a blood pressure-lowering effect, so dizziness or drowsiness may occur when starting or adjusting the dose, which requires caution when driving or operating machinery. There may be interactions with other drugs, so it is essential to consult a doctor or pharmacist, especially if taking potassium supplements, diuretics, antihypertensives, non-steroidal anti-inflammatory drugs (NSAIDs), or lithium. The hydrochlorothiazide component can react sensitively to sunlight, so prolonged exposure to sunlight should be avoided; if there are skin reactions, notify a doctor immediately. Pregnant women or women who may become pregnant should not take this medication, and breastfeeding women should either discontinue breastfeeding or consult a doctor before taking it. Safety for children and adolescents has not been established, so this medication should not be administered to minors. Overdose may result in symptoms such as hypotension, changes in heart rate, and electrolyte imbalances, so if abnormal symptoms occur, medical attention should be sought immediately. This medication should be stored in its original container, kept out of the reach of children, and not shared or transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema (including swelling of lips and eyelids and facial rash), skin exfoliation and hemolysis, chest pain, facial swelling, syncope, angina, arrhythmia (atrial fibrillation, sinus bradycardia, tachycardia, ventricular tachycardia, ventricular fibrillation), cerebral vascular accident, hypotension, myocardial infarction, secondary atrioventricular block, blood coagulation disorders (thrombocytopenia), acute respiratory distress syndrome (ARDS), dyspnea, vasculitis (Henoch–Schönlein purpura),

Mild side effects

Abdominal pain, edema/swelling, palpitations, back pain, dizziness, cough, sinusitis, upper respiratory infection, weakness/fatigue, diarrhea, nausea, headache, bronchitis, pharyngitis, chest pain, facial swelling, fever, orthostatic hypotension, syncope, angina, arrhythmia (atrial fibrillation, sinus bradycardia, tachycardia, ventricular tachycardia, ventricular fibrillation), hypotension, myocardial infarction, secondary atrioventricular block, loss of appetite, constipation, toothache, dry mouth, dyspepsia, flatulence, gastritis, vomiting, lethargy,

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

Storage

This drug is sensitive to light and should be stored in a container that blocks light. It is also recommended to store the medication at room temperature, between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pale 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.