Medication info

Rosacoplus Tablet

Prescription medicationTablet경구Expired
Ingredient · strength
Losartan Potassium›50mg / 1 tabletHydrochlorothiazide›12.5mg / 1 tablet
Manufacturer / importer
삼성제약(주)
Appearance
Yellow oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 201804688 · Approved 2018.11.27

This product's status changed to Expired on 2023.11.27. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of blood pressure control when monotherapy is insufficient for hypertension
Who takes it
Adults · Children
Adult dose
The usual dosage for this medication is 50 mg of losartan potassium / 12.5 mg of hydrochlorothiazide, taken once daily, one tablet. The maximum dose can be increased to 100 mg of losartan potassium / 25 mg of hydrochlorothiazide, taken once daily, one tablet. The medication can be taken regardless of meals. For patients with renal impairment, the standard dose is given if the creatinine clearance is above 30 mL/min, while more severe renal impairment patients are not recommended for administration.
Child dose
There is no experience in using this medication in children and adolescents (under 18 years), so it is not administered.

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

Improvement of blood pressure control when monotherapy is insufficient for hypertension

  • Hypertension
View approved original text

This medicine is used for hypertension that is not adequately controlled by monotherapy.

How to take

Adult dose

The usual dosage for this medication is 50 mg of losartan potassium / 12.5 mg of hydrochlorothiazide, taken once daily, one tablet. The maximum dose can be increased to 100 mg of losartan potassium / 25 mg of hydrochlorothiazide, taken once daily, one tablet. The medication can be taken regardless of meals. For patients with renal impairment, the standard dose is given if the creatinine clearance is above 30 mL/min, while more severe renal impairment patients are not recommended for administration.

Child dose

There is no experience in using this medication in children and adolescents (under 18 years), so it is not administered.

Precautions

This medication can cause serious harm to the fetus and newborn, especially during the 2nd and 3rd trimesters of pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. This medication should not be administered to persons with certain conditions, such as anuria, severe liver or kidney disorders, or electrolyte imbalances. Patients with significantly low blood pressure, renal dysfunction, or certain cardiovascular diseases must use this medication with extreme caution and require regular monitoring. This medication can affect potassium levels, so taking it together with potassium supplements or other potassium-containing drugs can be dangerous. Due to the hydrochlorothiazide component, skin may become sensitive to sunlight, increasing the risk of skin cancer, so sun exposure should be minimized and skin conditions should be checked regularly. Symptoms such as dizziness, drowsiness, rash, cough, and low blood pressure may occur during treatment; consult a doctor if any unusual symptoms arise. Electrolytes and renal function should be regularly monitored through blood tests, and appropriate measures should be taken if abnormalities are detected. There is insufficient experience using this medication in children and adolescents, and it is not recommended for them. Elderly patients may experience adverse reactions more frequently when taking this medication, so caution is required. When taking this medication, it is important to follow the doctor's instructions precisely, and it should not be stopped or the dosage adjusted without consultation, nor should it be taken in combination with other medications without consulting a physician.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema (swelling of lips and eyelids and facial rash), angioedema (swelling of the larynx/glottis that can cause airway obstruction, swelling of the face/lips/pharynx/tongue), difficulty breathing, acute respiratory distress syndrome (ARDS), skin exfoliation, hemolysis, chest pain, facial swelling, fever, orthostatic hypotension, fainting, angina, arrhythmia (atrial fibrillation, sinus bradycardia, tachycardia, ventricular tachycardia, ventricular fibrillation), cerebrovascular accident, hypotension, myocardial infarction

Mild side effects

  • Abdominal pain
  • swelling/enlargement
  • 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
  • second-degree AV block
  • loss of appetite
  • constipation
  • toothache
  • dry mouth
  • dyspepsia
  • flatulence
  • gastritis
  • 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 tightly closed container that blocks light. Additionally, it is important to keep it at room temperature, between 1 degree and 30 degrees Celsius, to maintain its effectiveness.

Appearance and packaging

Appearance

Yellow oval film-coated tablet

Package unit

30 tablets/bottle, 100 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

No questions yet.

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.