Medication info

Rotain Plus F Tablets

Prescription medicationTablet경구Approval withdrawn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Approval withdrawn

MFDS item code 200608373 · Notified 2006.11.07

This product's status changed to Approval withdrawn on 2024.04.02. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of blood pressure control in patients with hypertension not adequately controlled by monotherapy.
Who takes it
Adults · Children
Adult dose
The usual dose of this drug is 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide once daily, in one tablet. Dosages exceeding 100 mg of losartan potassium and 25 mg of hydrochlorothiazide per day are undesirable. If blood pressure is not controlled, the dosage may be gradually increased. Patients with renal impairment should receive the usual dose if the creatinine clearance is more than 30 mL/min.
Child dose
There is no experience in using this medication in children and adolescents, so the losartan-hydrochlorothiazide combination should not be administered to them.

Ingredients

Manufacturer
(주)휴온스생명과학

Efficacy & effects

Improvement of blood pressure control in patients with hypertension not adequately controlled by monotherapy.

  • Hypertension
View approved original text

This drug is used for the treatment of hypertension in patients whose blood pressure is not adequately controlled by monotherapy.

How to take

Adult dose

The usual dose of this drug is 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide once daily, in one tablet. Dosages exceeding 100 mg of losartan potassium and 25 mg of hydrochlorothiazide per day are undesirable. If blood pressure is not controlled, the dosage may be gradually increased. Patients with renal impairment should receive the usual dose if the creatinine clearance is more than 30 mL/min.

Child dose

There is no experience in using this medication in children and adolescents, so the losartan-hydrochlorothiazide combination should not be administered to them.

Precautions

This drug can cause serious harm to the fetus if taken during pregnancy, especially in the second and third trimesters, so use should be discontinued immediately if pregnancy is confirmed. Those who are allergic to this medicine or its components, have severely impaired kidney function or anuria, have severe liver impairment, or specific electrolyte imbalances should not take this medication. Individuals with special health conditions such as hypotension, kidney disease, liver disease, diabetes, gout, or elderly patients should consult a physician before taking this medication, as it may lower blood pressure excessively. Due to the hydrochlorothiazide component, electrolyte imbalances can occur, necessitating regular blood tests and symptom monitoring, particularly for hypokalemia or hypercalcemia. This drug may interact with other medications; therefore, potassium supplements or medications containing potassium should not be taken arbitrarily and one must consult healthcare providers. Dizziness or drowsiness may occur during treatment, so caution is required when driving or operating machinery. This medication may increase sensitivity to sunlight, requiring sun protection and precautions when going outdoors, and any skin abnormalities should be reported to a doctor immediately. In breastfeeding, this drug may pass into mother’s milk and affect the baby, so breastfeeding should be stopped or discussed with a doctor. Safety has not been established for children and adolescents, so this drug should not be administered to them. In cases of overdose, symptoms such as hypotension or cardiac abnormalities may occur, requiring immediate medical attention; this drug is not removed by hemodialysis. Store this medication in its original container and keep it out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), difficulty breathing, chest tightness, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, mucosal pain in mouth/eyes, jaundice (yellowing of skin or eyes), severe lethargy, serious neurological symptoms (sudden and severe headache, lightning headache, seizures, mental confusion, visual disturbances, paralysis), markedly reduced urine output, severe swelling throughout the body, blood pressure changes.

Mild side effects

  • Abdominal pain
  • 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
  • hypotension
  • myocardial infarction
  • secondary AV block
  • loss of appetite
  • constipation
  • toothache
  • dry mouth
  • indigestion
  • flatulence
  • gastritis
  • vomiting
  • fatigue
  • anemia
  • gout
  • arm pain
  • joint pain
  • arthritis
  • tremor.

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

Storage

This medicine should be stored in a container that blocks light and air, and it is recommended to store it at room temperature between 1 to 30 degrees Celsius. Storing it this way can help maintain the drug's effectiveness for a longer period.

Appearance and packaging

Appearance

Pale yellow oval film-coated tablets

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.