Medication info
Rosatol Plus Tablet

Rosatol Plus Tablet

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

MFDS item code 201904374 · Approved 2019.06.26

Summary

Main use
Improvement of blood pressure control in patients with uncontrolled hypertension using monotherapy
Who uses it
Adults · Children
Adult dosage
The usual dosage of this medication is one tablet containing 50 mg of Losartan Potassium and 12.5 mg of Hydrochlorothiazide once daily. Doses exceeding 100 mg of Losartan Potassium and 25 mg of Hydrochlorothiazide daily are not preferable. Start with one tablet of 50 mg of Losartan Potassium and 12.5 mg of Hydrochlorothiazide once daily; if blood pressure is not controlled after 3 weeks, increase to a maximum of 100 mg of Losartan Potassium.
Children's dosage
There is no experience using this medication in children and adolescents; thus the combination of losartan and hydrochlorothiazide is not administered to children and adolescents.

Ingredients

Manufacturer
(유)한풍제약

Efficacy & effects

Improvement of blood pressure control in patients with uncontrolled hypertension using monotherapy

  • Hypertension
View approved original text

Used for hypertension that is not adequately controlled with monotherapy.

Dosage and Administration

Adult dosage

The usual dosage of this medication is one tablet containing 50 mg of Losartan Potassium and 12.5 mg of Hydrochlorothiazide once daily. Doses exceeding 100 mg of Losartan Potassium and 25 mg of Hydrochlorothiazide daily are not preferable. Start with one tablet of 50 mg of Losartan Potassium and 12.5 mg of Hydrochlorothiazide once daily; if blood pressure is not controlled after 3 weeks, increase to a maximum of 100 mg of Losartan Potassium.

Children's dosage

There is no experience using this medication in children and adolescents; thus the combination of losartan and hydrochlorothiazide is not administered to children and adolescents.

Precautions

This medication can cause serious harm to the fetus if taken during pregnancy, especially during the second and third trimesters, and should be discontinued immediately upon confirmation of pregnancy. This medication should not be administered to certain patients, for instance, those allergic to this medication or its components, patients with severely impaired kidney function, severe liver impairment, women who are pregnant or may become pregnant, and those with specific electrolyte abnormalities. Additionally, patients with low blood pressure or problems with renal blood vessels, those with a history of liver disease, diabetes or gout, and the elderly should use this medication with caution, and sun exposure should be limited due to an increased risk of skin cancer, while skin condition should be monitored frequently. During the use of this medication, electrolyte imbalances, especially changes in potassium levels, should be carefully monitored, as symptoms of excessively low blood pressure, dizziness, or drowsiness may occur, requiring caution while driving or operating machinery. As this medication may interact with other drugs, especially potassium-sparing diuretics, potassium supplements, non-steroidal anti-inflammatory drugs, and lithium preparations, consultation with a physician is advised if taken in combination. This medication also requires caution in nursing women, and it is necessary to decide whether to discontinue breastfeeding or consult a doctor prior to administration. The safety of this medication in children and adolescents has not been established, thus it is not administered to this age group. If any abnormal symptoms appear during administration, consult a healthcare professional immediately, especially in cases of suspected allergic reactions such as skin rash, difficulty breathing, or severe dizziness; discontinue use immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), difficulty breathing, angioedema (swelling of lips and eyelids and facial rashes, laryngeal/pharyngeal edema potentially causing airway obstruction), severe allergic reactions, severe cutaneous adverse reactions (severe rash, blisters, skin sloughing, Stevens-Johnson syndrome, toxic epidermal necrolysis), acute respiratory distress syndrome (ARDS), liver

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
  • 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 should be stored in a tightly closed container that blocks light, and the storage temperature should be maintained between 1 degrees and 30 degrees Celsius at room temperature. By storing it this way, the efficacy of the medication can be safely maintained.

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

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.