Medication info
Rosabesil Tablet 5/100 mg (Amlodipine, Losartan Potassium)

Rosabesil Tablet 5/100 mg (Amlodipine, Losartan Potassium)

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.944mg / 1 tabletLosartan Potassium›100mg / 1 tablet
Manufacturer / importer
건일바이오팜주식회사
Appearance
Light pink, rectangular film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202002054 · Approved 2020.03.24 · Insurance code 073000590

Summary

Main use
Improvement in blood pressure control for essential hypertension and stage 2 hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage for this medication is 1 tablet once daily, to be taken with water regardless of meals. It is recommended to take it at the same time daily (e.g., in the morning). Typically, 5/50 mg of this medication is taken once daily; if blood pressure is not adequately controlled after 2 weeks, the dosage may be increased to 10/50 mg taken once daily.
Child dose
Safety and efficacy have not been established for pediatric patients under 18 years of age, and thus the administration of this medication is not recommended.

Ingredients

Manufacturer
건일바이오팜주식회사

Efficacy & effects

Improvement in blood pressure control for essential hypertension and stage 2 hypertension

  • Essential hypertension
  • stage 2 hypertension
View approved original text

This medicine is used for patients with essential hypertension whose blood pressure control is insufficient with monotherapy of amlodipine or losartan. It is also used as an initial treatment for stage 2 hypertension patients who require combination therapy to reach the target blood pressure. This helps effectively manage blood pressure and improves hypertension.

How to take

Adult dose

The recommended dosage for this medication is 1 tablet once daily, to be taken with water regardless of meals. It is recommended to take it at the same time daily (e.g., in the morning). Typically, 5/50 mg of this medication is taken once daily; if blood pressure is not adequately controlled after 2 weeks, the dosage may be increased to 10/50 mg taken once daily.

Child dose

Safety and efficacy have not been established for pediatric patients under 18 years of age, and thus the administration of this medication is not recommended.

Precautions

This medication can cause serious harm to the fetus if taken during pregnancy, especially in the second and third trimesters, so it should be discontinued immediately once pregnancy is confirmed. It may also pose risks to the fetus if taken in early pregnancy; therefore, women who may become pregnant should consult with a doctor. Patients with decreased effective blood volume, particularly those on diuretics, may experience symptoms of hypotension when first taking this medication, so caution is necessary. This medication should not be given to patients allergic to its active ingredients or related components, patients with severe liver dysfunction, severe aortic stenosis, or those in a state of shock. Patients with high potassium levels in the blood, severe kidney impairment, and those on strict salt restrictions should use this medication cautiously and require regular monitoring. This medication may cause side effects such as dizziness or drowsiness, so caution should be exercised when performing hazardous tasks like operating machinery or driving. Patients with impaired liver or kidney function should adjust the dosage or avoid use of this medication. If used with other antihypertensive agents, blood pressure may drop too low, so it should be taken as directed by a physician. This medication should be avoided with grapefruit juice as it may increase blood concentration. It is safest for pregnant or breastfeeding women to avoid this medication, and those planning pregnancy or suspecting they may be pregnant should consult with healthcare professionals. Safety and efficacy for pediatric and adolescent patients have not been established, so its use is not recommended. Elderly patients may require initial dose adjustments, so they should follow the instructions of their healthcare provider. In cases of overdose, severe hypotension and cardiac issues can occur, so immediate medical attention is required. This medication should be stored out of reach of children, and it is advisable not to transfer the medication to another container.

Side effects and when to seek care immediately

Serious side effects

Rash, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, wheezing or difficulty breathing, asthma attack, respiratory symptoms accompany cough and fever, jaundice (yellowing of the skin or eyes), severe malaise, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • weakness
  • chest discomfort
  • chest pain
  • early satiety
  • peripheral edema
  • pit edema
  • abdominal discomfort
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  • indigestion
  • nausea
  • gastroesophageal reflux
  • constipation
  • itching
  • rash
  • palpitations
  • flushing
  • orthostatic hypotension
  • conjunctival injection
  • frequent urination
  • drowsiness
  • cerebrovascular accident
  • lowering of blood pressure
  • sinoatrial block
  • atrioventricular block
  • abdominal discomfort
  • diarrhea
  • loose stools
  • constipation
  • skin flushing
  • maculopapular rash
  • heaviness
  • warmth
  • impaired glucose tolerance.

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

Storage

This medication must be stored in a tightly closed container to protect it from air and moisture. It is best to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature to ensure the medication’s effectiveness is preserved safely.

Appearance and packaging

Appearance

Light pink, rectangular film-coated tablet

Package unit

30 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.