Medication info
Rosabesil Tablet 10/50 mg (Amlodipine, Losartan Potassium)

Rosabesil Tablet 10/50 mg (Amlodipine, Losartan Potassium)

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›13.888mg / 1 tabletLosartan Potassium›50mg / 1 tablet
Manufacturer / importer
건일바이오팜주식회사
Appearance
Pink oval film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202002055 · Approved 2020.03.24 · Insurance code 073000600

Summary

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

Ingredients

Manufacturer
건일바이오팜주식회사

Efficacy & effects

Improvement of blood pressure control in essential hypertension and achieving target blood pressure

  • Essential hypertension
  • stage 2 hypertension
View approved original text

This medication is used in patients with essential hypertension whose blood pressure is not adequately controlled with monotherapy of Amlodipine or Losartan, or in patients with stage 2 hypertension who require combination therapy to achieve target blood pressure.

How to take

Adult dose

The recommended dosage for this medication is 1 tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). Typically, 5/50 mg of this medication is administered once daily, and if blood pressure remains inadequately controlled after 2 weeks, it may be increased to 10/50 mg once daily.

Child dose

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

Precautions

This medicine can cause serious harm to the fetus if taken during pregnancy, especially in the second and third trimesters, so it should be discontinued immediately upon confirmation of pregnancy. Hypotensive symptoms may occur when administering this drug initially to patients with low blood volume, so these patients should manage their blood volume prior to administration. Patients who are allergic to any of the ingredients of this medication or who have severe liver diseases, aortic stenosis, or are in a state of shock should not take this drug. Patients with decreased blood volume, strict salt restrictions, or moderate to severe renal impairment should use this drug cautiously. Dizziness or drowsiness may occur during treatment; therefore, caution should be taken when driving or operating hazardous machinery. This medication may affect liver and kidney function; therefore, patients with liver or kidney diseases should undergo regular check-ups as directed by their physician. Care should be taken if taken with other antihypertensive drugs or potassium-sparing diuretics as potassium levels may increase. It is advisable not to take this medicine while breastfeeding, and it is not recommended for children under 18 years of age as safety and efficacy have not been established. Overdose may cause severe hypotension and cardiac issues, so it is important to adhere precisely to the dosage and seek immediate medical attention in case of overdose. This medication should be kept out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral or ocular mucosa, shortness of breath or difficulty breathing, asthma attack, breathing difficulties associated with coughing and fever, yellowing of skin or eyes, extreme fatigue, sudden and severe headache, thunderclap headache, seizure, confusion, visual disturbances, paralysis, significantly reduced urine output

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • asthenia
  • chest discomfort
  • chest pain
  • early satiety
  • peripheral edema
  • pit edema
  • abdominal discomfort
Show 25 more
  • dyspepsia
  • nausea
  • gastroesophageal reflux
  • constipation
  • pruritus
  • generalized urticaria
  • palpitations
  • flushing
  • orthostatic hypotension
  • conjunctival injection
  • polyuria
  • drowsiness
  • fatigue
  • pain
  • weight gain or loss
  • hypotension
  • vasculitis
  • tension elevation
  • sensory loss
  • paresthesia
  • peripheral neuropathy
  • syncope
  • taste disturbance
  • tremor
  • erectile dysfunction

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly closed container. It is important to maintain the storage temperature between 1 and 30 degrees Celsius to preserve the effectiveness of the medication for a long time.

Appearance and packaging

Appearance

Pink oval 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.