Medication info
Rosabecil Tablet 5/50 mg (Amlodipine, Losartan Potassium)

Rosabecil Tablet 5/50 mg (Amlodipine, Losartan Potassium)

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.944mg / 1 tabletLosartan Potassium›50mg / 1 tablet
Manufacturer / importer
건일바이오팜주식회사
Appearance
White oblong film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202002053 · Approved 2020.03.24 · Insurance code 073000580

Summary

Main use
Improvement of blood pressure control in essential hypertension and treatment target blood pressure.
Who takes it
Adults · Children
Adult dose
The recommended dose of this medication is one tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time every day (for example, in the morning). Generally, this medication 5/50 mg is administered once daily, and if blood pressure is still not adequately controlled after two weeks of administration, it may be increased to 10/50 mg once daily.
Child dose
Safety and efficacy in pediatric patients under 18 years of age have not been established, and this medication is not recommended for use.

Ingredients

Manufacturer
건일바이오팜주식회사

Efficacy & effects

Improvement of blood pressure control in essential hypertension and treatment target blood pressure.

  • Essential hypertension
  • Stage 2 hypertension
View approved original text

This medication is used in patients with essential hypertension when blood pressure is not adequately controlled with monotherapy using amlodipine or losartan. Additionally, it is prescribed as initial therapy when patients with Stage 2 hypertension require combination therapy to reach the target blood pressure. Thus, this drug helps to effectively manage hypertension and control blood pressure within a normal range.

How to take

Adult dose

The recommended dose of this medication is one tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time every day (for example, in the morning). Generally, this medication 5/50 mg is administered once daily, and if blood pressure is still not adequately controlled after two weeks of administration, it may be increased to 10/50 mg once daily.

Child dose

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

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 if pregnancy is confirmed. Caution is required when first administering it to patients with reduced blood volume as hypotension may occur, and it is advisable not to use this medication in such patients. It should not be taken by those allergic to its active ingredients or similar compounds. It is not administered to patients with severe liver dysfunction, severe aortic stenosis, or those in shock. It should be used with caution in patients with reduced blood volume or moderate to severe renal impairment, and in those with hyperkalemia. Side effects such as dizziness, headache, drowsiness, swelling, dyspepsia, itching, and others may occur, and if unusual symptoms arise, consultation with a physician is necessary. If blood pressure drops sharply leading to loss of consciousness or shock, use should be discontinued immediately and treatment sought. Care is needed when performing high-risk work or driving. Patients with liver or kidney impairment should consult with a healthcare provider before using this medication, and care should be taken when taken with potassium-sparing diuretics or potassium supplements due to possible increases in potassium levels. If taken with other antihypertensives, blood pressure-lowering effects may increase, so it should be taken as directed by a healthcare provider. This medication is not recommended during breastfeeding, and safety and efficacy in children under 18 years of age have not been established, so it is not recommended. In cases of overdose, blood pressure may drop severely or heart rhythm may become irregular, so the prescribed dose should be strictly adhered to and medical attention sought in case of suspected overdose. This medication should be kept out of reach of children and not transferred to other containers for safety.

Side effects and when to seek care immediately

Serious side effects

Rash, angioedema, shortness of breath, chest tightness, pallor, cold sweat, high fever with severe rash, blisters, skin peeling, pain in oral/ocular mucosa, difficulty breathing, asthma attack, respiratory issues accompanied by cough and fever, jaundice of skin or eyes, generalized malaise, hepatitis, sudden severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, marked decrease in urine output, generalized severe edema.

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • fatigue
  • chest discomfort
  • chest pain
  • early satiety
  • peripheral edema
  • pitting edema
  • abdominal discomfort
Show 26 more
  • dyspepsia
  • nausea
  • gastroesophageal reflux
  • constipation
  • itching
  • rash
  • palpitations
  • flushing
  • orthostatic hypotension
  • facial flushing
  • shortness of breath
  • cough
  • conjunctival injection
  • frequent urination
  • fatigue
  • vasculitis
  • tension increase
  • sensory loss
  • paresthesia
  • peripheral neuropathy
  • syncope
  • taste disturbance
  • tremors
  • erectile dysfunction
  • gynecomastia
  • defecation.

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air and moisture. It is best kept at room temperature, between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White oblong 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.