Medication info
Besilsartan Tablets 10/50 mg (Amlodipine, Losartan Potassium)

Besilsartan Tablets 10/50 mg (Amlodipine, Losartan Potassium)

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›13.888mg / 1 tabletLosartan Potassium›50mg / 1 tablet
Manufacturer / importer
(주)휴온스
Appearance
Light pink rectangular film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201502640 · Approved 2015.04.30 · Insurance code 670607230

Summary

Main use
Improvement in blood pressure control of 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 each day (e.g., in the morning). Typically, this medication (5/50 mg) is administered once daily, and if blood pressure is not sufficiently controlled after 2 weeks of treatment, the dosage may be increased to 10/50 mg once daily.
Child dose
Safety and efficacy in pediatric patients under 18 years have not been established, and the use of this medication is not recommended.

Ingredients

Manufacturer
(주)휴온스

Efficacy & effects

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

  • Essential hypertension
  • stage 2 hypertension
View approved original text

This medication is used to effectively lower blood pressure in patients with essential hypertension whose blood pressure is not sufficiently controlled by amlodipine or losartan alone. It is also used as an initial treatment in cases where combination therapy is required to reach the target blood pressure in patients with stage 2 hypertension. Therefore, it helps improve blood pressure control and prevent hypertension-related complications.

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 each day (e.g., in the morning). Typically, this medication (5/50 mg) is administered once daily, and if blood pressure is not sufficiently controlled after 2 weeks of treatment, the dosage may be increased to 10/50 mg once daily.

Child dose

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

Precautions

This medication can cause serious harm to the fetus when taken during pregnancy, especially in the second and third trimesters, and should be discontinued immediately upon confirmation of pregnancy. Taking this medication during pregnancy may result in several dangerous symptoms, including reduced fetal kidney function, low blood pressure, cranial formation abnormalities, and pulmonary developmental issues. If unavoidable use is required early in pregnancy, the fetal health status should be periodically monitored via ultrasound or other means, and the medication should be stopped if any abnormal symptoms are found. Patients with decreased intravascular effective blood volume, such as those taking diuretics, should be cautious as hypotension may occur upon initiation of this medication. This medication should not be used in patients who are allergic to its components or similar medications, pregnant women or women of childbearing potential, breastfeeding women, patients with severe liver dysfunction, patients with severe aortic stenosis, or patients in shock. Caution is also warranted in patients with low blood volume or those on strict salt restriction, those with severe kidney dysfunction or on dialysis, and patients with hyperkalemia. Neurological symptoms such as dizziness, drowsiness, headache may occur while taking this medication, so operating high-risk machinery or driving should be avoided. If there are abnormalities in liver or kidney function, consult a doctor for appropriate dosage adjustment before taking this medication. When taken with other antihypertensive drugs, caution is advised as blood pressure may become too low, and grapefruit juice may enhance the effects, so it is best to avoid it. Pregnant or breastfeeding women should not take this medication, and if pregnancy is planned or confirmed, they should inform their healthcare provider immediately. Safety and efficacy in children and adolescents under 18 years have not been established, so its use is not recommended. In case of overdose, severe hypotension or heart rhythm abnormalities may occur, so appropriate treatment should be sought immediately at a medical facility. This medication should be kept out of reach of children and should not be transferred to other containers to maintain its quality.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with high fever, blisters, shedding skin, pain in oral/ocular mucosa, severe skin reactions, difficulty breathing or dyspnea, asthma attacks, respiratory abnormalities with cough and fever, breathing problems, yellowing of the skin or eyes (jaundice), profound lethargy, liver abnormalities (jaundice), sudden

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • weakness
  • chest discomfort
  • chest pain
  • early satiety
  • peripheral edema
  • pitting edema
  • abdominal discomfort
Show 25 more
  • dyspepsia
  • nausea
  • gastroesophageal reflux
  • constipation
  • itching
  • systemic urticaria
  • palpitations
  • flushing
  • orthostatic hypotension
  • facial flushing
  • dyspnea
  • cough
  • conjunctival injection
  • nocturia
  • drowsiness
  • hypertonia
  • sensory loss
  • paresthesia
  • peripheral neuropathy
  • syncope
  • taste disturbance
  • tremor
  • erectile dysfunction
  • gynecomastia
  • bowel habit changes

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius. This will help maintain the medication's effectiveness for a longer period.

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.