Medication info
Besilsartan Tablets 5/50 mg (Amlodipine, Losartan Potassium)

Besilsartan Tablets 5/50 mg (Amlodipine, Losartan Potassium)

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

MFDS item code 201502639 · Approved 2015.04.30 · Insurance code 670607250

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 is 1 tablet once daily, to be taken with water regardless of meals. It is advised 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 is not adequately controlled after 2 weeks of treatment, the dosage can be increased to 10/50 mg once daily.
Child dose
Safety and efficacy in pediatric patients under 18 have not been established, thus its use is not recommended.

Ingredients

Manufacturer
(주)휴온스

Efficacy & effects

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

  • Essential hypertension
  • stage 2 hypertension
View approved original text

For patients with essential hypertension who have difficulty controlling blood pressure with monotherapy alone, the combination of amlodipine and losartan can effectively manage blood pressure. Additionally, this medication is suitable for stage 2 hypertension patients who require combination therapy from the start to reach the target blood pressure. This combination aids in more stable control of blood pressure, helping to reduce the risk of cardiovascular diseases. Therefore, this medication is effectively used in the treatment of hypertension.

How to take

Adult dose

The recommended dosage is 1 tablet once daily, to be taken with water regardless of meals. It is advised 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 is not adequately controlled after 2 weeks of treatment, the dosage can be increased to 10/50 mg once daily.

Child dose

Safety and efficacy in pediatric patients under 18 have not been established, thus its use is not recommended.

Precautions

This medication may cause serious injury or death to the fetus when taken during pregnancy, especially in the second and third trimesters, so it should be immediately discontinued upon confirmation of pregnancy. Hypotension may occur on initial administration in patients with low blood volume, so the underlying condition should be treated first before administration. This medication should not be used in individuals with allergies to specific components, pregnant or breastfeeding women, patients with severe liver dysfunction, severe aortic stenosis, or those in shock. It should be administered cautiously in patients with low blood volume or those requiring strict sodium restrictions, moderate to severe renal impairment, or hyperkalemia. Side effects such as dizziness, headache, drowsiness, dyspepsia, skin rash may occur during use, and if any unusual symptoms develop, a consultation with a physician is advised. When taken with other antihypertensive medications, there may be a potentiation of blood pressure-lowering effects, so caution is needed when co-administered. Taking grapefruit juice may enhance the effects of this medication, so it is better to avoid combining it. Pregnant or breastfeeding women should refrain from taking this medication, and especially during pregnancy, it poses a risk to the fetus, so consultation with a healthcare provider is necessary. Safety and efficacy in patients under 18 have not been established, thus its use is not recommended. Elderly patients, particularly those over 75, need dosage adjustment at initiation; thus, consultation with healthcare providers is required before taking this medication. In case of overdose, severe hypotension or cardiac arrhythmias may occur, so it is important to adhere to the prescribed dosage and inform healthcare professionals immediately in the event of an overdose. This medication should be kept out of the reach of children and should not be transferred to another container for safety. Regular monitoring of blood pressure, kidney function, and serum potassium levels is required while taking this medication.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, palpitations, chest discomfort, dyspnea, angioedema (swelling of lips and eyelids and facial rash), anaphylactic reaction, vasculitis, systemic urticaria, severe allergic reactions, angioedema, shock symptoms associated with hypotension, fulminant hepatitis, hepatitis, liver function abnormalities, jaundice, hepatic abnormalities, severe skin adverse reactions, erythema, toxic epidermal necrolysis, serious neurological symptoms, cerebral infarction, syncope, consciousness impairment

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • weakness
  • chest discomfort
  • chest pain
  • early satiety
  • peripheral edema
  • pitting edema
  • abdominal discomfort
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  • dyspepsia
  • nausea
  • gastroesophageal reflux
  • constipation
  • itching
  • urticaria
  • palpitations
  • flushing
  • orthostatic hypotension
  • conjunctival injection
  • frequent urination
  • muscle cramps
  • back pain
  • leg pain
  • nasal congestion
  • upper respiratory tract infection
  • sinusitis
  • diarrhea
  • cough
  • sinus disorders
  • pharyngitis
  • myalgia
  • insomnia
  • fatigue
  • edema
  • abdominal pain
  • vasculitis
  • tension

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

Storage

This medication should be stored in a tightly closed container to prevent air and moisture ingress. The recommended storage temperature is room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White rectangular film-coated tablets

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.