Medication info
Bisoprolol 5/80 milligrams (Amlodipine Besilate, Valsartan)

Bisoprolol 5/80 milligrams (Amlodipine Besilate, Valsartan)

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.94mg / 1 tabletValsartan›80mg / 1 tablet
Manufacturer / importer
(주)한국파비스제약
Appearance
Bright yellow round film-coated tablet
Packaging
30 tablets/box [15 tablets/Alu-Alu*2]
Approval status
Active

MFDS item code 201308557 · Approved 2013.07.31 · Insurance code 621802400

Summary

Main use
Improvement in blood pressure control in essential hypertension with the combination of amlodipine and valsartan
Who takes it
Adults · Children
Adult dose
The recommended dose is one tablet once daily, to be taken with water without regard to meals. It is advisable to take at the same time each day (e.g., in the morning). The dosages of 5/80 milligrams, 5/160 milligrams, and 10/160 milligrams may be administered based on blood pressure control. Dose adjustment and caution are necessary for patients with renal impairment, liver impairment, or the elderly.
Child dose
The safety and efficacy of this medication in pediatric patients under 18 years of age have not been established, therefore its use is not recommended.

Ingredients

Manufacturer
(주)한국파비스제약

Efficacy & effects

Improvement in blood pressure control in essential hypertension with the combination of amlodipine and valsartan

  • Essential hypertension
View approved original text

This medication is used for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled by monotherapy with amlodipine or valsartan.

How to take

Adult dose

The recommended dose is one tablet once daily, to be taken with water without regard to meals. It is advisable to take at the same time each day (e.g., in the morning). The dosages of 5/80 milligrams, 5/160 milligrams, and 10/160 milligrams may be administered based on blood pressure control. Dose adjustment and caution are necessary for patients with renal impairment, liver impairment, or the elderly.

Child dose

The safety and efficacy of this medication in pediatric patients under 18 years of age have not been established, therefore its use is not recommended.

Precautions

This medicine can cause serious harm to the fetus and newborns if taken during the second and third trimesters of pregnancy, therefore it should be discontinued immediately upon confirmation of pregnancy. Patients who are allergic to any of the components of this medication, are pregnant or breastfeeding, have severe kidney or liver disease, or have certain heart conditions should not take it. Patients with low sodium or fluid levels in the body may experience hypotension, so their condition should be carefully checked before use, and blood pressure should be closely monitored during treatment. Patients with high potassium levels may have further increases in potassium concentration due to medications taken with this drug, so regular blood tests to check potassium levels are necessary. Patients with renal artery issues or those recently having undergone kidney transplants should use this medication cautiously as it may worsen kidney function. If symptoms of angioedema such as swelling of the face, lips, or tongue occur while taking this medication, it should be discontinued immediately and medical attention sought. Patients with heart failure or after myocardial infarction may experience changes in kidney function or hypotension when taking this medication, thus requiring regular assessment and monitoring. Caution is warranted for patients with specific heart conditions such as acute myocardial infarction or aortic stenosis and mitral valve stenosis when using this drug. This medication may interact with other antihypertensives, diuretics, and potassium-sparing agents, so any other medications being taken should be discussed with healthcare professionals. Patients should exercise caution while driving or operating machinery as dizziness or fatigue may occur. Overdose may lead to severe hypotension or cardiac arrhythmias, necessitating immediate medical assistance in such cases. This medication is not recommended for pediatric patients under 18 years of age as safety and efficacy have not been established for this population. Elderly patients can be administered similar doses as adults but should follow healthcare providers' instructions according to their status. Women who are pregnant or planning to become pregnant, as well as those who are breastfeeding should avoid using this medication, as severe risks to the fetus may occur during pregnancy. If any unusual symptoms or discomfort occur during treatment with this medication, it is essential to consult with healthcare providers promptly for appropriate measures.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/eye mucosa, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities associated with cough and fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusional state, vision changes, paralysis.

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • orthostatic dizziness
  • paresthesia
  • vertigo
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
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  • orthostatic hypotension
  • hypotension
  • cough
  • pharyngeal and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • back pain
  • arthritis
  • muscle cramps
  • lethargy
  • polyuria
  • excessive urination
  • erectile dysfunction
  • edema
  • peripheral edema
  • facial edema
  • peripheral edema
  • fatigue
  • flush
  • debility.

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees in a cool, dry place. Proper storage will help maintain the medication's efficacy and ensure safe use.

Appearance and packaging

Appearance

Bright yellow round film-coated tablet

Package unit

30 tablets/box [15 tablets/Alu-Alu*2]

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.