Medication info
BISPOZIGE 10/160 mg (Amlodipine Besylate, Valsartan)

BISPOZIGE 10/160 mg (Amlodipine Besylate, Valsartan)

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›13.87mg / 1 tabletValsartan›160mg / 1 tablet
Manufacturer / importer
(주)한국파비스제약
Appearance
Bright yellow oval film-coated tablet
Packaging
30 tablets/box [10 tablets/Alu-Alu*3)]
Approval status
Active

MFDS item code 201907034 · Approved 2019.10.02 · Insurance code 621803920

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dose of this medication is one tablet once a day, to be taken with water regardless of meals. It is advised to take it at the same time every day (e.g., in the morning) if possible.
Child dose
The safety and efficacy of this drug in pediatric patients under 18 years of age have not been established, and its use is not recommended.

Ingredients

Manufacturer
(주)한국파비스제약

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

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

How to take

Adult dose

The recommended dose of this medication is one tablet once a day, to be taken with water regardless of meals. It is advised to take it at the same time every day (e.g., in the morning) if possible.

Child dose

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

Precautions

This drug can cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy; therefore, it must be discontinued immediately upon confirmation of pregnancy. Patients with hypersensitivity to any component of this drug, pregnant or nursing women, patients with severe renal or liver dysfunction, or those with a history of certain heart conditions or angioedema should not take this medication. Patients with sodium or fluid depletion should correct their condition before taking this drug, and if symptoms of hypotension occur, should lie down immediately and receive intravenous therapy if necessary. Patients with high potassium levels should exercise caution when taking this drug with potassium supplements or medications that increase potassium levels, and should have their serum potassium levels tested frequently. Patients with issues related to renal vasculature may experience worsening renal function during treatment with this drug and require close monitoring by a physician. Patients with heart failure or post-myocardial infarction should carefully monitor for changes in renal function while taking this drug, and patients with acute myocardial infarction or certain heart valve diseases should also take it cautiously. This medication may cause dizziness or fatigue when driving or operating machinery, so caution is advised. Interactions may occur with other antihypertensives, potassium-sparing diuretics, NSAIDs, certain antibiotics, grapefruit juice, etc., so patients must consult with their physician or pharmacist regarding any concomitant medications. Pregnant women, those planning to become pregnant, or nursing mothers are advised not to use this medication, and it is not recommended for children under 18 years of age due to insufficient safety and efficacy data. In cases of overdose, hypotension and cardiac issues may arise, so immediate medical assistance is necessary.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reaction, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, skin or eye jaundice, extreme lethargy, liver dysfunction (jaundice), sudden and

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • paresthesia
  • vertigo
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
Show 28 more
  • hypotension
  • cough
  • throat and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • lumbar pain
  • arthritis
  • muscle cramps
  • weakness
  • polyuria
  • nocturia
  • erectile dysfunction
  • edema
  • facial swelling
  • peripheral edema
  • fatigue
  • flushing
  • asthenia
  • facial flushing
  • diplopia

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. The storage temperature should be kept between 1 to 30 degrees Celsius at room temperature to maintain its effectiveness.

Appearance and packaging

Appearance

Bright yellow oval film-coated tablet

Package unit

30 tablets/box [10 tablets/Alu-Alu*3)]

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.