Medication info

Infosizigen 5/80mg

Prescription medicationTablet경구
Ingredient · strength
Valsartan›80mg / 1 tabletAmlodipine Besylate›6.935mg / 1 tablet
Manufacturer / importer
(주)인트로바이오파마
Appearance
Dark yellow round film-coated tablet
Packaging
30 tablets/PTP (10 tablets/PTP * 3)
Approval status
Active

MFDS item code 201603878 · Approved 2016.06.24

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 1 tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning) if possible.
Child dose
Safety and efficacy in pediatric patients under 18 years of age have not been established, so the administration of this medication is not recommended.

Ingredients

Manufacturer
(주)인트로바이오파마

Efficacy & effects

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

  • Essential hypertension
View approved original text

It is used to effectively lower and control blood pressure in patients with essential hypertension where blood pressure is not sufficiently controlled with either amlodipine or valsartan monotherapy.

How to take

Adult dose

The recommended dose is 1 tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning) if possible.

Child dose

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

Precautions

This medication can cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. This medication should not be used in individuals with allergies to the active ingredient or similar compounds, pregnant or breastfeeding women, and patients with severe renal or liver impairment. In patients with sodium or fluid depletion, low blood pressure may occur, so the condition should be thoroughly checked before administration, and appropriate measures should be taken if hypotension occurs. Patients with high potassium levels or those taking medications that can increase potassium levels should have their potassium levels monitored frequently. Caution must be taken when using in patients with renal artery stenosis or those who have recently received a kidney transplant due to the risk of worsening renal function. If signs of angioedema occur, use should be discontinued immediately, and re-administration is prohibited. Patients with heart failure or after myocardial infarction should be closely monitored for changes in renal function while taking this medication. This medication may cause dizziness or fatigue when driving or operating machinery, so caution is advised. While taking this medication, blood pressure, renal function, and electrolyte levels should be regularly tested to ensure there are no abnormalities. Overdose can result in hypotension and arrhythmias, requiring immediate medical treatment. Women who are pregnant or planning to become pregnant should avoid taking this medication, and breastfeeding women are also advised against its use. It is not recommended in children due to insufficient safety and effectiveness data. Elderly patients may use the same dosage as general adults, but caution is required based on their condition. This medication may interact with other antihypertensive drugs, potassium supplements, and certain anti-inflammatory drugs; hence, individuals should consult their doctor or pharmacist about any other medications they are taking.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash accompanied by high fever, blisters, skin peeling, pain of oral/ocular mucosa, difficulty or shortness of breath, asthma attacks, respiratory distress with cough and fever, jaundice (yellowing of skin or eyes), extreme fatigue, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • paresthesia
  • light-headedness
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
Show 28 more
  • hypotension
  • cough
  • pharyngeal and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • dry mouth
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • back pain
  • arthritis
  • muscle cramps
  • lethargy
  • polyuria
  • nocturia
  • erectile dysfunction
  • edema
  • facial swelling
  • peripheral edema
  • fatigue
  • flushing
  • weakness
  • facial flushing
  • nasal congestion

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

Storage

This medication may be sensitive to air and moisture; therefore, it should be stored in a tightly closed container. The recommended storage temperature is between 1 to 30 degrees Celsius. This helps to maintain the efficacy of the drug for a longer time and ensures safe use.

Appearance and packaging

Appearance

Dark yellow round film-coated tablet

Package unit

30 tablets/PTP (10 tablets/PTP * 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

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.