Medication info
Uniprazole 5/80 mg

Uniprazole 5/80 mg

Prescription medicationTablet경구
Ingredient · strength
Valsartan›80mg / 1 tabletAmlodipine Besylate›6.94mg / 1 tablet
Manufacturer / importer
한국유니온제약(주)
Appearance
Dark yellow round film-coated tablet
Packaging
28 tablets (14 tablets/Alu-Alu X 2)
Approval status
Active

MFDS item code 201309146 · Approved 2013.08.30 · Insurance code 665506450

Summary

Main use
Improvement of blood pressure control in essential hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage of this medication is to take one tablet once daily, with or without food, preferably at the same time each day (e.g., in the morning). In patients with mild to moderate renal impairment, dose adjustment is not necessary, but patients with severe renal impairment or those on dialysis should not be administered this medication. For patients with mild to moderate hepatic impairment, the daily dose of Valsartan should not exceed 80 mg.
Child dose
Safety and efficacy in pediatric patients under 18 years old have not been established, and therefore the administration of this medication is not recommended.

Ingredients

Manufacturer
한국유니온제약(주)

Efficacy & effects

Improvement of blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

This medication is used in patients with essential hypertension who do not achieve adequate blood pressure control with either Amlodipine or Valsartan monotherapy. It helps to effectively manage high blood pressure and reduce the risk of cardiovascular complications. Therefore, it is used to maintain stable blood pressure control.

How to take

Adult dose

The recommended dosage of this medication is to take one tablet once daily, with or without food, preferably at the same time each day (e.g., in the morning). In patients with mild to moderate renal impairment, dose adjustment is not necessary, but patients with severe renal impairment or those on dialysis should not be administered this medication. For patients with mild to moderate hepatic impairment, the daily dose of Valsartan should not exceed 80 mg.

Child dose

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

Precautions

This medication can cause serious harm to the fetus if taken during pregnancy, especially in the second and third trimesters, so it should be discontinued immediately upon confirmation of pregnancy. This medication should not be used in women who are allergic to the active ingredients, pregnant or breastfeeding, patients with severe renal or liver disease, or those with certain heart diseases. Caution is required when administering this medication to patients with insufficient sodium or fluid levels in the body, as there is a risk of excessively low blood pressure, and appropriate treatment must be received immediately if symptoms of hypotension occur. Patients with high potassium levels or those taking medications that may increase potassium levels should have their potassium levels monitored frequently. This medication should be used carefully in patients with renal artery stenosis or those who have received a kidney transplant, as it may impact renal function. If symptoms of angioedema occur, treatment should be stopped immediately and should not be resumed, and patients recovering from heart failure or myocardial infarction should use it while periodically monitoring renal function. Special caution is needed when administering to patients with acute myocardial infarction or certain valve diseases. When used in combination with other blood pressure medications, there may be an increased risk of hypotension, worsening renal function, and hyperkalemia, so blood pressure, renal function, and electrolyte status should be closely monitored during combined therapy. Caution is advised while driving or operating machinery as dizziness or fatigue may occur. In case of overdose, severe hypotension or abnormal heart rate may arise, requiring immediate medical attention. Furthermore, this medication is not recommended for patients under 18 years of age due to insufficient evidence of safety and efficacy.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in oral/ocular mucous membranes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination issues.

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • paresthesia
  • vertigo
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
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  • hypotension
  • cough
  • throat and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • low back pain
  • arthritis
  • muscle cramps
  • lethargy
  • polyuria
  • nocturia
  • erectile dysfunction
  • edema
  • non-specific edema
  • facial edema
  • peripheral edema
  • fatigue
  • flushing
  • asthenia
  • facial flushing
  • nasal bleeding.

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

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture ingress, and it is best kept at room temperature between 1 and 30 degrees Celsius. This way, the medication's effectiveness can be well maintained.

Appearance and packaging

Appearance

Dark yellow round film-coated tablet

Package unit

28 tablets (14 tablets/Alu-Alu X 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.