Medication info
Levobalsartan Tablet 2.5/160 mg

Levobalsartan Tablet 2.5/160 mg

Prescription medicationTablet경구
Ingredient · strength
Valsartan›160mg / 1 tabletS-Amlodipine Besylate 2.5 Hydrate›3.74mg / 1 tablet
Manufacturer / importer
안국뉴팜(주)
Appearance
Dark yellow rectangular film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201903024 · Approved 2019.05.10 · Insurance code 053601210

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 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 blood pressure control is inadequate, a switch to this medication after individual component monotherapy may be considered. Examples of dosages include 2.5/80 mg, 2.5/160 mg, and 5/160 mg. Patients with renal impairment should have dosage adjustments if they have mild to moderate impairment.
Child dose
The safety and efficacy of this medication in pediatric patients under 18 years of age have not been established, so its use is not recommended.

Ingredients

Manufacturer
안국뉴팜(주)

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 with monotherapy using S-Amlodipine (Amlodipine) or Valsartan. It helps to lower and control blood pressure, thereby reducing the risk of cardiovascular complications. It effectively aids patients who have difficulty in managing hypertension to control their blood pressure. Regular intake contributes to maintaining healthy blood pressure levels. It is used for the treatment of essential hypertension due to these benefits.

How to take

Adult dose

The recommended dose of this medication is one 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 blood pressure control is inadequate, a switch to this medication after individual component monotherapy may be considered. Examples of dosages include 2.5/80 mg, 2.5/160 mg, and 5/160 mg. Patients with renal impairment should have dosage adjustments if they have mild to moderate impairment.

Child dose

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

Precautions

This medication can cause serious harm to the fetus if taken during the second and third trimesters of pregnancy, so it should be discontinued immediately if pregnancy is confirmed. Patients allergic to the active ingredients or similar medications, pregnant or nursing women, individuals with severe kidney or liver disease, and those with certain heart conditions should not take this medication. Patients with sodium or fluid depletion may experience hypotension, so their condition should be carefully assessed prior to use, and blood pressure and status should be closely monitored during treatment. Patients with high potassium levels or those taking potassium-containing medications should have their potassium levels checked regularly, and caution is needed for patients with poor kidney function. Renal transplant recipients or those with a history of angioedema may face risks when taking this medication, requiring special attention. Patients with heart failure or post-myocardial infarction should have their kidney function and blood pressure regularly evaluated while on this medication, and some heart disease patients should exercise caution when using it. The risk of hypotension, worsening kidney function, and hyperkalemia may increase when this medication is taken in conjunction with other antihypertensives, so it should be taken under medical supervision. Side effects such as dizziness, headache, edema, rash, and cough may occur; if any unusual symptoms arise, consultation with a healthcare professional is advised. Dizziness or fatigue may occur when driving or operating machinery, so caution is warranted. Women who are pregnant or planning to become pregnant should not take this medication, and it is also not recommended for nursing mothers. The safety and efficacy of this medication have not been established in children under 18 years of age, so it is not recommended for this population. Severe hypotension or heart abnormalities may occur in cases of overdose, so it is important to comply with the prescribed dosage, and in case of overdose, seek immediate medical attention.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizure, altered consciousness, visual disturbances, paralysis, urination.

Mild side effects

  • Nasopharyngitis
  • influenza
  • hypersensitivity
  • visual disturbances
  • anxiety
  • headache
  • dizziness
  • drowsiness
  • orthostatic dizziness
  • paresthesia
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  • vertigo
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
  • hypotension
  • cough
  • pain in the pharynx and larynx
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • back pain
  • arthritis
  • muscle cramps
  • lethargy
  • polyuria
  • diuresis
  • erectile dysfunction
  • edema
  • etc.

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 sealed container. It is advisable to keep it at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the efficacy of the medication for a longer period.

Appearance and packaging

Appearance

Dark yellow rectangular film-coated tablet

Package unit

30 tablets/bottle, 300 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.