Medication info
Balten X Tablet 5/160 mg

Balten X Tablet 5/160 mg

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.94mg / 1 tabletValsartan›160mg / 1 tablet
Manufacturer / importer
동광제약(주)
Appearance
Dark yellow oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201308570 · Approved 2013.07.31 · Insurance code 645905470

Summary

Main use
Improvement of blood pressure control in essential hypertension with the combination of amlodipine and valsartan
Who takes it
Adults · Children
Adult dose
The recommended dose of this medication is 1 tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). Available dosages are 5/80 mg, 5/160 mg, and 10/160 mg, and the specific dosages are used when blood pressure is not controlled with the monotherapy of the individual components. For patients with renal impairment, dose adjustment is not needed in mild to moderate cases.
Child dose
The safety and efficacy of this medication in pediatric patients under the age of 18 have not been established, so its use is not recommended.

Ingredients

Manufacturer
동광제약(주)

Efficacy & effects

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

  • Essential hypertension
View approved original text

This medication effectively lowers blood pressure in patients with essential hypertension who have difficulty controlling blood pressure with either amlodipine or valsartan monotherapy. Proper blood pressure control is crucial for reducing the risk of cardiovascular diseases, and this medication is used to enhance health through adequate blood pressure management.

How to take

Adult dose

The recommended dose of this medication is 1 tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). Available dosages are 5/80 mg, 5/160 mg, and 10/160 mg, and the specific dosages are used when blood pressure is not controlled with the monotherapy of the individual components. For patients with renal impairment, dose adjustment is not needed in mild to moderate cases.

Child dose

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

Precautions

This medication can cause serious harm to the fetus when taken during pregnancy, especially in the second and third trimesters, so it should be stopped immediately if pregnancy is confirmed. This medication should not be used in patients with hypersensitivity to its ingredients, pregnant women or those who may become pregnant, nursing mothers, or patients with severe kidney or liver diseases. Patients with low sodium or fluid levels may experience hypotension, so their condition should be assessed before starting the medication, and blood pressure should be closely monitored during use. Patients with high potassium levels or those taking medications that can increase potassium should have their potassium levels frequently checked. For patients with renal vascular issues or those who have recently undergone kidney transplantation, kidney function must be closely monitored before using this medication. If symptoms of angioedema occur, use should be stopped immediately, and it should not be readministered. Patients with heart failure or those who have had a myocardial infarction should carefully monitor kidney function while taking this medication, as there may be risks for worsening heart failure. Caution is needed when driving or operating machinery, as dizziness or fatigue may occur. This medication may interact with other antihypertensives or specific drugs; therefore, it is essential to consult with a healthcare provider if any other medications are being taken. In cases of overdose, hypotension or cardiac-related symptoms may occur, so the dosage must be strictly followed, and medical attention should be sought immediately if any symptoms develop. It is not recommended for children or adolescents under 18 years old, as safety and efficacy have not been adequately established. Elderly patients may use similar dosages as the general adult population, but administration should be done with careful monitoring of their condition. It is important to regularly check blood pressure, kidney function, and electrolyte levels during the use of this medication to ensure there are no abnormalities.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), angioedema, intestinal angioedema, vasculitis, angioedema, Stevens-Johnson syndrome, serious allergic reactions, severe skin reactions, jaundice, hepatitis, hives, Stevens-Johnson syndrome, severe neurological symptoms, fainting, severe swelling or urination abnormalities, renal failure, kidney damage, acute renal failure, thrombocytopenia, leukopenia, confusion, exfoliative dermatitis, toxic epidermal necrolysis, heart failure.

Mild side effects

  • Nasopharyngitis
  • influenza
  • hypersensitivity
  • visual disturbances
  • anxiety
  • headache
  • dizziness
  • drowsiness
  • postural dizziness
  • sensory abnormalities
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  • vertigo
  • tinnitus
  • tachycardia
  • palpitations
  • fainting
  • orthostatic hypotension
  • hypotension
  • cough
  • sore throat and larynx
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • low back pain
  • arthritis
  • muscle cramps
  • weakness
  • frequent urination
  • polyuria
  • erectile dysfunction
  • edema
  • etc.

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air and moisture and kept at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Dark yellow oval film-coated tablet

Package unit

30 tablets/bottle, 100 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.