Medication info

Bielastraset Tablet

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›325mg / 1 tabletTramadol Hydrochloride›37.5mg / 1 tablet
Manufacturer / importer
성이바이오제약주식회사
Appearance
Pale yellow, rectangular film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 202107098 · Approved 2021.10.25

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults
Adult dose
Children aged 12 and older and adults: The dosage should be adjusted according to the patient's level of pain and therapeutic response. An initial dose of 2 tablets is recommended, thereafter maintaining a minimum interval of 6 hours, not exceeding 8 tablets per day. The lowest effective dose should be administered for as short a duration as possible. Avoid administering this medication for longer than necessary, but if prolonged use is required due to the nature and severity of the condition, regular monitoring should be conducted to verify ongoing use of this medication. Elderly Administer the usual adult dose. However, in elderly patients over 75 years, the elimination half-life of tramadol increases by 17% when orally administered, so a minimum interval of 6 hours should be maintained for this medication. Renal impairment For moderate renal impairment (creatinine clearance of 10-30 ml/min), extend the dosing interval to 12 hours. For severe renal impairment (creatinine clearance of less than 10 ml/min), administration is not recommended. Tramadol is removed very slowly during hemodialysis and filtration, so it is not necessary to re-administer this medication after dialysis for maintaining analgesic effect. Hepatic impairment In cases of moderate hepatic impairment, cautious consideration should be given to extending the dosing interval. For severe hepatic impairment, this medication should not be administered.

Ingredients

Manufacturer
성이바이오제약주식회사

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Acute pain
  • chronic pain
View approved original text

This medication is used to relieve acute and chronic pain ranging from moderate to severe.

How to take

Adult dose

Children aged 12 and older and adults: The dosage should be adjusted according to the patient's level of pain and therapeutic response. An initial dose of 2 tablets is recommended, thereafter maintaining a minimum interval of 6 hours, not exceeding 8 tablets per day. The lowest effective dose should be administered for as short a duration as possible. Avoid administering this medication for longer than necessary, but if prolonged use is required due to the nature and severity of the condition, regular monitoring should be conducted to verify ongoing use of this medication. Elderly Administer the usual adult dose. However, in elderly patients over 75 years, the elimination half-life of tramadol increases by 17% when orally administered, so a minimum interval of 6 hours should be maintained for this medication. Renal impairment For moderate renal impairment (creatinine clearance of 10-30 ml/min), extend the dosing interval to 12 hours. For severe renal impairment (creatinine clearance of less than 10 ml/min), administration is not recommended. Tramadol is removed very slowly during hemodialysis and filtration, so it is not necessary to re-administer this medication after dialysis for maintaining analgesic effect. Hepatic impairment In cases of moderate hepatic impairment, cautious consideration should be given to extending the dosing interval. For severe hepatic impairment, this medication should not be administered.

Precautions

This medication may put strain on the liver, so those who drink several servings of alcohol daily should consult with a physician or pharmacist before use. If a rash or allergic reaction occurs while taking this medication, discontinue use immediately and inform healthcare personnel. The ingredients in this medication can cause seizures, so individuals with a history of seizures or a high risk of seizures should exercise caution. Patients with impaired respiratory function or asthma may experience serious breathing problems while using this medication and should only use it in a monitored healthcare environment. Taking this medication with other sedatives or alcohol may cause respiratory depression or severe drowsiness, so co-administration should be avoided or done with extreme caution. Patients with head injuries or brain diseases should avoid this medication as there is a risk of decreased consciousness. This medication may cause dependence, so dosages and duration should be adjusted according to a physician's instructions when used for extended periods. Patients with severe liver or kidney impairment should avoid this medication or use it cautiously after consulting a physician. This medication should not be administered to children, especially those under 12 years of age, or to adolescents under 18 years of age after tonsil or adenoid surgery. Women who are pregnant or breastfeeding should consult a physician before taking this medication, and breastfeeding mothers are advised to discontinue breastfeeding while using this medication. This medication may cause drowsiness or dizziness, so caution is needed when driving or operating machinery. In case of overdose, serious respiratory depression, seizures, liver damage, and other complications may occur, so adhere to the prescribed dosage and immediately visit a medical facility if unusual symptoms arise. There may be potential interactions with other medications during use, so inform healthcare personnel about any other medications being taken.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, paleness, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, difficulty breathing or shortness of breath, asthma attack, abnormal breathing accompanied by cough + fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, vision abnormalities, paralysis, urinary retention

Mild side effects

  • Loss of appetite
  • insomnia
  • depression
  • dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
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  • diarrhea
  • indigestion
  • abdominal pain
  • abdominal discomfort
  • flatulence
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • nervous irritability
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • spatial disorientation
  • excitement
  • abnormal dreams
  • substance abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • drowsiness
  • sensory impairment
  • tremor
  • sensation loss

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

Storage

This medication should be stored in a sealed container to prevent air or moisture from entering. It is recommended to maintain the storage temperature between 1 degree and 30 degrees Celsius. This will help keep the medication's effectiveness and safety for a longer period.

Appearance and packaging

Appearance

Pale yellow, rectangular film-coated tablets

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.