Medication info
Ultrapen Tablet

Ultrapen Tablet

Prescription medicationTablet경구
Ingredient · strength
Tramadol Hydrochloride›37.5mg / 1 tabletAcetaminophen›325mg / 1 tablet
Manufacturer / importer
영풍제약(주)
Appearance
Light yellow rectangular film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 200804556 · Notified 2008.04.23 · Insurance code 661902090

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
Children over 12 years and adults: Dosage should be adjusted according to the level of pain and treatment response. It is recommended to start with a dose of 2 tablets, and thereafter the dosing interval should be at least 6 hours apart but not exceed 8 tablets per day. The effective lowest dose should be used for the shortest duration possible. Avoid unnecessary prolonged usage of this medication, and if long-term administration is needed due to the nature and severity of the disease, regular monitoring should be conducted to assess the necessity of continuous use of this medication.
Child dose
Children over 12 years and adults: Dosage should be adjusted according to the level of pain and treatment response. It is recommended to start with a dose of 2 tablets, and thereafter the dosing interval should be at least 6 hours apart but not exceed 8 tablets per day.

Ingredients

Manufacturer
영풍제약(주)

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 moderate to severe acute and chronic pain.

How to take

Adult dose

Children over 12 years and adults: Dosage should be adjusted according to the level of pain and treatment response. It is recommended to start with a dose of 2 tablets, and thereafter the dosing interval should be at least 6 hours apart but not exceed 8 tablets per day. The effective lowest dose should be used for the shortest duration possible. Avoid unnecessary prolonged usage of this medication, and if long-term administration is needed due to the nature and severity of the disease, regular monitoring should be conducted to assess the necessity of continuous use of this medication.

Child dose

Children over 12 years and adults: Dosage should be adjusted according to the level of pain and treatment response. It is recommended to start with a dose of 2 tablets, and thereafter the dosing interval should be at least 6 hours apart but not exceed 8 tablets per day.

Precautions

This medication may cause liver damage if taken by individuals who regularly consume more than three alcoholic beverages daily; consultation with a doctor or pharmacist is required. Rarely, serious skin reactions may occur with this medication. If a rash or allergic symptoms develop, discontinue use immediately and consult with medical personnel. One of the active ingredients, tramadol, may increase the risk of seizures, and this risk may be further elevated when taken with certain antidepressants or other narcotic analgesics, so caution is necessary. In rare cases, a life-threatening anaphylaxis reaction may occur with this medication, so if allergic symptoms arise, visit a medical facility immediately. Patients with acute and severe bronchial asthma have a higher risk of respiratory depression when taking this medication; administration should occur in an environment where monitoring is possible. Taking this medication with alcohol or central nervous system depressants can lead to severe drowsiness, respiratory depression, or even coma, therefore co-administration should either be avoided or conducted under medical supervision. Patients with elevated intracranial pressure or those who have a head injury may experience worsening of their condition due to respiratory depression from this medication, so caution is advised. This medication can lead to physical and psychological dependency; therefore, usage should be carefully monitored for dependency if used for an extended period. Patients with impaired liver function are at risk of liver damage when taking this medication, so consult with a doctor before usage. Especially in ultra-rapid metabolizers of CYP2D6, the active metabolite of this medication may increase quickly, raising the risk of respiratory depression, thus necessitating dosage adjustment and monitoring. This medication should not be administered to children under 12 years or adolescents under 18 years who have undergone tonsillectomy or adenoidectomy. Adolescents aged 12 to 18 should also avoid taking it if they have risk factors. This medication may cause sleep apnea and hypoxemia, so continuous observation is necessary for symptoms or exacerbation, and dosage may need to be reduced or discontinued if needed. Elderly patients and those at risk of hyponatremia should be closely monitored for occurrences of hyponatremia while taking this medication. This medication may interact with certain drugs, so inform medical personnel if other medications are being taken, particularly with warnings against co-administration with MAO inhibitors, antidepressants, or central nervous system depressants. Women who are pregnant or may become pregnant should consult a doctor before taking this medication, and nursing mothers should avoid use as it may cause sedation or respiratory depression in infants. This medication may cause drowsiness or dizziness, so caution is needed when driving or operating machinery. In case of overdose, severe respiratory depression, seizures, and liver damage may occur, so adhere to the prescribed dosage and seek immediate emergency treatment in the event of overdose. Store in a secure location out of reach of children to prevent accidental ingestion or misuse.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pale skin, severe rash accompanied by fever, blisters, skin peeling, pain in mouth/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), severe lethargy, sudden and intense headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Decreased appetite
  • insomnia
  • depression
  • dizziness
  • headaches
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
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  • diarrhea
  • indigestion
  • abdominal pain
  • abdominal discomfort
  • flatulence
  • itching
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • nervousness
  • mood instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • disorientation
  • agitation
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • drowsiness
  • sensory impairment
  • tremors
  • loss of sensation

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 from entering, and it is best stored at room temperature between 1 degree and 30 degrees Celsius. Storing in this manner will help maintain the medication's efficacy for a longer period.

Appearance and packaging

Appearance

Light 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.