Medication info
Megaspen Tablet

Megaspen Tablet

Prescription medicationTablet경구
Ingredient · strength
Tramadol Hydrochloride›37.5mg / 1 tabletAcetaminophen›325mg / 1 tablet
Manufacturer / importer
경동제약(주)
Appearance
Pale yellow oblong film-coated tablets
Packaging
For domestic use: 30 tablets/bottle, 100 tablets/bottle; for export: 100 tablets (10 tablets/PTP x 10)
Approval status
Active

MFDS item code 200804802 · Notified 2008.04.28 · Insurance code 648102530

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
It is recommended to administer an initial dose of 2 tablets, with a minimum interval of 6 hours thereafter, not to exceed 8 tablets in a day. The effective minimum dose should be administered for the shortest possible duration. For the elderly, the usual adult dosage should apply, with a minimum interval of 6 hours for those over 75 years of age. For moderate renal impairment (creatinine clearance of 10–30 ml/min), extend the dosing interval to 12 hours.
Child dose
Children over 12 years old should be administered the same dosage as adults.

Ingredients

Manufacturer
경동제약(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

It is recommended to administer an initial dose of 2 tablets, with a minimum interval of 6 hours thereafter, not to exceed 8 tablets in a day. The effective minimum dose should be administered for the shortest possible duration. For the elderly, the usual adult dosage should apply, with a minimum interval of 6 hours for those over 75 years of age. For moderate renal impairment (creatinine clearance of 10–30 ml/min), extend the dosing interval to 12 hours.

Child dose

Children over 12 years old should be administered the same dosage as adults.

Precautions

This medication can exert stress on the liver, so individuals who regularly consume more than three drinks a day should consult a doctor or pharmacist before taking it. It contains acetaminophen, which can rarely cause serious skin allergic reactions, so if any skin rash or hypersensitivity occurs, discontinue use immediately and consult a healthcare professional. The tramadol component can induce seizures; therefore, individuals with a history of seizures or those at risk of seizures should exercise caution, as the risk may increase when taken with certain antidepressants or other opioid analgesics. For patients with asthma and compromised respiratory function, this medication can pose risks and should be administered under medical supervision, considering alternatives like non-opioid analgesics. Combining with alcohol or benzodiazepines can lead to severe drowsiness, respiratory depression, and coma, so it should be used with extreme caution in such cases. Patients with increased intracranial pressure or head injuries need to be cautious as the respiratory-depressant effect of this medication may worsen their condition. This medication may cause dependence similar to morphine, thus requiring careful use to prevent potential dependence with prolonged use. Patients with impaired liver function may suffer liver damage due to the acetaminophen included in this medication, so they must consult with a doctor prior to use. Particularly, those with a variant of the CYP2D6 enzyme that acts very quickly need to be cautious, as the components of this medication may activate rapidly in their bodies, increasing the risk of respiratory depression. It is safest not to use this medication in children under 12 years old and adolescents under 18 who have undergone tonsillectomy or adenoidectomy. Patients with sleep apnea or hypoxemia may experience worsening symptoms after taking this medication, thus requiring continuous observation and dose adjustment as necessary. Elderly patients or those at risk for hyponatremia should be closely monitored for symptoms of hyponatremia while taking this medication. This medication has multiple drug interactions; therefore, anyone taking other medications must inform their physician, especially if using MAO inhibitors, antidepressants, antibiotics, or antifungals. Pregnant or breastfeeding women should consult with healthcare professionals before using this medication, as infants may experience sedation or respiratory depression as side effects during breastfeeding requiring monitoring. This medication may cause drowsiness or dizziness, necessitating caution when driving or operating machinery, and using it with alcohol may exacerbate these symptoms. In the case of overdose, severe respiratory depression, seizures, and liver damage may occur, thus the prescribed dosage must be strictly adhered to, and if overdose is suspected, immediate medical attention is required. This medication must be stored in a secure location out of the reach of children to prevent misuse or accidents.

Side effects and when to seek care immediately

Serious side effects

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

Mild side effects

  • Loss of appetite
  • insomnia
  • depression
  • dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
Show 29 more
  • diarrhea
  • indigestion
  • abdominal pain
  • abdominal discomfort
  • flatulence
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • reduced libido
  • confusion
  • disorientation
  • excitement
  • abnormal dreams
  • drug dependence
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory disturbance
  • tremors
  • paresthesia
  • inattention

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 exposure, preferably at a temperature between 1 and 30 degrees Celsius. Proper storage aids in maintaining the drug's effectiveness and prevents degradation.

Appearance and packaging

Appearance

Pale yellow oblong film-coated tablets

Package unit

For domestic use: 30 tablets/bottle, 100 tablets/bottle; for export: 100 tablets (10 tablets/PTP x 10)

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.