Medication info
Arappen Tablet

Arappen Tablet

Prescription medicationTablet경구
Ingredient · strength
Tramadol Hydrochloride›37.5mg / 1 tabletAcetaminophen›325mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
Pale yellow, rectangular film-coated tablet
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 200707944 · Notified 2007.07.10 · Insurance code 693900300

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
Children aged 12 and older and adults: Dosage should be adjusted according to the severity of the pain and treatment response. Initial dosage is recommended at 2 tablets, with subsequent dosing intervals of at least 6 hours, and should not exceed 8 tablets in a day. Administer the lowest effective dosage for the shortest duration possible. Elderly: Administer the usual adult dosage, ensuring that those over 75 years are given doses at least 6 hours apart. Renal impairment patients: In moderate renal impairment patients (creatinine clearance 10-30 ml/min), dosing interval should be extended to 12 hours. Not recommended for severe renal impairment patients (creatinine clearance below 10 ml/min). Tramadol is eliminated very slowly during blood dialysis and filtration, so re-administration after dialysis is not required to maintain analgesic effect.
Child dose
No separate pediatric dosage indicated for children aged 12 and older and adults.

Ingredients

Manufacturer
(주)셀트리온제약

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate to severe acute pain
  • chronic pain
View approved original text

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

How to take

Adult dose

Children aged 12 and older and adults: Dosage should be adjusted according to the severity of the pain and treatment response. Initial dosage is recommended at 2 tablets, with subsequent dosing intervals of at least 6 hours, and should not exceed 8 tablets in a day. Administer the lowest effective dosage for the shortest duration possible. Elderly: Administer the usual adult dosage, ensuring that those over 75 years are given doses at least 6 hours apart. Renal impairment patients: In moderate renal impairment patients (creatinine clearance 10-30 ml/min), dosing interval should be extended to 12 hours. Not recommended for severe renal impairment patients (creatinine clearance below 10 ml/min). Tramadol is eliminated very slowly during blood dialysis and filtration, so re-administration after dialysis is not required to maintain analgesic effect.

Child dose

No separate pediatric dosage indicated for children aged 12 and older and adults.

Precautions

This medication may cause liver damage if taken by individuals who regularly consume more than three alcoholic drinks a day, so it is essential to consult a physician or pharmacist. If significant skin reactions such as skin rashes or itching occur while taking this medication, discontinue use immediately and seek medical attention. Patients with a history of seizures or those taking medications that may induce seizures should use this drug with caution due to the risk of seizures. Administration in patients with acute and severe asthma may pose life-threatening risks and should only be done in a facility equipped for such care. Combining this medication with alcohol or central nervous system depressants can cause severe drowsiness, respiratory depression, and coma, so such combinations should be avoided. Patients with increased intracranial pressure or head injuries may see worsened symptoms with use of this medication, therefore caution is necessary. This medication may result in psychological and physical dependence, thus long-term use should be under a physician's guidance. Patients with impaired liver function should be cautious as one of the ingredients may strain the liver, and consultation with a physician is required before use. Patients with specific genetic metabolic characteristics may experience elevated levels of the active ingredient, leading to severe respiratory depression, so caution is advised. This medication is not to be administered to children under the age of 12 or to certain postoperative pediatric patients. Patients with sleep apnea or hypoxia should be closely monitored as symptoms may worsen during use of this medication. Drowsiness or dizziness may occur while taking this medication, so caution is advised while driving or operating machinery. Overdose may lead to serious side effects such as respiratory depression, seizures, and liver damage, so it is crucial to adhere to prescribed dosages and seek medical help for any unusual symptoms. Using this medication alongside other analgesics or drugs containing acetaminophen increases the risk of liver damage, so such combinations should be avoided. Women who are pregnant or breastfeeding must consult a physician before taking this medication, as it may be transmitted through breast milk and pose risks to the baby. If any allergic reactions or breathing difficulties occur during use of this medication, notify medical personnel immediately. This medication may interact with various other drugs, so inform your physician or pharmacist of any other medications currently being taken. Elderly patients may have weaker liver, kidney, or heart functions, so they should be observed more closely while taking this medication. This medication should be stored in a safe place out of the reach of children, and precautions should be taken to prevent misuse by others.

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 the skin or eyes (jaundice), extreme drowsiness, sudden and severe headaches, thunderclap headaches, seizures, confusion of consciousness, vision abnormalities, paralysis, urinary retention

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
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • spatial disorientation
  • excitement
  • abnormal dreams
  • substance abuse
  • hallucinations
  • withdrawal syndrome
  • migraines
  • drowsiness
  • sensory impairment
  • tremors
  • sensory changes

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

Storage

This medication should be stored in a sealed container that prevents air from entering and kept at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

Pale yellow, rectangular film-coated tablet

Package unit

30 tablets/bottle, 500 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.