Medication info

Orphen Sustained Release Tablet

Prescription medicationTablet경구Expired
Ingredient · strength
Acetaminophen›325mg / 1 tabletTramadol Hydrochloride›75mg / 1 tablet
Manufacturer / importer
대우제약(주)
Appearance
Pale yellow rectangular sustained-release film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 202002827 · Approved 2020.04.21

This product's status changed to Expired on 2025.04.21. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults
Adult dose
The initial recommended dose is 1 tablet, after which the interval between doses should be at least 12 hours, but no more than 4 tablets per day should be taken. Long-term use of this medication should be avoided unless regularly monitored, and the necessity for its continuation should be reassessed. For the elderly, the standard adult dosage is recommended, but for those aged 75 and older, an interval of at least 12 hours is required.

Ingredients

Manufacturer
대우제약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate acute pain
  • severe 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

The initial recommended dose is 1 tablet, after which the interval between doses should be at least 12 hours, but no more than 4 tablets per day should be taken. Long-term use of this medication should be avoided unless regularly monitored, and the necessity for its continuation should be reassessed. For the elderly, the standard adult dosage is recommended, but for those aged 75 and older, an interval of at least 12 hours is required.

Precautions

This medication poses a risk of liver damage; therefore, individuals who regularly consume more than three alcoholic beverages a day should consult a physician or pharmacist. This medication can rarely cause severe rashes or allergic reactions on the skin; if a rash or hypersensitivity reaction occurs after taking it, discontinuation should occur immediately. One of the ingredients in this medication may increase the risk of seizures, so individuals with a history of seizures or those at high risk for seizures should take caution. During treatment with this medication, there is a rare possibility of severe allergic reactions, so if symptoms such as difficulty breathing or facial swelling occur, medical personnel should be informed immediately. Acute bronchial asthma patients may experience difficulty breathing when taking this medication, so administration should be done in a facility equipped with medical equipment. This medication may cause severe drowsiness, respiratory depression, or coma if taken with alcohol or central nervous system depressants; therefore, co-administration should be avoided or done under a physician’s guidance. Patients with head injuries or brain diseases should be cautious as the respiratory depressant effect of this medication may worsen their symptoms. This medication can cause psychological and physical dependence, so careful monitoring for the development of dependence is recommended during long-term use. Patients with poor liver function should consult a physician before taking this medication and should not exceed the daily recommended dose to reduce the risk of liver damage. Patients with certain genotypes may metabolize this medication more rapidly, increasing the risk of respiratory depression; dosage adjustments or alternative medications may be necessary in such cases. Children under 12 years old or those who have had certain surgeries under 18 years old should not take this medication; teenagers aged 12 to 18 should avoid it if they have specific risk factors. This medication may cause hyponatremia, so symptoms should be monitored during use, especially in older patients or those at risk for hyponatremia. This medication should not be administered to individuals with hypersensitivity to any ingredients, central nervous system drug abusers, severe respiratory depression patients, head injury patients, those taking MAO inhibitors, patients with severe liver, kidney, or heart disorders, nursing mothers, or children under 12 years old. The risk of seizures and respiratory depression may increase when this medication is taken with other opioids or central nervous system depressants, so it must be taken according to a physician's instructions. Those taking this medication should be cautious about engaging in hazardous activities such as driving or operating machinery, as drowsiness or dizziness may occur. Serious side effects such as respiratory depression, coma, liver damage, etc., may occur with overdose, so if an overdose is suspected, immediate contact with a medical institution is essential. Discontinuation of this medication abruptly may lead to withdrawal symptoms such as anxiety, insomnia, and sweating, so it is safer to gradually taper off under the guidance of a physician. Pregnant women or nursing mothers should consult a physician before taking this medication, especially nursing mothers as the ingredients may pass into breast milk and pose risks to the baby. Elderly patients should be monitored carefully as they may have impaired liver and kidney function when taking this medication.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, paleness, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, seizures, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), severe lethargy, sudden and severe headaches, lightning headaches, confusion of consciousness, visual disturbances, paralysis, significantly reduced urine output, full-body extreme symptoms

Mild side effects

  • Weakness
  • fatigue
  • flushing
  • stiffness
  • fainting
  • withdrawal symptoms
  • hypertension
  • worsening hypertension
  • hypotension
  • arrhythmia
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  • palpitations
  • tachycardia
  • dizziness
  • headache
  • tremor
  • ataxia
  • tension
  • migraine
  • worsening migraine
  • involuntary muscle contractions
  • sensory disturbances
  • confusion
  • dizziness
  • abdominal pain
  • constipation
  • diarrhea
  • dyspepsia
  • flatulence
  • dry mouth
  • nausea
  • vomiting
  • dysphagia
  • bloody stool
  • tongue swelling
  • decreased appetite
  • anxiety
  • confusion
  • insomnia
  • irritability
  • drowsiness

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

Storage

This medication should be stored in a sealed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the effectiveness and safety of the medication for a long period.

Appearance and packaging

Appearance

Pale yellow rectangular sustained-release 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

No questions yet.

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.