Medication info

Doran-jjinju 50mg (Tramadol Hydrochloride)

Prescription medicationInjections근육 · 정맥
Ingredient · strength
Tramadol Hydrochloride›50mg / 1mL
Manufacturer / importer
삼성제약(주)
Appearance
Brown ampoule injection containing a colorless transparent liquid
Packaging
1 ampoule (1mL) x 50 ampoules
Approval status
Active

MFDS item code 198700215 · Notified 1987.11.24 · Insurance code 642300341

Summary

Main use
Relief of severe and moderate acute and chronic pain (cancer, pain after diagnosis and surgery, etc.)
Who receives it
Adults
Adult administration
As Tramadol Hydrochloride, administer 50-100mg by intravenous or intramuscular injection and repeat every 4-5 hours as needed. A maximum of 400mg can be administered per day.

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

Relief of severe and moderate acute and chronic pain (cancer, pain after diagnosis and surgery, etc.)

  • Severe pain
  • moderate acute and chronic pain
  • various cancer pain
  • post-diagnostic pain
  • post-surgical pain
View approved original text

This medication is used to relieve severe and moderate acute and chronic pain, for example, pain caused by various cancers or pain occurring after diagnosis and surgery.

How it is given

Adult administration

As Tramadol Hydrochloride, administer 50-100mg by intravenous or intramuscular injection and repeat every 4-5 hours as needed. A maximum of 400mg can be administered per day.

Precautions

This medication may cause seizures if taken in excess of the recommended dose; therefore, it should be used with caution in patients who are particularly at risk for seizures or epilepsy. Long-term use can lead to psychological and physical dependence; therefore, it should be administered for short periods under strict supervision in patients with a history of drug abuse or dependence. Taking this medication with alcohol or central nervous system depressants from the benzodiazepine class can significantly increase the risk of severe drowsiness, respiratory depression, and coma, and such combinations should be avoided. Individuals who metabolize this medication rapidly due to genetic factors may experience increased accumulation of the drug, raising the risk of respiratory depression; thus, dosage adjustment and monitoring of symptoms are necessary in such cases. This medication should not be used in children under 12 years old or adolescents under 18 years old who have undergone tonsillectomy and adenoidectomy. Special caution should also be taken when administering to adolescents between the ages of 12 and 18 with specific risk factors. When using the ampoule injection, glass fragments may be present, so care should be taken when cutting the container, especially when administering to children or the elderly. This medication should not be administered to patients with acute alcohol intoxication, severe respiratory depression, severe liver or kidney disorders, pregnant or nursing women, and patients taking certain medications. Care must be taken if this medication is used in combination with morphine or other opioids, as withdrawal symptoms may occur; also, caution is warranted in patients who consume alcohol or are on central nervous system depressants. During treatment, drowsiness and dizziness may occur, so driving or operating dangerous machinery should be avoided. Long-term use of this medication may lead to tolerance, necessitating dosage increases, and abrupt discontinuation may lead to withdrawal symptoms; therefore, the dosage should be gradually reduced. In case of overdose, severe respiratory depression and seizures may occur, requiring immediate emergency treatment, with naloxone as an antidote. This medication may interact with various drugs; therefore, patients should consult their doctor or pharmacist before taking other medications. Pregnant or nursing women should not use this medication, especially while nursing, as severe adverse effects may occur in infants. All patients receiving this medication should be closely monitored for adverse reactions and should consult healthcare professionals immediately if any adverse symptoms occur.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions (shock, anaphylaxis, anaphylactic symptoms), severe rash with high fever, blisters, skin peeling, pain in oral and ocular mucosa, severe skin reactions (Stevens-Johnson syndrome), shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, respiratory distress, respiratory depression, impaired liver function,

Mild side effects

  • Drowsiness
  • dizziness
  • headache
  • heaviness in the head
  • excitement
  • tremors
  • tinnitus
  • anxiety
  • fatigue
  • lethargy
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  • sweating
  • staggering
  • discomfort
  • difficulty urinating
  • dry mouth
  • thirst
  • coordination difficulties
  • dysphoria
  • restlessness
  • sleep disturbances
  • cognitive impairment
  • hallucinations
  • amnesia
  • concentration difficulties
  • depression
  • changes in appetite
  • sensory disturbances
  • hiccups
  • nausea
  • vomiting
  • abdominal bloating
  • abdominal distension
  • abdominal pain
  • loss of appetite
  • constipation
  • gastrointestinal irritation
  • hypertonia
  • motor weakness
  • urinary retention

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

Storage

This medication is sensitive to light, so it should be stored in a container that is not transparent to light. It is advisable to store it at room temperature between 1°C and 30°C. It is important to avoid excessively hot or cold places and to maintain an appropriate temperature at all times.

Appearance and packaging

Appearance

Brown ampoule injection containing a colorless transparent liquid

Package unit

1 ampoule (1mL) x 50 ampoules

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.