Medication info

Tramadol Hydrochloride Injection 50 mg

Prescription medicationInjections근육 · 정맥
Ingredient · strength
Tramadol Hydrochloride›50mg
Manufacturer / importer
(주)일화
Appearance
Brown ampoule injection containing a colorless and transparent liquid
Packaging
50 ampoules/box [1 milliliter/ampoule * 50]
Approval status
Active

MFDS item code 201907653 · Notified 2019.11.01 · Insurance code 640903941

Summary

Main use
Relief of severe and moderate acute and chronic pain (such as pain from cancer, diagnosis, and postoperative pain)
Who receives it
Adults
Adult administration
Administer 50-100 mg of tramadol hydrochloride via intravenous or intramuscular injection, and repeat every 4-5 hours as needed. Up to 400 mg can be administered per day.

Ingredients

Manufacturer
(주)일화

Efficacy & effects

Relief of severe and moderate acute and chronic pain (such as pain from cancer, diagnosis, and postoperative pain)

  • Severe and moderate acute and chronic pain
  • various cancer pain
  • postoperative pain
  • pain after diagnosis
View approved original text

This medication is used to relieve severe and moderate acute and chronic pain, such as pain caused by cancer or pain that occurs after diagnosis and surgery.

How it is given

Adult administration

Administer 50-100 mg of tramadol hydrochloride via intravenous or intramuscular injection, and repeat every 4-5 hours as needed. Up to 400 mg can be administered per day.

Precautions

This medication can cause seizures if taken in doses exceeding the recommended amount; therefore, the prescribed dosage must be strictly adhered to. Additionally, patients at risk of seizures or convulsions should use this medication only when absolutely necessary. Long-term use may lead to physical and psychological dependence, requiring patients with a history of substance abuse or dependency to take it under strict supervision for a limited time. Taking this medication together with alcohol or central nervous system depressants may result in severe sedation, respiratory depression, coma, and potentially death, so it should be avoided or used with extreme caution. In particular, individuals who genetically metabolize this medication rapidly are at higher risk for respiratory depression and require dose adjustment and close monitoring. This medication should not be used in children under 12 years old or adolescents under 18 years old who have undergone tonsillectomy or adenoidectomy, and it should also be avoided in teenagers aged 12 to 18 with risk factors. Patients with acute alcohol intoxication, severe respiratory depression, severe kidney or liver impairment, pregnant or breastfeeding women, and patients taking certain medications should not use this medication. Patients with opioid dependency or a history of drug abuse, such as with morphine, should use this medication with caution due to increased risk of dependence and abuse. During treatment with this medication, drowsiness and dizziness may occur, making it advisable to avoid driving or operating dangerous machinery. Additionally, abrupt cessation of this medication can lead to withdrawal symptoms, so the dosage should be gradually reduced according to a physician's instructions. When taken in combination with other central nervous system depressants, antidepressants, antipsychotic medications, etc., the risk of side effects may increase due to interactions, so it's essential to consult healthcare professionals. In cases of overdose, serious respiratory depression and seizures may occur, and immediate medical attention is necessary.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (including angioedema), chest tightness, difficulty breathing, cold sweat, pallor, shock, anaphylaxis, severe allergic reactions, severe rash, blisters, skin peeling, pain in oral/ocular mucosa, Stevens-Johnson syndrome, severe skin reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory issues accompanied by cough and fever, respiratory depression, respiratory problems, jaundice of the skin or eyes

Mild side effects

  • Nausea
  • vomiting
  • drowsiness
  • dizziness
  • unsteadiness
  • palpitations
  • cold sweat
  • anxiety
  • vasodilation
  • hypotension
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  • arrhythmia
  • pale face
  • fainting
  • orthostatic hypotension
  • tachycardia
  • bradycardia
  • hypertension
  • headache
  • heaviness of the head
  • agitation
  • tremors
  • tinnitus
  • numbness in both hands
  • anxiety
  • lethargy
  • fatigue
  • malaise
  • sweating
  • discomfort
  • urinary difficulty
  • dry mouth
  • thirst
  • confusion
  • coordination problems
  • hallucinations
  • forgetfulness

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

Storage

This medication is sensitive to light and must be stored in an opaque container. It should also be kept at room temperature, not too hot or cold, to maintain its effectiveness.

Appearance and packaging

Appearance

Brown ampoule injection containing a colorless and transparent liquid

Package unit

50 ampoules/box [1 milliliter/ampoule * 50]

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.