Medication info

Initramadol Injection (Tramadol Hydrochloride)

Prescription medicationExpired
Ingredient · strength
Tramadol Hydrochloride›Strength being verified
Manufacturer / importer
(주)비보존제약
Appearance
A colorless, transparent ampoule filled with a clear, colorless liquid
Packaging
1 ml/ampoule x 50 ampoules
Approval status
Expired

MFDS item code 201802105 · Notified 2018.05.18

This product's status changed to Expired on 2023.05.18. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of severe and moderate acute and chronic pain (e.g., cancer, pain after diagnosis and surgery)
Who uses it
Adults
Adult dosage
As Tramadol Hydrochloride, administer 50-100 mg by intravenous or intramuscular injection, and repeat every 4-5 hours as needed. The maximum daily dosage is 400 mg.

Ingredients

Manufacturer
(주)비보존제약

Efficacy & effects

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

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

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

Dosage and Administration

Adult dosage

As Tramadol Hydrochloride, administer 50-100 mg by intravenous or intramuscular injection, and repeat every 4-5 hours as needed. The maximum daily dosage is 400 mg.

Precautions

This medication can cause seizures if the recommended dose is exceeded, so the prescribed dosage must be strictly followed. Especially in patients with epilepsy or those at risk of seizures, this medication should only be used when strictly necessary. Prolonged use may result in psychological and physical dependence, and patients with a history of substance misuse should be monitored carefully. Taking this medication with alcohol or central nervous system depressants can cause severe drowsiness, respiratory depression, and loss of consciousness, so concurrent use should be avoided. Special caution is needed in patients with rapid action of the CYP2D6 enzyme, as excessive formation of the active metabolite can increase the risk of respiratory depression. This medication is not for use in children under 12 years of age or in adolescents under 18 years of age who have undergone tonsillectomy or adenoidectomy. When using ampoule injectable products, care should be taken to avoid contamination with glass fragments, and extra caution should be taken when used in children or the elderly. This medication should not be administered to individuals who are acutely intoxicated with alcohol, those with central nervous system drug overdoses, severe respiratory depression, head injury patients, or those taking MAO inhibitors. It should not be used in patients with severely impaired liver or kidney function, or in pregnant or breastfeeding women. When administering this medication, drowsiness or dizziness may occur, so driving or operating dangerous machinery should be avoided. Prolonged use may lead to tolerance requiring dose increases, and abrupt cessation may cause dependence and withdrawal symptoms, so the dose should be reduced gradually. This medication increases the risk of side effects when taken with other central nervous system depressants, so when taken together, dosages should be reduced and the patient closely monitored. In case of overdose, severe respiratory depression and seizures may occur, requiring immediate emergency treatment, and naloxone may be used as an antidote. Store this product out of the reach of children, and keep it in its original container to prevent misuse or degradation in quality.

Side effects and when to seek care immediately

Serious side effects

Seizures, hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions, severe rash with high fever, blisters, skin peeling, mucosal pain in the mouth/eyes, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, jaundice, generalized malaise, liver abnormalities (jaundice), sudden

Mild side effects

  • Nausea
  • vomiting
  • drowsiness
  • dizziness
  • lightheadedness
  • palpitations
  • coldness
  • restlessness
  • vasodilation
  • hypotension
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  • arrhythmia
  • facial pallor
  • fainting
  • orthostatic hypotension
  • tachycardia
  • bradycardia
  • headache
  • heaviness in the head
  • excitement
  • tremors
  • tinnitus
  • numbness in both hands
  • anxiety
  • weakness
  • fatigue
  • lethargy
  • sweating
  • discomfort
  • urinary difficulties
  • dry mouth
  • thirst
  • confusion
  • impaired coordination
  • hallucinations
  • forgetfulness
  • concentration difficulties

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

Storage

This medication should be stored in a sealed container to prevent air or moisture ingress. The storage temperature should be kept between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

A colorless, transparent ampoule filled with a clear, colorless liquid

Package unit

1 ml/ampoule 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.