Medication info

Shinil Tramadol Hydrochloride Injection 100 mg

Prescription medicationInjections근육 · 정맥Approval withdrawn
Ingredient · strength
Tramadol Hydrochloride›50mg / 1mL
Manufacturer / importer
신일제약(주)
Appearance
A brown ampoule injection filled with a colorless and transparent liquid
Packaging
2 mL/ampoule X 50
Approval status
Approval withdrawn

MFDS item code 199602181 · Notified 1996.07.18

This product's status changed to Approval withdrawn on 2023.11.24. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of severe and moderate acute chronic pain (e.g., cancer, post-diagnostic and post-surgical pain)
Who receives it
Adults
Adult administration
Administer 50-100 mg of tramadol hydrochloride intravenously or intramuscularly, and repeat as needed every 4-5 hours. The maximum daily dose can be 400 mg.

Ingredients

Manufacturer
신일제약(주)

Efficacy & effects

Relief of severe and moderate acute chronic pain (e.g., cancer, post-diagnostic and post-surgical pain)

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

This medication is used for the relief of severe and moderate acute chronic pain, particularly pain caused by various cancers and pain that occurs after diagnosis and surgery.

How it is given

Adult administration

Administer 50-100 mg of tramadol hydrochloride intravenously or intramuscularly, and repeat as needed every 4-5 hours. The maximum daily dose can be 400 mg.

Precautions

This medication may cause seizures if used in excess of the recommended dosage, and caution is required, especially in patients with a history of epilepsy or seizure risks. It should only be administered carefully when necessary. Prolonged use can lead to psychological and physical dependence, so it should only be used for a short duration under strict supervision in patients with a history of drug abuse or dependency. Concurrent use with alcohol or central nervous system depressants can lead to severe sedation, respiratory depression, coma, or even death, so caution is needed when used together. Patients who metabolize this medication quickly due to genetic factors may have an increased risk of respiratory depression due to higher drug concentrations than expected, requiring dosage adjustment and monitoring. This medication should not be used in children under 12 years of age or in children under 18 years who have undergone tonsillectomy or adenoidectomy, and administration should also be avoided in adolescents aged 12 to 18 if there are risk factors. It should not be administered to certain patients such as those with acute alcohol poisoning, central nervous system drug overdose, severe respiratory depression, or head injury. Caution should be exercised when administering to patients with liver dysfunction, kidney dysfunction, or those who consume alcohol, and particularly in patients with severely impaired kidney function, the dosage should be reduced. This medication may cause side effects such as drowsiness and dizziness, so activities such as driving or operating dangerous machinery should be avoided after administration. Tolerance may develop with prolonged use, leading to an increase in dosage, and sudden cessation can cause withdrawal symptoms, so the dosage should be gradually reduced. This medication may interact with various drugs, so it is important to consult with a doctor or pharmacist when used alongside other medications. It is safer for pregnant or breastfeeding women to avoid this medication, and caution should be exercised during breastfeeding as the drug may pass to the infant. In case of overdose, severe respiratory depression and seizures may occur, requiring immediate emergency treatment. When used as an injection, the injection site should be changed, and if severe pain or blood backflow occurs during the injection, it should be injected in another site immediately. This medication should be kept out of reach of children and stored in its original container to prevent misuse or degradation of quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in oral or ocular mucosa, difficulty breathing or shortness of breath, asthma attacks, respiratory issues accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, changes in urine output

Mild side effects

  • Drowsiness
  • dizziness
  • unsteadiness
  • nausea
  • vomiting
  • abdominal bloating
  • abdominal pain
  • loss of appetite
  • constipation
  • dry mouth
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  • headache
  • feeling of heaviness in the head
  • excitement
  • tremor
  • tinnitus
  • numbness in both hands
  • anxiety
  • exhaustion
  • fatigue
  • malaise
  • sweating
  • discomfort
  • dysuria
  • dry mouth
  • confusion
  • coordination problems
  • hyperactivity
  • restlessness
  • sleep disturbances
  • cognitive impairment
  • hallucinations
  • forgetfulness
  • concentration difficulties
  • changes in appetite
  • sensory abnormalities
  • convulsions
  • involuntary muscle contractions
  • fainting
  • hypertension

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

Storage

This medication is sensitive to light and should be stored in a container that blocks light. It is also important to store it in a sealed container to prevent air from entering. The storage temperature should be maintained between 1°C and 30°C, avoiding very hot or very cold places.

Appearance and packaging

Appearance

A brown ampoule injection filled with a colorless and transparent liquid

Package unit

2 mL/ampoule X 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.