Medication info

KemaDol Injection (Tramadol Hydrochloride)

Prescription medicationInjections근육 · 정맥
Ingredient · strength
Tramadol Hydrochloride›50mg / 1mL
Manufacturer / importer
(주)경보제약
Appearance
A colorless liquid contained in a colorless ampoule, transparent.
Packaging
1mL/ampoule × 50
Approval status
Active

MFDS item code 201604403 · Notified 2016.07.18 · Insurance code 665002081

Summary

Main use
Relief of severe and moderate acute and chronic pain (e.g., cancer, post-diagnostic and post-surgical pain).
Who receives it
Adults
Adult administration
As Tramadol Hydrochloride, administer 50-100 mg by intravenous or intramuscular injection, then repeat every 4-5 hours as needed. The maximum allowable dose per day is 400 mg.

Ingredients

Manufacturer
(주)경보제약

Efficacy & effects

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

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

This medication is used for the relief of severe and moderate acute or chronic pain, such as pain due to cancer or pain occurring after diagnosis and surgery.

How it is given

Adult administration

As Tramadol Hydrochloride, administer 50-100 mg by intravenous or intramuscular injection, then repeat every 4-5 hours as needed. The maximum allowable dose per day is 400 mg.

Precautions

This medication can cause seizures if taken in doses exceeding the recommended amount; therefore, it is essential to adhere to the prescribed dosage. Patients with a history of epilepsy or seizure risk should only use this medication when absolutely necessary. Long-term use may lead to psychological and physical dependence, so patients at risk of drug abuse should be closely monitored and restricted to short-term use. Taking this medication with alcohol or central nervous system depressants may lead to dangerous side effects, such as severe sedation or respiratory depression, so co-administration should be avoided or used with extreme caution. Individuals with a genetic predisposition to metabolize this medication rapidly may have elevated levels of active metabolites in the bloodstream, increasing the risk of respiratory depression, so dose adjustments and careful monitoring are required. This medication should not be administered to children under 12 years of age, or adolescents under 18 years who have undergone tonsillectomy or adenoidectomy, and adolescents aged 12 to 18 should also avoid use if they have specific risk factors. This medication is not for use in patients with acute alcohol intoxication, central nervous system drug intoxication, severe respiratory depression, head trauma or brain lesions, those currently taking or who have recently taken MAO inhibitors, severe renal or hepatic impairment, pregnant or breastfeeding women. Additionally, this medication should not be used in patients with hypersensitivity to it or with inadequately treated epilepsy, or for the purpose of treating opioid withdrawal symptoms, or in certain genetic condition patients. Patients using morphine concurrently or those receiving repeat doses, those with biliary tract disease, liver disease, alcoholic patients, patients hypersensitive to opioids, renal disease patients, those on central nervous system depressants, those with a history of seizures, and those with a history of drug abuse or mental illness should use this medication with caution. Drowsiness, dizziness, nausea, and other symptoms may occur upon administration, so this medication should be taken in a stable environment and driving or operating dangerous machinery should be avoided. Long-term use can lead to tolerance, requiring increased doses, and sudden discontinuation may cause withdrawal symptoms, so doses should be gradually reduced. Overdosing can result in severe respiratory depression and seizures, requiring immediate emergency care, and naloxone may be used as an antidote. This medication can interact with various drugs, so inform your doctor or pharmacist if you are taking other medications, especially central nervous system depressants, antidepressants, and MAO inhibitors, as such combinations may be risky. Pregnant or breastfeeding women should not use this medication, and breastfeeding mothers should be cautious as this medication can be excreted in breast milk and affect the baby. This medication should not be given to children, especially those under 12 years of age, and dosage should be limited for elderly patients (over 75 years of age).

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylaxis, respiratory depression, difficulty breathing, asthma exacerbation, pallor, fainting, bradycardia, hypertension, seizures, interstitial seizures, hepatic abnormality (elevated liver enzyme levels), Stevens-Johnson syndrome, severe allergic reactions, severe skin reactions, severe edema, severe headache, altered consciousness, visual disturbances, paralysis, severe neurological symptoms, decreased urine output, elevated blood pressure, psychological and physical dependence, severe hot.

Mild side effects

  • Drowsiness
  • dizziness
  • nausea
  • vomiting
  • headache
  • heaviness in the head
  • excitement
  • tremor
  • tinnitus
  • anxiety
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  • malaise
  • fatigue
  • lethargy
  • sweating
  • unsteadiness
  • discomfort
  • urinary difficulty
  • dry mouth
  • thirst
  • confusion
  • coordination disorder
  • joylessness
  • restlessness
  • sleep disturbance
  • cognitive impairment
  • hallucinations
  • forgetfulness
  • concentration difficulties
  • depression
  • changes in appetite
  • sensory abnormalities
  • hiccups
  • hypertonicity
  • motor weakness
  • urinary retention
  • frequent urination
  • menopausal syndrome
  • urinary disorders
  • menstrual disorders
  • sweating
  • skin.

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 from entering, and it is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. In other words, it should be kept safely at an appropriate temperature, avoiding too hot or too cold conditions to effectively maintain the medication's efficacy.

Appearance and packaging

Appearance

A colorless liquid contained in a colorless ampoule, transparent.

Package unit

1mL/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.