Medication info

Kestamadol Hydrochloride Injection

Prescription medicationInjections근육 · 정맥Expired
Ingredient · strength
Tramadol Hydrochloride›50mg / 1mL
Manufacturer / importer
주식회사케이에스제약
Appearance
A colorless and odorless transparent liquid contained in a colorless and transparent ampule injection.
Packaging
1 milliliter/ampule[x 50], 2 milliliters/ampule[x 50]
Approval status
Expired

MFDS item code 202000757 · Notified 2020.02.10

This product's status changed to Expired on 2025.02.10. 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 (such as 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. The maximum daily dose can be up to 400mg.

Ingredients

Manufacturer
주식회사케이에스제약

Efficacy & effects

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

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

This medication is used for severe and moderate acute and chronic pain. It is particularly effective for pain caused by various reasons, including cancer, as well as post-diagnostic and post-surgical pain. It can help in managing the patient's pain.

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. The maximum daily dose can be up to 400mg.

Precautions

This medication must be taken at the recommended dosage, as exceeding the dosage may result in seizures. Special care is needed for patients at risk of epilepsy or seizures, and it should only be administered when absolutely necessary. Long-term use of this medication may lead to psychological or physical dependence, so it should be managed strictly for a short period in patients with a history of drug abuse or dependence. When taken with alcohol or central nervous system depressants like benzodiazepines, it can cause severe drowsiness, respiratory depression, coma, and, in severe cases, death; therefore, concurrent use should be avoided or approached with extreme caution. Especially, individuals with the enzyme CYP2D6 that acts very quickly may produce excessive active metabolites of this medication, increasing the risk of respiratory depression, requiring dosage adjustment and careful monitoring. This medication should not be administered to children under 12 years or adolescents under 18 years who have undergone tonsillectomy or adenoidectomy without special risk factors. Special care should be taken for adolescents aged 12 to 18 with special risk factors. When using this injectable medication, be cautious when cutting the container, as glass fragments may mix in; this is especially important when administering to children or the elderly. This medication should not be given to patients with acute alcohol intoxication, central nervous system drug intoxication, severe respiratory depression, head injury or brain lesions, those taking MAO inhibitors, severe kidney or liver dysfunction patients, pregnant women, and nursing mothers. Given the potential for drug interactions, consult with a doctor or pharmacist when using this medication with other central nervous system depressants, antidepressants, anticoagulants, antibiotics, etc., and monitor dosage and symptoms closely. Patients taking this medication may experience drowsiness, dizziness, nausea, vomiting, etc.; therefore, they should avoid driving or operating hazardous machinery. Sudden discontinuation can lead to withdrawal symptoms, and dosage should be reduced gradually following a doctor's instructions. In the event of overdose, severe respiratory depression and seizures may occur; immediate medical attention should be sought. This medication should be used cautiously with dosage adjustments in children, the elderly, and patients with impaired liver and kidney function, particularly ensuring that those over 75 years do not exceed 300mg per day. It is unsafe for women who are pregnant or breastfeeding to use this medication, as it can be transmitted to the infant through breast milk and may cause severe side effects. Patients receiving this medication should be closely monitored for symptoms of seizures, respiratory depression, allergic reactions, etc., and should report any abnormal symptoms to medical personnel immediately.

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, oral/ocular mucosal pain, severe skin adverse reactions, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), severe general malaise, liver dysfunction (jaundice), sudden and very severe headache, thunderclap headache, seizures.

Mild side effects

  • Drowsiness
  • dizziness
  • unsteadiness
  • nausea
  • vomiting
  • abdominal distension
  • abdominal pain
  • loss of appetite
  • constipation
  • thirst
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  • hypertonia
  • muscle weakness
  • urinary retention
  • frequent urination
  • menopause syndrome
  • urinary disorders
  • menstrual disorders
  • sweating
  • itching
  • rash
  • hives
  • visual impairment
  • taste disturbance
  • weight loss
  • injection site irritation
  • fatigue
  • hallucinations
  • confusion
  • sleep disturbances
  • anxiety
  • nightmares
  • fatigue
  • sweating
  • headache
  • heaviness in the head
  • agitation
  • tremors
  • tinnitus
  • numbness in both hands.

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

Storage

This medication should be stored in a sealed container to prevent exposure to air and kept at room temperature between 1 degree and 30 degrees Celsius. Proper storage will safely maintain the medication's efficacy.

Appearance and packaging

Appearance

A colorless and odorless transparent liquid contained in a colorless and transparent ampule injection.

Package unit

1 milliliter/ampule[x 50], 2 milliliters/ampule[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.