Medication info

Phenymadol Injection 50 milligrams (Tramadol Hydrochloride)

Prescription medicationInjections근육 · 정맥
Ingredient · strength
Tramadol Hydrochloride›50mg / 1mL
Manufacturer / importer
(주)유영제약
Appearance
A colorless, transparent solution in an ampoule.
Packaging
1ml/ampoule x 50
Approval status
Active

MFDS item code 198902354 · Notified 1989.03.13 · Insurance code 648201961

Summary

Main use
Relief of moderate to severe acute chronic pain (e.g., cancer pain, pain after diagnosis and surgery)
Who receives it
Adults
Adult administration
Inject 50-100mg of tramadol hydrochloride intravenously or intramuscularly, then repeat as needed every 4-5 hours. A maximum of 400mg per day can be administered.

Ingredients

Manufacturer
(주)유영제약

Efficacy & effects

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

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

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

How it is given

Adult administration

Inject 50-100mg of tramadol hydrochloride intravenously or intramuscularly, then repeat as needed every 4-5 hours. A maximum of 400mg per day can be administered.

Precautions

This medication may cause seizures if used above the recommended dose, so the prescribed dosage must be strictly followed. Patients at risk for seizures or those with epilepsy should only use this medication when absolutely necessary, and extra caution is needed when taking other medications that increase the risk of seizures. Prolonged use of this medication may lead to psychological or physical dependence, so patients with a history of drug abuse or dependence should only use it for a short period under strict supervision. Taking this medication with alcohol or central nervous system depressants can lead to severe drowsiness, respiratory depression, coma, or even death, so caution must be exercised when used in combination with such medications. Individuals who metabolize this drug rapidly due to genetic factors may experience unexpectedly stronger effects and risks, requiring careful dosage adjustments and monitoring. It should not be used in children under 12 years old, or in adolescents under 18 years who have undergone tonsillectomy or adenoidectomy, and those between 12 and 18 should also avoid use if they have specific risk factors. It should not be administered to individuals with acute alcohol intoxication, central nervous system drug overdose, severe respiratory depression, head injuries, or those taking MAO inhibitors. Patients with severely impaired liver or kidney function, as well as pregnant or nursing women, should avoid using this medication as it is safer not to do so. Drowsiness and dizziness may occur when using this drug, so driving or operating dangerous machinery should be avoided. Moreover, if this medication is stopped suddenly, withdrawal symptoms may occur, thus the dosage should be reduced gradually as per the doctor's advice. There are many interactions with other drugs; taking it with benzodiazepines, antidepressants, antipsychotics, alcohol, etc., increases the risk of side effects, so one must consult their healthcare provider. During pregnancy or breastfeeding, it should not be used as it may pose risks to the fetus or newborn, especially during breastfeeding as it may transfer to breast milk and cause serious side effects in the baby. In cases of overdose, severe respiratory depression and seizures may occur, and immediate emergency care is needed, with naloxone potentially being used as an antidote. This medication should be kept out of the reach of children and stored in its original container safely.

Side effects and when to seek care immediately

Serious side effects

Seizures, severe allergic reactions (shock, anaphylaxis, hives, bronchospasm, angioedema), respiratory depression, difficulty breathing, exacerbation of asthma, facial pallor, severe skin reactions (Stevens-Johnson syndrome), severe swelling, liver abnormalities (elevated liver enzyme levels, potential jaundice), serious neurological symptoms (seizures, altered consciousness, fainting), cardiovascular issues (arrhythmias, low blood pressure, high blood pressure, fainting, tachycardia, bradycardia), severe anxiety

Mild side effects

  • Drowsiness
  • dizziness
  • unsteadiness
  • nausea
  • vomiting
  • abdominal pain
  • headache
  • heaviness in the head
  • agitation
  • tremors
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  • tinnitus
  • tingling
  • anxiety
  • faintness
  • lethargy
  • sweating
  • discomfort
  • urinary difficulties
  • dry mouth
  • thirst
  • coordination difficulties
  • restlessness
  • sleep disturbances
  • perception disturbances
  • hallucinations
  • memory problems
  • concentration difficulties
  • changes in appetite
  • sensory disturbances
  • seizure-like episodes
  • involuntary muscle contractions
  • fainting
  • hiccups
  • palpitations
  • coldness
  • mimicry concerns
  • vasodilation
  • low blood pressure

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 maintained at room temperature between 1 to 30 degrees Celsius for safety. Maintaining appropriate temperature and sealing conditions can prolong the medication's effectiveness.

Appearance and packaging

Appearance

A colorless, transparent solution in an ampoule.

Package unit

1ml/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.