Medication info
Zitramex XL Extended-release Tablet 150mg (Tramadol Hydrochloride)

Zitramex XL Extended-release Tablet 150mg (Tramadol Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Tramadol Hydrochloride›150mg / 1 tablet
Manufacturer / importer
한국먼디파마(유)
Appearance
White film-coated oblong extended-release tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 199806740 · Approved 1998.12.05 · Insurance code 678000140

Summary

Main use
Relief of severe and moderate acute and chronic pain (e.g., cancer)
Who takes it
Adults · Children
Adult dose
Adults and children aged 12 and older typically receive 150mg of tramadol hydrochloride once daily. If sufficient pain relief is not achieved, the dosage may be increased. This medication should be administered at 24-hour intervals and should be swallowed whole without chewing. To minimize side effects, it is advisable to gradually increase the dosage. In elderly patients and those over 75 with kidney or liver dysfunction, consider extending the dosing interval.
Child dose
The same dosage applies to adults and children aged 12 and older.

Ingredients

Importer
한국먼디파마(유)

Efficacy & effects

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

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

This medication is used to alleviate severe and moderate acute and chronic pain, such as pain associated with various cancers, as well as pain that occurs after diagnosis or surgery.

How to take

Adult dose

Adults and children aged 12 and older typically receive 150mg of tramadol hydrochloride once daily. If sufficient pain relief is not achieved, the dosage may be increased. This medication should be administered at 24-hour intervals and should be swallowed whole without chewing. To minimize side effects, it is advisable to gradually increase the dosage. In elderly patients and those over 75 with kidney or liver dysfunction, consider extending the dosing interval.

Child dose

The same dosage applies to adults and children aged 12 and older.

Precautions

This medication may cause seizures if taken in excess of the recommended dosage. Caution is advised, particularly for patients with epilepsy or those at risk of seizures; use of this medication should be limited to essential cases only. Prolonged use may lead to psychological and physical dependence, so patients with a history of drug abuse should use it for a short period under strict supervision. Co-administration with central nervous system depressants or alcohol can lead to severe sedation, respiratory depression, hypotension, or coma, so it is advisable not to use them together. Patients for whom the CYP2D6 enzyme acts very rapidly may experience excessive accumulation of the active ingredient in the body, increasing the risk of respiratory depression, necessitating dosage adjustments and careful monitoring. This medication should not be used in children under 12 years old or teenagers under 18 years old who have undergone tonsillectomy or adenoidectomy; administration should be avoided in adolescents between 12 and 18 years with specific risk factors. Symptoms of sleep apnea or hypoxemia may occur, so continuous monitoring of symptom worsening is essential, and dosage should be reduced or discontinued if necessary. This medication should not be used in patients with acute alcohol poisoning, central nervous system drug toxicity, severe respiratory depression, head injury, those taking MAO inhibitors, pregnant women, nursing mothers, or those with hypersensitivity to this medication or opioids. Patients with poor liver or kidney function, those who consume alcohol, a history of seizures, mental health issues, or a history of drug abuse should use it carefully and require thorough observation by a physician. Drowsiness or dizziness may occur while taking this medication, so patients should avoid driving or operating hazardous machinery. Moreover, prolonged use may lead to tolerance and reduced effectiveness, and sudden discontinuation may induce withdrawal symptoms, hence dosage should be gradually reduced. In the case of overdose, severe respiratory depression, seizures, or loss of consciousness may occur, requiring immediate emergency treatment, and naloxone may be used as an antidote. This medication should be stored out of reach of children and kept in its original container to prevent misuse or deterioration.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, severe allergic reactions, anaphylaxis, severe dermatologic reactions (Stevens-Johnson syndrome, severe rashes, blisters, skin peeling), chest tightness, difficulty breathing, respiratory distress, severe respiratory depression, respiratory arrest, asthma attacks, liver abnormalities (jaundice), severe neurological symptoms (severe headache, seizures, altered consciousness, visual disturbances, paralysis), severe edema, elevated blood pressure, markedly decreased urine output.

Mild side effects

  • Nausea
  • vomiting
  • drowsiness
  • dizziness
  • unsteadiness
  • palpitations
  • coolness
  • vasodilation
  • hypotension
  • arrhythmia
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  • pallor
  • fainting
  • orthostatic hypotension
  • tachycardia
  • bradycardia
  • elevated blood pressure
  • headache
  • heaviness in the head
  • agitation
  • tremors
  • tinnitus
  • numbness in both hands
  • anxiety
  • weakness
  • fatigue
  • lethargy
  • sweating
  • discomfort
  • urinary difficulties
  • dry mouth
  • thirst
  • confusion
  • cooperation difficulties
  • restlessness
  • sleep disturbances
  • cognitive disturbances
  • hallucinations
  • forgetfulness
  • concentration difficulties.

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

Storage

Store this medication in a tightly sealed container to prevent air exposure and keep it at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

White film-coated oblong extended-release tablet

Package unit

30 tablets/bottle

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.