50mg/ml Solution for Injection (IM/IV)
For the relief of moderate to severe pain and postoperative pain.
DOSAGE AND ADMINISTRATION
For adult, subsequent doses of 50mg or 100mg every hour to five hours may be given, up to 400mg as a total daily dose by intravenous or intramuscular injection.
Dosage adjustment is based on age or severity.
- Acute intoxication with alcohol
- Acute intoxication with CNS drug such as hyponotics, analgesics, opioids or psychotropic drugs
- Patients under severe respiratory depression (list respiratory depression may occur)
- Patients with head injury, encephalopathy, resulting in the risk of clouding of consciousness
- Patients who are taking MAO inhibitors
- Pregnant woman and nursing mothers
- Individuals with known hypersensitivity to tramadol or opioids
- Seizure risk: Incidence of seizure may be increased when doses of tramadol exceed the recommended upper daily dose limit. Also, seizure has been reported in patients receiving tramadol at the recommended dose levels.
- Hypersensitivity in skin: In the occurrence of shock reactions and anaphylaxis, the drug is discontinued and appropriate are taken. At the first dose, severe anaphylactoid reaction has been reported (rarely life threatening). Also itching, bronchial convulsion and angioedema may occur.
- Respiratory: Occasionally respiratory depression may occur. In this case, artificial respiration (aerobic respiration if necessary) or dimorpholamine is useful.
- Circulatory: Occasionally palpitation, clammy sweat, vasolidation, hypotension, arrhythmia, ashy face may occur. Rarely it may influence on cardiovascular system. Also syncope, orthostatic hypotension, frequent pulse may occur
- CNS: Drowsiness, sleeping, headache, heavy head, excitation, tremor, tinnitus, numbness in hands. Anxiety, collapse, fatigue, malaise, sweating, drowsiness, stagger, dysphoria, dysuria, dry mouth, hydrodipsomania, confusion, coordinate disorder, euphoria, agitation, sleeping disorder, hypermetamorphosis, hallucination, amnesia, attention disorder, depression may occur.
- GI: Occasionally nausea, vomiting, abdominal distension, rugitus, anorexia may occur.
- Musculoskeletal: Hypertension may occur.
- Urinary: urinary retention, urinary frequency, postmenopausal syndrome, disturbances of urination, menstrual disorder may occur.
- Skin: Urticaria, vesicle, Steven-Johnsons syndrome may occur.
- Drug dependence; This drug is contraindicated in patients with opioid dependence, as physical dependence of the morphine-type may develop. Reinstatement of physical dependence in patients that have previously been dependent, may occur with this drug. It is not recommended to patients with drug abuse tendency or a history of drug dependence, patients who has used opioid chronically.
- Others: febricity, burning sense, chilly sense, cooling sense, urticarial, rash, visual disorder, dysgensia, weight loss and irritation on injection site may occur.
- Patients with the concurrent use with morphine, patients with repeated administration (In animal study, light counteraction has been reported with morphine. Light withdrawal symptoms may occur.)
- Patients with biliary tract disease (In animal study with massive administration, contraction of oddis sphincter has been reported)
- Patients with hepatic disease (Elevation of activity of serum AST, ALT has been reported in animal study)
- Patients taking alcohol
- Patients with a hypersensitivity to opioid
- Patients with renal failure (Impaired renal function results in a decreased rate and extent of excretion of tramadol and its active metabolite, M1. In patients with creantinine clearances of less than 30ml/min, dosage reduction is recommended).
- Patients receiving CNS depressants such as alcohol, opioids, anaesthetic agents, phenothiazines, tranquilizers or seductive hypnotics (dosage is reduced)
- Patients with a history of convulsion
- With the drug nausea, rarely vomiting, drowsiness, dizziness and stagger may occur. Therefore, outpatients need to take a rest for stabilization after administration and go back home.
- Patients should be advised to avoid driving or operating machinery whilst taking tramadol.
- It is not used for light pain
- In prolonged use, it is difficult to exclude completely the possibility of drug independence. Therefore period of administration is adjusted or transient drug discontinuation is taken.
- It may make a misdiagnose of patients status in patients with acute abdominal disorder
- Use with CNS depressants (alcohol, tranquilizers or sedative hypnotics) : The concurrent use of tramadol with CNS depressants may potentiate the CNS depressant effects
- The concurrent use with carbamazepine may potentiate the metabolism of tramadol. Therefore, this drug dose is increased to twice in patients receiving 800mg of carbamazepine.
- Rarely it changes toxicity in digoxin, effect of warfarin
- Careful administration is required because digoxin intoxication has been reported in the concurrent use of tramadol with digoxin
- In the concurrent use with warfarin, the warfarin effect including prolonged prothrombin time has been reported.
PREGNANCY AND LACTATION
- In animal study and in vitro test, carcinogenesis, mtagenesis and impairment of fertility have been reported. Therefore the drug is contraindicated to pregnant woman or woman with child-bearing potential and nursing mothers because it is excreted in breast milk.
- This drug is excreted in human milk. Therefore, this drug is contraindicated to nursing mother.
Safely in pediatrics has not been established. Therefore it is not recommended be used for pediatrics.
Serum concentration can be lightly elevated. Therefore the daily dose in patients 75 years of age and over is limited to 300mg.
Serious potential consequences of overdose are respiratory depression and seizure. Convulsions occurring in mice following the administration of toxic dose of tramadol could be suppressed with barbiturates or benzodiazepines, but were increased with naloxone. Adequate ventilation shold be maintained. Haemodialysis is not expected to be helpful because it removes below 7% over 4 hours.
Store at temperature not exceeding 25˚C