Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2022 Publisher: Seqirus (NZ) Ltd, PO Box 62 590, Greenlane, Auckland 1546, New Zealand, Telephone: 0800 502 757
Relief of moderate to severe pain.
The dose of tramadol should be titrated to the severity of the pain and the clinical response of the individual patient. Tramadol is approved for use in adults, adolescents and children over the age of 12 years.
The recommended dosage of Tramal capsules, Tramal solution for injection, and Tramal SR tablets respectively are as follows:
Oral administration - for the treatment of moderate pain Tramal 50-100 mg administered two or three times daily may be sufficient. Tramal 50 mg may be adequate as the initial dose for moderate pain.
For moderate to severe pain, 50-100 mg as needed for relief, every four to six hours may be administered. Tramal 100mg is usually more effective as the initial dose for more severe pain.
The maximum daily dose should not exceed 400 mg per day.
Parenteral administration - Tramal injection may be administered by intravenous injection by intravenous or intramuscular injection. Few data are available on the administration of Tramal by repeated intramuscular injection. Intravenous injections should be given slowly over 2-3 minutes.
For postoperative pain, an initial bolus of 100 mg should be administered. Subsequent doses of 50 mg or 100mg every four to six hours may be given, up to a total daily dose of 600 mg.
For less severe pain, 50 mg or 100 mg every four to six hours to a maximum of 400 mg per day.
PHARMACEUTICAL PRECAUTIONS:
Tramal solution for injection is incompatible with injection solutions containing diclofenac, indomethacin, phenylbutazone, diazepam, flunitrazepam, glyceryl trinitrate or midazolam. Tramal solution for injection is compatible with the following intravenous fluids: 0.9% sodium chloride, 5% glucose, 4.2% sodium bicarbonate, Ringer’s solution, Ringer’s lactate solution, Dextran 40 (10%) or polygeline 3.5%.
Oral administration - the recommended dose of Tramal SR in adults and adolescents over the age of 12 years is 100 mg to 200 mg twice daily, preferably morning and evening.
For initial titration therapy, a lower starting dose may be appropriate for some patients.
The tablets are to be taken whole, not divided or chewed, with sufficient liquid, irrespective of food intake.
The maximum daily dose should not exceed 400 mg per day.
Tramal solution for injection are approved for use in children 12 years old and over. Analgesic dosage of Tramal solution for injection must be individualised by the physician according to the severity of pain as well as on the basis of patient’s age and weight.
In patients with renal insufficiency the elimination of tramadol is delayed. In these patient’s prolongation of the dosage intervals should be carefully considered according to the patient’s requirements. In cases of severe renal insufficiency Tramal prolonged-release tablets are not recommended. Since only 7% of an administered dose is removed by haemodialysis, dialysis patients can receive their regular dose on the day of dialysis.
Tramal SR should not be used in patients with severe hepatic insufficiency. In these patients, the immediate release (IR) form of oral tramadol (capsule) may be administered if appropriate. In hepatic impairment, the initial oral dose of tramadol is 50 mg of the immediate release formulation. Depending on the severity of the impairment and individual clinical response, the recommended dosage interval (4-6 hours) may require to be extended, and/or the dose level titrated as required.
Tramal injection is compatible with the following intravenous fluids: 0.9% sodium chloride, 5% glucose, 4.2% sodium bicarbonate, Ringer’s solution, Ringer’s lactate solution, Dextran 40 (10%) or polygeline 3.5%.
For method of administration see section 4.2 Dose and method of administration.
Symptoms of overdosage with tramadol are similar to those of other centrally acting analgesics (opioids) and include miosis, vomiting, cardiovascular collapse, consciousness disorders including coma, convulsions, respiratory depression and respiratory arrest. Serotonin syndrome has also been reported.
Should overdosage occur, general emergency measures should be implemented. Keep the respiratory airways open, and maintain respiration and circulation. If overdosage is due to ingestion of an oral dose form.
Activated charcoal may reduce absorption of the drug if given within 1-2 hours after ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube, once the airway is protected.
Naloxone will reverse respiratory depression, but not all symptoms caused by overdosage with tramadol. Convulsions occurring in mice following the administration of toxic doses of tramadol could be suppressed with barbiturates or benzodiazepines, but were increased with naloxone. If convulsions are observed, diazepam should be given intravenously. Naloxone did not change the lethality of an overdose in mice.
Tramadol is minimally eliminated from the serum by haemodialysis or haemofiltration. Therefore treatment of overdosage with tramadol with haemodialysis or haemofiltration alone is not suitable for detoxification.
For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).
Tramal capsules have a shelf-life of 36 months when stored below 30°C.
Tramal solution for injection and Tramal SR 100, 150 and 200 mg tablets have a shelf-life of 60 months when stored below 30°C.
Tramal SR 50 mg tablets have a shelf life of 36 months when stored below 30°C.
For storage conditions of the medicine, see section 6.3 Shelf-life.
Tramal 50mg immediate release capsules-packs of 6, 10, 20, 30 and 50 capsules.
Tramal 50, solution for injection-pack containing 5 ampoules of 1 mL each.
Tramal 100, solution for injection-pack containing 5 ampoules of 2 mL each.
Tramal SR 50 mg, 100 mg, 150 mg and 200 mg sustained release tablets – packs of 20 and 60 tablets.
Not all pack sizes may be marketed.
Tramal capsules:
If your doctor tells you to stop taking TRAMAL capsules or it passes its expiry date, ask your pharmacist what to do with any TRAMAL capsules that are left over.
Tramal solution for injection:
If your doctor tells you to stop taking TRAMAL or it passes its expiry date, ask your pharmacist what to do with any TRAMAL that is left over.
Tramal SR tablets:
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any Tramal SR that is left over.
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