Tramal Ampoules

/ Tec-O-Pharm

The injection is for parenteral administration either intramuscularly, by slow intravenous injection or, when diluted in solution, by infusion or patient controlled analgesia. As with all analgesic drugs the dosing of Tramal Injection should be adjusted depending on the severity of the pain and the individual clinical response of the patient.
Adults: A single dose of 50 or 100 mg 4-6 hourly (1 or 2 ml Injection) is usually required. Intravenous injections must be given slowly over 2-3 minutes. In severe (post-operative) pain, an initial bolus of 100 mg is administered 10-20 minutes up to a total dose of 250 mg including the initial bolus. Subsequent doses should be 50 or 100 mg administered 4-6 hourly. If the administration of Tramal injection has been forgotten, the pain may return. The dose should not be doubled. Administration should be continued as before. A total daily dose of 400 mg should not be exceeded except in special clinical circumstances. Tramal 100 mg, solution for injection is injected into the veins (usually into a blood vessel under the surface of the arm), muscles (usually the buttocks) or under the skin. Administration into the veins is slow with 1 ml Tramal 100 mg, solution for injection (equivalent to 50 mg tramadol hydrochloride) per minute. Alternatively Tramal injection may be diluted with a suitable infusion solution (e.g. 0.9% physiological saline or 5% glucose solution) for i.v. infusion or for patient-controlled analgesia (PCA).
Elderly patients: Dosing as for adults but it should be noted that in a study in elderly volunteers (aged over 75 years) the elimination half-life for orally administered tramadol was increased by 17%.
Patients with renal insufficiency/renal dialysis: As the elimination of tramadol may be prolonged in patients with renal impairment, the usual initial adult doses should be employed, but prolongation of the dosage interval should be carefully considered according to the patient’s requirements. For creatinine clearance <30 ml/min the dosing should be increased to 12 hourly intervals. For creatinine clearance <10 ml/min (severe renal impairment) tramadol is not recommended. Tramadol is removed very slowly by haemodialysis or haemofiltration and therefore post dialysis dosing to maintain analgesia is usually unnecessary.
Patients with hepatic insufficiency: It should be noted that as the elimination of tramadol may be prolonged in severe hepatic impairment, although the usual initial adult doses should be used, prolongation of the dosing should be at 12 hourly intervals.
Children Over 14 years: Dosage as for adults. Children aged 1 to 14 years receive 1-2 mg tramadol hydrochloride per kg body weight as a single dose. In this case 100 solution for injection is diluted in water for injection. The following table shows which concentrations are achieved (1 ml 100 solution for injection contains 50 mg tramadol hydrochloride)

Moderate to severe pain.

Tramal Injection should not be given to patients who have previously shown hypersensitivity to the product. The product should not be administered to patients suffering from acute intoxication with hypnotics, centrally acting analgesics, opioids, psychotropic drugs or alcohol. In common with other opioid analgesics, tramadol should not be administered to patients who are receiving monoamine oxidase (MAO) inhibitors or within 2 weeks of their withdrawal. The product must not be used in epilepsy not adequately controlled by treatment.

NOTE: At therapeutic doses, Tramadol has the potential to cause withdrawal symptoms. Rarely cases of dependence and abuse have been reported. Because of this potential the clinical need for continued analgesic treatment should be reviewed regularly. In patients with a tendency to drug or alcohol abuse or dependence, treatment should be for short periods and under strict medical supervision, because in these cases there is a risk of suicidal tendency. Tramal Injection is not a suitable substitute in opioid dependent patients. The product does not suppress morphine withdrawal symptoms although it is an opioid agonist. Convulsions have been reported at therapeutic doses and the risk may be increased at doses exceeding the usual upper daily dose limit (400 mg tramadol). Patients with a history of epilepsy or those susceptible to seizures should only be treated with tramadol if there are compelling reasons. The risk of convulsions may increase in patients taking tramadol and concomitant medication that can lower the seizure thrershold.

Most commonly nausea and dizziness were reported. Common effects were headache, muzziness, constipation, dry mouth, vomiting and sweating. Uncommon effects include disorders of cardiovascular regulation (e.g. palpitation, tachycardia, postural hypotension up to cardiovascular collapse), further, retching and gastrointestinal irritation, or dermal reactions (e.g. pruritus, rash or urticaria). Rarely reported effects include bradycardia, muscle twitching, coordination disorders, temporary loss of consciousness – syncope, increase in blood pressure, change in appetite, paraesthesia, tremor, hallucinations, confusion sleep disorders and nightmares, changes in mood (usually elation, occasionally dysphoria), change in activity, change in cognitive and sensorial capacity (e.g. perception disorders), breathlessness (dyspnoea). Rare effects are also motorial weakness, blurred vision and micutition disorders. In a few isolated cases an increase in liver enzyme values has been reported in a temporal connection with the therapeutic use of tramadol. Respiratory depression has been reported. Convulsions have been reported rarely. Dependence, abuse and withdrawal reactions have been reported. If treatment is discontinued abruply, typical opiate withdrawal reactions include agitation, anxiety,nervousness, insomnia, hyperkinesia, tremor and gastro-intestinal symptoms may occur; very rarely panick attacks, severe anxiety, paraesthesias, tinnitus and unusual CNS symptoms have been reported. There have been rare cases of blood dyscrasias observed with tramadol treatment but direct causality has not been confirmed. Allergy to tramadol is characterised by dyspnoea, wheezing,bronchospasm, worsening of existing asthma, angioneurotic oedema and anaphylaxis.

Tramal Injection may potentiate the CNS depressant effects of other centrally acting drugs (including alcohol, sedatives, sleeping pills and certain painkillers such as morphine and codeine) when administered concomitantly with such drugs. The patient might feel dazed or that he is going to faint. Tramadol may increase the potential for both selective serotonin re-uptake inhibitors (SSRIs) and tricyclic antidepressants (TCAs) to cause convulsions (See Special Warnings and Precautions for Use and Pharmacokinetic Properties sections). Isolated cases of serotonine syndrome have been reported in temporal connection with concomitant use of tramadol and selective serotonine re-uptake inhibitors (SSRI) and MAO inhibitors. Symptoms of serotonine syndrome are, for example, confusion, restlessness, high temperature, sweating, uncoordinated movements of the limbs or eyes, uncontrollable muscle twitching or diarrhoea. Increased INR and ecchymoses have been reported during concomitant treatment with tramadol and coumarin derivatives. Administration of Tramal Injection together with carbamazepine, pentazocine, nalbuphine or buprenorphine (painkillers), ondansetron (for nausea) results in markedly decreased serum concentrations of tramadol which may reduce analgesic effectiveness and shorten the duration of action. Changes in serum concentrations of tramadol have been associated with simultaneous dosing of cimetidine. However, such changes are clinically insignificant and therefore no dosage adjustment for Tramal Injection is recommended in patients receiving chronic cimetidine therapy. Inhibitors of CYP3A4 (e.g.ketoconazole or erythromycin) may inhibit the tramadol metabolism. The action on blood clotting of coumarin anticoagulants, for example warfarin, may be affected while taking them with Tramal injection, and bleeding may occur.

Sufficient evidence of the safety of tramadol during pregnancy in humans is not available. Therefore you should not use Tramal injection throughout pregnancy. The repeated use of Tramal injection during pregnancy may lead to habituation in the unborn child and as a result, the child may experience withdrawal symptoms after birth. Tramal injection should not be administered during breast-feeding. Tramadol is excreted in very small amounts into the breast milk. After a single administration of tramadol it is not usually necessary to stop breast-feeding.

Accidental administration of an additional dose of Tramal injection usually has no negative effects. The next dose should be given as planned. After administration very high doses, pin-point pupils, vomiting, fall in blood pressure, fast heart-beat, feeling faint, reduced level of consciousness up to coma (deep unconsciousness), epileptic-like fits, and difficulty in breathing up to stoppage of breathing may occur. Treatment of overdose requires the maintenance of the airway and cardiovascular functions. Respiratory depression may be reversed using naloxone and fits controlled with diazepam. The treatment of acute overdose of tramadol using haemodialysis or haemofiltration alone is not sufficient or suitable due to the slow elimination of tramadol from the serum by these routes