Tramadol 100 mg Ampoule
Tramadol HCl 100 mg/amp. (2 ml)Company Name
Alexandria
Pharmaceutical form
Ampoule
Package
3 Ampoules x 2 ml
Indications
Tramadol is indicated for the management of moderate to moderately severe pain.Warning & Precautions
The pediatric use of tramadol is not recommended in patient under 16 years. Seizure Risk: Seizures have been reported in patients receiving Tramadol within the recommended dosage range. Spontaneous post-marketing reports indicate that seizure risk is increased with doses of Tramadol above the recommended range. Concomitant use of Tramadol increases the seizure risk in patients taking: • Selective serotonin reuptake inhibitors ( SSRI antidepressants or anoretics ) • Tricyclic antidepressants (TCAs), and other tricyclic compounds(e.g., cyclobenzaprine, promethazine, etc.), or Opioids Administration of Tramadol may enhance the seizure risk in patients taking: • MAO inhibitors (use with MAO inhibitors ) • Neuroleptics , or other drugs that reduce the seizure threshold Risk of convulsions may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk of seizures ( such as head trauma, metabolic disorders, alcohol and drug withdrawal , CNS infections). In tramadol overdose, naloxone administration may increase the risk of seizures. Anaphylactoid Reaction Serious and rarely fatal anaphylactoid reactions have been reported in patients receiving therapy with tramadol. These reactions often occur following the first dose. Other reported reactions include pruritis , hives , bronchospasm and angioedema. Patients with a history of anaphylactoid reactions to codeine and other opioids may be at increased risk and therefore should not receive Tramadol. Use in Opioid dependent patients Tramadol should not be used in opioid-dependent patients . Tramadol has been shown to reinitiate physical dependence in some patients that have been previously dependent on other opioids. Consequently, in patients with a tendency to opioid abuse or opioid dependence, treatment with Tramadol is not recommended . Use with CNS depressants Tramadol should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics. Use with MAO inhibitors Use Tramadol with great caution in patients taking monoamine oxidase inhibitors, because animal studies have shown increased deaths with combined administration .Product Type
Human
Dosage
As directed by the physician or as follows : For the treatment of painful conditions, Tramadol 50 mg to 100 mg (½ -1ampoule) can be administered as needed for relief every 4-6 hours not to exceed 400 mg per day. For moderate pain: Tramadol 50 mg (½ ampoule) may be adequate as the initial dose. For more severe pain: Tramadol 100 mg (1 ampoule) is usually more effective as the initial dose. In a clinical trial, fewer discontinuations due to adverse events, especially dizziness and vertigo, were observed when titrating the dose in increments of 50 mg/day every 3 days until an effective dose ( not exceeding 400 mg/day ) was reached. Individualization of Dose : Available data do not suggest that a dosage adjustment is necessary in elderly patients 65 to 75 years of age unless they also have renal or hepatic impairment. For elderly patients over 75 years old, not more than 300 mg/day in divided doses as above is recommended. In all patients with creatinine clearance less than 30 ml/min., it is recommended that the dosing interval of Tramadol be increased to 12 hours, with a maximum daily dose of 200 mg. Since only 7 % of an administered dose is removed by hemodialysis, dialysis patients can receive their regular dose on the day of dialysis. The recommended dose for patients with cirrhosis is 50 mg every 12 hours. Patients receiving chronic carbamazepine doses up to 800 mg daily may require up to twice the recommended dose of Tramadol.
Adverse Reactions
Cardiovascular: Vasodilation Central nervous system : Anxiety, confusion, coordination disturbance, euphoria, nervousness, sleep disorder. Gastrointestinal : Abdominal pain , anorexia , flatulence. Musculoskeletal : Hypertonia. Skin : Rash. Special Senses : Visual disturbance. Urogenital : Menopausal symptoms, urinary frequency , urinary retention. Incidence less than 1% possibly causally related; the following lists adverse reactions that occurred with an incidence of less than 1% in clinical trials and/or reported in post marketing experience. Body as a whole : Accidental injury, allergic reaction, anaphylaxis, suicidal tendency, weight loss. Cardiovascular : Orthostatic hypotension, syncope, tachycardia. Central Nervous System : Abnormal gait , amnesia, cognitive dysfunction, depression, difficulty in concentration, hallucinations, paresthesia, seizure, tremor. Respiratory : Dyspnea. Skin : Stevens-Johnson syndrome/Toxic epidermal necrolysis, urticaria, vesicles. Specials Senses : dysgeusia. Urogenital : Dysuria , menstrual disorder.
Contra Indications
Tramadol should not be administered to patients who have previously demonstrated hypersensitivity to Tramadol , any other component of this product or opioids. It is also contraindicated in cases of acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.
Drug Interactions
Carbamazepine : Concomitant administration of Tramadol with carbamazepine causes a significant increase in Tramadol metabolism, presumably through metabolic induction by carbamazepine. Patients receiving chronic carbamazepine doses of up to 800 mg daily may require up to twice the recommended dose of Tramadol. Quinidine: Tramadol is metabolized to M1 by the CYP2D6 P-450 isoenzyme. Quinidine is a selective inhibitor of that isoenzyme; so that concomitant administration of quinidine and Tramadol results in increased concentrations of Tramadol and reduced concentrations of M1. The clinical consequences of these findings are unknown. In vitro drug interaction studies in human liver microsomes indicate that Tramadol has no effect on quinidine metabolism. Inhibitors of CYP2D6: In vitro drug interaction studies in human liver microsomes indicate that concomitant administration with inhibitors of CYP2D6 such as fluoxetine, paroxetine, and amitriptyline could result in some inhibition of the metabolism of Tramadol.
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