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Benzodiazepines: Due to additive pharmacologic effect, the concomitant use of opioids with benzodiazepines increases the risk of respiratory depression, profound sedation, coma and death.
The concomitant use of opioids and benzodiazepines increases the risk of respiratory depression because of actions at different receptor sites in the central nervous system that control respiration. Opioids interact primarily at μ-receptors, and benzodiazepines interact at GABAA sites. When opioids and benzodiazepines are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists.
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate (see PRECAUTIONS). Limit dosage and duration of concomitant use of benzodiazepines and opioids, and follow patients closely for respiratory depression and sedation.
Serotonergic Drugs: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue ANALAB CAPSULE/INJECTION if serotonin syndrome is suspected. Examples of serotonergic drugs are selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g. mirtazapine, trazodone, tramadol), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue) (See PRECAUTIONS).
Capsule: It should be given with extreme caution in patients taking monoamine oxidase inhibitors or within 14 days of stopping such treatment.
The depressant effects of ANALAB CAPSULE are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives, tricyclic antidepressants and phenothiazines.
Opioid analgesics with some antagonist activity such as buprenorphine, butorphanol, nalbuphine or pentazocine may precipitate withdrawal symptoms in patients who have recently used pure agonists such as ANALAB CAPSULE.
On the concomitant administration of ANALAB CAPSULE with substances which also act on the central nervous system (e.g tranquilizers, hypnotics) the sedative effects (fatigue) may be intensified. At the same time, however, combining ANALAB CAPSULE with a tranquilizer, for example, will probably have a favourable effect on the pain sensation.
ANALAB CAPSULE should not be used in patients receiving MAO inhibitors.
Injection: Concurrent use of tramadol and other CNS-depressant drugs and/or alcohol may enhance the central adverse effects of tramadol, respiratory depression in particular. Concomitant treatment with tramadol and antipsychotic drugs has occasionally been associated with epileptic seizures.
Carbamazepine markedly reduces the serum concentrations of tramadol and may reduce both the analgesic effect and the duration of action of tramadol.
Patients treated with MAOIs within 14 days prior to administration of the opioid pethidine have experienced life-threatening interactions affecting the central nervous system as well as the respiratory and circulatory centers. Similar interactions with MAOIs cannot be ruled out for tramadol either.
Concomitant administration of tramadol with cimetidine (enzyme inhibitor) does not result in clinically significant changes in tramadol pharmacokinetics.
Therefore, no alteration of tramadol dosage regimen is recommended.
Concomitant use of tramadol with mixed agonist/antagonists (e.g., buprenorphine, nalbuphine, pentazocine) is not recommended because the analgesic effect of a pure agonist may be reduced.
Tramadol increases the seizure risk in patients taking selective serotonin-reuptake inhibitors (SSRIs), tricyclic antidepressants, neuroleptics and other seizure threshold lowering drugs.
Other drug known to inhibit the CYP3A4 isoenzyme of cytochrome P450, such as ketoconazole and erythromycin may inhibit the metabolism (via N-demethylation) of tramadol and probably the metabolism of M1. The clinical importance of such an interaction has not been established.
There is a theoretical possibility that tramadol could interact with lithium due to their respective mechanisms of action. ANALAB INJECTION is incompatible with injection solutions of diclofenac, indomethacin, phenylbutazone, diazepam, flunitrazepam, midazolam and nitroglycerin.
