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Paediatric population: The safety and efficacy of ANALAB CAPSULE/INJECTION has not been studied in the paediatric population. Therefore, use of ANALAB CAPSULE/INJECTION is not recommended in patients under 12 years of age.
Respiratory depression: Administer ANALAB CAPSULE/INJECTION cautiously in patients at risk for respiratory depression, including patients with substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression, as in these patients, even therapeutic doses of ANALAB CAPSULE/INJECTION may decrease respiratory drive to the point of apnea. In these patients, alternative non-opioid analgesics should be considered. When large doses of tramadol are administered with anaesthetic medication or alcohol, respiratory depression may result. Respiratory depression should be treated as an overdose. If naloxone is to be administered, use cautiously because it may precipitate seizures.
Cytochromes P450 (CYP) 2D6 Ultra-Rapid Metabolism: Some individuals may be CYP2D6 ultra-rapid metabolizers.
These individuals convert tramadol more rapidly than other people into its more potent opioid metabolites O-desmethyltramadol (M1). This rapid conversion could result in higher than expected opioid-like side effects including life-threatening respiratory depression. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese.
Japanese and Hispanics, 1 to 10% in Caucasians, 3% in African, Americans, and 16-28% in North Africans, Ethiopians, and Arabs. Data are not available for other ethnic groups.
Risks from Concomitant Use with Benzodiazepines: Profound sedation, respiratory depression, coma, and death may result from the concomitant use of ANALAB CAPSULE/INJECTION with benzodiazepines. Observational studies have demonstrated that concomitant use of opioids and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
If the decision is made to newly prescribe a benzodiazepine and an opioid together, prescribe the lowest effective dosages and minimum durations of concomitant use.
If the decision is made to prescribe a benzodiazepine in a patient already receiving an opioid, prescribe a lower initial dose of the benzodiazepine than indicated in the absence of an opioid, and titrate based on clinical response.
If the decision is made to prescribe an opioid in a patient already taking a benzodiazepine, prescribe a lower initial dose of the opioid, and titrate based on clinical response.
Follow patients closely for signs and symptoms of respiration depression and sedation. Advise both patients and caregivers about the risks of respiratory depression and sedation when ANALAB CAPSULE/INJECTION is used with benzodizepines. Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine have been determined.
Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of benzodiazepines (see INTERACTIONS).
Serotonin Syndrome with Concomitant Use of Serotonergic Drugs: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concurrent use of ANALAB CAPSULE/INJECTION with serotonergic drugs (See INTERACTIONS). This may occur within the recommended dosage range.
Serotonin syndrome symptoms may include mental-status changes (e.g. agitation, hallucinations, coma), autonomic instability (e.g. tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g. hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) and can be fatal (see INTERACTIONS). The onset of symptoms generally occurs within several hours to a few days of concomitant use, but may occur later than that. Discontinue ANALAB CAPSULE/INJECTION if serotonin syndrome is suspected.
Adrenal Insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, decreased appetite, fatigue, weakness, dizziness, and low blood pressure.
If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement dosing of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency.
The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.
Sexual Function/Reproduction: Long term use of opioids may be associated with decreased sex hormone levels and symptoms such as low libido, erectile dysfunction, or infertility (See Postmarketing Experience under Side Effects).
Use in pregnancy: Tramadol has been shown to cross the placenta. There are no adequate and well-controlled studies in pregnant women. Safe use in pregnancy has not been established. ANALAB CAPSULE/INJECTION is not recommended for pregnant women.
Use in lactation: Approximately 0.1% of the maternal dose of tramadol is excreted in breast milk. In the immediate post-partum period, for maternal oral daily dosage up to 400 mg, this corresponds to a mean amount of tramadol ingested by breast-fed infants of 3% of the maternal weight-adjusted dosage. For this reason tramadol should not be used during lactation or alternatively, breast-feeding should be discontinued during treatment with tramadol.
Discontinuation of breast-feeding is generally not necessary following a single dose of tramadol.
Capsule: It should be used with extreme caution in patients with the following conditions: Decreased respiratory reserves; and should not be given during an attack of bronchial asthma or in heart failure secondary to chronic lung disease, hypothyroidism, adrenocortical insufficiency, impaired kidney or liver function, prostatic hypertrophy, shock or inflammatory or obstructive bowel disorders, myasthenia gravis.
It should be given with great care to infants, especially neonates.
The administration of opioid analgesics during labour may cause respiratory depression in the newborn infant.
Even when administered according to instructions, the preparations may affect the reaction ability of the patients to such extent that his capacity to drive or operate machines may be impaired. This applies particularly in conjunction with alcohol.
Information for the patients: ANALAB CAPSULE/INJECTION is a potent drug for the relief of pain, e.g. in wound pain, fractures, severe nerve pain, tumor pain, heart attack. It should not be used for minor pain. The effect sets in quickly and lasts for some hours.
Injection: Dependence on opioids: Tramadol is not recommended as a substitute in opioid-dependent patients. Although tramadol is an opiate agonist, it cannot suppress opioid i.e., morphine, withdrawal symptoms. Because of the difficulty in assessing dependence in patients who have previously received substantial amounts of opioid agonists, tramadol should be used with caution in patients with such a patients.
Reduced level of consciousness disorders of uncertain origin.
Patients in shock should be carefully monitored during treatment.
Increase in intracranial pressure due to head injuries or brain diseases tramadol should be used with caution in patients with increased intracranial pressure due to head injuries or brain diseases, since the respiratory depressant effects of opiate agonists include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure and such effects may be markedly exaggerated in these patients. Also, pupillary changes (miosis) from tramadol may obscure the existence, extent or course of intracranial pathology. Clinicians also should maintain a high index of suspicion for adverse drug reaction when evaluating alter mental status in this patients if they are receiving tramadol.
In patients sensitive to opiates the medicinal product should only be used with caution.
Patients with tendency to drug abuse.
Tramadol has a low dependence potential. On long-term use tolerance, psychotic and physical dependence may develop. In patients with a tendency to drug abuse or dependence, treatment should only be carried out for short periods under strict medical supervision.
To avoid alcohol.
Tramadol should not be used concomitantly with alcohol consumption. The use of tramadol in patients with liver disease is not recommended.
