Patients with stomach and intestine problems
Patients with stomach and intestine problems such as intestinal
paralysis (paralytic
ileus) should not use this medicine. These patients may experience disturbances in the flow of bile juices and an increase in blood amylase. Patients with biliary tract disease such as inflammation in the pancreas (acute
pancreatitis) should be monitored for worsening of symptoms.
Patients with epilepsy, seizures and conditions which increase the risk of seizures
Patients with
epilepsy,
seizures or conditions which increase the risk of seizures such as head trauma, metabolic disorders,
alcohol, drug withdrawal and central nervous system infections are at increased risk when using this medicine. These patients are at an increased risk of seizures.
Suicidal behaviour or addiction-prone patients
Patients with addiction-prone or suicidal behaviour are at an increased risk when using this medicine. These patients are at increased risk of
suicide when using this medicine. Austell Tramadol should not be used in such patients. Use of non-narcotic
analgesics should be considered in such patients. Patients are advised not to use more than the recommended dose and not to drink excess
alcohol.
Patients with a history of misuse or currently taking central nervous system-active drugs, emotional disturbance, excess alcohol, or depression
Patients with a history of misuse, emotional disturbance, excess
alcohol use,
depression or currently taking central nervous system-active drugs such as
antidepressant drugs or tranquilizers are at increased risk. These patients are at an increased risk of
suicide when using this medicine. Precaution should be taken when using Austell Tramadol in such patients. Patients are advised not to use more than the recommended dose and not to drink excess alcohol.
Use of tricyclic compounds, monoamine oxidase inhibitors, or neuroleptics which are used to treat neurological disorders
Patients taking tricyclic compounds (cyclobenzaprine, promethazine), monoamine oxidase inhibtors or neuroleptics are at an increased risk when using this medicine. Patients using Austell Tramadol with tricyclic compounds, monoamine oxidase inhibtors or neuroleptics are at increased risk of
seizures. Austell Tramadol should not be used in patients taking MAOIs and within 14 days of stopping the MAOI therapy.
Prolonged use of Austell Tramadol in pregnant women
Infants are at an increased risk when pregnant women use this medicine for long-term. Infants are at increased risk of neonatal
opioid withdrawal
syndrome (symptoms occur in a newborn due to addictive opiate drugs while in the
pregnancy) when pregnant women use this medicine for a long duration which can be life-threatening. The newborn should be observed for the withdrawal syndrome and should be treated as needed. Pregnant women using Austell Tramadol for longer duration should be informed about the risk of neonatal opioid withdrawal syndrome, and provide treatment accordingly.
Use of cytochrome P450 2D6 inhibitors
Patients using Austell Tramadol with cytochrome P450 2D6 inhibitors such as amiodarone, quinidine, which are used to treat irregular heartbeat are at increased risk when using this medicine. Patients using Austell Tramadol with P450 2D6 inhibitors may result in an increased level of Austell Tramadol and decreased metabolite levels in the blood. It may result in an increased risk of serious harmful effects such as
seizures, serotonin
syndrome, and withdrawal (after stopping or reducing intake of a drug) syndrome in patients who have the physical dependence on Austell Tramadol. In the case of discontinuation of the combined use of CYP2D6 inhibitors with Austell Tramadol, results in decreased levels of Austell Tramadol and increased metabolite levels in the blood which may increase the harmful effect of
opioid and fatal slow and ineffective breathing. These patients should also be monitored for seizures, serotonin syndrome, harmful effects of opioids and signs or symptoms of opioid withdrawal.
Use of CYP3A4 inhibitors and cytochrome P450 3A4 inducers
Patients using CYP3A4 inhibitors such as erythromycin, ritonavir and ketoconazole, which are used to treat bacterial, and fungal infections respectively or cytochrome P450 3A4 inducer such as carbamazepine, rifampin and phenytoin, which are used to treat
seizures are at increased risk when using this medicine. When using Austell Tramadol with cytochrome P450 3A4 inhibitors or discontinuing cytochrome P450 3A4 inducer may experience an increase in the level of Austell Tramadol in the blood which may result in increased serious harmful effects including seizures, serotonin
syndrome (serotonin-inducing symptoms), and may cause potentially slow or ineffective breathing. The use of Austell Tramadol with cytochrome P450 3A4 inducers or discontinuing cytochrome P450 3A4 inhibitors may decrease the level of Austell Tramadol in the blood that results in sign and symptoms of
opioid withdrawal. These patients should also be monitored for signs and symptoms of opioid withdrawal.
Using benzodiazepines or other central nervous system depressants with Austell Tramadol
Patients using benzodiazepines or other central nervous system depressants (anxiolytics, tranquilizers, muscle relaxants, general anaesthetics, antipsychotics, other
opioids,
alcohol, non-benzodiazepine sedative/hypnotics) are at increased risk when using this medicine. These patients may experience extreme sedation, slow and ineffective breathing,
coma, and possibly fatal when using Austell Tramadol with central nervous system depressants. When Austell Tramadol is used with benzodiazepine or other CNS depressant, treatment should be started with the lowest effective dose for the shortest duration. Patients should be monitored for the signs of slow or ineffective breathing and sedation. Patients are also advised not to drive or operate heavy machinery when using benzodiazepines or other CNS depressants in combination. Examine the patients for the risk of drug abuse and inform them for risk of overdose and fatality.
Use of serotonergic drugs therapy
Patients undergoing serotonergic drugs therapy such as tricyclic
antidepressants, selective serotonin reuptake inhibitors (
SSRIs), triptans, serotonin and norepinephrine reuptake inhibitors (SNRIs), 5-HT3 receptor antagonists, MAO inhibitors which are used to treat
depression, are at increased risk when using this medicine. Patients using Austell Tramadol with serotonergic drugs are at increased risk of
seizures and serotonin
syndrome. Symptoms of serotonin syndrome may occur within several hours to a few days, which may include incoordination, blood pressure,
hallucinations,
anxiety,
nausea,
coma, increased heartbeat, increased body temperature, overresponsive reflexes (hyperreflexia), rigidity, vomiting, and
diarrhea. Patients should stop using Austell Tramadol if serotonin syndrome occurs.
History of mental illness or substance abuse
Patients with a history of mental illness or substance abuse are at an increased risk when using this medicine. Such patients are at an increased risk of addiction, misuse or abuse of Austell Tramadol, which may lead to overdose and fatal. These patients should be monitored for the risk and development of addiction, misuse or abuse before using Austell Tramadol. To reduce these risks, a small dose medicine should be prescribed and patients should be advised to dispose off the remaining unused drug.
Life-threatening slow and ineffective breathing
Patients undergoing Austell Tramadol therapy are at increased risk when using this medicine. These patients are at an increased risk of serious, life-threatening, or fatal slow and ineffective breathing during starting or increasing dose of Austell Tramadol. It can be possibly fatal in patients when converting from another
opioid to Austell Tramadol due to overdose with the first dose. Patients should be monitored for slow and ineffective breathing within 24-72 hours of starting or increased dose of Austell Tramadol therapy. Proper dosing is recommended to reduce the risk of slow and ineffective breathing. Management of slow and ineffective breathing includes supportive measures (oxygen and vasopressors), close observation and use of opioid antagonists if needed. Patients are advised to swallow the whole tablet of Austell Tramadol to avoid patient's exposure to a harmful dose.
Children taking Austell Tramadol
Children younger than 12 years, children under 18 years with a history of organ removal
surgery and children under 12- 18 years with risk factors such as
obesity, serious sleep disease (obstructive sleep apnea), neuromuscular disease, severe pulmonary disease, and combined use of other medicines are at increased risk when using this medicine. Such patients are at an increased risk of life-threatening slow or ineffective breathing and it can be possibly fatal. Avoid the use of Austell Tramadol in such patients.
Breastfeeding mother taking Austell Tramadol
Infants who are
breastfeeding from mother taking Austell Tramadol are at an increased risk. Infants are at an increased risk of slow and ineffective breathing when a mother is using this medicine. Austell Tramadol should not be used during
breastfeeding.
Ultra-rapid metabolizers taking Austell Tramadol
Patients who rapidly convert Austell Tramadol into O-desmethyltramadol are at increased risk. These patients are at increased risk of fatal and life-threatening slow or ineffective breathing or experience signs of overdose such as
confusion, extreme sleepiness, or shallow breathing when using this medicine. Austell Tramadol should not be used in such patients.