Duocetz Special Precautions

General: The recommended dose of Duocetz should not be exceeded.
Do not co-administer Duocetz with other tramadol or paracetamol-containing products.
Acute Abdominal Conditions: The administration of DUOCETZ may complicate the clinical assessment of patients with acute abdominal conditions.
Renal Impairment: Tramadol HCl and paracetamol tablets have not been studied in patients with impaired renal function. Experience with tramadol suggests that impaired renal function results in a decreased rate and extent of excretion of tramadol and its active metabolite, M1. In patients with creatinine clearances of <30 mL/min, it is recommended that the dosing interval of Duocetz be increased not >2 tablets every 12 hrs.
Hepatic Impairment: Tramadol HCl and paracetamol tablets have not been studied in patients with impaired hepatic function. The use of Duocetz in patients with hepatic impairment is not recommended.
Information for Patients: Patients should be informed that Duocetz may cause seizures and/or serotonin syndrome with concomitant use of serotonergic agents (including SSRIs, SNRIs, and triptans) or drugs that significantly reduce the metabolic clearance of tramadol.
Duocetz should not be taken with alcohol containing beverages. The patient should be instructed not to take Duocetz in combination with other tramadol or paracetamol-containing products, including over-the-counter preparations. Duocetz should be used with caution when taking medications eg, tranquilizers, hypnotics or other opiate containing analgesics. The patient should be instructed to inform the physician if they are pregnant, think they might become pregnant or are trying to become pregnant. The patient should understand the single-dose and 24-hr dose limit and the time interval between doses, since exceeding these recommendations can result in respiratory depression, seizures, hepatic toxicity and death.
Effects on the Ability to Drive or Operate Machinery: Duocetz may impair mental or physical abilities required for the performance of potentially hazardous tasks eg, driving a car or operating machinery.
Labor and Delivery: Duocetz should not be used in pregnant women prior to or during labor unless the potential benefits outweigh the risks. Safe use in pregnancy has not been established. Chronic use during pregnancy may lead to physical dependence and post-partum withdrawal symptoms in the newborn.
Tramadol has been shown to cross the placenta. The mean ratio of serum tramadol in the umbilical veins compared to maternal veins was 0.83 for 40 women given tramadol during labor. The effect of tramadol HCl and acetaminophen tablets, if any, on the later growth, development and functional maturation of the child is unknown.
Use in Pregnancy: There are no adequate and well-controlled studies in pregnant women. Duocetz should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonatal seizures, neonatal withdrawal syndrome, fetal death and still birth have been reported with tramadol HCl during post-marketing.
Use in Lactation: Following a single IV 100 mg dose of tramadol, the cumulative excretion in breast milk within 16 hrs post-dose was 100 mcg of tramadol (0.1% of the maternal dose) and 27 mcg of M1.
Use in Children: The safety and effectiveness of Duocetz has not been studied in the pediatric population.
Use in the Elderly: In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function; of concomitant disease and multiple drug therapy.