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.
Use in Renal Disease: Tramadol hydrochloride and paracetamol tablet 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 clearance of less than 30mL/min, it is recommended that dosing interval of DUOCETZ be increased not to exceed 2 tablets every 12 hours.
Use in Hepatic Disease: Tramadol hydrochloride 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 may impair mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
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 such as tranquilizers, hypnotics or other opiates containing analgesics.
The patients should be instructed to inform the physician if they are pregnant, or are trying to become pregnant.
The patient should understand the single dose and 24-hour dose limit and the time interval between doses, since exceeding these recommendation can result in respiratory depression, seizures, hepatic toxicity and death.
Drug Abuse and Dependence: Abuse: Tramadol has mu-opioid agonist activity. DUOCETZ, a tramadol-containing product, can be abused and may be subject to criminal diversion.
Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestation. Drug addiction is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, use for non-medical purposes, continued use despite harm or risk of harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common.
"Drug-seeking" behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated "loss" of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). "Doctor shopping" to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.
Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of tramadol hydrochloride and acetaminophen tablets can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances.
Concerns about abuse and addiction should not prevent the proper management of pain. However all patients treated opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries risk of addiction even under appropriate medical use.
Proper assessment of the patient and periodic re-evaluation of therapy are appropriate measures that help to limit the potential abuse of this product.
Dependence: Tolerance is the need for increasing doses of drugs to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist.
The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms may also develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.
Generally, tolerance and/or withdrawal are more likely to occur the longer a patient is on continuous therapy with DUOCETZ.
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 of an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function of concomitant disease and multiple drug therapy.