Ulcetra Special Precautions

General: The recommended dose of Ulcetra should not be exceeded.
Do not co-administer Ulcetra with other Tramadol or Paracetamol-containing products. (see Use with Other Paracetamol-containing Products and Risk of Overdosage under WARNINGS).
Acute Abdominal Disorder: The administration of Ulcetra may complicate the clinical assessment of patients with acute abdominal condition.
Serious Skin Reactions: Serious skin reactions such as Acute Generalized Exanthematous Pustulosis (AGEP), Steven-Johnson syndrome (SJS), and Toxic Epidermal Necrolysis (TEN), have been reported but are very rare in patients receiving Paracetamol. Patients should be informed of any signs of serious skin reactions, and drug use should be discontinued on the first appearance of skin rashes or other signs of hypersensitivity.
Patient's Information: Ulcetra may impair mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
Ulcetra should not be taken with alcohol containing beverages.
Patients should be instructed not to take Ulcetra in combination with other Tramadol or Paracetamol-containing products, including over-the-counter medications.
Ulcetra should be used with caution when taking medications such as tranquilizers, hypnotics or other opiate containing analgesics.
Patients should be instructed to inform the physician if they are pregnant, think they might become pregnant, or are trying to become pregnant.
Patients should understand the single-dose and 24-hour dose limit and the time interval between doses, since exceeding these recommendations can result in respiratory depression, seizures, hepatic toxicity and death.
Effects on Driving and Operating Machine: Ulcetra can disrupt the mental or physical capabilities required for the performance of potentially dangerous tasks such as driving a car or operating a machine.
Use in Renal Disease: Ulcetra has 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 less than 30 mL/min, it is recommended that the dosing interval of Ulcetra be increased not to exceed 2 tablets every 12 hours.
Use in Hepatic Disease: Ulcetra has not been studied in patients with impaired hepatic function. The use of Ulcetra in patients with hepatic impairment is not recommended. (see Use with Alcohol under WARNINGS).
Use in Children: The safety and effectiveness of Ulcetra have not been studied in pediatric population.
Use in Elderly: In general, dose selection for an elderly patients should be cautions, reflecting the greater frequency of decreased hepatic, renal, or cardiac function; of concomitant disease and multiple drug therapy.