Theratramadol-90

INDICATIONS AND USAGE Tramadol hydrochloride tablets are indicated for the management of moderate to moderately severe pain in adults.

ADVERSE REACTIONS Tramadol hydrochloride was administered to 550 patients during the double-blind or open-label extension periods in U.S. studies of chronic nonmalignant pain. Of these patients, 375 were 65 years old or older. Table 2 reports the cumulative incidence rate of adverse reactions by 7, 30 and 90 days for the most frequent reactions (5% or more by 7 days). The most frequently reported events were in the central nervous system and gastrointestinal system. Although the reactions listed in the table are felt to be probably related to tramadol hydrochloride administration, the reported rates also include some events that may have been due to underlying disease or concomitant medication. The overall incidence rates of adverse experiences in these trials were similar for tramadol hydrochloride and the active control groups, acetaminophen 300 mg with codeine phosphate 30 mg, and aspirin 325 mg with codeine phosphate 30 mg however the rates of withdrawals due to adverse events appeared to be higher in the tramadol hydrochloride groups.

Table 2

Cumulative Incidence of Adverse Reactions for Tramadol Hydrochloride in Chronic Trials of Nonmalignant Pain (N=427)

Seizure Risk Seizures have been reported in patients receiving tramadol hydrochloride tablets within the recommended dosage range. Spontaneous post- marketing reports indicate that seizure risk is increased with doses of tramadol hydrochloride tablets above the recommended range. Concomitant use of tramadol hydrochloride tablets increases the seizure risk in patients taking: • Selective serotonin reuptake inhibitors (SSRI antidepressants or anoretics), • Tricyclic antidepressants (TCAs), and other tricyclic compounds (e.g., cyclobenzaprine, promethazine, etc.), or • Other opioids. Administration of tramadol hydrochloride tablets may enhance the seizure risk in patients taking: • MAO inhibitors (see also WARNINGS - Use with MAO inhibitors), • Neuroleptics, or • Other drugs that reduce the seizure threshold. Risk of convulsions may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections). In tramadol hydrochloride tablets overdose, naloxone administration may increase the risk of seizure. Anaphylactoid Reactions Serious and rarely fatal anaphylactoid reactions have been reported in patients receiving therapy with tramadol hydrochloride tablets. When these events do occur it is often following the first dose. Other reported allergic reactions include pruritus, hives, bronchospasm, and angioedema, toxic epidermal necrolysis and Stevens Johnson syndrome. Patients with a history of anaphylactoid reactions to codeine and other opioids may be at increased risk and therefore should not receive tramadol hydrochloride tablets (see CONTRAINDICATIONS). Respiratory Depression Administer tramadol hydrochloride tablets cautiously in patients at risk for respiratory depression. In these patients alternative non-opioid analgesics should be considered. When large doses of tramadol hydrochloride tablets are administered with anesthetic medications 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 (see WARNINGS, Seizure Risk and OVERDOSAGE). Interaction with Central Nervous System (CNS) Depressants Tramadol should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers or sedative hypnotics. Tramadol increased the risk of CNS and respiratory depression in these patients. Increased Intracranial Pressure or Head Trauma Tramadol hydrochloride tablets should be used with caution in patients with increased intracranial pressure or head injury. The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure, and may be markedly exaggerated in those patients. Additionally, pupillary changes (miosis) from tramadol may obscure the existence, extent, or course of intracranial pathology. Clinicians should also maintain a high index of suspicion for adverse drug reaction when evaluating altered mental status in these patients if they are receiving tramadol hydrochloride tablets. (See Respiratory Depression) Use in Ambulatory Patients Tramadol may impair the mental and or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patients using this drug should be cautioned accordingly.Enter section text here

Use with MAO Inhibitors and serotonin re-uptake inhibitors Use tramadol hydrochloride tablets with great caution in patients taking monoamine oxidase inhibitors. Animal studies have shown increased deaths with combined administration. Concomitant use of tramadol hydrochloride tablets with MAO inhibitors or SSRI's increases the risk of adverse events, including seizure and serotonin syndrome. Withdrawal Withdrawal symptoms may occur if tramadol hydrochloride tablets are discontinued abruptly. (See DRUG ABUSE and DEPENDENCE) These symptoms may include: anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely hallucinations. Clinical experience suggests that withdrawal symptoms may be relieved by tapering the medication.

Physical Dependence and Abuse Tramadol hydrochloride tablets may induce psychic and physical dependence of the morphine-type (µ-opioid) (See DRUG ABUSE and DEPENDENCE). Tramadol hydrochloride tablets should not be used in opioid-dependent patients. Tramadol hydrochloride has been shown to reinitiate physical dependence in some patients that have been previously dependent on other opioids. Dependence and abuse, including drug-seeking behavior and taking illicit actions to obtain the drug, are not limited to those patients with prior history of opioid dependence.

Risk of Overdosage Serious potential consequences of overdosage with tramadol hydrochloride tablets are central nervous system depression, respiratory depression and death. In treating an overdose, primary attention should be given to maintaining adequate ventilation along with general supportive treatment (See OVERDOSAGE).