Drug Interactions between esketamine and Soma Compound with Codeine

GENERALLY AVOID: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants (e.g., nonbenzodiazepine sedatives/hypnotics, anxiolytics, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol) may result in profound sedation, respiratory depression, coma, and death. The risk of hypotension may also be increased with some CNS depressants (e.g., alcohol, benzodiazepines, phenothiazines).

MANAGEMENT: The use of opioids in conjunction with benzodiazepines or other CNS depressants should generally be avoided unless alternative treatment options are inadequate. If coadministration is necessary, the dosage and duration of each drug should be limited to the minimum required to achieve desired clinical effect, with cautious titration and dosage adjustments when needed. Patients should be monitored closely for signs and symptoms of respiratory depression and sedation, and advised to avoid driving or operating hazardous machinery until they know how these medications affect them. Cough medications containing opioids (e.g., codeine, hydrocodone) should not be prescribed to patients using benzodiazepines or other CNS depressants including alcohol. For patients who have been receiving extended therapy with both an opioid and a benzodiazepine and require discontinuation of either medication, a gradual tapering of dose is advised, since abrupt withdrawal may lead to withdrawal symptoms. Severe cases of benzodiazepine withdrawal, primarily in patients who have received excessive doses over a prolonged period, may result in numbness and tingling of extremities, hypersensitivity to light and noise, hallucinations, and epileptic seizures.

MONITOR CLOSELY: Concomitant use of esketamine with central nervous system (CNS) depressants may increase sedation and impairment of attention, judgment, thinking, reaction speed, and psychomotor skills. In clinical trials, 49% to 61% of esketamine-treated patients developed sedation based on the Modified Observer's Alertness/Sedation scale (MOAA/s), and 0.3% of esketamine-treated patients experienced loss of consciousness (MOAA/s score of 0). In the MOAA/s scale, 5 means "responds readily to name spoken in normal tone" and 0 means "no response after painful trapezius squeeze," and any decrease in MOAA/s from pre-dosing of esketamine is considered to indicate presence of sedation. Dose-related increases in the incidence of sedation were also observed in a fixed-dose study. Additionally, cognitive performance decline was reported in a study in healthy volunteers who received a single intranasal dose of esketamine. Compared to placebo-treated subjects, esketamine-treated subjects required a greater effort to complete cognitive tests at 40 minutes post-dose, although results were comparable between the two groups at 2 hours post-dose. Drowsiness was comparable after 4 hours post-dose.

MANAGEMENT: Caution is advised and patients should be closely monitored during concomitant use of esketamine with CNS depressants or other drugs that can cause sedation or dizziness. Due to the risk of delayed or prolonged sedation and other adverse effects, patients should be monitored for at least 2 hours after esketamine administration, followed by an assessment to determine when the patient is considered clinically stable and ready to leave the healthcare setting. Patients should be instructed not to engage in potentially hazardous activities that require complete mental alertness and motor coordination, such as driving a motor vehicle or operating machinery, until the next day after a restful sleep.

MONITOR CLOSELY: Concomitant use of esketamine with central nervous system (CNS) depressants may increase sedation and impairment of attention, judgment, thinking, reaction speed, and psychomotor skills. In clinical trials, 49% to 61% of esketamine-treated patients developed sedation based on the Modified Observer's Alertness/Sedation scale (MOAA/s), and 0.3% of esketamine-treated patients experienced loss of consciousness (MOAA/s score of 0). In the MOAA/s scale, 5 means "responds readily to name spoken in normal tone" and 0 means "no response after painful trapezius squeeze," and any decrease in MOAA/s from pre-dosing of esketamine is considered to indicate presence of sedation. Dose-related increases in the incidence of sedation were also observed in a fixed-dose study. Additionally, cognitive performance decline was reported in a study in healthy volunteers who received a single intranasal dose of esketamine. Compared to placebo-treated subjects, esketamine-treated subjects required a greater effort to complete cognitive tests at 40 minutes post-dose, although results were comparable between the two groups at 2 hours post-dose. Drowsiness was comparable after 4 hours post-dose.

MANAGEMENT: Caution is advised and patients should be closely monitored during concomitant use of esketamine with CNS depressants or other drugs that can cause sedation or dizziness. Due to the risk of delayed or prolonged sedation and other adverse effects, patients should be monitored for at least 2 hours after esketamine administration, followed by an assessment to determine when the patient is considered clinically stable and ready to leave the healthcare setting. Patients should be instructed not to engage in potentially hazardous activities that require complete mental alertness and motor coordination, such as driving a motor vehicle or operating machinery, until the next day after a restful sleep.