Seglentis

Assess the potential need for access to naloxone when initiating and renewing therapy. Consider prescribing naloxone based on risk factors for overdose (eg, concomitant use of CNS depressants, history of opioid use disorder, prior opioid overdose, household members or other close contacts at risk for accidental ingestion or overdose). Abuse potential (monitor). Life-threatening respiratory depression; monitor within 1^st 24–72hrs of initiating therapy and following dose increases. Accidental exposure may cause fatal overdose (esp. in children). Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. Increased risk of serious cardiovascular thrombotic events (including MI, stroke). Avoid in recent MI, severe heart failure; if necessary, monitor. Increased risk for serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of peptic ulcer disease and/or GI bleeding. Risk of life-threatening respiratory depression and death related to ultra-rapid metabolizers of tramadol (esp. in children for post-tonsillectomy and/or adenoidectomy pain). Avoid in adolescents 12–18yrs with conditions associated with hypoventilation (eg, post-op status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, concomitant use of drugs that cause respiratory depression). COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Circulatory shock, impaired consciousness, or coma; avoid. Increased intracranial pressure, brain tumors; monitor. Head injury. Biliary tract disease. Acute pancreatitis. Discontinue at 1^st sign of skin rash or any other hypersensitivity. Hypertension; monitor BP closely. Coagulation disorders. May mask signs of infection or fever. Seizure disorders. Avoid in depressed, suicidal, or addiction-prone patients; consider non-narcotic analgesics. Emotional disturbance. Dehydration. Hypovolemia. Hyperkalemia. Preexisting asthma (monitor). Adrenal insufficiency. Hyponatremia. Hypoglycemia. Diabetes. Drug abusers. Ultra-rapid metabolizers (due to CYP2D6 polymorphism), CYP2C9 poor metabolizers, moderate and severe hepatic or severe renal impairment: not recommended. Reevaluate periodically. Avoid abrupt cessation. Elderly (esp. >75yrs). Cachetic. Debilitated. May be associated with a reversible delay in ovulation in females of reproductive potential. Pregnancy (avoid during ≥30 weeks gestation): increased risk of premature closure of the fetal ductus arteriosus; (20–30 weeks gestation): may cause fetal renal dysfunction/oligohydramnios; if treatment needed, limit dose and duration of use. Potential neonatal opioid withdrawal syndrome with prolonged use. Labor & delivery, nursing mothers: not recommended.