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Nalbuphine Hcl Generic Name & Formulations
Legal Class
Rx
General Description
Nalbuphine HCl 10mg/mL, 20mg/mL; soln for SC, IM or IV inj.
Pharmacological Class
Opioid (agonist-antagonist).
How Supplied
Contact supplier.
Manufacturer
Nalbuphine Hcl Indications
Indications
Pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Pre-op and post-op pain. Pain during labor and delivery. Supplement to balanced anesthesia.
Nalbuphine Hcl Dosage and Administration
Adult
Pain: Individualize. Initially 10mg per 70kg SC, IM, or IV every 3–6hrs as needed. Non-tolerant: max single dose of 20mg; max total daily dose of 160mg. Anesthesia (induction): usual range: 0.3–3mg/kg IV over 10–15mins; (maintenance): usual range: 0.25–0.5mg/kg in single IV administrations as needed.
Children
<18yrs: not established.
Nalbuphine Hcl Contraindications
Contraindications
Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus.
Nalbuphine Hcl Boxed Warnings
Not Applicable
Nalbuphine Hcl Warnings/Precautions
Warnings/Precautions
Life-threatening respiratory depression; monitor within first 24–72hrs of initiating therapy and following dose increases. Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Abuse potential (monitor). Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. MI with nausea/vomiting. Drug abusers. Renal or hepatic impairment. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy; avoid; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery. Nursing mothers.
Nalbuphine Hcl Pharmacokinetics
See Literature
Nalbuphine Hcl Interactions
Interactions
Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor. During or within 14 days of MAOIs: not recommended. Avoid concomitant full opioid agonist analgesic. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, cyclobenzaprine, metaxalone, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics.
Nalbuphine Hcl Adverse Reactions
Adverse Reactions
Sedation, sweaty/clammy, nausea/vomiting, dizziness/vertigo, dry mouth, headache, allergic reactions; respiratory depression, severe hypotension, syncope.
Nalbuphine Hcl Clinical Trials
See Literature
Nalbuphine Hcl Note
Notes
Formerly known under the brand name Nubain.
Nalbuphine Hcl Patient Counseling
See Literature
