Nulphin Dosage/Direction for Use

Posology: NULPHIN Injection should be administered as a supplement to general anesthesia only by persons specifically trained in the use of intravenous anesthetics and management of the respiratory effects of potent opioids.
Naloxone, resuscitative and intubation equipment and oxygen should be readily available.
Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse (see Precautions).
Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with NULPHIN Injection and adjust the dosage accordingly (see Precautions).
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Initial Dosage: The usual recommended adult dose is 10 mg for a 70 kg individual administered subcutaneously, intramuscularly, or intravenously; this dose may be repeated every 3 to 6 hours as necessary. Dosage should be adjusted according to the severity of the pain, physical status of the patient, and other medications which the patient may be receiving (see Precautions). In nontolerant individuals, the recommended single maximum dose is 20 mg with a maximum total daily dose of 160 mg.
The use of NULPHIN Injection as a supplement to balanced anesthesia requires larger doses than those recommended for analgesia. Induction doses of nalbuphine hydrochloride range from 0.3 mg/kg to 3 mg/kg intravenously to be administered over a 10 to 15 minutes period with maintenance doses of 0.25 to 0.5 mg/kg in single intravenous administrations as required. The use of NULPHIN Injection may be followed by respiratory depression which can be reversed with the opioid antagonist naloxone hydrochloride.
Titration and Maintenance of Therapy: Individually titrate NULPHIN Injection to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving nalbuphine hydrochloride to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse (see Precautions). Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.
If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the nalbuphine hydrochloride dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse events.
Discontinuation of NULPHIN Injection: When a patient who has been taking NULPHIN Injection regularly and may be physically dependent no longer requires therapy with NULPHIN Injection, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue NULPHIN Injection in a physically-dependent patient (see Precautions).
Pediatric Use: Safety and effectiveness in pediatric patients below the age of 18 years have not been established.
Geriatric Use: Elderly patients (aged 65 years or older) may have increased sensitivity to NULPHIN Injection. In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.
Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. Titrate the dosage of NULPHIN Injection slowly in geriatric patients (see Precautions).
Nalbuphine is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.