Nalbuphine hydrochloride is a synthetic opioid agonist-antagonist analgesic of the phenanthrene series. It is chemically related to both the widely used opioid antagonist, naloxone, and the potent opioid analgesic, oxymorphone.
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses, reserve nalbuphine hydrochloride for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]
[See USP Controlled Room Temperature. ]. Store at 20 to 25°C (68 to 77°F).
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.
Nubain is a sterile solution suitable for subcutaneous, intramuscular, or intravenous injection. Nubain is available in two concentrations, 10 mg and 20 mg of nalbuphine hydrochloride per mL. Nubain by itself has potent opioid antagonist activity at doses equal to or lower than its.
Less frequent reactions were: sweaty/clammy 99 (9%), nausea/vomiting 68 (6%), dizziness/vertigo 58 (5%), dry mouth 44 (4%), and headache 27 (3%).
The administration of single doses of 72 mg of Nubain subcutaneously to eight normal subjects has been reported to have resulted primarily in symptoms of sleepiness and mild dysphoria.
Generic Name: nalbuphine hydrochloride Dosage Form: Injection.
Other adverse reactions which occurred (reported incidence of 1% or less) were:
NDC (sulfite-free) 10 mg/mL, 10 mL multiple dose vials (box of 1) NDC (sulfite/paraben-free) 10 mg/mL, 1 mL ampuls (box of 10) NDC (sulfite-free) 20 mg/mL, 10 mL multiple dose vials (box of 1) NDC (sulfite/paraben-free) 20 mg/mL, 1 mL ampuls (box of 10).
Nubain is indicated for the relief of moderate to severe pain.
Physician reviewed Nubain patient information - includes Nubain description, dosage and directions.
Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.
other narcotic medications--opioid pain medicine or prescription cough medicine;
Although nalbuphine is sometimes used during labor and delivery, this medicine can cause breathing problems or life-threatening withdrawal symptoms in the newborn. If you receive nalbuphine during labor and delivery, your caregivers will watch your baby closely for any serious side effects of nalbuphine.
Nalbuphine is a semi-synthetic opioid agonist-antagonist used commercially as an analgesic under a variety of trade names, including Nubain and Manfine.
It is also marketed under the brand name Kinz and Nalbin in Pakistan by Sami and Global Pharmaceuticals. Medicaids Pakistan also markets the product under the brand name of ANALIN, while Another local pharmaceutical company Indus Pharma, has recently launched Nalbuphine with brand name of EXNAL.
As reported in the current Nubain Package Insert (2005), the most frequent side effect in 1066 patients treated with nalbuphine was sedation in 381 (36%).
(2001) published a review of clinical trials relating to the prevalence of morphine induced pruritus and its pharmacologic control.
Easy to read patient leaflet for Nubain. Includes indications, proper use, special instructions, precautions, and possible side effects.
Contact (the American Association of Poison Control Centers), your local poison control center, or emergency room immediay. Symptoms may include general discomfort; restlessness; sleepiness.
Check with your doctor if any of these most COMMON side effects persist or become bothersome:. All medicines may cause side effects, but many people have no, or minor, side effects.
Contact your doctor or health care provider right away if any of these apply to you.
It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Nubain.