Nubain (Nalbuphine hydrochloride)
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Nubain (Nalbuphine hydrochloride)

NUBAIN®
(nalbuphine hydrochloride)

DRUG DESCRIPTION

NUBAIN (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. Chemically nalbuphine hydrochloride is 17-(cyclobutylmethyl)-4,5α-epoxymorphinan-3,6α,14-triol hydrochloride. Nalbuphine hydrochloride molecular weight is 393.91 and is soluble in H2O (35.5 mg/mL @ 25?C) and ethanol (0.8%); insoluble in CHCl3 and ether. Nalbuphine hydrochloride has pKa values of 8.71 and 9.96. The molecular formula is C21H27NO4·HCl. The structural formula is:

NUBAIN (nalbuphine hydrochloride) structural formula illustration

NUBAIN (nalbuphine hydrochloride) is a sterile solution suitable for subcutaneous, intramuscular, or intravenous injection. NUBAIN (nalbuphine hydrochloride) is available in two concentrations, 10 mg and 20 mg of nalbuphine hydrochloride per mL. Both strengths in 10 mL vials contain 0.94% sodium citrate hydrous, 1.26% citric acid anhydrous, and 0.2% of a 9:1 mixture of methylparaben and propylparaben as preservatives; pH is adjusted, if necessary, to 3.5 to 3.7 with hydrochloric acid. The 10 mg/mL strength contains 0.2% sodium chloride.

NUBAIN (nalbuphine hydrochloride) is also available in ampuls in a sterile, paraben-free formulation in two concentrations, 10 mg and 20 mg of nalbuphine hydrochloride per mL. One mL of each strength contains 0.94% sodium citrate hydrous, and 1.26% citric acid anhydrous; pH is adjusted, if necessary, to 3.5 to 3.7 with hydrochloric acid. The 10 mg/mL strength contains 0.2% sodium chloride.

What are the possible side effects of nalbuphine (Nubain)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have any of these serious side effects:

  • weak or shallow breathing;
  • fast or slow heart rate;
  • cold, clammy skin;
  • confusion, hallucinations, unusual thoughts or behavior;
  • severe weakness or dizziness; or
  • feeling like you might pass out.

Less serious side effects are more likely to occur, such as:

  • warmth, tingling, or...

Read All Potential Side Effects and See Pictures of Nubain »

Last reviewed on RxList: 1/4/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

NUBAIN (nalbuphine hydrochloride) is indicated for the relief of moderate to severe pain. NUBAIN (nalbuphine hydrochloride) can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery.

DOSAGE AND ADMINISTRATION

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 Interaction with Other Central Nervous System Depressants under WARNINGS). In non-tolerant individuals, the recommended single maximum dose is 20 mg, with a maximum total daily dose of 160 mg.

The use of NUBAIN (nalbuphine hydrochloride) as a supplement to balanced anesthesia requires larger doses than those recommended for analgesia. Induction doses of NUBAIN (nalbuphine hydrochloride) range from 0.3 mg/kg to 3 mg/kg intravenously to be administered over a 10 to 15 minute period with maintenance doses of 0.25 to 0.5 mg/kg in single intravenous administrations as required. The use of NUBAIN (nalbuphine hydrochloride) may be followed by respiratory depression which can be reversed with the opioid antagonist NARCAN® (naloxone hydrochloride).

NUBAIN (nalbuphine hydrochloride) is physically incompatible with nafcillin and keterolac.

Patients Dependent on Opioids

Patients who have been taking opioids chronically may experience withdrawal symptoms upon the administration of NUBAIN (nalbuphine hydrochloride) . If unduly troublesome, opioid withdrawal symptoms can be controlled by the slow intravenous administration of small increments of morphine, until relief occurs. If the previous analgesic was morphine, meperidine, codeine, or other opioid with similar duration of activity, one-fourth of the anticipated dose of NUBAIN (nalbuphine hydrochloride) can be administered initially and the patient observed for signs of withdrawal, i.e., abdominal cramps, nausea and vomiting, lacrimation, rhinorrhea, anxiety, restlessness, elevation of temperature or piloerection. If untoward symptoms do not occur, progressively larger doses may be tried at appropriate intervals until the desired level of analgesia is obtained with NUBAIN (nalbuphine hydrochloride) .

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

HOW SUPPLIED

NUBAIN® (nalbuphine hydrochloride) injection for intramuscular, subcutaneous, or intravenous use is a sterile solution available in:

NDC 63481-508-05 (sulfite-free) 10 mg/mL, 10 mL multiple dose vials (box of 1)
NDC 63481-432-10 (sulfite/paraben-free) 10 mg/mL, 1 mL ampuls (box of 10)
NDC 63481-509-05 (sulfite-free) 20 mg/mL, 10 mL multiple dose vials (box of 1)
NDC 63481-433-10 (sulfite/paraben-free) 20 mg/mL, 1 mL ampuls (box of 10)

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.] Protect from excessive light. Store in carton until contents have been used.

Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317. Manufactured by: Bristol-Myers Squibb Holdings Pharma, Ltd. Manati, Puerto Rico 00674, USA. NUBAIN® (nalbuphine hydrochloride) is a Registered Trademark of Endo Pharmaceuticals Inc. NARCAN® is a Registered Trademark of Endo Pharmaceuticals Inc. /January, 2005. FDA Rev date: 8/23/2005

Last reviewed on RxList: 1/4/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The most frequent adverse reaction in 1066 patients treated in clinical studies with NUBAIN (nalbuphine hydrochloride) was sedation 381 (36%).

Less frequent reactions were: sweaty/clammy 99 (9%), nausea/vomiting 68 (6%), dizziness/vertigo 58 (5%), dry mouth 44 (4%), and headache 27 (3%).

Other adverse reactions which occurred (reported incidence of 1% or less) were:

CNS Effects: Nervousness, depression, restlessness, crying, euphoria, floating, hostility, unusual dreams, confusion, faintness, hallucinations, dysphoria, feeling of heaviness, numbness, tingling, unreality. The incidence of psychotomimetic effects, such as unreality, depersonalization, delusions, dysphoria and hallucinations has been shown to be less than that which occurs with pentazocine.

Cardiovascular: Hypertension, hypotension, bradycardia, tachycardia.

Gastrointestinal: Cramps, dyspepsia, bitter taste.

Respiratory: Depression, dyspnea, asthma.

Dermatologic: Itching, burning, urticaria.

Miscellaneous: Speech difficulty, urinary urgency, blurred vision, flushing and warmth.

Allergic Reactions: Anaphylactic/anaphylactoid and other serious hypersensitivity reactions have been reported following the use of nalbuphine and may require immediate, supportive medical treatment. These reactions may include shock, respiratory distress, respiratory arrest, bradycardia, cardiac arrest, hypotension, or laryngeal edema. Some of these allergic reactions may be life-threatening. Other allergic-type reactions reported include stridor, bronchospasm, wheezing, edema, rash, pruritus, nausea, vomiting, diaphoresis, weakness, and shakiness.

Events Observed during Post-marketing Surveillance of NUBAIN (nalbuphine hydrochloride) : Due to the nature and limitations of spontaneous reporting, causality has not been established for the following adverse events received for NUBAIN (nalbuphine hydrochloride) : abdominal pain, pyrexia, depressed level or loss of consciousness, somnolence, tremor, anxiety, pulmonary edema, agitation, seizures, and injection site reactions such as pain, swelling, redness, burning, and hot sensations. Death has been reported from severe allergic reactions to NUBAIN (nalbuphine hydrochloride) treatment. Fetal death has been reported where mothers received NUBAIN (nalbuphine hydrochloride) during labor and delivery.

Drug Abuse And Dependence

There have been reports of abuse and dependence associated with NUBAIN (nalbuphine hydrochloride) among health care providers, patients and bodybuilders. There have been reported instances of psychological and physical dependence and tolerance in patients abusing NUBAIN (nalbuphine hydrochloride) . Individuals with a prior history of opioid or other substance abuse or dependence may be at greater risk in responding to reinforcing properties of NUBAIN (nalbuphine hydrochloride) .

Abrupt discontinuation of NUBAIN (nalbuphine hydrochloride) following prolonged use has been followed by symptoms of opioid withdrawal, i.e., abdominal cramps, nausea and vomiting, rhinorrhea, lacrimation, restlessness, anxiety, elevated temperature and piloerection.

Read the Nubain (nalbuphine hydrochloride) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information available.

Last reviewed on RxList: 1/4/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

NUBAIN (nalbuphine hydrochloride) 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.

Drug Abuse

Caution should be observed in prescribing NUBAIN (nalbuphine hydrochloride) for emotionally unstable patients, or for individuals with a history of opioid abuse. Such patients should be closely supervised when long-term therapy is contemplated (see Drug Abuse And Dependence).

Use in Ambulatory Patients

NUBAIN (nalbuphine hydrochloride) may impair the mental or physical abilities required for the performance of potentially dangerous tasks such as driving a car or operating machinery. Therefore, NUBAIN (nalbuphine hydrochloride) should be administered with caution to ambulatory patients who should be warned to avoid such hazards.

Use in Emergency Procedures

Maintain patient under observation until recovered from NUBAIN (nalbuphine hydrochloride) effects that would affect driving or other potentially dangerous tasks.

Use in Pregnancy (Other Than Labor)

Severe fetal bradycardia has been reported when NUBAIN (nalbuphine hydrochloride) is administered during labor. Naloxone may reverse these effects. Although there are no reports of fetal bradycardia earlier in pregnancy, it is possible that this may occur. This drug should be used in pregnancy only if clearly needed, if the potential benefit outweighs the risk to the fetus, and if appropriate measures such as fetal monitoring are taken to detect and manage any potential adverse effect on the fetus.

Use During Labor and Delivery

The placental transfer of nalbuphine is high, rapid, and variable with a maternal to fetal ratio ranging from 1:0.37 to 1:6. Fetal and neonatal adverse effects that have been reported following the administration of nalbuphine to the mother during labor include fetal bradycardia, respiratory depression at birth, apnea, cyanosis, and hypotonia. Some of these events have been life-threatening. Maternal administration of naloxone during labor has normalized these effects in some cases. Severe and prolonged fetal bradycardia has been reported. Permanent neurological damage attributed to fetal bradycardia has occurred. A sinusoidal fetal heart rate pattern associated with the use of nalbuphine has also been reported. NUBAIN (nalbuphine hydrochloride) should be used during labor and delivery only if clearly indicated and only if the potential benefit outweighs the risk to the infant. Newborns should be monitored for respiratory depression, apnea, bradycardia and arrhythmias if NUBAIN (nalbuphine hydrochloride) has been used.

Head Injury and Increased Intracranial Pressure

The possible respiratory depressant effects and the potential of potent analgesics to elevate cerebrospinal fluid pressure (resulting from vasodilation following CO2 retention) may be markedly exaggerated in the presence of head injury, intracranial lesions or a pre- existing increase in intracranial pressure. Furthermore, potent analgesics can produce effects which may obscure the clinical course of patients with head injuries. Therefore, NUBAIN (nalbuphine hydrochloride) should be used in these circumstances only when essential, and then should be administered with extreme caution.

Interaction with Other Central Nervous System Depressants

Although NUBAIN (nalbuphine hydrochloride) possesses opioid antagonist activity, there is evidence that in nondependent patients it will not antagonize an opioid analgesic administered just before, concurrently, or just after an injection of NUBAIN (nalbuphine hydrochloride) . Therefore, patients receiving an opioid analgesic, general anesthetics, phenothiazines, or other tranquilizers, sedatives, hypnotics, or other CNS depressants (including alcohol) concomitantly with NUBAIN (nalbuphine hydrochloride) may exhibit an additive effect. When such combined therapy is contemplated, the dose of one or both agents should be reduced.

PRECAUTIONS

General

Impaired Respiration:

At the usual adult dose of 10 mg/70 kg, NUBAIN (nalbuphine hydrochloride) causes some respiratory depression approximately equal to that produced by equal doses of morphine. However, in contrast to morphine, respiratory depression is not appreciably increased with higher doses of NUBAIN (nalbuphine hydrochloride) . Respiratory depression induced by NUBAIN (nalbuphine hydrochloride) can be reversed by NARCAN® (naloxone hydrochloride) when indicated. NUBAIN (nalbuphine hydrochloride) should be administered with caution at low doses to patients with impaired respiration (e.g., from other medication, uremia, bronchial asthma, severe infection, cyanosis, or respiratory obstructions).

Impaired Renal or Hepatic Function:

Because NUBAIN (nalbuphine hydrochloride) is metabolized in the liver and excreted by the kidneys, NUBAIN (nalbuphine hydrochloride) should be used with caution in patients with renal or liver dysfunction and administered in reduced amounts.

Myocardial Infarction:

As with all potent analgesics, NUBAIN (nalbuphine hydrochloride) should be used with caution in patients with myocardial infarction who have nausea or vomiting.

Biliary Tract Surgery:

As with all opioid analgesics, NUBAIN (nalbuphine hydrochloride) should be used with caution in patients about to undergo surgery of the biliary tract since it may cause spasm of the sphincter of Oddi.

Cardiovascular System:

During evaluation of NUBAIN (nalbuphine hydrochloride) in anesthesia, a higher incidence of bradycardia has been reported in patients who did not receive atropine pre-operatively.

Laboratory Tests

NUBAIN (nalbuphine hydrochloride) may interfere with enzymatic methods for the detection of opioids depending on the specificity/sensitivity of the test. Consult the test manufacturer for specific details.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Long term carcinogenicity studies were performed in rats (24 months) and mice (19 months) by oral administration at doses up to 200 mg/kg (1180 mg/m2) and 200 mg/kg (600 mg/m2) per day, respectively. There was no evidence of an increase in tumors in either species related to NUBAIN (nalbuphine hydrochloride) administration. The maximum recommend human dose (MRHD) in a day is 160 mg subcutaneously, intramuscularly or intravenously, or approximately 100 mg/m2/day for a 60 kg subject.

Mutagenesis

NUBAIN (nalbuphine hydrochloride) did not have mutagenic activity in the AMES test with four bacterial strains, in the Chinese Hamster Ovary HGPRT assays or in the Sister Chromatids Exchange Assay. However, NUBAIN (nalbuphine hydrochloride) induced an increased frequency of mutation in the mouse lymphoma assay. Clastogenic activity was not observed in the mouse micronucleus test of the cytogenicity bone marrow assay in rats.

Impairment of Fertility

A reproduction study was performed in male and female rats at subcutaneous doses up to 56 mg/kg/day or 330 mg/m2/day. NUBAIN (nalbuphine hydrochloride) did not affect either male or female fertility rats.

Usage in Pregnancy

Teratogenic Effects: Pregnancy Category B

Reproduction studies have been performed in rats by subcutaneous administration of nalbuphine up to 100 mg/kg/day, or 590 mg/m2/day which is approximately 6 times the MRHD, and in rabbits by intravenous administration of nalbuphine up to 32 mg/kg/day, or 378 mg/m2/day which is approximately 4 times the MRHD. The results did not reveal evidence of developmental toxicity, including teratogenicity, or harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Non-teratogenic Effects

Neonatal body weight and survival rates were reduced at birth and during lactation when nalbuphine was subcutaneously administered to female and male rats prior to mating and throughout gestation and lactation or to pregnant rats during the last third of gestation and throughout lactation at doses approximately 4 times the maximum recommended human dose.

Use During Labor and Delivery

See WARNINGS.

Nursing Mothers

Limited data suggest that NUBAIN (nalbuphine hydrochloride) is excreted in maternal milk but only in a small amount (less than 1% of the administered dose) and with a clinically insignificant effect. Caution should be exercised when NUBAIN (nalbuphine hydrochloride) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 18 years have not been established.

Last reviewed on RxList: 1/4/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

The immediate intravenous administration an opiate antagonist such as naloxone or nalmefene is a specific antidote. Oxygen, intravenous fluids, vasopressors and other supportive measures should be used as indicated.

The administration of single doses of 72 mg of NUBAIN (nalbuphine hydrochloride) subcutaneously to eight normal subjects has been reported to have resulted primarily in symptoms of sleepiness and mild dysphoria.

CONTRAINDICATIONS

NUBAIN (nalbuphine hydrochloride) should not be administered to patients who are hypersensitive to nalbuphine hydrochloride, or to any of the other ingredients in NUBAIN (nalbuphine hydrochloride) .

Last reviewed on RxList: 1/4/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

NUBAIN (nalbuphine hydrochloride) is a potent analgesic. Its analgesic potency is essentially equivalent to that of morphine on a milligram basis. Receptor studies show that NUBAIN (nalbuphine hydrochloride) binds to mu, kappa, and delta receptors, but not to sigma receptors. NUBAIN (nalbuphine hydrochloride) is primarily a kappa agonist/partial mu antagonist analgesic.

The onset of action of NUBAIN (nalbuphine hydrochloride) occurs within 2 to 3 minutes after intravenous administration, and in less than 15 minutes following subcutaneous or intramuscular injection. The plasma half-life of nalbuphine is 5 hours, and in clinical studies the duration of analgesic activity has been reported to range from 3 to 6 hours.

The opioid antagonist activity of NUBAIN (nalbuphine hydrochloride) is one-fourth as potent as nalorphine and 10 times that of pentazocine.

NUBAIN (nalbuphine hydrochloride) may produce the same degree of respiratory depression as equianalgesic doses of morphine. However, NUBAIN (nalbuphine hydrochloride) exhibits a ceiling effect such that increases in dose greater than 30 mg do not produce further respiratory depression in the absence of other CNS active medications affecting respiration.

NUBAIN (nalbuphine hydrochloride) by itself has potent opioid antagonist activity at doses equal to or lower than its analgesic dose. When administered following or concurrent with mu agonist opioid analgesics (e.g., morphine, oxymorphone, fentanyl), NUBAIN (nalbuphine hydrochloride) may partially reverse or block opioid-induced respiratory depression from the mu agonist analgesic. NUBAIN (nalbuphine hydrochloride) may precipitate withdrawal in patients dependent on opioid drugs. NUBAIN (nalbuphine hydrochloride) should be used with caution in patients who have been receiving mu opioid analgesics on a regular basis.

Last reviewed on RxList: 1/4/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Patients should be advised of the following information:

- NUBAIN (nalbuphine hydrochloride) is associated with sedation and may impair mental and physical abilities required for the performance of potentially dangerous tasks such as driving a car or operating machinery.

- NUBAIN (nalbuphine hydrochloride) is to be used as prescribed by a physician. Dose or frequency should not be increased without first consulting with a physician since NUBAIN (nalbuphine hydrochloride) may cause psychological or physical dependence.

- The use of NUBAIN (nalbuphine hydrochloride) with other opioids can cause signs and symptoms of withdrawal.

- Abrupt discontinuation of NUBAIN (nalbuphine hydrochloride) after prolonged usage may cause signs and symptoms of withdrawal.

Last reviewed on RxList: 1/4/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Patients should be advised of the following information:

- NUBAIN (nalbuphine hydrochloride) is associated with sedation and may impair mental and physical abilities required for the performance of potentially dangerous tasks such as driving a car or operating machinery.

- NUBAIN (nalbuphine hydrochloride) is to be used as prescribed by a physician. Dose or frequency should not be increased without first consulting with a physician since NUBAIN (nalbuphine hydrochloride) may cause psychological or physical dependence.

- The use of NUBAIN (nalbuphine hydrochloride) with other opioids can cause signs and symptoms of withdrawal.

- Abrupt discontinuation of NUBAIN (nalbuphine hydrochloride) after prolonged usage may cause signs and symptoms of withdrawal.

Last reviewed on RxList: 1/4/2008
This monograph has been modified to include the generic and brand name in many instances.

NUBAIN®
(nalbuphine hydrochloride)

DRUG DESCRIPTION

NUBAIN (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. Chemically nalbuphine hydrochloride is 17-(cyclobutylmethyl)-4,5α-epoxymorphinan-3,6α,14-triol hydrochloride. Nalbuphine hydrochloride molecular weight is 393.91 and is soluble in H2O (35.5 mg/mL @ 25?C) and ethanol (0.8%); insoluble in CHCl3 and ether. Nalbuphine hydrochloride has pKa values of 8.71 and 9.96. The molecular formula is C21H27NO4·HCl. The structural formula is:

NUBAIN (nalbuphine hydrochloride) structural formula illustration

NUBAIN (nalbuphine hydrochloride) is a sterile solution suitable for subcutaneous, intramuscular, or intravenous injection. NUBAIN (nalbuphine hydrochloride) is available in two concentrations, 10 mg and 20 mg of nalbuphine hydrochloride per mL. Both strengths in 10 mL vials contain 0.94% sodium citrate hydrous, 1.26% citric acid anhydrous, and 0.2% of a 9:1 mixture of methylparaben and propylparaben as preservatives; pH is adjusted, if necessary, to 3.5 to 3.7 with hydrochloric acid. The 10 mg/mL strength contains 0.2% sodium chloride.

NUBAIN (nalbuphine hydrochloride) is also available in ampuls in a sterile, paraben-free formulation in two concentrations, 10 mg and 20 mg of nalbuphine hydrochloride per mL. One mL of each strength contains 0.94% sodium citrate hydrous, and 1.26% citric acid anhydrous; pH is adjusted, if necessary, to 3.5 to 3.7 with hydrochloric acid. The 10 mg/mL strength contains 0.2% sodium chloride.

Last reviewed on RxList: 1/4/2008
This monograph has been modified to include the generic and brand name in many instances.

NUBAIN®
(nalbuphine hydrochloride)

DRUG DESCRIPTION

NUBAIN (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. Chemically nalbuphine hydrochloride is 17-(cyclobutylmethyl)-4,5α-epoxymorphinan-3,6α,14-triol hydrochloride. Nalbuphine hydrochloride molecular weight is 393.91 and is soluble in H2O (35.5 mg/mL @ 25?C) and ethanol (0.8%); insoluble in CHCl3 and ether. Nalbuphine hydrochloride has pKa values of 8.71 and 9.96. The molecular formula is C21H27NO4·HCl. The structural formula is:

NUBAIN (nalbuphine hydrochloride) structural formula illustration

NUBAIN (nalbuphine hydrochloride) is a sterile solution suitable for subcutaneous, intramuscular, or intravenous injection. NUBAIN (nalbuphine hydrochloride) is available in two concentrations, 10 mg and 20 mg of nalbuphine hydrochloride per mL. Both strengths in 10 mL vials contain 0.94% sodium citrate hydrous, 1.26% citric acid anhydrous, and 0.2% of a 9:1 mixture of methylparaben and propylparaben as preservatives; pH is adjusted, if necessary, to 3.5 to 3.7 with hydrochloric acid. The 10 mg/mL strength contains 0.2% sodium chloride.

NUBAIN (nalbuphine hydrochloride) is also available in ampuls in a sterile, paraben-free formulation in two concentrations, 10 mg and 20 mg of nalbuphine hydrochloride per mL. One mL of each strength contains 0.94% sodium citrate hydrous, and 1.26% citric acid anhydrous; pH is adjusted, if necessary, to 3.5 to 3.7 with hydrochloric acid. The 10 mg/mL strength contains 0.2% sodium chloride.

Last reviewed on RxList: 1/4/2008
This monograph has been modified to include the generic and brand name in many instances.

NUBAIN®
(nalbuphine hydrochloride)

DRUG DESCRIPTION

NUBAIN (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. Chemically nalbuphine hydrochloride is 17-(cyclobutylmethyl)-4,5α-epoxymorphinan-3,6α,14-triol hydrochloride. Nalbuphine hydrochloride molecular weight is 393.91 and is soluble in H2O (35.5 mg/mL @ 25?C) and ethanol (0.8%); insoluble in CHCl3 and ether. Nalbuphine hydrochloride has pKa values of 8.71 and 9.96. The molecular formula is C21H27NO4·HCl. The structural formula is:

NUBAIN (nalbuphine hydrochloride) structural formula illustration

NUBAIN (nalbuphine hydrochloride) is a sterile solution suitable for subcutaneous, intramuscular, or intravenous injection. NUBAIN (nalbuphine hydrochloride) is available in two concentrations, 10 mg and 20 mg of nalbuphine hydrochloride per mL. Both strengths in 10 mL vials contain 0.94% sodium citrate hydrous, 1.26% citric acid anhydrous, and 0.2% of a 9:1 mixture of methylparaben and propylparaben as preservatives; pH is adjusted, if necessary, to 3.5 to 3.7 with hydrochloric acid. The 10 mg/mL strength contains 0.2% sodium chloride.

NUBAIN (nalbuphine hydrochloride) is also available in ampuls in a sterile, paraben-free formulation in two concentrations, 10 mg and 20 mg of nalbuphine hydrochloride per mL. One mL of each strength contains 0.94% sodium citrate hydrous, and 1.26% citric acid anhydrous; pH is adjusted, if necessary, to 3.5 to 3.7 with hydrochloric acid. The 10 mg/mL strength contains 0.2% sodium chloride.

Last reviewed on RxList: 1/4/2008
This monograph has been modified to include the generic and brand name in many instances.

Nubain Patient Information Including Side Effects

Brand Names: Nubain

Generic Name: nalbuphine (Pronunciation: NAL bue feen)

What is nalbuphine (Nubain)?

Nalbuphine is in a group of drugs called narcotic pain relievers. It is similar to morphine.

Nalbuphine is used to treat moderate to severe pain. It is also used for treating pain just after surgery or childbirth.

Nalbuphine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of nalbuphine (Nubain)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have any of these serious side effects:

  • weak or shallow breathing;
  • fast or slow heart rate;
  • cold, clammy skin;
  • confusion, hallucinations, unusual thoughts or behavior;
  • severe weakness or dizziness; or
  • feeling like you might pass out.

Less serious side effects are more likely to occur, such as:

  • warmth, tingling, or redness under your skin;
  • nausea, vomiting,, stomach cramps;
  • dizziness, spinning sensation;
  • dry mouth, unpleasant taste;
  • sweating;
  • itching or burning sensation;
  • headache; or
  • trouble with speech or vision.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Nubain (nalbuphine hydrochloride) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about nalbuphine (Nubain)?

Nalbuphine may be habit-forming and should be used only by the person it was prescribed for. Nalbuphine should never be shared with another person, especially someone who has a history of drug abuse or addiction.

Nalbuphine may cause unpleasant side effects if you are already taking other narcotic pain medicines. Before you receive nalbuphine, tell your doctor about all other pain medicines you have recently used.

Also tell your doctor if you are allergic to any drugs, or if you have asthma or other breathing disorder, liver or kidney disease, gallbladder disease, mental illness, or a history of drug or alcohol addiction.

Tell your doctor if you take other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or any other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

Nalbuphine may cause unpleasant side effects if you are already taking other narcotic pain medicines. Before you receive nalbuphine, tell your doctor about all other pain medicines you have recently used.

Side Effects Centers

Nubain Patient Information including How Should I Take

What should I discuss with my healthcare provider before I receive nalbuphine (Nubain)?

You should not receive this medication if you are allergic to nalbuphine.

Nalbuphine may cause unpleasant side effects if you are already taking other narcotic pain medicines. Before you receive nalbuphine, tell your doctor about all other pain medicines you have recently used.

Nalbuphine may be habit-forming and should be used only by the person it was prescribed for. Nalbuphine should never be shared with another person, especially someone who has a history of drug abuse or addiction.

Before receiving nalbuphine, tell your doctor if you are allergic to any drugs, or if you have:

  • asthma, COPD (chronic obstructive pulmonary disease), or other breathing disorder;
  • liver or kidney disease;
  • a history of head injury or brain tumor;
  • gallbladder disease;
  • mental illness; or
  • a history of drug or alcohol addiction.

FDA pregnancy category B. Nalbuphine is not expected to be harmful to an unborn baby. However, do not receive this medication without telling your doctor if you are pregnant.

Nalbuphine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is nalbuphine given (Nubain)?

This medication is given as an injection into a muscle or under your skin, or through a needle placed into a vein. You will receive this injection in a clinic or hospital setting.

Nalbuphine is usually given every 3 to 6 hours.

Tell your doctor if the medicine seems to stop working as well in relieving your pain.

You should not stop using nalbuphine suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Side Effects Centers

Nubain Patient Information including If I Miss a Dose

What happens if I miss a dose (Nubain)?

Since nalbuphine is usually given by a healthcare provider, it is not likely that you will miss a dose.

What happens if I overdose (Nubain)?

Seek emergency medical attention if you think you have received too much of this medicine.

Overdose symptoms may include drowsiness and confusion.

What should I avoid while receiving nalbuphine (Nubain)?

Do not drink alcohol while you are using this medication. Alcohol can increase some of the side effects of nalbuphine.

Nalbuphine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What other drugs will affect nalbuphine (Nubain)?

Tell your doctor if you take other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or any other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

Other narcotic medications include fentanyl (Actiq, Duragesic), hydrocodone (Lortab, Vicodin), hydromorphone (Dilaudid, Palladone), morphine (Kadian, MS Contin, Oramorph, and others), oxycodone (OxyContin), oxymorphone (Numorphan, Opana), and others.

Nalbuphine may cause unpleasant side effects if you are already taking other narcotic pain medicines. Before you receive nalbuphine, tell your doctor about all other pain medicines you have recently used.

This list is not complete and there may be other drugs that can interact with nalbuphine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about nalbuphine.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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