Nalbun Injection 1ml

Description:

Description
Nalbuphine Hydrochloride is a synthetic opioid analgesic, which binds with mu, kappa and delta receptor. Its analgesic potency is equivalent to Morphine on a milligram basis and 10 times more than that of Pentazocine but has lower side effects and less abuse potential than Morphine. The onset of action of Nalbuphine occurs within 2 to 3 minutes after intravenous administration and in less than 15 minutes following intramuscular injection. The plasma half-life of Nalbuphine is 5 hours and the duration of analgesic activity is 3 to 6 hours.

Indications
Relief of moderate to severe pain associated with myocardial infarction (MI)

As a supplement of balanced anesthesia

Pre-operative and post-operative analgesia

Obstetrical analgesia during labor and delivery

Dosage & Administration
Moderate to severe pain: by intravenous or intramuscular injection 10-20 mg for 70 kg patient, adjusted
as required. Child up to 0.3 mg/kg repeated once or twice as necessary.
In balanced anesthesia: by intravenous or intramuscular injection 0.1-0.2 mg/kg.
Obstetrical analgesia during labor and delivery: by intravenous injection 0.3-1 mg/kg over 10-15 minutes with maintenance dose of 0.25-0.5 mg/kg in single intravenous administration as required.
Intra-operative analgesia: by intravenous injection 0.25-0.5 mg/kg at 30 minutes intervals.
Myocardial infarction: by slow intravenous injection 10-20 mg repeated after 30 minutes if necessary. Larger dose is required when used as supplement of anesthesia than that required for analgesia.
Children from 18 months to 15 years old: usually 0.2 mg/kg body-weight, given preferably by
intravenous or intramuscular injection. Maintenance doses may be given at intervals of 4 to 6 hours or the
dose must be determined by the physician.
Side Effects
Generally Nalbuphine is well tolerated. However few side-effects like sedation, sweating, nausea, vomiting, dizziness, vertigo, dry mouth, headache, respiratory depression, dyspnea and asthma may be seen.

Precautions
Caution should be taken in the following conditions: impaired respiration, impaired renal or hepatic function, billiary tract surgery, myocardial infarction and hypotension.

Use in Pregnancy & Lactation
Nalbuphine is pregnancy category B. The placental transfer of Nalbuphine is high and rapid. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed.

Less than 1% of the administered dose is excreted in milk. However cautions should be exercised when Nalbuphine is administered to a nursing mother.

Over Dose
The immediate intravenous administration of 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. Sleepiness and mild dysphoria may occur due to overdose.Nalbun 1 is a pain relieving medicine. It is used to treat moderate to severe pain. It is also used as a premedication before surgery. This medicine is generally used when alternative medicines are ineffective or inadequate. Nalbun 1 is generally administered by a healthcare professional. You should not self-administer this medicine at home. The dose and duration will depend on what you are taking it for and how well it helps your symptoms. The most common side effects of this medicine include injection site reactions (such as pain, redness, and swelling), nausea, vomiting, sweating a lot, and tiredness. If any of these side effects persist or get worse, you should let your doctor know. Your doctor may be able to suggest ways of preventing or reducing the symptoms. Before using it, you should let your doctor know if you have a history of stomach ulcers, heart diseases, high blood pressure, and liver or kidney disease. Let your doctor also know about all the other medicines you are taking because they may affect, or be affected by, this medicine. If you are pregnant or breastfeeding, it is important to ask the advice of your doctor before taking this medicine. Your doctor may also regularly monitor your kidney function, liver function, and levels of blood components if you are taking this medicine for long-term treatment.Uses of Nalbun 1Moderate to severe painSide effects of Nalbun 1CommonHeadacheDizzinessSleepinessVomitingNauseaConstipationHow to use Nalbun 1Your doctor or nurse will give you this medicine. Kindly do not self administer.How Nalbun 1 worksNalbun 1 is an opioid analgesic (pain reliever) which works by blocking transmission of pain signals to the brain to lower pain perception.What if you forget to take Nalbun 1?If you miss a dose of Nalbun 1, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.Quick TipsUse Nalbun 1 as instructed by your doctor. Never take in greater amounts or more often than prescribed.It causes sleepiness or drowsiness. If this happens to you, do not drive or use machinery.Avoid consuming alcohol when taking the Nalbun 1, as it may cause excessive sleepiness or drowsiness.Inform your doctor if you have ever been diagnosed with kidney or liver problems.Store opioid pain relievers in a safe place and out of reach of others.Brief DescriptionIndicationModerate to severe pain, Pain associated with MI, Balanced anaesthesiaAdministrationIV Administration Administer each 10 mg by IV push over 3-5 minutesAdult DoseParenteral Moderate to severe pain Adult: IM/IV/SC: 10-20 mg 3-6 hrly as required. Non-opioid-tolerant patients: Max single dose: 20 mg. Max daily dose: 160 mg. Intravenous Adjunct in balanced anaesthesia Adult: Induction: 0.3-3 mg/kg over 10-15 min. Maintenance: 0.25-0.5 mg/kg as single admin if required. Hepatic impairment: Caution; dose reduction may be necessary; monitorChild DosePain <1 year: Safety and efficacy not established >1 year: 0.1-0.2 mg/kg IV/IM/SC q3-4hr PRN; individual dose not to exceed 20 mg; not to exceed 160 mg/dayRenal DoseRenal impairment: Caution; dose reduction may be necessary; monitorContraindicationHypersensitivity. Absolute: Diarrhea associated with toxins, pseudomembranous colitis, respiratory depression (<12 beats/min) Acute asthma, bradycardia, inflammatory bowel disease, respiratory impairmentMode of ActionNalbuphine is a phenanthrene derivative opioid analgesic with mixed opioid agonist and antagonist activity. It inhibits the ascending pain pathways, altering the perception of and response to pain by binding to opiate receptors in the CNS. It also produces generalised CNS depression.PrecautionMay impair ability to drive or operate machinery. Emotionally unstable patients or patients with history of opiate abuse; closely monitor these patients during long-term therapy. Impaired respiration due to other drugs, uraemia, bronchial asthma, severe infection, cyanosis, respiratory obstruction. MI patients who exhibit nausea and vomiting and in those about to undergo biliary tract surgery. Head injury, intracranial lesions or pre-existing increased intracranial pressure. Renal or hepatic impairment. Elderly and debilitated patients. Pregnancy and lactation. Lactation: Insignificant amount distributed in milk; use with cautionSide Effect>10% Sedation (36%) 1-10% Clamminess (9%),Nausea and vomiting (6%),Dizziness (5%),Xerostomia (4%),Headache (3%) <1% Asthma,Bradycardia,Burning,Dyspnea,Hypertension,Hypotension,Itching,Miosis,Pulmonary edema,Respiratory depression,Tachycardia,Urticaria,Vertigo Potentially Fatal: Anaphylactic or anaphylactoid and other serious hypersensitivity reactions e.g. shock, respiratory distress, respiratory arrest, bradycardia, cardiac arrest, hypotension, laryngeal oedema.Pregnancy Category NotePregnancy category: B; D if used for prolonged periods or near termInteractionAdditive CNS depressant effects may occur with other CNS depressants e.g. alcohol, anaesthetics, anxiolytics, hypnotics, TCAs and antipsychotics.