Nalbuphine

(nal' byoo feen)

P  - Caution when used during pregnancy

L  - Caution when used during lactation

Molecule Info

 
Indication & Dosage Parenteral
Moderate to severe pain
Adult: 10-20 mg IM/IV/SC every 3-6 hr as required. Nonopioid-tolerant patients: Max single dose: 20 mg. Max daily dose: 160 mg. 
Child: As hydrochloride: Initially, up to 300 mcg/kg then repeat once or twice as needed.
Renal impairment: Reduce dose.
Hepatic impairment: Reduce dose.
Parenteral
Premedication before anaesthesia
Adult: 100-200 mcg/kg. May be given via IM/SC/IV admin. 
Renal impairment: Reduce dose.
Hepatic impairment: Reduce dose.
Intravenous
Adjunct in balanced anaesthesia
Adult: Induction: 0.3-1 mg/kg IV over 10-15 minutes; up to 3 mg/kg have been used. Maintenance: 250-500 mcg/kg every 30 minutes.
Renal impairment: Reduce dose.
Hepatic impairment: Reduce dose.
Intravenous
Pain associated with myocardial infarction
Adult: 10-30 mg by slow IV inj; give a 2nd 20-mg dose after 30 min if necessary.

Special Populations: Reduce dose in elderly or debilitated patients and in patients with hepatic or renal impairment.

Incompatibility: Incompatible with allopurinol, amphotericin B cholesteryl sulfate complex, cefepime, docetaxel, ketorolac, methotrexate, nafcillin, piperacillin/tazobactam, sargramostim, sodium bicarbonate for Y-site admin. Do not mix in the same syringe as diazepam, ketorolac, pentobarbital.
Administration May be taken with or without food.
Overdosage Symptoms: CNS depression, respiratory depression, miosis, hypotension, bradycardia. Management: Symptomatic. To reverse opioid effects, naloxone 2 mg IV with repeat admin as needed up to a total dose of 10 mg may be given.
Special Precautions May 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.
Adverse Drug Reactions Sedation, dizziness, vertigo, miosis, headache; nausea, vomiting, dry mouth; itching, burning, urticaria. Respiratory depression, dyspnoea, asthma; speech difficulty, urinary urgency, blurred vision, flushing, warmth; clamminess.
Potentially Fatal: Anaphylactic or anaphylactoid and other serious hypersensitivity reactions e.g. shock, respiratory distress, respiratory arrest, bradycardia, cardiac arrest, hypotension, laryngeal oedema.
Drug Interactions Additive CNS depressant effects may occur with other CNS depressants e.g. alcohol, anaesthetics, anxiolytics, hypnotics, TCAs and antipsychotics. Please consult detailed drug interactions before prescribing.
Food Interaction Additive CNS depression may occur with valerian, St John's wort, kava kava, gotu kola.
Pregnancy Category (US FDA) Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1sttrimester (and there is no evidence of a risk in later trimesters).
 

Category D
: If prolonged use/high doses at term. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Storage Intravenous: Store at 15-30°C (59-86°F). Protect from light. Parenteral: Store at 15-30°C (59-86°F). Protect from light.
Pharmacology Nalbuphine 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.
Onset: IV: 2-3 minutes; SC/IM: 15 minutes.
Duration: 3-6 hr.
Absorption: Peak plasma concentrations after 30 minutes (IM/IV).
Distribution: Crosses the placenta.
Metabolism: Undergoes extensive first-pass metabolism in GI mucosa and liver.
Excretion: Via urine and faeces (as unchanged drug and conjugates). Elimination half-life: 5 hr.
ATC Classification N02AF02 - nalbuphine ; Belongs to the class of morphinan derivative opioids. Used to relieve pain.

Brand/Product Info


Total Products : 5     
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
Nalbun 1 ml Incepta Pharmaceuticals Limited Nalbuphine Hydrochloride 10 mg/ml Injection Injection 1x5's:MRP 300 Tk
Nalbun 2 ml Incepta Pharmaceuticals Limited Nalbuphine Hydrochloride 20 mg/2 ml Injection Injection 1x5's:MRP 500 Tk
NALPHIN The Acme Laboratories Ltd. Nalbuphine hydrochloride INN 10mg/1ml & 20mg/2ml (I/V) Injection 5's each: 301.10 & 501.90 MRP
RADIRIF INJ Square Pharmaceuticals Ltd. Nalbuphine 20mg/2 ml IM/IV Injection 4x1's: 402.72 MRP
RALTROX Opsonin Pharma Limited Nalbuphine hydrochloride INN 10mg/1ml & 20mg/2ml (I/V) Injection 10mg x3's, 20mg x1's: 180.00 & 100.00 MRP

Gen. MedInfo

Why is this medication prescribed?

Nalbuphine is an analgesic used to relieve moderate to severe pain. The drug will be injected into a large muscle (such as buttock or hip), under skin or into a vein.

Nalbuphine may be given every 3 to 6 hours as needed to control pain. This medication is sometimes prescribed for other uses; ask your doctor for more information.

Your health care provider may measure the effectiveness and side effects of your treatment using laboratory tests and physical examinations. It is important to keep all appointments with your doctor and the laboratory. The length of treatment depends on how you respond to the medication.

Precautions

Before administering nalbuphine,

  • tell your doctor if you are allergic to nalbuphine, medications containing sulfites, or any other drugs.
  • tell your doctor what prescription and nonprescription medications you are taking, especially antidepressants; medications for cough, cold, or allergies; naloxone (Narcan); naltrexone (ReVia); other pain relievers; sedatives; sleeping pills; tranquilizers; and vitamins.
  • tell your doctor if you have or have ever had breathing difficulties, including asthma and other respiratory diseases, liver or kidney disease, severe inflammatory bowel disease, or a history of drug dependence.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking nalbuphine, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking nalbuphine.
  • you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how nalbuphine will affect you.
  • remember that alcohol can add to the drowsiness caused by this drug.

Administering your medication

Before you administer nalbuphine, look at the solution closely. It should be clear and free of floating material. Observe the solution container to make sure there are no leaks. Do not use the solution if it is discolored, if it contains particles, or if the container leaks. Use a new solution, but show the damaged one to your health care provider.

It is important that you use your medication exactly as directed. Nalbuphine can be habit forming. Do not administer it more often or for a longer period than your doctor tells you. Do not change your dosing schedule without talking to your health care provider.

Side effects 

Nalbuphine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away, 

  • dizziness

  • lightheadedness

  • drowsiness

  • r

    upset stomach

  • vomiting

  • dry mouth

  • headache

  • stomach cramps

  • itchy skin

  • bitter taste

  • confusion or hallucinations

  • feeling of heaviness

  • unusual weakness

 If you experience either of the following symptoms, call your doctor immediately:

  • difficulty breathing

  • fainting

Storing your medication

  • Your health care provider will probably give you a several-day supply of nalbuphine at a time and provide you with directions on how to prepare each dose. Store the vials at room temperature.

Store your medication only as directed. Make sure you understand what you need to store your medication properly.

Keep your supplies in a clean, dry place when you are not using them, and keep all medications and supplies out of the reach of children. Your health care provider will tell you how to throw away used needles, syringes, tubing, and containers to avoid accidental injury.

Signs of infection

If you are receiving nalbuphine in your vein or under your skin, you need to know the symptoms of a catheter-related infection (an infection where the needle enters your vein or skin). If you experience any of these effects near your intravenous catheter, tell your health care provider as soon as possible:

  • tenderness

  • warmth

  • irritation

  • drai nage

  • redness

  • swelling

  • pain

 Ref:  U.S. National Library of Medicine.


This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.