Nulphin

Nulphin

nalbuphine

Manufacturer:

Genovate Biotechnology

Distributor:

American Taiwan Biopharm

Marketer:

American Taiwan Biopharm
Concise Prescribing Info
Contents
Nalbuphine HCl
Indications/Uses
Relief of moderate to severe pain. As supplement to surgical anaesth; adjunct to pre-op & post-op analgesia, & obstetrical analgesia during labor & delivery.
Dosage/Direction for Use
SC, IM or IV Adult weighing 70 kg Usual recommended dose: 10 mg; may be repeated every 3-6 hr. Non-tolerant individuals Single max dose: 20 mg. Max total daily dose: 160 mg. IV As a supplement to balance anaesth Induction doses: 0.3-3 mg/kg over 10-15 min. Maintenance doses: 0.25-0.50 mg/kg in single IV administration as required.
Contraindications
Hypersensitivity. Significant resp depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GIT obstruction, including paralytic ileus.
Special Precautions
Serious, life-threatening, or fatal resp depression may occur. Closely monitor patients for resp depression, especially w/in the 1st 24-72 hr of initiating therapy w/ & following increasing dosage. Concomitant use w/ benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesth, antipsychotics, other opioids, alcohol); do not start MAOIs during therapy; avoid concomitant use w/ full opioid agonist analgesic. Contraindicated in patients w/ acute or severe bronchial asthma in an unmonitored setting or in the absence or resuscitative equipment; known or suspected GIT obstruction, including paralytic ileus. Patients w/ significant COPD & those w/ substantially decreased resp reserve, hypoxia, hypercapnia, or preexisting resp depression. Adrenal insufficiency. Monitor for signs of hypotension after initiating or titrating Nulphin; monitor patients who may be susceptible to the intracranial effects of CO2 retention for signs of sedation & resp depression, especially when initiating Nulphin; monitor patients w/ biliary tract disease including acute pancreatitis; monitor patients w/ history of seizure disorders during therapy; monitor newborns for resp depression, apnea, bradycardia & arrhythmias. Avoid in patients w/ circulatory shock & w/ impaired consciousness or coma. Do not abruptly discontinue in a physically-dependent patient. Increased risk of opioid addiction in patients w/ personal or family history of substance abuse or mental illness. Renal or liver dysfunction. Patients w/ MI who have nausea or vomiting. Patients w/ potential for severe constipation. May interfere w/ enzymatic methods for detection of opioids. Serotonin syndrome. May impair mental or physical abilities needed to perform potentially hazardous activities eg, driving a car or operating machinery. Pregnancy (avoid) & lactation. Elderly, cachectic or debilitated patients.
Adverse Reactions
Sedation. Sweat/clammy, nausea/vomiting, dizziness/vertigo, dry mouth, headache.
Drug Interactions
Increased risk of resp depression, profound sedation, coma & death w/ other opioid analgesics, benzodiazepines, or other CNS depressants eg, alcohol, other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesth, antipsychotics, & other opioids. Serotonin syndrome may occur w/ SSRIs, SNRIs, TCAs, triptans, 5-HT3 receptor antagonists, drugs that affect the neurotransmitter system (eg, mirtazapine, trazodone, tramadol), & MAOIs (drugs for psychiatric disorders, linezolid & IV methylene blue). May enhance neuromuscular blocking action of skeletal muscle relaxants. May reduce the efficacy of diuretics. May increase risk of urinary retention &/or severe constipation w/ anticholinergics. Serotonin syndrome or opioid toxicity may manifest w/ MAOIs eg, phenelzine, tranylcypromine, linezolid).
MIMS Class
Analgesics (Opioid)
ATC Classification
N02AF02 - nalbuphine ; Belongs to the class of morphinan derivative opioids. Used to relieve pain.
Presentation/Packing
Form
Nulphin soln for inj 10 mg/mL
Packing/Price
10 × 1's
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