Nalphin
Generic Name
Nalbuphine Hydrochloride
Manufacturer
Generic Pharmaceutical Company
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| nalphin 20 mg injection | ৳ 90.61 | N/A |
Description
Overview of the medicine
Nalbuphine is a synthetic opioid analgesic used for the management of moderate to severe pain. It is an opioid agonist-antagonist, meaning it acts as an agonist at kappa opioid receptors and an antagonist at mu opioid receptors.
Uses & Indications
Dosage
Adults
The usual recommended adult single dose is 10 mg for a 70 kg individual, administered intravenously, intramuscularly, or subcutaneously. This dose may be repeated every 3 to 6 hours as necessary. Maximum single dose: 20 mg. Maximum daily dose: 160 mg.
Elderly
Lower initial doses may be required, and titration should be done carefully due to potential for increased sensitivity and decreased renal/hepatic function.
Renal_impairment
Reduce dose and/or increase dosing interval due to potential for prolonged effect and accumulation of metabolites. Monitor closely.
How to Take
Administered by healthcare professionals via intravenous (IV), intramuscular (IM), or subcutaneous (SC) injection. The IV route should be administered slowly over a few minutes.
Mechanism of Action
Acts as an agonist at kappa (κ) opioid receptors, producing analgesia and sedation, and as an antagonist at mu (μ) opioid receptors, which may reduce the risk of respiratory depression and physical dependence compared to pure mu agonists.
Pharmacokinetics
Onset
Intravenous (IV): 2-3 minutes; Intramuscular (IM)/Subcutaneous (SC): Less than 15 minutes.
Excretion
Excreted primarily in urine as metabolites, with a small amount excreted in feces.
Half life
Approximately 2.5-3 hours.
Absorption
Rapidly absorbed after intramuscular (IM) or subcutaneous (SC) injection; bioavailability is approximately 81% (IM).
Metabolism
Primarily metabolized in the liver.
Side Effects
Contraindications
- Known hypersensitivity to nalbuphine or any component of the formulation.
- Patients with severe respiratory depression or acute bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment.
- Patients with gastrointestinal obstruction, including paralytic ileus.
Drug Interactions
Monoamine Oxidase Inhibitors (MAOIs):
Risk of serotonin syndrome or severe neurotoxicity with some opioids; use with caution.
Opioid Agonists (e.g., morphine, fentanyl):
Nalbuphine's antagonist activity at mu receptors may precipitate withdrawal symptoms in patients physically dependent on pure opioid agonists.
CNS Depressants (e.g., alcohol, benzodiazepines, other opioids, sedatives, hypnotics):
Increased risk of respiratory depression, profound sedation, coma, and death. Use with caution and reduce dose of one or both agents.
Storage
Store at controlled room temperature (20-25°C, 68-77°F). Protect from light and excessive heat/freezing. Do not refrigerate.
Overdose
Symptoms of overdose include respiratory depression, somnolence, stupor, coma, flaccidity, cold and clammy skin, constricted pupils, and possibly circulatory collapse. Treatment involves immediate administration of an opioid antagonist (e.g., naloxone), establishment of an airway, and ventilatory support.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. May cause neonatal opioid withdrawal syndrome if used for prolonged periods. Excreted in breast milk; use with caution in nursing mothers, consider potential risks to the infant.
Side Effects
Contraindications
- Known hypersensitivity to nalbuphine or any component of the formulation.
- Patients with severe respiratory depression or acute bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment.
- Patients with gastrointestinal obstruction, including paralytic ileus.
Drug Interactions
Monoamine Oxidase Inhibitors (MAOIs):
Risk of serotonin syndrome or severe neurotoxicity with some opioids; use with caution.
Opioid Agonists (e.g., morphine, fentanyl):
Nalbuphine's antagonist activity at mu receptors may precipitate withdrawal symptoms in patients physically dependent on pure opioid agonists.
CNS Depressants (e.g., alcohol, benzodiazepines, other opioids, sedatives, hypnotics):
Increased risk of respiratory depression, profound sedation, coma, and death. Use with caution and reduce dose of one or both agents.
Storage
Store at controlled room temperature (20-25°C, 68-77°F). Protect from light and excessive heat/freezing. Do not refrigerate.
Overdose
Symptoms of overdose include respiratory depression, somnolence, stupor, coma, flaccidity, cold and clammy skin, constricted pupils, and possibly circulatory collapse. Treatment involves immediate administration of an opioid antagonist (e.g., naloxone), establishment of an airway, and ventilatory support.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. May cause neonatal opioid withdrawal syndrome if used for prolonged periods. Excreted in breast milk; use with caution in nursing mothers, consider potential risks to the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years, refer to the specific product packaging for exact expiry date.
Availability
Hospitals, retail pharmacies (with prescription)
Approval Status
Approved
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Nalbuphine has undergone extensive clinical trials demonstrating its efficacy and safety in various pain management settings, including postoperative, obstetric, and chronic pain.
Lab Monitoring
- Monitor respiratory rate, depth, and rhythm.
- Assess blood pressure, heart rate, and level of consciousness.
- Monitor for signs of CNS depression and for adverse effects.
Doctor Notes
- Careful monitoring of respiratory status is essential, especially in opioid-naive patients or those receiving other CNS depressants.
- Avoid use in patients with pre-existing opioid dependence to prevent precipitation of withdrawal symptoms.
- Adjust dose for renal or hepatic impairment.
- Nalbuphine is an opioid agonist-antagonist, not a pure agonist. Its effects can be complex, especially in mixed opioid use scenarios.
Patient Guidelines
- Inform your healthcare provider about all current medications, especially other central nervous system depressants or opioids.
- Do not consume alcohol during treatment.
- Avoid driving or operating heavy machinery if you experience dizziness or sedation.
- Report any unusual or severe side effects immediately.
Missed Dose Advice
As an injectable medication usually administered in a clinical setting, a missed dose is unlikely. If administered on a regular schedule, inform your healthcare provider immediately.
Driving Precautions
Nalphin Injection may cause drowsiness, dizziness, or impaired mental and physical abilities. Patients should avoid driving or operating hazardous machinery if these effects occur.
Lifestyle Advice
- Follow all instructions given by your healthcare professional regarding dosage and administration.
- Maintain open communication with your doctor about your pain management plan.
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