Naloxone Injection

Therapeutic Class: Others

Dosage Forms: Injectables

Brand Name: Naloxone Injection 400 mcg/ml

Best naloxone injection manufacturer, supplier & exporter In India.

How it works?

Uses of Naloxone Injection

What are the uses of  Naloxone Injection?

1. Reversal of Opioid-Induced Depression

  • Complete or partial reversal of respiratory and central nervous system (CNS) depression caused by:
    • Natural opioids (e.g., morphine, codeine)
    • Synthetic opioids (e.g., methadone, propoxyphene)
    • Mixed agonist-antagonist analgesics (e.g., nalbuphine, pentazocine, butorphanol, cyclazocine)

2. Emergency Treatment of Opioid Overdose

  • Indicated for the diagnosis and management of known or suspected acute opioid overdosage
  • Rapid restoration of breathing and consciousness in overdose situations

3. Postoperative Opioid Reversal

  • Used to partially reverse respiratory depression following opioid use during surgical procedures.
  • Helps restore adequate ventilation without compromising analgesia.

4. Adjunctive Use in Septic Shock

  • May be beneficial in raising blood pressure in patients experiencing hypotension due to septic shock.
  • Optimal dosage and duration of therapy remain under investigation.

Dosages administration of Naloxone Injection

How to Use Naloxone Injection (400 mcg/ml):

Routes of Administration

  • Intravenous (IV)—Fastest action; preferred in emergencies
  • Intramuscular (IM) or Subcutaneous (SC)—Used when IV access is not available

Opioid Overdose (Adults)

  • Initial Dose: 0.4 mg to 2 mg IV
  • Repeat: Every 2–3 minutes if needed
  • Maximum: If no response after 10 mg, reassess diagnosis
  • Alternative Routes: IM or SC if IV is not possible

Postoperative Opioid Depression

  • Initial Dose: 0.1–0.2 mg IV
  • Repeat every 2–3 minutes until breathing improves
  • Caution: Avoid large or rapid doses to prevent pain, nausea, or circulatory stress
  • Repeat Dosing: May be needed every 1–2 hours depending on opioid type and duration

Intravenous Infusion

  • Dilution: Mix 2 mg naloxone in 500 mL of:
    • 0.9% sodium chloride OR
    • 5% dextrose
  • Concentration: 0.004 mg/mL
  • Use Within: 24 hours; discard unused solution after that
  • Titration: Adjust rate based on patient’s response

Important Mixing Precautions

  • Do NOT mix with:
    • Bisulfite or metabisulfite
    • Alkaline solutions
    • High molecular weight compounds
  • Only mix with other drugs if proven safe and stable

Septic Shock

  • Use: May help with low blood pressure
  • Note: Optimal dose and duration not yet established.

Side effects of Naloxone Injection

Side Effects of Naloxone Injection

In Postoperative Patients

  • Heart-related issues: Low or high blood pressure, fast or irregular heartbeat, fluid in the lungs (pulmonary edema), and in rare cases, cardiac arrest
  • Breathing problems: Shortness of breath (dyspnea)
  • Severe outcomes: Coma, brain damage (encephalopathy), and death (in rare cases)
  • Agitation: May occur if pain relief is reversed too strongly

During Opioid Overdose Reversal

  • Sudden withdrawal symptoms:
    • Nausea, vomiting, sweating
    • Fast heartbeat (tachycardia), high blood pressure
    • Shaking, seizures, fluid in lungs, and rarely, cardiac arrest

In Opioid-Dependent Patients

Abrupt reversal may cause acute withdrawal, including:

  • Body aches, fever, chills, runny nose, sneezing
  • Yawning, weakness, restlessness, irritability
  • Diarrhea, nausea, stomach cramps
  • High blood pressure and fast heartbeat

In newborns, withdrawal may include:

  • Seizures
  • Excessive crying
  • Overactive reflexes

Other Side Effects of Naloxone Injection

System Side Effects
Heart Pulmonary edema, cardiac arrest, fast/irregular heartbeat
Digestive Nausea, vomiting
Nervous System Seizures, tingling (paraesthesia)
Mental Health Agitation, hallucinations, tremors
Breathing Difficulty breathing, low oxygen levels
Skin Sweating, injection site reactions
Blood Vessels High/low blood pressure, flushing or hot flashes

Precautions of Naloxone Injection

  • Always ensure availability of resuscitative measures:
    • Free airway maintenance
    • Artificial ventilation
    • Cardiac massage
    • Vasopressor agents
  • These may be required alongside naloxone in cases of acute opioid poisoning

Postoperative Use Risks

  • Abrupt reversal of opioid effects may lead to:
    • Nausea, vomiting, sweating
    • Tremors, tachycardia, hypertension
    • Seizures, pulmonary edema
    • Ventricular arrhythmias and cardiac arrest (potentially fatal)
  • Excessive doses may cause:
    • Agitation
    • Significant loss of analgesia

Cardiovascular Caution

  • Serious adverse events reported in postoperative patients:
    • Hypotension, hypertension
    • Ventricular tachycardia/fibrillation
    • Pulmonary edema, cardiac arrest
    • Coma, encephalopathy, and death
  • Most cases involved patients with:
    • Pre-existing heart conditions
    • Concurrent medications with cardiovascular side effects
  • Use naloxone with caution in these populations.

Pulmonary Edema Risk

  • May result from a massive catecholamine surge (similar to neurogenic pulmonary edema)
  • Leads to:
    • Sudden blood volume shift into lungs.
    • Increased hydrostatic pressure in pulmonary vessels.

Storage instruction of Naloxone Injection

Store at a temperature not exceeding 25°C. Protect from light.

Packing details of Naloxone Injection

5 × 1 ml Ampoule

Naloxone Hydrochloride Injection  0.4 mg/ml is available as 1 ml in an Amber Blue Dot glass ampoule. Such 5 glass ampoules in a unit carton with a pack insert.

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