Naloxone Injection 400 mcg/ml
Naloxone Injection 400 mcg/ml
Therapeutic Class: Others
Dosage Forms: Injectables
Brand Name: Naloxone Injection 400 mcg/ml™
How it works?
Uses of Naloxone Injection 400 mcg/ml
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.
Precautions of Naloxone Injection 400 mcg/ml
- 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.
Dosages administration of Naloxone Injection 400 mcg/ml
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 400 mcg/ml
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 |
Storage instruction of Naloxone Injection 400 mcg/ml
Store at a temperature not exceeding 25°C. Protect from light.
Packing details of Naloxone Injection 400 mcg/ml
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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SAMPLES AVAILABLE
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LEAD TIME
45–60 days for timely delivery, ensuring reliable supply chain management
SHELF LIFE
18 months when stored below 30°C, ensuring maximum stability and viability
Quality & Regulatory Certifications
WHO-GMP Certified Facility • FDA Approved (Jordan) • Full Regulatory Dossier Support • Certificate of Analysis • Free Sale Certificate • COPP Documentation
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