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:
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- 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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Reliable GMP Certified Naloxone Injection 400 mcg/ml Manufacturer
Conical Pharmaceuticals, headquartered in Ahmedabad, India, is a GMP‑certified manufacturer & exporter of Naloxone Injection 400 mcg/ml, delivering premium pharmaceutical and nutraceutical solutions worldwide. Belonging to the opioid antagonist therapeutic class, Naloxone Injection is widely indicated for the emergency management of opioid overdose, reversal of respiratory depression, and as a diagnostic aid in suspected opioid intoxication. Its rapid action restores normal breathing and consciousness, making it a critical life‑saving intervention.
With exports planned into Central Africa, Central America, and the CIS Region, and expanding into Nigeria, Ghana, Zambia, Zimbabwe, Kenya, the Philippines, Singapore, and Afghanistan, Conical Pharmaceuticals ensures reliable supply and smooth market entry. Importers benefit from complete regulatory dossier support, including GMP Certification, COPP, COA, and Free Sale Certificates.
We also provide third‑party contract manufacturing, bulk supply of pharmaceutical injectables, private labelling, and custom formulation options, empowering partners to launch their own brands with tailored solutions. With advanced R&D, flexible MOQ options, and consistent quality assurance, Conical Pharmaceuticals enables partners to expand their market presence while delivering effective, high‑quality emergency care therapies worldwide.
CUSTOM PACKAGING
Options available in size and style to meet your exact specifications and branding needs
SAMPLES AVAILABLE
Test before committing to bulk orders with complimentary samples for quality verification
LEAD TIME
45–60 days for timely delivery, ensuring reliable supply chain management
SHELF LIFE
Shelf Life: 24 months.
Frequently Asked Questions
Questions are useful tools, they open lines of communication; give us information; improve interactions, facilitate analysis, and many more.
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Conical Pharmaceuticals, headquartered in Ahmedabad, India, is a GMP‑certified manufacturer & exporter of Naloxone Injection 400 mcg/ml.
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