Expiration date: 07/2026

Structure and Composition:

Injection 1 ml

0.4 mg naloxone hydrochloride

Excipients: sodium chloride - 8.55 mg water for injection - up to 1 ml

in ampoules of 1 ml vials in box 10.

Pharmachologic effect:

It prevents, reduces or eliminates the effects of opioid agonists. Restore breathing, reduces sedative and euphoric effects, weakens hypotension.

Pharmacokinetics:

The on / in effect is administered within the first 2 min, i / m and s / c - a few minutes and lasts 20-45 min after i / v injection and after 2.5-3 h / m or m / to administration. T1 / 2 -. About 1 hour is metabolized in the liver and excreted by the kidneys.

Indications:

Acute poisoning with narcotic analgesics: full (morphine Promedolum, fentanyl) and partial (buprenorphine) agonists and antagonists-agonists (pentazocine, butorphanol, nalbuphine, and OE) termination of the narcotic analgesics restore breathing in newborns, after the introduction of maternity opioid analgesics diagnosis of opioid dependence.

Contraindications:

Hypersensitivity, pregnancy, breastfeeding.

Application of pregnancy and breastfeeding:

Contraindicated during pregnancy. At the time of treatment should stop breastfeeding.

Side effect:

• From the nervous system and sensory organs: tremors, convulsions.
  
• Cardio-vascular system and blood (blood, hemostasis): hypertension, tachycardia, cardiac arrest.
  
• From the digestive tract: nausea, vomiting.
  
• Other: increased sweating.
  

Dosage and administration:

B / in slowly (within 2-3 min) / m or n / k.

If poisoning opioid analgesics: the initial dose - 0.4 mg, if necessary repeatedly at intervals of 3-5 minutes until the consciousness and spontaneous breathing recovery, maximum dose - 10 mg for children (starting dose) - 0.005-0.01 mg / kg.

To speed up release of the surgical anesthesia: 0.1-0.2 mg (1.5 -3 mg / kg) every 2-3 minutes until adequate pulmonary ventilation and the awakening of the patient's children - 0,001-0,002 mg / kg / in, with no effect - again to 0.1 mg / kg every 2 min until recovery of spontaneous breathing and consciousness. If it is impossible to / introduced into the injection / m or p / neonates in divided doses in the initial dose - 0.01 mg / kg.

If respiratory depression in the newborn caused by the introduction of narcotic analgesics during labor: 0.1 mg / kg / m, n / c or / in, then maybe prophylactic administration of a dose - 0.2 mg (0.06 mg / kg ) / m.

In order to diagnose opioid addiction: 0.8 mg / in.

Precautionary measures:

It will be appreciated that when using postoperatively in doses exceeding the minimum necessary, can cause termination of analgesia, stimulation, hypertension or hypotension, ventricular tachycardia, ventricular fibrillation and pulmonary edema. Given that the duration of action of some opioids may exceed that of naloxone, must be constant monitoring of the patient and creating conditions for mechanical ventilation, and other resuscitation.