Naloxone Hydrochloride Injection

1. Completely or partially correct the central inhibitory effects of opioids. Such as respiratory depression, sedation and hypotension. 2. Has a wake-promoting effect on animals with acute ethanol poisoning. 3. It is a pure opioid receptor antagonist, that is, it does not have the excitatory or morphine-like effects of other opioid receptor antagonists; it does not cause respiratory depression, psychotomimetic reactions or mydriasis reactions. 4. No drug resistance, nor physiological or psychological dependence, has been observed. 5. Although the mechanism of action is not yet fully understood, there is sufficient evidence to show that it antagonizes the effects of opioids by competing for the same receptor sites.

The main component of this product and its chemical name are: 17-allyl-4,5a-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride dihydrate. Its structural formula is: Molecular formula: C19H21NO4HCl2H2O, molecular weight: 399.87.

This product is a colorless clear liquid.

This product is the most widely used opioid receptor antagonist in clinical practice. It is mainly used for: 1. Rescue acute poisoning by narcotic analgesics, antagonize the respiratory depression of this type of drug, and awaken the patient. 2. Antagonize the residual effects of narcotic analgesics. Newborns are affected by narcotic analgesics in their mothers and suffer respiratory depression, which can be antagonized by this product. 3. Rescue acute ethanol poisoning: intravenous injection of naloxone 0.4-0.6mg can awaken the patient. 4. For those suspected of being addicted to narcotic analgesics, intravenous injection of 0.2-0.4mg can stimulate withdrawal symptoms and has diagnostic value. 5. Awakening effect, which may activate the physiological awakening system through cholinergic effects to awaken the patient, and is used for general anesthesia awakening and anti-shock and some comatose patients.

Common dosage: naloxone 5mg/kg, wait 15 minutes and then intramuscularly inject 10mg/kg. Or first give a loading dose: 1.5-3.5mg/kg, and maintain at 3mg/kggh. In detoxification treatment, intramuscular or intravenous injection: 0.4-0.8mg each time. In the process of methadone withdrawal, you can try a small dose of methadone (5-10mg per day), give naloxone 1.2mg every half hour for several hours (3-6 hours), and then switch to naloxone. Use it 3 times a week to achieve the purpose of withdrawal.

Adverse reactions of this product in postoperative patients are occasionally: hypotension, hypertension, ventricular tachycardia and ventricular fibrillation, dyspnea, pulmonary edema and cardiac arrest. The sequelae of death, coma and encephalopathy have been reported. Overdose of this product in postoperative patients may reverse analgesia and cause patient agitation. Reversal of opioid inhibition A sudden reversal of opioid inhibition may cause nausea, vomiting, sweating, palpitations, increased blood pressure, shivering, seizures, ventricular tachycardia and ventricular fibrillation, pulmonary edema and cardiac arrest, and may even lead to death. Opioid dependence A sudden reversal of the opioid effect in patients who are physically dependent on opioids may cause acute withdrawal syndrome, including but not limited to the following symptoms and signs: body pain, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, chills or tremors, nervousness, restlessness or irritability, dysentery, nausea or vomiting, abdominal cramps, increased blood pressure, palpitations. In neonates, symptoms of opioid withdrawal may include: convulsions; excessive crying; hyperreflexia. Adverse reactions to postoperative use of this drug and dose reduction are classified by organ system as follows: Cardiac: pulmonary edema, cardiac arrest or failure, hypercardia, ventricular fibrillation, and ventricular tachycardia. Death, coma, and encephalopathy have been reported as sequelae. Gastrointestinal: vomiting, nausea. Nervous: convulsions, paresthesias, grand mal seizures. Psychiatric: agitation, hallucinations, tremors. Respiratory, thoracic, and diaphragmatic: dyspnea, respiratory depression, hypoxia. Skin and subcutaneous injections: nonspecific injection site reactions, sweating. Vascular disorders: hypertension, hypotension, hot flashes or redness.

Use with caution in patients with heart dysfunction or hypertension.

Precautions for children: Using this product on sick children or newborns can reverse the effects of opioids. Children with opioid poisoning react strongly to this product, so they need to be closely monitored for at least 24 hours until the product is completely metabolized. Precautions for pregnancy and lactation: 1. The doses of reproductive toxicity tests on mice and rats were 4 to 8 times the usual human dose, and the results did not show that naloxone had embryotoxicity or teratogenicity. Since there have been no adequate and effective studies in pregnant women, pregnant women should only consider using the drug when necessary. 2. Maternal dependence is often accompanied by fetal dependence, so the risk to the fetus should be considered before using this product on pregnant women with known or suspected opioid dependence. Naloxone can cross the placenta and induce withdrawal symptoms in the mother and fetus. Patients with mild to moderate hypertension should be closely monitored when using naloxone during labor to avoid severe hypertension. 3. It is not clear whether this product will affect labor and/or delivery time, but published studies have shown that the use of naloxone during labor will not have adverse effects on mothers and newborns. 4. It is not clear whether this product will be secreted through human milk. Because the drug may be secreted into human milk, this product should be used with caution in breastfeeding women. Elderly precautions: There are not enough clinical trials of this product in patients aged 65 years and over, and no difference in the response of elderly patients to naloxone was found between younger patients and elderly patients. In general, the dose selection for elderly patients should be cautious, and the drug should be started at a low dose, considering the high probability of decreased liver, kidney or heart function and concomitant diseases or other drug treatments.

1. The low binding rate and slow dissociation rate of buprenorphine to opioid receptors determine its long duration of action. Therefore, a large dose of naloxone should be used to antagonize the effects of buprenorphine. The antagonism of buprenorphine needs to be gradually enhanced to reverse the effect and shorten the duration of respiratory depression. 2. Methynilbarbital can block the acute withdrawal symptoms induced by naloxone in opioid addicts. 3. This product should not be mixed with preparations containing sodium bisulfate, sodium bisulfite, long-chain polymer anions or any alkaline. Before adding drugs or chemical reagents to the solution of this product, its effect on the chemical and physical stability of the solution should be determined first.

Keep tightly closed in a cool, dark place.

1ml:0.4mg

24 months

Chengdu Easton Bio Pharmaceuticals Co., Ltd.

• Founded in:

  2009-06-01

• Address:

  No. 8, Xiyuan Avenue, Chengdu Hi-tech Zone

• Tax NO.:

  91510100689030428K

• Registered Funds:

  176.532256 million yuan

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