Naloxone Hydrochloride Injection

1. Completely or partially correct the central inhibitory effects of opioids. Such as respiratory depression, sedation and hypotension. 2. It 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 mental 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.

Naloxone hydrochloride. Its chemical name is: 17-allyl-4,5alpha-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride dihydrate.

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

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.

Patients who are allergic to this product are contraindicated.

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 sufficient 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 affects 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. Precautions for the elderly: 1. There are not enough clinical trials of this product in patients aged 65 and above, and no difference in the response of elderly patients to naloxone was found between younger patients and elderly patients. 2. In general, the dose selection for elderly patients should be cautious. Considering the high probability of decreased liver, kidney or heart function and concomitant diseases or other drug treatments, the medication should be started at a low dose.

Not yet clear.

Keep tightly closed in a cool, dark place.

1ml:0.4mg

24 months

Beijing Sihuan Pharmaceutical Co., Ltd.

• Founded in:

  1995-12-26

• Address:

  Room 101, 1st-5th Floor, Building 5, No. 13 Guangyuan West Street, Tongzhou District, Beijing

• Tax NO.:

  91110112102444497K

• Registered Funds:

  250 million yuan

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