Composition:
Application:
Utilisé dans le traitement:
Examiné médicalement par Kovalenko Svetlana Olegovna, Pharmacie Dernière mise à jour le 10.04.2022
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Jian Tian Neng (naloxone) est indiqué pour l'inversion complète ou partielle de la dépression opioïde, y compris la dépression respiratoire, induite par des opioïdes naturels et synthétiques, y compris le propoxyphène, la méthadone et certains analgésiques agonistes-antagonistes mixtes: nalbuphine, pentazocine, butorphanol et cyclazocine. Jian Tian Neng (naloxone) est également indiqué pour le diagnostic d'un surdosage aigu d'opioïdes suspecté ou connu.
Jian Tian Neng (naloxone) peut être utile comme agent d'appoint pour augmenter la pression artérielle dans la gestion du choc septique (voir PHARMACOLOGIE CLINIQUE; Utilisation adjuvante dans le choc septique).
Jian Tian Neng peut être utilisé pour l'inversion complète ou partielle de la dépression opioïde, y compris la dépression respiratoire légère à sévère induite par les opioïdes naturels et synthétiques, y compris le dextropropoxyphène, la méthadone et certains analgésiques agonistes / antagonistes mixtes: nalbuphine et pentazocine. Il peut également être utilisé pour le diagnostic d'un surdosage aigu d'opioïdes suspectés. Jian Tian Neng peut également être utilisé pour lutter contre la dépression respiratoire et autre du SNC chez le nouveau-né résultant de l'administration d'analgésiques à la mère pendant l'accouchement.
La naloxone peut être utilisée pour l'inversion complète ou partielle de la dépression opioïde, y compris la dépression respiratoire légère à sévère induite par les opioïdes naturels et synthétiques, y compris la dextropropoxyphène, la méthadone et certains analgésiques agonistes / antagonistes mixtes: nalbuphine et pentazocine. Il peut également être utilisé pour le diagnostic d'un surdosage aigu d'opioïdes suspectés. La naloxone peut également être utilisée pour lutter contre la dépression respiratoire et autre du SNC chez le nouveau-né résultant de l'administration d'analgésiques à la mère pendant l'accouchement.
Jian Tian Neng est un antagoniste des opioïdes indiqué pour le traitement d'urgence d'un surdosage d'opioïdes connu ou suspecté, comme en témoigne la dépression du système nerveux respiratoire et / ou central chez les adultes et les patients pédiatriques.
Jian Tian Neng est destiné à une administration immédiate en tant que thérapie d'urgence dans les environnements où des opioïdes peuvent être présents.
Jian Tian Neng ne remplace pas les soins médicaux d'urgence.
NARCAN (naloxone) est indiqué pour l'inversion complète ou partielle de la dépression opioïde, y compris la dépression respiratoire, induite par des opioïdes naturels et synthétiques, y compris la propoxyphène, la méthadone et certains analgésiques agonistes-antagonistes mixtes: nalbuphine, pentazocine, butorphanol et cyclazocine. NARCAN (naloxone) est également indiqué pour le diagnostic d'un surdosage aigu d'opioïdes suspecté ou connu.
NARCAN (naloxone) peut être utile comme agent d'appoint pour augmenter la pression artérielle dans la gestion du choc septique (voir PHARMACOLOGIE CLINIQUE; Utilisation adjuvante dans le choc septique).
Jian Tian Neng (naloxone) may be administered intravenously, intramuscularly, or subcutaneously. The most rapid onset of action is achieved by intravenous administration, which is recommended in emergency situations.
Since the duration of action of some opioids may exceed that of Jian Tian Neng (naloxone) , the patient should be kept under continued surveillance. Repeated doses of Jian Tian Neng (naloxone) should be administered, as necessary.
Intravenous Infusion
Jian Tian Neng (naloxone) may be diluted for intravenous infusion in normal saline or 5% dextrose solutions. The addition of 2 mg of Jian Tian Neng (naloxone) in 500 mL of either solution provides a concentration of 0.004 mg/mL. Mixtures should be used within 24 hours. After 24 hours, the remaining unused mixture must be discarded. The rate of administration should be titrated in accordance with the patient's response.
Jian Tian Neng (naloxone) should not be mixed with preparations containing bisulfite, metabisulfite, long-chain or high molecular weight anions, or any solution having an alkaline pH. No drug or chemical agent should be added to Jian Tian Neng (naloxone) unless its effect on the chemical and physical stability of the solution has first been established.
General
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Usage in Adults
Opioid Overdose-Known or Suspected: An initial dose of 0.4 mg to 2 mg of Jian Tian Neng (naloxone) may be administered intravenously. If the desired degree of counteraction and improvement in respiratory functions are not obtained, it may be repeated at two- to three-minute intervals. If no response is observed after 10 mg of Jian Tian Neng (naloxone) have been administered, the diagnosis of opioid-induced or partial opioid-induced toxicity should be questioned. Intramuscular or subcutaneous administration may be necessary if the intravenous route is not available.
Postoperative Opioid Depression: For the partial reversal of opioid depression following the use of opioids during surgery, smaller doses of Jian Tian Neng (naloxone) are usually sufficient. The dose of Jian Tian Neng (naloxone) should be titrated according to the patient's response. For the initial reversal of respiratory depression, Jian Tian Neng (naloxone) should be injected in increments of 0.1 to 0.2 mg intravenously at two- to three-minute intervals to the desired degree of reversal, i.e., adequate ventilation and alertness without significant pain or discomfort. Larger than necessary dosage of Jian Tian Neng (naloxone) may result in significant reversal of analgesia and increase in blood pressure. Similarly, too rapid reversal may induce nausea, vomiting, sweating or circulatory stress.
Repeat doses of Jian Tian Neng (naloxone) may be required within one- to two-hour intervals depending upon the amount, type (i.e., short or long acting) and time interval since last administration of an opioid. Supplemental intramuscular doses have been shown to produce a longer lasting effect.
Septic Shock: The optimal dosage of Jian Tian Neng (naloxone) or duration of therapy for the treatment of hypotension in septic shock patients has not been established (see CLINICAL PHARMACOLOGY).
Usage in Children
Opioid Overdose-Known or Suspected: The usual initial dose in children is 0.01 mg/kg body weight given I.V If this dose does not result in the desired degree of clinical improvement, a subsequent dose of 0.1 mg/kg body weight may be administered. If an I.V. route of administration is not available, Jian Tian Neng (naloxone) may be administered I.M. or S.C. in divided doses. If necessary, Jian Tian Neng (naloxone) can be diluted with sterile water for injection.
Postoperative Opioid Depression: Follow the recommendations and cautions under Adult Postoperative Depression. For the initial reversal of respiratory depression, Jian Tian Neng (naloxone) should be injected in increments of 0.005 mg to 0.01 mg intravenously at two- to three-minute intervals to the desired degree of reversal.
Usage in Neonates
Opioid-induced Depression: The usual initial dose is 0.01 mg/kg body weight administered I.V., I.M. or S.C. This dose may be repeated in accordance with adult administration guidelines for postoperative opioid depression.
Jian Tian Neng is for intravenous, intramuscular or subcutaneous injection or intravenous infusion.
Intravenous infusion: Jian Tian Neng may be diluted for intravenous infusion in normal saline (0.9%) or 5% dextrose in water or saline: the addition of 2mg (2ml of 1mg/1ml concentration) of Jian Tian Neng in 500ml of either solution provides a concentration of 4 micrograms/ml. Mixtures should be used within 12 hours. After 12 hours, the remaining unused solution must be discarded. The rate of administration should be titrated in accordance with the patient's response to both Jian Tian Neng infusion and to any previous bolus doses administered.
Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration whenever solution and container permit.
Adults:
Opioid overdosage (known or suspected)
An initial dose of 400 to 2000 micrograms of Jian Tian Neng may be administered intravenously. If the desired degree of counteraction and improvement in respiratory function is not obtained it may be repeated at 2 to 3 minute intervals. If no response is observed after 10mg of Jian Tian Neng have been administered the diagnosis of opioid-induced or partial opioid induced toxicity should be questioned. Intramuscular or subcutaneous administration may be necessary if dosing by the intravenous route is not feasible.
N.B. The duration of action of certain opioids can outlast that of an IV bolus of Jian Tian Neng, e.g. dextropropoxyphene (present in commonly prescribed analgesics which in over-dosage have been associated with suicide), dihydrocodeine and methadone. In situations where one of these opioids is known or suspected it is recommended that an infusion of Jian Tian Neng be used to produce sustained antagonism to the opioid without repeated injection.
Post Operative Use
When Jian Tian Neng is used postoperatively, the dose should be titrated for each patient in order to obtain optimum respiratory response while maintaining adequate analgesia. Intravenous doses of 100-200 micrograms (approximately 1.5-3 micrograms/kg body weight) are usually sufficient, but a full two minutes should be allowed between each 100 micrograms increment of Jian Tian Neng administered. Further intramuscular doses may be needed within one to two hours, depending on the interval since the last opioid administration and the amount and type (i.e. long or short-acting) of drug used. Alternatively Jian Tian Neng may be administered as an intravenous infusion (see above).
Children
The usual initial dose in children is 10 micrograms/kg body weight given i.v. If this dose does not result in the desired degree of clinical improvement, a subsequent dose of 100 micrograms/kg of bodyweight may be administered. Jian Tian Neng may be required by infusion as described above. If an i.v. route of administration is not feasible, Jian Tian Neng may be administered i.m. or s.c. in divided doses.
Neonatal Use
An adequate airway should be established in the apnoeic infant before Jian Tian Neng is administered. The usual dose is for opioid-induced depression is 10 micrograms/kg body weight administered i.v., i.m., or s.c.. If the desired degree of counteraction and improvement in respiratory function is not obtained it may be repeated at 2-3 minute intervals. Alternatively, a single dose of 200 micrograms, approximately 60 micrograms/kg body weight may be given intramuscularly at birth.
It should, however, be noted that onset of action is slower following i.m. injection. In neonates needing infusion of Jian Tian Neng in saline, care should be taken to avoid excessive sodium intake.
Elderly
There have been no specific studies for use in the elderly.
Naloxone is for intravenous, intramuscular or subcutaneous injection or intravenous infusion.
Intravenous infusion: Naloxone may be diluted for intravenous infusion in normal saline (0.9%) or 5% dextrose in water or saline: the addition of 2mg (2ml of 1mg/1ml concentration) of Naloxone in 500ml of either solution provides a concentration of 4 micrograms/ml. Mixtures should be used within 12 hours. After 12 hours, the remaining unused solution must be discarded. The rate of administration should be titrated in accordance with the patient's response to both Naloxone infusion and to any previous bolus doses administered.
Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration whenever solution and container permit.
Adults:
Opioid overdosage (known or suspected)
An initial dose of 400 to 2000 micrograms of Naloxone may be administered intravenously. If the desired degree of counteraction and improvement in respiratory function is not obtained it may be repeated at 2 to 3 minute intervals. If no response is observed after 10mg of Naloxone have been administered the diagnosis of opioid-induced or partial opioid induced toxicity should be questioned. Intramuscular or subcutaneous administration may be necessary if dosing by the intravenous route is not feasible.
N.B. The duration of action of certain opioids can outlast that of an IV bolus of Naloxone, e.g. dextropropoxyphene (present in commonly prescribed analgesics which in over-dosage have been associated with suicide), dihydrocodeine and methadone. In situations where one of these opioids is known or suspected it is recommended that an infusion of Naloxone be used to produce sustained antagonism to the opioid without repeated injection.
Post Operative Use
When Naloxone is used postoperatively, the dose should be titrated for each patient in order to obtain optimum respiratory response while maintaining adequate analgesia. Intravenous doses of 100-200 micrograms (approximately 1.5-3 micrograms/kg body weight) are usually sufficient, but a full two minutes should be allowed between each 100 micrograms increment of Naloxone administered. Further intramuscular doses may be needed within one to two hours, depending on the interval since the last opioid administration and the amount and type (i.e. long or short-acting) of drug used. Alternatively Naloxone may be administered as an intravenous infusion (see above).
Children
The usual initial dose in children is 10 micrograms/kg body weight given i.v. If this dose does not result in the desired degree of clinical improvement, a subsequent dose of 100 micrograms/kg of bodyweight may be administered. Naloxone may be required by infusion as described above. If an i.v. route of administration is not feasible, Naloxone may be administered i.m. or s.c. in divided doses.
Neonatal Use
An adequate airway should be established in the apnoeic infant before Naloxone is administered. The usual dose is for opioid-induced depression is 10 micrograms/kg body weight administered i.v., i.m., or s.c.. If the desired degree of counteraction and improvement in respiratory function is not obtained it may be repeated at 2-3 minute intervals. Alternatively, a single dose of 200 micrograms, approximately 60 micrograms/kg body weight may be given intramuscularly at birth.
It should, however, be noted that onset of action is slower following i.m. injection. In neonates needing infusion of Naloxone in saline, care should be taken to avoid excessive sodium intake.
Elderly
There have been no specific studies for use in the elderly.
Important Administration Instructions
Jian Tian Neng is for intramuscular and subcutaneous use only.
Because treatment of suspected opioid overdose must be performed by someone other than the patient, instruct the prescription recipient to inform those around them about the presence of Jian Tian Neng and the Instructions for Use.
Instruct the patient or caregiver to read the Instructions for Use at the time they receive a prescription for Jian Tian Neng. Emphasize the following instructions to the patient or caregiver:
- Seek emergency medical care immediately after use. Since the duration of action of most opioids exceeds that of naloxone hydrochloride and the suspected opioid overdose may occur outside of supervised medical settings, seek immediate emergency medical assistance, keep the patient under continued surveillance until emergency personnel arrive, and administer repeated doses of Jian Tian Neng as necessary. Always seek emergency medical assistance in the event of a suspected, potentially life-threatening opioid emergency after administration of the first dose of Jian Tian Neng.
- Additional doses of Jian Tian Neng may be required until emergency medical assistance becomes available.
- Do not attempt to reuse Jian Tian Neng. Each Jian Tian Neng contains a single dose of naloxone.
- Visually inspect Jian Tian Neng through the viewing window for particulate matter and discoloration prior to administration. Do not administer unless the solution is clear and the glass container is undamaged.
- Jian Tian Neng must be administered according to the printed instructions on the device label or the electronic voice instructions (Jian Tian Neng contains a speaker that provides voice instructions to guide the user through each step of the injection). If the Jian Tian Neng electronic voice instruction system does not operate properly, Jian Tian Neng will still deliver the intended dose of naloxone hydrochloride when used according to the printed instructions on its label.
- Once the red safety guard is removed, Jian Tian Neng must be used immediately or disposed of properly. Do not attempt to replace the red safety guard once it is removed.
Upon actuation, Jian Tian Neng automatically inserts the needle intramuscularly or subcutaneously, delivers the naloxone hydrochloride injection, and retracts the needle fully into its housing. Post injection, the black base locks in place, a red indicator appears in the viewing window, and electronic visual and audible instructions signal that Jian Tian Neng has delivered the intended dose of naloxone hydrochloride and instructs the user to seek emergency medical attention.
Dosing Information
Initial Dosing
Administer the initial dose of Jian Tian Neng to adult or pediatric patients intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary, and seek emergency medical assistance. Administer Jian Tian Neng as quickly as possible because prolonged respiratory depression may result in damage to the central nervous system or death.
Repeat Dosing
The requirement for repeat doses of Jian Tian Neng depends upon the amount, type, and route of administration of the opioid being antagonized.
If the desired response is not obtained after 2 or 3 minutes, an additional dose of Jian Tian Neng may be administered. If there is still no response and additional doses are available, additional doses of Jian Tian Neng may be administered every 2 to 3 minutes until emergency medical assistance arrives. Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.
If the patient responds to Jian Tian Neng and relapses back into respiratory depression before emergency assistance arrives, an additional dose of Jian Tian Neng may be administered.
Reversal of respiratory depression by partial agonists or mixed agonist/antagonists, such as buprenorphine and pentazocine, may be incomplete and may require higher doses of naloxone hydrochloride or repeated administration of Jian Tian Neng.
Dosing In Adults And Pediatric Patients Over Age One Year
Instruct patients or their caregivers to administer Jian Tian Neng according to the Instructions for Use, intramuscularly or subcutaneously.
Dosing In Pediatric Patients Under Age One Year
In pediatric patients under the age of one year, the caregiver should pinch the thigh muscle while administering Jian Tian Neng. Carefully observe the administration site for signs of infection following injection and resolution of the opioid emergency.
There may be clinical settings, particularly the postpartum period in neonates with known or suspected exposure to maternal opioid use, where it is preferable to avoid the abrupt precipitation of opioid withdrawal symptoms. In these settings, consider use of an alternative, naloxone product which can be titrated to effect and, where applicable, dosed according to weight.
NARCAN (naloxone) may be administered intravenously, intramuscularly, or subcutaneously. The most rapid onset of action is achieved by intravenous administration, which is recommended in emergency situations.
Since the duration of action of some opioids may exceed that of NARCAN (naloxone) , the patient should be kept under continued surveillance. Repeated doses of NARCAN (naloxone) should be administered, as necessary.
Intravenous Infusion
NARCAN (naloxone) may be diluted for intravenous infusion in normal saline or 5% dextrose solutions. The addition of 2 mg of NARCAN (naloxone) in 500 mL of either solution provides a concentration of 0.004 mg/mL. Mixtures should be used within 24 hours. After 24 hours, the remaining unused mixture must be discarded. The rate of administration should be titrated in accordance with the patient's response.
NARCAN (naloxone) should not be mixed with preparations containing bisulfite, metabisulfite, long-chain or high molecular weight anions, or any solution having an alkaline pH. No drug or chemical agent should be added to NARCAN (naloxone) unless its effect on the chemical and physical stability of the solution has first been established.
General
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Usage in Adults
Opioid Overdose-Known or Suspected: An initial dose of 0.4 mg to 2 mg of NARCAN (naloxone) may be administered intravenously. If the desired degree of counteraction and improvement in respiratory functions are not obtained, it may be repeated at two- to three-minute intervals. If no response is observed after 10 mg of NARCAN (naloxone) have been administered, the diagnosis of opioid-induced or partial opioid-induced toxicity should be questioned. Intramuscular or subcutaneous administration may be necessary if the intravenous route is not available.
Postoperative Opioid Depression: For the partial reversal of opioid depression following the use of opioids during surgery, smaller doses of NARCAN (naloxone) are usually sufficient. The dose of NARCAN (naloxone) should be titrated according to the patient's response. For the initial reversal of respiratory depression, NARCAN (naloxone) should be injected in increments of 0.1 to 0.2 mg intravenously at two- to three-minute intervals to the desired degree of reversal, i.e., adequate ventilation and alertness without significant pain or discomfort. Larger than necessary dosage of NARCAN (naloxone) may result in significant reversal of analgesia and increase in blood pressure. Similarly, too rapid reversal may induce nausea, vomiting, sweating or circulatory stress.
Repeat doses of NARCAN (naloxone) may be required within one- to two-hour intervals depending upon the amount, type (i.e., short or long acting) and time interval since last administration of an opioid. Supplemental intramuscular doses have been shown to produce a longer lasting effect.
Septic Shock: The optimal dosage of NARCAN (naloxone) or duration of therapy for the treatment of hypotension in septic shock patients has not been established (see CLINICAL PHARMACOLOGY).
Usage in Children
Opioid Overdose-Known or Suspected:
Postoperative Opioid Depression: Follow the recommendations and cautions under Adult Postoperative Depression. For the initial reversal of respiratory depression, NARCAN (naloxone) should be injected in increments of 0.005 mg to 0.01 mg intravenously at two- to three-minute intervals to the desired degree of reversal.
Usage in Neonates
Opioid-induced Depression: The usual initial dose is 0.01 mg/kg body weight administered I.V., I.M. or S.C. This dose may be repeated in accordance with adult administration guidelines for postoperative opioid depression.
Jian Tian Neng (naloxone) est contre-indiqué chez les patients connus pour être hypersensibles au chlorhydrate de naloxone ou à l'un des autres composants contenus dans Jian Tian Neng (naloxone).
Jian Tian Neng ne doit pas être administré aux patients connus pour être hypersensibles au médicament.
La naloxone ne doit pas être administrée aux patients connus pour être hypersensibles au médicament.
Jian Tian Neng est contre-indiqué chez les patients connus pour être hypersensibles au chlorhydrate de naloxone ou à l'un des autres composants.
NARCAN (naloxone) est contre-indiqué chez les patients connus pour être hypersensibles au chlorhydrate de naloxone ou à l'un des autres composants contenus dans NARCAN (naloxone).
WARNINGS
Drug Dependence
Jian Tian Neng (naloxone) should be administered cautiously to persons including newborns of mothers who are known or suspected to be physically dependent on opioids. In such cases an abrupt and complete reversal of opioid effects may precipitate an acute withdrawal syndrome.
The signs and symptoms of opioid withdrawal in a patient physically dependent on opioids may include, but are not limited to, the following: body aches, diarrhea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure. In the neonate, opioid withdrawal may also include: convulsions, excessive crying, and hyperactive reflexes.
Repeat Administration
The patient who has satisfactorily responded to Jian Tian Neng (naloxone) should be kept under continued surveillance and repeated doses of Jian Tian Neng (naloxone) should be administered, as necessary, since the duration of action of some opioids may exceed that of Jian Tian Neng (naloxone).
Respiratory Depression due to Other Drugs
Jian Tian Neng (naloxone) is not effective against respiratory depression due to non-opioid drugs and in the management of acute toxicity caused by levopropoxyphene. Reversal of respiratory depression by partial agonists or mixed agonist/antagonists, such as buprenorphine and pentazocine, may be incomplete or require higher doses of naloxone. If an incomplete response occurs, respirations should be mechanically assisted as clinically indicated.
PRECAUTIONS
General
In addition to Jian Tian Neng (naloxone) , other resuscitative measures such as maintenance of a free airway, artificial ventilation, cardiac massage, and vasopressor agents should be available and employed when necessary to counteract acute opioid poisoning.
Abrupt postoperative reversal of opioid depression may result in nausea, vomiting, sweating, tremulousness, tachycardia, increased blood pressure, seizures, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest which may result in death. Excessive doses of Jian Tian Neng (naloxone) in postoperative patients may result in significant reversal of analgesia and may cause agitation (see PRECAUTIONS and DOSAGE AND ADMINISTRATION; Usage in Adults-Postoperative Opioid Depression)
Several instances of hypotension, hypertension, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest have been reported in postoperative patients. Death, coma, and encephalopathy have been reported as sequelae of these events. These have occurred in patients most of whom had pre-existing cardiovascular disorders or received other drugs which may have similar adverse cardiovascular effects. Although a direct cause and effect relationship has not been established, Jian Tian Neng (naloxone) should be used with caution in patients with pre-existing cardiac disease or patients who have received medications with potential adverse cardiovascular effects, such as hypotension, ventricular tachycardia or fibrillation, and pulmonary edema. It has been suggested that the pathogenesis of pulmonary edema associated with the use of Jian Tian Neng (naloxone) is similar to neurogenic pulmonary edema, i.e., a centrally mediated massive catecholamine response leading to a dramatic shift of blood volume into the pulmonary vascular bed resulting in increased hydrostatic pressures.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies in animals to assess the carcinogenic potential of Jian Tian Neng (naloxone) have not been conducted. Jian Tian Neng (naloxone) was weakly positive in the Ames mutagenicity and in the in vitro human lymphocyte chromosome aberration test but was negative in the in vitro Chinese hamster V79 cell HGPRT mutagenicity assay and in the in vivo rat bone marrow chromosome aberration study. Reproduction studies conducted in mice and rats at doses 4-times and 8-times, respectively, the dose of a 50 kg human given 10 mg/day (when based on surface area or mg/m2), demonstrated no embryotoxic or teratogenic effects due to Jian Tian Neng (naloxone).
Use in Pregnancy
Teratogenic Effects: Pregnancy Category C: Teratology studies conducted in mice and rats at doses 4-times and 8-times, respectively, the dose of a 50 kg human given 10 mg/day (when based on surface area or mg/m2), demonstrated no embryotoxic or teratogenic effects due to Jian Tian Neng (naloxone). There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Jian Tian Neng (naloxone) should be used during pregnancy only if clearly needed.
Non-teratogenic Effects: Risk-benefit must be considered before Jian Tian Neng (naloxone) is administered to a pregnant woman who is known or suspected to be opioid-dependent since maternal dependence may often be accompanied by fetal dependence. Naloxone crosses the placenta, and may precipitate withdrawal in the fetus as well as in the mother. Patients with mild to moderate hypertension who receive naloxone during labor should be carefully monitored as severe hypertension may occur.
Use in Labor and Delivery
It is not known if Jian Tian Neng (naloxone) affects the duration of labor and/or delivery. However, published reports indicated that administration of naloxone during labor did not adversely affect maternal or neonatal status.
Nursing Mothers
It is not known whether Jian Tian Neng (naloxone) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Jian Tian Neng (naloxone) is administered to a nursing woman.
Pediatric Use
Jian Tian Neng (naloxone hydrochloride injection, USP) may be administered intravenously, intramuscularly or subcutaneously in children and neonates to reverse the effects of opiates. The American Academy of Pediatrics, however, does not endorse subcutaneous or intramuscular administration in opiate intoxication since absorption may be erratic or delayed. Although the opiate-intoxicated child responds dramatically to Jian Tian Neng (naloxone) , he/she must be carefully monitored for at least 24 hours as a relapse may occur as naloxone is metabolized.
When Jian Tian Neng (naloxone) is given to the mother shortly before delivery, the duration of its effect lasts only for the first two hours of neonatal life. It is preferable to administer Jian Tian Neng (naloxone) directly to the neonate if needed after delivery. Jian Tian Neng (naloxone) has no apparent benefit as an additional method of resuscitation in the newly born infant with intrauterine asphyxia which is not related to opioid use.
Usage in Pediatric Patients and Neonates for Septic Shock: The safety and effectiveness of Jian Tian Neng (naloxone) in the treatment of hypotension in pediatric patients and neonates with septic shock have not been established. One study of two neonates in septic shock reported a positive pressor response; however, one patient subsequently died after intractable seizures.
Geriatric Use
Clinical studies of Jian Tian Neng (naloxone) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Renal Insufficiency/Failure
The safety and effectiveness of Jian Tian Neng (naloxone) in patients with renal insufficiency/failure have not been established in well-controlled clinical trials. Caution should be exercised when Jian Tian Neng (naloxone) is administered to this patient population
Liver Disease
The safety and effectiveness of Jian Tian Neng (naloxone) in patients with liver disease have not been established in well-controlled clinical trials. Caution should be exercised when Jian Tian Neng (naloxone) is administered to patients with liver disease.
It should be administered cautiously to patients who have received large doses of opioids or to those physically dependent on opioids since too rapid reversal of opioid effects by Jian Tian Neng may precipitate an acute withdrawal syndrome in such patients. The same caution is needed when giving Jian Tian Neng to neonates delivered of such patients.
The signs and symptoms of opioid withdrawal in a patient physically dependent on opioids may include but are not limited to the following: body aches, diarrhoea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea, vomiting, nervousness, restlessness, irritability, shivering, trembling, abdominal cramps, weakness and increased blood pressure. In the neonate, opioid withdrawal may also include: convulsions, excessive crying and hyperactive reflexes.
Patients who have responded satisfactorily to Jian Tian Neng should be kept under observation. Repeated doses of Jian Tian Neng may be necessary since the duration of action of some opioids may exceed that of Jian Tian Neng.
Jian Tian Neng is not effective against respiratory depression caused by non-opioid drugs. Reversal of buprenorphine-induced respiratory depression may be incomplete. If an incomplete response occurs, respiration should be mechanically assisted.
Abrupt postoperative reversal of opioid depression may result in nausea, vomiting, sweating, tremulousness, tachycardia, increased blood pressure, seizures, ventricular tachycardia and fibrillation, pulmonary oedema and cardiac arrest which may result in death.
Several instances of hypotension, hypertension, ventricular tachycardia and fibrillation, pulmonary oedema and cardiac arrest have been reported in postoperative patients. Death, coma and encephalopathy have been reported as sequelae of these events. Although a direct cause and effect relationship has not been established, Jian Tian Neng should be used with caution in patients with pre-existing cardiac disease or patients who have received medications with potential adverse cardiovascular effects, such as hypotension, ventricular tachycardia or fibrillation and pulmonary oedema.
In addition to Jian Tian Neng, other resuscitative measures such as maintenance of a free airway, artificial ventilation, cardiac massage and vasopressor agents should be available and employed when necessary to counteract acute poisoning.
Renal Insufficiency/Failure: The safety and effectiveness of Jian Tian Neng in patients with renal insufficiency/failure have not been established in clinical trials. Caution should be exercised and patients monitored when Jian Tian Neng is administered to this patient population.
Liver disease: The safety and effectiveness of Jian Tian Neng in patients with liver disease have not been established in well-controlled clinical trials. In one small study in patients with liver cirrhosis, plasma Jian Tian Neng concentrations were approximately six times higher than in patients without liver disease. Jian Tian Neng administration had a diuretic effect in these patients with cirrhosis. Caution should be exercised when Jian Tian Neng is administered to a patient with liver disease.
It should be administered cautiously to patients who have received large doses of opioids or to those physically dependent on opioids since too rapid reversal of opioid effects by Naloxone may precipitate an acute withdrawal syndrome in such patients. The same caution is needed when giving Naloxone to neonates delivered of such patients.
The signs and symptoms of opioid withdrawal in a patient physically dependent on opioids may include but are not limited to the following: body aches, diarrhoea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea, vomiting, nervousness, restlessness, irritability, shivering, trembling, abdominal cramps, weakness and increased blood pressure. In the neonate, opioid withdrawal may also include: convulsions, excessive crying and hyperactive reflexes.
Patients who have responded satisfactorily to Naloxone should be kept under observation. Repeated doses of Naloxone may be necessary since the duration of action of some opioids may exceed that of Naloxone.
Naloxone is not effective against respiratory depression caused by non-opioid drugs. Reversal of buprenorphine-induced respiratory depression may be incomplete. If an incomplete response occurs, respiration should be mechanically assisted.
Abrupt postoperative reversal of opioid depression may result in nausea, vomiting, sweating, tremulousness, tachycardia, increased blood pressure, seizures, ventricular tachycardia and fibrillation, pulmonary oedema and cardiac arrest which may result in death.
Several instances of hypotension, hypertension, ventricular tachycardia and fibrillation, pulmonary oedema and cardiac arrest have been reported in postoperative patients. Death, coma and encephalopathy have been reported as sequelae of these events. Although a direct cause and effect relationship has not been established, Naloxone should be used with caution in patients with pre-existing cardiac disease or patients who have received medications with potential adverse cardiovascular effects, such as hypotension, ventricular tachycardia or fibrillation and pulmonary oedema.
In addition to Naloxone, other resuscitative measures such as maintenance of a free airway, artificial ventilation, cardiac massage and vasopressor agents should be available and employed when necessary to counteract acute poisoning.
Renal Insufficiency/Failure: The safety and effectiveness of Naloxone in patients with renal insufficiency/failure have not been established in clinical trials. Caution should be exercised and patients monitored when Naloxone is administered to this patient population.
Liver disease: The safety and effectiveness of Naloxone in patients with liver disease have not been established in well-controlled clinical trials. In one small study in patients with liver cirrhosis, plasma naloxone concentrations were approximately six times higher than in patients without liver disease. Naloxone administration had a diuretic effect in these patients with cirrhosis. Caution should be exercised when Naloxone is administered to a patient with liver disease.
WARNINGS
Included as part of the "PRECAUTIONS" Section
PRECAUTIONS
Risk Of Recurrent Respiratory And Central Nervous System Depression
The duration of action of most opioids may exceed that of Jian Tian Neng resulting in a return of respiratory and/or central nervous system depression after an initial improvement in symptoms. Therefore, it is necessary to seek emergency medical assistance immediately after delivering the first dose of Jian Tian Neng. Keep the patient under continued surveillance, and administer additional doses of Jian Tian Neng as necessary. Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.
Risk Of Limited Efficacy With Partial Agonists Or Mixed Agonist/Antagonists
Reversal of respiratory depression by partial agonists or mixed agonist/antagonists such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses of naloxone hydrochloride may be required to antagonize buprenorphine because the latter has a long duration of action due to its slow rate of binding and subsequent slow dissociation from the opioid receptor. Buprenorphine antagonism is characterized by a gradual onset of the reversal effects and a decreased duration of action of the normally prolonged respiratory depression.
Precipitation Of Severe Opioid Withdrawal
The use of Jian Tian Neng in patients who are opioid dependent may precipitate an acute abstinence syndrome characterized by the following signs and symptoms: body aches, diarrhea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated and may include the following signs and symptoms: convulsions, excessive crying and hyperactive reflexes. Monitor patients for the development of the signs and symptoms of opioid withdrawal.
Abrupt postoperative reversal of opioid depression after using naloxone hydrochloride may result in nausea, vomiting, sweating, tremulousness, tachycardia, hypotension, hypertension, seizures, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest. Death, coma, and encephalopathy have been reported as sequelae of these events. These events have primarily occurred in patients who had pre-existing cardiovascular disorders or received other drugs that may have similar adverse cardiovascular effects. Although a direct cause and effect relationship has not been established, after use of naloxone hydrochloride, monitor patients with preexisting cardiac disease or patients who have received medications with potential adverse cardiovascular effects for hypotension, ventricular tachycardia or fibrillation, and pulmonary edema in an appropriate healthcare setting. It has been suggested that the pathogenesis of pulmonary edema associated with the use of naloxone hydrochloride is similar to neurogenic pulmonary edema, i.e., a centrally mediated massive catecholamine response leading to a dramatic shift of blood volume into the pulmonary vascular bed resulting in increased hydrostatic pressures.
Patient Counseling Information
Advise the patient and family members or caregivers to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Instruct patients and their family members or caregivers to:
- Become familiar with the following information contained in the carton as soon as they receive Jian Tian Neng:
- Jian Tian Neng Instructions for Use
- Trainer for Jian Tian Neng Instructions for Use
- Trainer for Jian Tian Neng
- Become familiar with the device labeling color scheme of Jian Tian Neng and the Trainer for Jian Tian Neng
- The 2 mg dosage form of Jian Tian Neng is blue and purple.
- The Trainer for Jian Tian Neng is black and white.
- Practice using the Trainer before Jian Tian Neng is needed.
- Each Jian Tian Neng can only be used one time; however, Trainer for Jian Tian Neng can be re-used for training purposes and its red safety guard can be removed and replaced.
- Both Jian Tian Neng and Trainer for Jian Tian Neng incorporate the electronic voice instruction system.
- It is recommended that patients and caregivers become familiar with the Trainer for Jian Tian Neng provided and read the Instructions for Use; however, untrained caregivers or family members should still attempt to use Jian Tian Neng during a suspected opioid overdose while awaiting definitive emergency medical care.
Recognition Of Opioid Overdose
Instruct the patients and their family members or caregivers how to recognize the signs and symptoms of an opioid overdose requiring the use of Jian Tian Neng such as the following:
- Extreme sleepiness -inability to awaken a patient verbally or upon a firm sternal rub.
- Breathing problems -this can range from slow or shallow breathing to no breathing in a patient who cannot be awakened.
- Other signs and symptoms that may accompany sleepiness and breathing problems include the following:
- Extremely small pupils (the black circle in the center of the colored part of the eye) sometimes called “pinpoint pupils.”
- Slow heartbeat and/or low blood pressure.
Risk Of Recurrent Respiratory And Central Nervous System Depression
Limited Efficacy For/With Partial Agonists Or Mixed Agonist/Antagonists
Instruct patients and their family members or caregivers that the reversal of respiratory depression caused by partial agonists or mixed agonist/antagonists such as buprenorphine and pentazocine, may be incomplete and may require higher doses of naloxone hydrochloride or repeated administration of Jian Tian Neng.
Precipitation Of Severe Opioid Withdrawal
Instruct patients and their family members or caregivers that the use of Jian Tian Neng in patients who are opioid dependent may precipitate an acute abstinence syndrome characterized by the following signs and symptoms: body aches, diarrhea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure. In neonates, opioid withdrawal may be life threatening if not recognized and properly treated, and may include the following signs and symptoms: convulsions, excessive crying, and hyperactive reflexes.
Administration Instructions
Instruct patients and their family members or caregivers about the following important information:
- Make sure Jian Tian Neng is present whenever persons may be intentionally or accidentally exposed to an opioid to treat serious opioid overdose (i.e., opioid emergencies).
- Administer Jian Tian Neng as quickly as possible if a patient is unresponsive and an opioid overdose is suspected, even when in doubt, because prolonged respiratory depression may result in damage to the central nervous system or death. Jian Tian Neng is not a substitute for emergency medical care.
- Jian Tian Neng is user actuated and may be administered through clothing [e.g., pants, jeans, etc.] if necessary.
- Inject Jian Tian Neng while pressing into the anterolateral aspect of the thigh. In pediatric patients less than 1 year of age, pinch the thigh muscle while administering Jian Tian Neng.
- Upon actuation, Jian Tian Neng automatically inserts the needle intramuscularly or subcutaneously, delivers the naloxone, and retracts the needle fully into its housing. The needle is not visible before, during, or after injection.
- Each Jian Tian Neng can only be used one time.
- If the electronic voice instruction system on Jian Tian Neng does not work properly, Jian Tian Neng will still deliver the intended dose of naloxone hydrochloride when used according to the printed instructions on its label.
- The electronic voice instructions are independent of activating Jian Tian Neng and it is not necessary to wait for the voice instructions to be completed prior to moving to the next step in the injection process.
- Post-injection, the black base locks in place, a red indicator appears in the viewing window and electronic visual and audible instructions signal that Jian Tian Neng has delivered the intended dose of naloxone hydrochloride.
- Jian Tian Neng’s red safety guard should not be replaced under any circumstances. However, the Trainer is designed for re-use and its red safety guard can be removed and replaced.
- Periodically visually inspect the naloxone solution through the viewing window. If the solution is discolored, cloudy, or contains solid particles, replace it with a new Jian Tian Neng.
- Replace Jian Tian Neng before its expiration date.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Carcinogenesis
Long-term animal studies to evaluate the carcinogenic potential of naloxone have not been completed.
Mutagenesis
Naloxone was weakly positive in the Ames mutagenicity and in the in vitro human lymphocyte chromosome aberration test but was negative in the in vitro Chinese hamster V79 cell HGPRT mutagenicity assay and in the in vivo rat bone marrow chromosome aberration study.
Impairment Of Fertility
Reproduction studies conducted in mice and rats at doses 4-times and 8-times, respectively, the dose of a 50 kg human given 10 mg/day (when based on surface area or mg/m2), demonstrated no adverse effect of naloxone hydrochloride on fertility.
Use In Specific Populations
Pregnancy
Risk Summary
The limited available data on naloxone use in pregnant women are not sufficient to inform a drug-associated risk. However, there are risks to the fetus of the opioid-dependent mother with use of naloxone. In animal reproduction studies, no embryotoxic or teratogenic effects were observed in mice and rats treated with naloxone hydrochloride during the period of organogenesis at doses equivalent to 4-times and 8-times, respectively, the dose of a 50 kg human given 10 mg.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations
Fetal/Neonatal adverse reactions
Naloxone hydrochloride crosses the placenta, and may precipitate withdrawal in the fetus as well as in the opioid-dependent mother. The fetus should be evaluated for signs of distress after Jian Tian Neng is used. Careful monitoring is needed until the fetus and mother are stabilized.
Data
Animal Data
Naloxone hydrochloride was administered during organogenesis to mice and rats at doses 4-times and 8times, respectively, the dose of 10 mg/day given to a 50 kg human (when based on body surface area or mg/m2). These studies demonstrated no embryotoxic or teratogenic effects due to naloxone hydrochloride.
Lactation
Risk Summary
There is no information regarding the presence of naloxone in human milk, or the effects of naloxone on the breastfed infant or on milk production. Studies in nursing mothers have shown that naloxone does not affect prolactin or oxytocin hormone levels. Naloxone is minimally orally bioavailable. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Jian Tian Neng and any potential adverse effects on the breastfed infant from Jian Tian Neng or from the underlying maternal condition.
Pediatric Use
The safety and effectiveness of Jian Tian Neng (for intramuscular and subcutaneous use) have been established in pediatric patients of all ages for the emergency treatment of known or suspected opioid overdose. Use of naloxone hydrochloride in all pediatric patients is supported by adult bioequivalence studies coupled with evidence from the safe and effective use of another naloxone hydrochloride injectable product. No pediatric studies were conducted for Jian Tian Neng.
Absorption of naloxone hydrochloride following subcutaneous or intramuscular administration in pediatric patients may be erratic or delayed. Even when the opiate-intoxicated pediatric patient responds appropriately to naloxone hydrochloride injection, he/she must be carefully monitored for at least 24 hours as a relapse may occur as naloxone is metabolized.
In opioid-dependent pediatric patients, (including neonates), administration of naloxone hydrochloride may result in an abrupt and complete reversal of opioid effects, precipitating an acute opioid withdrawal syndrome. There may be clinical settings, particularly the postpartum period in neonates with known or suspected exposure to maternal opioid use, where it is preferable to avoid the abrupt precipitation of opioid withdrawal symptoms. Unlike acute opioid withdrawal in adults, acute opioid withdrawal in neonates manifesting as seizures may be life-threatening if not recognized and properly treated. Other signs and symptoms in neonates may include excessive crying and hyperactive reflexes. In these settings where it may be preferable to avoid the abrupt precipitation of acute opioid withdrawal symptoms, consider use of an alternative, naloxone hydrochloride product that can dosed according to weight and titrated to effect..
In pediatric patients under the age of one year, the caregiver should pinch the thigh muscle while administering Jian Tian Neng. Carefully observe the administration site for evidence of residual needle parts, signs of infection, or both..
Geriatric Use
Geriatric patients have a greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. Therefore, the systemic exposure of naloxone can be higher in these patients.
Clinical studies of naloxone hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
WARNINGS
Drug Dependence
NARCAN (naloxone) should be administered cautiously to persons including newborns of mothers who are known or suspected to be physically dependent on opioids. In such cases an abrupt and complete reversal of opioid effects may precipitate an acute withdrawal syndrome.
The signs and symptoms of opioid withdrawal in a patient physically dependent on opioids may include, but are not limited to, the following: body aches, diarrhea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure. In the neonate, opioid withdrawal may also include: convulsions, excessive crying, and hyperactive reflexes.
Repeat Administration
The patient who has satisfactorily responded to NARCAN (naloxone) should be kept under continued surveillance and repeated doses of NARCAN (naloxone) should be administered, as necessary, since the duration of action of some opioids may exceed that of NARCAN (naloxone).
Respiratory Depression due to Other Drugs
NARCAN (naloxone) is not effective against respiratory depression due to non-opioid drugs and in the management of acute toxicity caused by levopropoxyphene. Reversal of respiratory depression by partial agonists or mixed agonist/antagonists, such as buprenorphine and pentazocine, may be incomplete or require higher doses of naloxone. If an incomplete response occurs, respirations should be mechanically assisted as clinically indicated.
PRECAUTIONS
General
In addition to NARCAN (naloxone) , other resuscitative measures such as maintenance of a free airway, artificial ventilation, cardiac massage, and vasopressor agents should be available and employed when necessary to counteract acute opioid poisoning.
Abrupt postoperative reversal of opioid depression may result in nausea, vomiting, sweating, tremulousness, tachycardia, increased blood pressure, seizures, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest which may result in death. Excessive doses of NARCAN (naloxone) in postoperative patients may result in significant reversal of analgesia and may cause agitation (see PRECAUTIONS and DOSAGE AND ADMINISTRATION; Usage in Adults-Postoperative Opioid Depression)
Several instances of hypotension, hypertension, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest have been reported in postoperative patients. Death, coma, and encephalopathy have been reported as sequelae of these events. These have occurred in patients most of whom had pre-existing cardiovascular disorders or received other drugs which may have similar adverse cardiovascular effects. Although a direct cause and effect relationship has not been established, NARCAN (naloxone) should be used with caution in patients with pre-existing cardiac disease or patients who have received medications with potential adverse cardiovascular effects, such as hypotension, ventricular tachycardia or fibrillation, and pulmonary edema. It has been suggested that the pathogenesis of pulmonary edema associated with the use of NARCAN (naloxone) is similar to neurogenic pulmonary edema, i.e., a centrally mediated massive catecholamine response leading to a dramatic shift of blood volume into the pulmonary vascular bed resulting in increased hydrostatic pressures.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies in animals to assess the carcinogenic potential of NARCAN (naloxone) have not been conducted. NARCAN (naloxone) was weakly positive in the Ames mutagenicity and in the in vitro human lymphocyte chromosome aberration test but was negative in the in vitro Chinese hamster V79 cell HGPRT mutagenicity assay and in the in vivo rat bone marrow chromosome aberration study. Reproduction studies conducted in mice and rats at doses 4-times and 8-times, respectively, the dose of a 50 kg human given 10 mg/day (when based on surface area or mg/m2), demonstrated no embryotoxic or teratogenic effects due to NARCAN (naloxone).
Use in Pregnancy
Teratogenic Effects: Pregnancy Category C: Teratology studies conducted in mice and rats at doses 4-times and 8-times, respectively, the dose of a 50 kg human given 10 mg/day (when based on surface area or mg/m2), demonstrated no embryotoxic or teratogenic effects due to NARCAN (naloxone). There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, NARCAN (naloxone) should be used during pregnancy only if clearly needed.
Non-teratogenic Effects: Risk-benefit must be considered before NARCAN (naloxone) is administered to a pregnant woman who is known or suspected to be opioid-dependent since maternal dependence may often be accompanied by fetal dependence. Naloxone crosses the placenta, and may precipitate withdrawal in the fetus as well as in the mother. Patients with mild to moderate hypertension who receive naloxone during labor should be carefully monitored as severe hypertension may occur.
Use in Labor and Delivery
It is not known if NARCAN (naloxone) affects the duration of labor and/or delivery. However, published reports indicated that administration of naloxone during labor did not adversely affect maternal or neonatal status.
Nursing Mothers
It is not known whether NARCAN (naloxone) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when NARCAN (naloxone) is administered to a nursing woman.
Pediatric Use
NARCAN (naloxone hydrochloride injection, USP) may be administered intravenously, intramuscularly or subcutaneously in children and neonates to reverse the effects of opiates. The American Academy of Pediatrics, however, does not endorse subcutaneous or intramuscular administration in opiate intoxication since absorption may be erratic or delayed. Although the opiate-intoxicated child responds dramatically to NARCAN (naloxone) , he/she must be carefully monitored for at least 24 hours as a relapse may occur as naloxone is metabolized.
When NARCAN (naloxone) is given to the mother shortly before delivery, the duration of its effect lasts only for the first two hours of neonatal life. It is preferable to administer NARCAN (naloxone) directly to the neonate if needed after delivery. NARCAN (naloxone) has no apparent benefit as an additional method of resuscitation in the newly born infant with intrauterine asphyxia which is not related to opioid use.
Usage in Pediatric Patients and Neonates for Septic Shock: The safety and effectiveness of NARCAN (naloxone) in the treatment of hypotension in pediatric patients and neonates with septic shock have not been established. One study of two neonates in septic shock reported a positive pressor response; however, one patient subsequently died after intractable seizures.
Geriatric Use
Clinical studies of NARCAN (naloxone) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Renal Insufficiency/Failure
The safety and effectiveness of NARCAN (naloxone) in patients with renal insufficiency/failure have not been established in well-controlled clinical trials. Caution should be exercised when NARCAN (naloxone) is administered to this patient population
Liver Disease
The safety and effectiveness of NARCAN (naloxone) in patients with liver disease have not been established in well-controlled clinical trials. Caution should be exercised when NARCAN (naloxone) is administered to patients with liver disease.
Postopératoire
Les événements indésirables suivants ont été associés à l'utilisation de Jian Tian Neng (naloxone) chez les patients postopératoires: hypotension, hypertension, tachycardie ventriculaire et fibrillation, dyspnée, œdème pulmonaire et arrêt cardiaque. La mort, le coma et l'encéphalopathie ont été signalés comme des séquelles de ces événements. Des doses excessives de Jian Tian Neng (naloxone) chez les patients postopératoires peuvent entraîner une inversion significative de l'analgésie et peuvent provoquer une agitation (voir PRÉCAUTIONS et DOSAGE ET ADMINISTRATION; Utilisation dans la dépression opioïde postopératoire des adultes) Dépression des opioïdes
Une inversion brutale de la dépression aux opioïdes peut entraîner des nausées, des vomissements, de la transpiration, une tachycardie, une augmentation de la pression artérielle, des tremblements, des convulsions, une tachycardie ventriculaire et une fibrillation, un œdème pulmonaire et un arrêt cardiaque pouvant entraîner la mort (voir PRÉCAUTIONS).
Dépendance aux opioïdes
Une inversion brutale des effets des opioïdes chez les personnes physiquement dépendantes des opioïdes peut précipiter un syndrome de sevrage aigu qui peut inclure, mais sans s'y limiter, les signes et symptômes suivants: maux de corps, fièvre, transpiration, nez qui coule, éternuements, piloérection, bâillement, faiblesse, frissonnant ou tremblant, nervosité, agitation ou irritabilité, diarrhée, nausées ou vomissements, crampes abdominales, augmentation de la pression artérielle, tachycardie. Chez le nouveau-né, le retrait des opioïdes peut également inclure: des convulsions; pleurs excessifs; réflexes hyperactifs (voir AVERTISSEMENTS).
Les événements indésirables associés à l'utilisation postopératoire de Jian Tian Neng (naloxone) sont répertoriés par système d'organes et par ordre décroissant de fréquence comme suit:
Troubles cardiaques: œdème pulmonaire, arrêt ou défaillance cardiaque, tachycardie, fibrillation ventriculaire et tachycardie ventriculaire. La mort, le coma et l'encéphalopathie ont été signalés comme des séquelles de ces événements.
Troubles gastro-intestinaux: vomissements, nausées
Troubles du système nerveux: convulsions, paresthésie, convulsion grand mal
Troubles psychiatriques: agitation, hallucination, tremblements
Troubles thoraciques et médiastinaux respiratoires: dyspnée, dépression respiratoire, hypoxie
Troubles de la peau et des tissus sous-cutanés: réactions non spécifiques au site d'injection, transpiration
Troubles vasculaires: hypertension, hypotension, bouffées de chaleur ou bouffées vasomotrices.
Voir aussi PRÉCAUTIONS et DOSAGE ET ADMINISTRATION; Utilisation chez les adultes; Dépression opioïde postopératoire.
Abus de drogue et dépendance
Jian Tian Neng (naloxone) est un antagoniste des opioïdes. La dépendance physique associée à l'utilisation de Jian Tian Neng (naloxone) n'a pas été signalée. La tolérance à l'effet antagoniste opioïde de Jian Tian Neng (naloxone) n'est pas connue pour se produire.
Postopératoire: Les effets indésirables suivants ont été associés à l'utilisation de Jian Tian Neng chez les patients postopératoires: hypotension, hypertension, tachycardie ventriculaire et fibrillation, dyspnée, œdème pulmonaire et arrêt cardiaque. La mort, le coma et l'encéphalopathie ont été signalés comme des séquelles de ces événements. Des doses excessives de Jian Tian Neng chez les patients postopératoires peuvent entraîner une inversion significative de l'analgésie et provoquer une agitation.
Dépression des opioïdes: Une inversion brutale de la dépression aux opioïdes peut entraîner des nausées, des vomissements, de la transpiration, une tachycardie, une augmentation de la pression artérielle, des tremblements, des convulsions, une tachycardie ventriculaire et une fibrillation, un œdème pulmonaire et un arrêt cardiaque pouvant entraîner la mort (voir Mises en garde spéciales).
Dépendance aux opioïdes: Une inversion brutale des effets des opioïdes chez les personnes physiquement dépendantes des opioïdes peut précipiter un syndrome de sevrage aigu qui peut inclure, mais ne se limite pas aux signes et symptômes suivants: maux de corps, fièvre, transpiration, nez qui coule, éternuements, piloérection, bâillement, faiblesse, frissonnant, tremblant, nervosité, agitation, irritabilité, diarrhée, nausée, vomissements, crampes abdominales, augmentation de la pression artérielle et de la tachycardie. Dans le nouveau-né, le retrait des opioïdes peut également inclure des convulsions, des pleurs excessifs et des réflexes hyperactifs (voir Mises en garde spéciales).
L'agitation et les paresthésies ont été rarement signalées avec l'utilisation de Jian Tian Neng.
Postopératoire: Les effets indésirables suivants ont été associés à l'utilisation de la naloxone chez les patients postopératoires: hypotension, hypertension, tachycardie ventriculaire et fibrillation, dyspnée, œdème pulmonaire et arrêt cardiaque. La mort, le coma et l'encéphalopathie ont été signalés comme des séquelles de ces événements. Des doses excessives de Naloxone chez les patients postopératoires peuvent entraîner une inversion significative de l'analgésie et provoquer une agitation.
Dépression des opioïdes: Une inversion brutale de la dépression aux opioïdes peut entraîner des nausées, des vomissements, de la transpiration, une tachycardie, une augmentation de la pression artérielle, des tremblements, des convulsions, une tachycardie ventriculaire et une fibrillation, un œdème pulmonaire et un arrêt cardiaque pouvant entraîner la mort (voir Mises en garde spéciales).
Dépendance aux opioïdes: Une inversion brutale des effets des opioïdes chez les personnes physiquement dépendantes des opioïdes peut précipiter un syndrome de sevrage aigu qui peut inclure, mais ne se limite pas aux signes et symptômes suivants: maux de corps, fièvre, transpiration, nez qui coule, éternuements, piloérection, bâillement, faiblesse, frissonnant, tremblant, nervosité, agitation, irritabilité, diarrhée, nausée, vomissements, crampes abdominales, augmentation de la pression artérielle et de la tachycardie. Dans le nouveau-né, le retrait des opioïdes peut également inclure des convulsions, des pleurs excessifs et des réflexes hyperactifs (voir Mises en garde spéciales).
L'agitation et les paresthésies ont été rarement signalées avec l'utilisation de la naloxone.
Les effets indésirables graves suivants sont discutés ailleurs dans l'étiquetage:
- Précipitation du retrait sévère des opioïdes
Étant donné que les études cliniques sont menées dans des conditions très variables, les taux d'effets indésirables observés dans les études cliniques d'un médicament ne peuvent pas être directement comparés aux taux dans les études cliniques d'un autre médicament et peuvent ne pas refléter les taux observés dans la pratique.
Les effets indésirables suivants ont été observés dans les études cliniques de Jian Tian Neng. Dans deux études pharmacocinétiques avec un total de 54 sujets adultes en bonne santé exposés à 0,4 mg de Jian Tian Neng, 0,8 mg Jian Tian Neng (deux 0,4 mg de Jian Tian Nengs) ou 2 mg Jian Tian Neng, les effets indésirables survenant chez plus d'un sujet étaient des étourdissements et un érythème au site d'injection.
Les effets indésirables suivants ont été identifiés lors de l'utilisation post-approbation du chlorhydrate de naloxone dans le cadre postopératoire. Étant donné que ces réactions sont rapportées volontairement à partir d'une population de taille incertaine, il n'est pas toujours possible d'estimer de manière fiable leur fréquence ou d'établir une relation causale avec l'exposition au médicament: hypotension, hypertension, tachycardie ventriculaire et fibrillation, dyspnée, œdème pulmonaire et arrêt cardiaque. La mort, le coma et l'encéphalopathie ont été signalés comme des séquelles de ces événements. Des doses excessives de chlorhydrate de naloxone chez les patients postopératoires ont entraîné une inversion significative de l'analgésie et ont provoqué une agitation.
D'autres événements qui ont été signalés dans l'utilisation post-commercialisation de Jian Tian Neng comprennent l'agitation, la désorientation, la confusion et la colère.
L'inversion brutale des effets des opioïdes chez les personnes physiquement dépendantes des opioïdes a précipité un syndrome de sevrage aigu. Les signes et symptômes comprennent: maux de corps, fièvre, transpiration, nez qui coule, éternuements, piloérection, bâillement, faiblesse, frissons ou tremblements, nervosité, agitation ou irritabilité, diarrhée, nausées ou vomissements, crampes abdominales, augmentation de la pression artérielle, tachycardie. Chez les nouveau-nés, les signes et symptômes de sevrage opioïdes comprenaient également: convulsions, pleurs excessifs, réflexes hyperactifs.
Postopératoire
Les événements indésirables suivants ont été associés à l'utilisation de NARCAN (naloxone) chez les patients postopératoires: hypotension, hypertension, tachycardie ventriculaire et fibrillation, dyspnée, œdème pulmonaire et arrêt cardiaque. La mort, le coma et l'encéphalopathie ont été signalés comme des séquelles de ces événements. Des doses excessives de NARCAN (naloxone) chez les patients postopératoires peuvent entraîner une inversion significative de l'analgésie et peuvent provoquer une agitation (voir PRÉCAUTIONS et DOSAGE ET ADMINISTRATION; Utilisation dans la dépression opioïde postopératoire des adultes) Dépression des opioïdes
Une inversion brutale de la dépression aux opioïdes peut entraîner des nausées, des vomissements, de la transpiration, une tachycardie, une augmentation de la pression artérielle, des tremblements, des convulsions, une tachycardie ventriculaire et une fibrillation, un œdème pulmonaire et un arrêt cardiaque pouvant entraîner la mort (voir PRÉCAUTIONS).
Dépendance aux opioïdes
Une inversion brutale des effets des opioïdes chez les personnes physiquement dépendantes des opioïdes peut précipiter un syndrome de sevrage aigu qui peut inclure, mais sans s'y limiter, les signes et symptômes suivants: maux de corps, fièvre, transpiration, nez qui coule, éternuements, piloérection, bâillement, faiblesse, frissonnant ou tremblant, nervosité, agitation ou irritabilité, diarrhée, nausées ou vomissements, crampes abdominales, augmentation de la pression artérielle, tachycardie. Chez le nouveau-né, le retrait des opioïdes peut également inclure: des convulsions; pleurs excessifs; réflexes hyperactifs (voir AVERTISSEMENTS).
Les événements indésirables associés à l'utilisation postopératoire de NARCAN (naloxone) sont répertoriés par système d'organes et par ordre décroissant de fréquence comme suit:
Troubles cardiaques: œdème pulmonaire, arrêt ou défaillance cardiaque, tachycardie, fibrillation ventriculaire et tachycardie ventriculaire. La mort, le coma et l'encéphalopathie ont été signalés comme des séquelles de ces événements.
Troubles gastro-intestinaux: vomissements, nausées
Troubles du système nerveux: convulsions, paresthésie, convulsion grand mal
Troubles psychiatriques: agitation, hallucination, tremblements
Troubles thoraciques et médiastinaux respiratoires: dyspnée, dépression respiratoire, hypoxie
Troubles de la peau et des tissus sous-cutanés: réactions non spécifiques au site d'injection, transpiration
Troubles vasculaires: hypertension, hypotension, bouffées de chaleur ou bouffées vasomotrices.
Voir aussi PRÉCAUTIONS et DOSAGE ET ADMINISTRATION; Utilisation chez les adultes; Dépression opioïde postopératoire.
Abus de drogue et dépendance
NARCAN (naloxone) est un antagoniste des opioïdes. La dépendance physique associée à l'utilisation de NARCAN (naloxone) n'a pas été signalée. La tolérance à l'effet antagoniste des opioïdes de NARCAN (naloxone) n'est pas connue pour se produire.
L'expérience clinique avec le surdosage de Jian Tian Neng (naloxone) chez l'homme est limitée.
Patients adultes
Dans une petite étude, les volontaires qui ont reçu 24 mg / 70 kg n'ont pas démontré de toxicité.
Dans une autre étude, 36 patients atteints d'AVC aigu ont reçu une dose de charge de 4 mg / kg (10 mg / m2/ min) de Jian Tian Neng (naloxone) suivi immédiatement de 2 mg / kg / h pendant 24 heures. Vingt-trois patients ont présenté des événements indésirables associés à l'utilisation de la naloxone et la naloxone a été interrompue chez sept patients en raison d'effets indésirables. Les événements indésirables les plus graves ont été: convulsions (2 patients), hypertension sévère (1) et hypotension et / ou bradycardie (3).
À des doses de 2 mg / kg chez des sujets normaux, des troubles cognitifs et des symptômes comportementaux, notamment irritabilité, anxiété, tension, méfiance, tristesse, difficulté à se concentrer et manque d'appétit ont été signalés. De plus, des symptômes somatiques, notamment des étourdissements, des lourdeurs, de la transpiration, des nausées et des maux d'estomac ont également été signalés. Bien que des informations complètes ne soient pas disponibles, les symptômes comportementaux auraient souvent persisté pendant 2 à 3 jours.
Patients pédiatriques
Jusqu'à 11 doses de 0,2 mg de naloxone (2,2 mg) ont été administrées aux enfants après un surdosage de chlorhydrate de diphénoxylate avec du sulfate d'atropine. Les rapports pédiatriques incluent un enfant de 2 ans et demi qui a reçu par inadvertance une dose de 20 mg de naloxone pour le traitement de la dépression respiratoire après un surdosage avec du chlorhydrate de diphénoxylate avec du sulfate d'atropine. L'enfant a bien répondu et s'est rétabli sans séquelles défavorables. Il y a également un rapport d'un enfant de 4 ans et demi qui a reçu 11 doses au cours d'une période de 12 heures, sans séquelles indésirables.
Gestion des patients
Les patients qui présentent une surdose de Jian Tian Neng (naloxone) doivent être traités de manière symptomatique dans un environnement étroitement surveillé. Les médecins doivent contacter un centre anti-poison pour obtenir les informations de gestion des patients les plus récentes.
L'expérience clinique avec le surdosage de Jian Tian Neng chez l'homme est limitée.
Patients adultes: Dans une étude, les volontaires et les sujets dépendants de la morphine qui ont reçu une dose sous-cutanée unique de 24 mg / 70 kg n'ont pas démontré de toxicité.
Dans une autre étude, 36 patients atteints d'AVC aigu ont reçu une dose de charge de 4 mg / kg (10 mg / m2/ min) de Jian Tian Neng suivi immédiatement de 2 mg / kg / h pendant 24 heures. Il y a eu quelques rapports d'événements indésirables graves: convulsions (2 patients), hypertension sévère (1) et hypotension et / ou bradycardie (3).
À des doses de 2 mg / kg chez des sujets normaux, une insuffisance mémoire a été rapportée.
Patients pédiatriques: Jusqu'à 11 doses de 0,2 mg de Jian Tian Neng (2,2 mg) ont été administrées aux enfants après une surdose de chlorhydrate de diphénoxylate avec du sulfate d'atropine. Les rapports pédiatriques incluent un enfant de 2 ans et demi qui a reçu par inadvertance une dose de 20 mg de Jian Tian Neng et un enfant de 4 ans et demi qui a reçu 11 doses pendant une période de 12 heures, qui n'avaient pas de séquelles indésirables.
Gestion des patients: Les patients qui présentent une surdose de Jian Tian Neng doivent être traités de manière symptomatique dans un environnement étroitement surveillé. Les médecins doivent contacter un centre anti-poison pour obtenir les informations de gestion des patients les plus récentes.
L'expérience clinique avec un surdosage de Naloxone chez l'homme est limitée.
Patients adultes: Dans une étude, les volontaires et les sujets dépendants de la morphine qui ont reçu une dose sous-cutanée unique de 24 mg / 70 kg n'ont pas démontré de toxicité.
Dans une autre étude, 36 patients atteints d'AVC aigu ont reçu une dose de charge de 4 mg / kg (10 mg / m2/ min) de Naloxone suivi immédiatement de 2 mg / kg / h pendant 24 heures. Il y a eu quelques rapports d'événements indésirables graves: convulsions (2 patients), hypertension sévère (1) et hypotension et / ou bradycardie (3).
À des doses de 2 mg / kg chez des sujets normaux, une insuffisance mémoire a été rapportée.
Patients pédiatriques: Jusqu'à 11 doses de 0,2 mg de naloxone (2,2 mg) ont été administrées aux enfants après une surdose de chlorhydrate de diphénoxylate avec du sulfate d'atropine. Les rapports pédiatriques incluent un enfant de 2 ans et demi qui a reçu par inadvertance une dose de 20 mg de naloxone et un enfant de 4 ans et demi qui a reçu 11 doses pendant une période de 12 heures, qui n'avaient pas de séquelles indésirables.
Gestion des patients: Les patients qui présentent une surdose de Naloxone doivent être traités de manière symptomatique dans un environnement étroitement surveillé. Les médecins doivent contacter un centre anti-poison pour obtenir les informations de gestion des patients les plus récentes.
Aucune information fournie
L'expérience clinique avec le surdosage de NARCAN (naloxone) chez l'homme est limitée.
Patients adultes
Dans une petite étude, les volontaires qui ont reçu 24 mg / 70 kg n'ont pas démontré de toxicité.
Dans une autre étude, 36 patients atteints d'AVC aigu ont reçu une dose de charge de 4 mg / kg (10 mg / m2/ min) de NARCAN (naloxone) suivi immédiatement de 2 mg / kg / h pendant 24 heures. Vingt-trois patients ont présenté des événements indésirables associés à l'utilisation de la naloxone et la naloxone a été interrompue chez sept patients en raison d'effets indésirables. Les événements indésirables les plus graves ont été: convulsions (2 patients), hypertension sévère (1) et hypotension et / ou bradycardie (3).
À des doses de 2 mg / kg chez des sujets normaux, des troubles cognitifs et des symptômes comportementaux, notamment irritabilité, anxiété, tension, méfiance, tristesse, difficulté à se concentrer et manque d'appétit ont été signalés. De plus, des symptômes somatiques, notamment des étourdissements, des lourdeurs, de la transpiration, des nausées et des maux d'estomac ont également été signalés. Bien que des informations complètes ne soient pas disponibles, les symptômes comportementaux auraient souvent persisté pendant 2 à 3 jours.
Patients pédiatriques
Jusqu'à 11 doses de 0,2 mg de naloxone (2,2 mg) ont été administrées aux enfants après un surdosage de chlorhydrate de diphénoxylate avec du sulfate d'atropine. Les rapports pédiatriques incluent un enfant de 2 ans et demi qui a reçu par inadvertance une dose de 20 mg de naloxone pour le traitement de la dépression respiratoire après un surdosage avec du chlorhydrate de diphénoxylate avec du sulfate d'atropine. L'enfant a bien répondu et s'est rétabli sans séquelles défavorables. Il y a également un rapport d'un enfant de 4 ans et demi qui a reçu 11 doses au cours d'une période de 12 heures, sans séquelles indésirables.
Gestion des patients
Les patients qui présentent une surdose de NARCAN (naloxone) doivent être traités de manière symptomatique dans un environnement étroitement surveillé. Les médecins doivent contacter un centre anti-poison pour obtenir les informations de gestion des patients les plus récentes.
Jian Tian Neng est un antagoniste compétitif des récepteurs µ, δ et Îo-opioïdes. Jian Tian Neng est le plus puissant chez le récepteur µ. Jian Tian Neng, donné seul, produit très peu d'effet. Cependant, s'il est administré à des doses plus élevées, il inverse rapidement l'effet de la morphine et d'autres opioïdes, y compris la pentazocine et la nalorphine. Jian Tian Neng a peu d'effet sur le seuil de douleur dans des conditions normales, mais provoque une hyperalgésie dans des conditions stressantes où des opioïdes endogènes sont produits. Jian Tian Neng inhibe également l'analgésie acupuncture, qui est associée à la libération de peptides opioïdes. Jian Tian Neng empêche également l'analgésie produite par la stimulation du PAG (matière grise péri-éducative). PAG est un site d'action dans la transmission de la douleur. Jian Tian Neng est administré par voie intraveineuse et ses effets sont produits immédiatement. Il est rapidement métabolisé par le foie et son effet ne dure que 1 à 2 heures, ce qui est beaucoup plus court que celui de la plupart des médicaments de type morphine. Il faudra donc peut-être le donner à plusieurs reprises.
La naloxone est un antagoniste compétitif des récepteurs µ, δ et Îo-opioïdes. La naloxone est la plus puissante chez le récepteur µ. La naloxone, donnée seule, produit très peu d'effet. Cependant, s'il est administré à des doses plus élevées, il inverse rapidement l'effet de la morphine et d'autres opioïdes, y compris la pentazocine et la nalorphine. La naloxone a peu d'effet sur le seuil de douleur dans des conditions normales, mais provoque une hyperalgésie dans des conditions stressantes où des opioïdes endogènes sont produits. La naloxone inhibe également l'analgésie d'acupuncture, qui est associée à la libération de peptides opioïdes. La naloxone empêche également l'analgésie produite par la stimulation du PAG (matière grise péri-éducative). PAG est un site d'action dans la transmission de la douleur. La naloxone est administrée par voie intraveineuse et ses effets sont produits immédiatement. Il est rapidement métabolisé par le foie et son effet ne dure que 1 à 2 heures, ce qui est beaucoup plus court que celui de la plupart des médicaments de type morphine. Il faudra donc peut-être le donner à plusieurs reprises.
Lorsque le chlorhydrate de naloxone est administré par voie intraveineuse, le début de l'action est généralement apparent en deux minutes. Le délai d'apparition de l'action est plus court pour les voies d'administration intraveineuses que sous-cutanée ou intramusculaire.
La durée d'action dépend de la dose et de la voie d'administration du chlorhydrate de naloxone.
Jian Tian Neng is rapidly absorbed following oral administration but high presystemic metabolism makes this route unreliable. Jian Tian Neng is highly lipid soluble and is thus rapidly distributed throughout the body, with a volume of distribution of 5.1kg -1. High concentrations occur in brain, kidney, lung, heart and skeletal muscle. The brain/serum ratio has been estimated to be 1.5-4.6, approximately 15 times that of morphine. Levels of Jian Tian Neng in the central nervous system are short-lived as rapid redistribution occurs and this could account for the short duration of action. About 50% of Jian Tian Neng is bound to plasma proteins, principally albumin. The plasma half-life is 1-2 hours. When Jian Tian Neng reaches the liver it undergoes extensive biotransformation, almost none of the drug excreted being unchanged. Metabolites are excreted largely in the urine, 70% of the dose being recoverable over 72 hours. In the neonate the elimination half-life is prolonged because of reduced hepatic metabolism.
Naloxone is rapidly absorbed following oral administration but high presystemic metabolism makes this route unreliable. Naloxone is highly lipid soluble and is thus rapidly distributed throughout the body, with a volume of distribution of 5.1kg -1. High concentrations occur in brain, kidney, lung, heart and skeletal muscle. The brain/serum ratio has been estimated to be 1.5-4.6, approximately 15 times that of morphine. Levels of naloxone in the central nervous system are short-lived as rapid redistribution occurs and this could account for the short duration of action. About 50% of naloxone is bound to plasma proteins, principally albumin. The plasma half-life is 1-2 hours. When naloxone reaches the liver it undergoes extensive biotransformation, almost none of the drug excreted being unchanged. Metabolites are excreted largely in the urine, 70% of the dose being recoverable over 72 hours. In the neonate the elimination half-life is prolonged because of reduced hepatic metabolism.
Il n'y a pas de données précliniques pertinentes pour le prescripteur qui s'ajoutent à celles déjà incluses dans d'autres sections du RCP
Il est recommandé de ne pas mélanger les perfusions de chlorhydrate de nian de Jian Tian avec des préparations contenant du bisulfite, du métabisulfite, des anions à longue chaîne ou à haut poids moléculaire, ou des solutions à pH alcalin (Martindale, 1996).
Il est recommandé de ne pas mélanger les perfusions de Jian Tian Neng avec des préparations contenant du bisulfite, du métabisulfite, des anions à longue chaîne ou à haut poids moléculaire, ou des solutions à pH alcalin (Martindale, 1996).
Utilisez une fois et jetez toute solution restante.