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NARCAN (naloxone) is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids, including propoxyphene, methadone and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine. NARCAN (naloxone) is also indicated for diagnosis of suspected or known acute opioid overdosage.
DOSAGE AND ADMINISTRATION
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.
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.
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.
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, NARCAN (naloxone) may be administered I.M. or S.C. in divided doses. If necessary, NARCAN (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, 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.
NARCAN (naloxone hydrochloride injection, USP) for intravenous, intramuscular, and subcutaneous administration is available as:
Multiple Dose Vials
0.4 mg/mL..........................10 mL multiple dose vial-box of 1, NDC 63481-365-05
1 mg/mL.............................10 mL multiple dose vial-box of 1, NDC 63481-368-05
0.02 mg/mL.............................2 mL unit dose ampule-box of 10, NDC 63481-359-10
0.4 mg/mL.............................1 mL unit dose ampule-box of 10, NDC 63481-358-10
1 mg/mL.............................2 mL unit dose ampule-box of 10, NDC 63481-377-10
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Protect from light. Store in carton until contents have been used.
Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317. Manufactured by: Bristol-Myers Squibb Holdings Pharma, Ltd. Manati, Puerto Rico 00674 USA. October 2001.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/20/2009
Additional Narcan Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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