Naloxone Hydrochloride Injection is indicated for the complete or partial reversal of narcotic depression, including respiratory depression, induced by opioids including natural and synthetic narcotics, propoxyphene, methadone and the narcotic-antagonist analgesics: nalbuphine, pentazocine and butorphanol. Naloxone Hydrochloride Injection is also indicated for the diagnosis of suspected acute opioid overdosage.

Naloxone Hydrochloride Injection may be administered intravenously, intramuscularly, or subcutaneously. The most rapid onset of action is achieved by intravenous administration, and this route is recommended in emergency situations.

Since the duration of action of some narcotics may exceed that of naloxone, the patient should be kept under continued surveillance, and repeated doses of naloxone hydrochloride should be administered, as necessary.

Intravenous Infusion

Naloxone Hydrochloride Injection may be diluted for intravenous infusion in 0.9% Sodium Chloride Injection or 5% Dextrose Injection. The addition of 2 mg of naloxone hydrochloride 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 solution must be discarded. The rate of administration should be titrated in accordance with the patient's response.

Naloxone Hydrochloride Injection 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 Naloxone Hydrochloride Injection unless its effect on the chemical and physical stability of the solution has first been established.

Usage in Adults

Narcotic Overdose-Known or Suspected: An initial dose of 0.4 mg to 2 mg of naloxone hydrochloride may be administered intravenously. If the desired degree of counteraction and improvement in respiratory functions is not obtained, it may be repeated at 2 to 3 minute intervals. If no response is observed after 10 mg of naloxone hydrochloride have been administered, the diagnosis of narcotic induced or partial narcotic induced toxicity should be questioned. Intramuscular or subcutaneous administration may be necessary if the intravenous route is not available.

Postoperative Narcotic Depression: For the partial reversal of narcotic depression following the use of narcotics during surgery, smaller doses of naloxone hydrochloride are usually sufficient. The dose of naloxone hydrochloride should be titrated according to the patient's response. For the initial reversal of respiratory depression, Naloxone Hydrochloride Injection 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 naloxone hydrochloride 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 naloxone hydrochloride 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 narcotic. Supplemental intramuscular doses have been shown to produce a longer lasting effect.

Usage in Children

Narcotic Overdose-Known or Suspected: The usual initial dose in children is 0.01 mg/kg body weight given intravenously. 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 intravenous route of administration is not available, Naloxone Hydrochloride Injection may be administered intramuscularly or subcutaneously in divided doses. If necessary, Naloxone Hydrochloride Injection can be diluted with Sterile Water for Injection.

Postoperative Narcotic Depression: Follow the recommendations and cautions under Usage in Adults - Postoperative Narcotic Depression (above). For the initial reversal of respiratory depression, naloxone hydrochloride 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

When using naloxone hydrochloride injection in neonates, a product containing 0.02 mg/mL should be used.

Narcotic-Induced Depression: The usual initial dose is 0.01 mg/kg body weight administered intravenously, intramuscularly or subcutaneously. This dose may be repeated in accordance with adult administration guidelines for postoperative narcotic depression.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Naloxone Hydrochloride Injection is available in the following packages:

0.4 mg/mL

1 mL DOSETTE^® ampuls packaged in 10s (NDC 0641-1451-33)

1 mL DOSETTE^® vials packaged in 10s (NDC 0641-0442-23)

10 mL Multiple Dose vials packaged individually (NDC 0641-2521-41)

STORAGE

Protect from light Store at controlled room temperature 15°- 30° C ( 59°- 86° F).

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