A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Narcan Indications, Dosage, Storage, Stability - Naloxone
Narcan Indications, Dosage, Storage, Stability - Naloxone
INDICATIONS
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.
DOSAGE AND ADMINISTRATION
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.
HOW SUPPLIED
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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