Narcan Warnings, Precautions, Pregnancy, Nursing, Abuse - Naloxone

Narcan Warnings, Precautions, Pregnancy, Nursing, Abuse - Naloxone

WARNINGS

Naloxone Hydrochloride Injection should be administered cautiously to persons including newborns of mothers who are known or suspected to be physically dependent on oploids. In such cases, an abrupt and complete reversal of narcotic effects may precipitate an acute abstinence syndrome.

The patient who has satisfactorily responded to naloxone should be kept under continued surveillance and repeated doses should be administered, as necessary, since the duration of action of some narcotics may exceed that of naloxone.

Naloxone is not effective against respiratory depression due to non-opiold drugs. Reversal of buprenorphine-induced respiratory depression may be incomplete. If an incomplete response occurs, respirations should be mechanically assisted.

PRECAUTIONS

In addition to Naloxone Hydrochloride Injection, 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 narcotic poisoning.

Several instances of hypotension, hypertension, ventricular tachycardia and fibrillation, and pulmonary edema have been reported. These have occurred in postoperative 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, Naloxone Hydrochloride Injection should be used with caution in patients with pre-existing cardiac disease or patients who have received potentially cardiotoxic drugs.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity and mutagenicity studies have not been performed with naloxone hydrochloride. Reproductive studies in mice and rats demonstrated no impairment of fertility.

Pregnancy

Teratogenlc Effects - Pregnancy Category B. Reproduction studies have been performed in mice and rats at doses up to 1000 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to naloxone hydrochloride. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Naloxone Hydrochloride Injection is administered to a nursing woman.