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NDC 76329-3369-01

Naloxone Hydrochloride 1 mg/mL INJECTION

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NDC
76329-3369-01
Generic Name
Naloxone Hydrochloride
Brand Name
Naloxone Hydrochloride
Strength
1 mg/mL
Dosage Form
INJECTION
Route
PARENTERAL
Package Size
Labeler
International Medication Systems, Limited

FDA Drug Information

Indications & Usage

INDICATIONS AND USAGE Naloxone hydrochloride injection 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 and butorphanol and cyclazocine. Naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage. Naloxone hydrochloride injection may be useful as a…

Important Warnings

WARNINGS Drug Dependence Naloxone hydrochloride 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,…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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