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Basic Drug Info
Drug Name:Naloxone Hydrochloride
Manufacturer:Hospira, Inc.
Other Info:

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.



Clinical Trials:


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, 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 an adjunctive agent to increase blood pressure in the management of septic shock (see CLINICAL PHARMACOLOGY: Adjunctive Use in Septic Shock).
LUNG FUNCTION DECREASED --

Septic Shock -- Sepsis associated with HYPOTENSION or hypoperfusion despite adequate fluid resuscitation. Perfusion abnormalities may include, but are not limited to LACTIC ACIDOSIS; OLIGURIA; or acute alteration in mental status.

Contraindications
Naloxone hydrochloride injection is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or any of the other ingredients contained in the formulation.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Naloxone hydrochloride injection 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, but are not limited to, the following: body aches, diarrhea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.

In the neonate, opioid withdrawal may also include: convulsions, excessive crying, and hyperactive reflexes.
Branded Drugs
The following US Branded drugs contain Naloxone Hydrochloride


SUBOXONE -- RECKITT BENCKISER PHARMACEUTICALS INC

NALOXONE -- BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE

NALOXONE -- WYETH AYERST LABORATORIES

NARCAN -- BRISTOL MYERS SQUIBB PHARMA CO

NARCAN -- ENDO PHARMACEUTICALS INC

NALOXONE HYDROCHLORIDE AND PENTAZOCAINE -- ACTAVIS TOTOWA LLC

PENTAZOCINE AND NALOXONE HYDROCHLORIDES -- RANBAXY PHARMACEUTICALS INC

PENTAZOCINE AND NALOXONE HYDROCHLORIDES -- WATSON LABORATORIES INC

TALWIN NX -- SANOFI AVENTIS US LLC


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