Naloxone Hydrochloride, 1 mg/mL — 2 mL Syringe, Pack of 10

NALOXONE HYDROCHLORIDE INJECTION USP, 2 mg/2 mL (1 mg/mL)

PRODUCT OVERVIEW

Naloxone Hydrochloride Injection USP is a prescription opioid antagonist indicated for complete or partial reversal of opioid depression, including respiratory depression, caused by natural and synthetic opioids. It is also indicated for diagnosis of suspected or known acute opioid overdose. The labeling also describes postoperative opioid depression and cautious adjunctive use in septic shock.

PRESENTATION

This package contains 10 preservative-free, single-dose 2 mL Luer-Jet Luer-Lock prefilled syringes. Each syringe contains 2 mg naloxone hydrochloride in 2 mL (1 mg/mL). A needle is not included. Discard any unused portion.

ADMINISTRATION

May be administered intravenously, intramuscularly, or subcutaneously by trained healthcare professionals. Intravenous administration provides the most rapid onset and is recommended in emergency situations. Because the duration of some opioids may exceed naloxone's effect, continue surveillance and repeat dosing as necessary according to the prescribing information. Airway support, ventilation, cardiac support, and other resuscitative measures should be available.

IMPORTANT SAFETY INFORMATION

Contraindicated in patients with known hypersensitivity to naloxone or any ingredient. Abrupt reversal in opioid-dependent patients, including newborns of opioid-dependent mothers, can precipitate acute withdrawal. Cardiovascular instability, pulmonary edema, seizures, nausea, vomiting, and agitation have been reported, particularly with abrupt postoperative reversal. Naloxone is not effective for respiratory depression caused by non-opioid drugs.

STORAGE

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F), USP Controlled Room Temperature. Protect from light and store in the carton until used.

PRODUCT DETAILS

• Active ingredient: Naloxone hydrochloride

• Strength: 2 mg/2 mL (1 mg/mL)

• Drug class: Opioid antagonist

• Dosage form: Preservative-free injection in prefilled syringe

• Routes: Intravenous, intramuscular, or subcutaneous

• Package: 10 x 2 mL single-dose Luer-Lock syringes

• Manufacturer: International Medication Systems (IMS), an Amphastar company

• NDC: 76329-3369-01 (76329336901)

• GTIN: 00376329336916

Prescription product. For use by licensed healthcare professionals. See the current FDA-approved labeling for complete indications, dosing, contraindications, warnings, and precautions.

Source: DailyMed, Naloxone Hydrochloride Injection USP — https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=236349ef-2cb5-47ca-a3a5-99534c3a4996