NARCAN- naloxone hydrochloride spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N)

Available from:

Proficient Rx LP

Administration route:

NASAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

NARCAN Nasal Spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. NARCAN Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. NARCAN Nasal Spray is not a substitute for emergency medical care. Limitations of Use: Restrict prescription of NARCAN Nasal Spray 2 mg to opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts. NARCAN Nasal Spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients. Risk Summary The limited available data on naloxone use in pregnant women are not sufficient to inform a drug-associated risk. However, there are clinical considerations [see Error! Hyperlink reference not valid. ] . In animal reproduction studies, no embryotoxic o

Product summary:

NARCAN Nasal Spray 4 mg is supplied as Carton containing two (2) blister packages (NDC 71205-528-02) each with a single spray device. NARCAN Nasal Spray is not made with natural rubber latex. Store NARCAN Nasal Spray in the blister and cartons provided. Store below 77°F (25°C). Excursions permitted up to 104°F (40°C). Do not freeze or expose to excessive heat above 104°F (40°C). Protect from light. NARCAN Nasal Spray freezes at temperatures below 5°F (-15°C). If this happens, the device will not spray. If NARCAN Nasal Spray is frozen and is needed in an emergency, do NOT wait for NARCAN Nasal Spray to thaw. Get emergency medical help right away. However, NARCAN Nasal Spray may be thawed by allowing it to sit at room temperature for 15 minutes, and it may still be used if it has been thawed after being previously frozen.

Authorization status:

New Drug Application

Summary of Product characteristics

NARCAN- NALOXONE HYDROCHLORIDE SPRAY
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NARCAN NASAL SPRAY
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NARCAN
NASAL SPRAY.
NARCAN (NALOXONE HYDROCHLORIDE) NASAL SPRAY
INITIAL U.S. APPROVAL: 1971
INDICATIONS AND USAGE
NARCAN Nasal Spray is an opioid antagonist indicated for the emergency
treatment of known or
suspected opioid overdose, as manifested by respiratory and/or central
nervous system depression. (1)
NARCAN Nasal Spray is intended for immediate administration as
emergency therapy in settings where
opioids may be present. (1)
NARCAN Nasal Spray is not a substitute for emergency medical care. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Nasal spray: 2 mg and 4 mg of naloxone hydrochloride in 0.1 mL. (3)
CONTRAINDICATIONS
Hypersensitivity to naloxone hydrochloride. (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The following adverse reactions were observed in a NARCAN Nasal Spray
clinical study: increased blood
pressure, constipation, toothache, muscle spasms, musculoskeletal
pain, headache, nasal dryness, nasal
edema, nasal congestion, nasal inflammation, rhinalgia, and xeroderma.
(6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ADAPT PHARMA, INC. AT
1-844-4NARCAN
(1-844-462-7226) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 8/2022
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NARCAN Nasal Spray is for intranasal use only. (2.1)
Seek emergency medical care immediately after use. (2.1)
Administration of a single spray of NARCAN Nasal Spray intranasally
into one nostril. (2.2)
Administer additional doses of NARCAN Nasal Spray, using a new nasal
spray with each dose, if the
patient does not respond or responds and then relapses into
respiratory depression, additional doses
of NARCAN Nasal Spray may be given every 2 to 3 minutes until
emergency medical assistance
ar