NARCAN- naloxone hydrochloride spray NARCAN- naloxone hydrochloride spray

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Emergent Devices Inc.

INN (Διεθνής Όνομα):

NALOXONE HYDROCHLORIDE

Σύνθεση:

NALOXONE HYDROCHLORIDE 2 mg in 0.1 mL

Οδός χορήγησης:

NASAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 Clinical Considerations] . In animal reproduction studies, no embryotoxic or teratogenic ef

Περίληψη προϊόντος:

NARCAN Nasal Spray 2 mg is supplied as a carton containing four (4) blister packages (NDC 69547-212-04) each with a single spray device and as a carton containing twenty-four (24) blister packages (NDC 69547-212-24) each with a single spray device. NARCAN Nasal Spray 4 mg is supplied as Carton containing two (2) blister packages (NDC 69547-353-02) 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.

Καθεστώς αδειοδότησης:

New Drug Application

Φύλλο οδηγιών χρήσης

Adapt Pharma Inc
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PATIENT INFORMATION
NARCAN (NAR´ KAN)
(NALOXONE HYDROCHLORIDE)
NASAL SPRAY
This Patient Information has been approved by the U.S. Food and
Drug Administration.
Issued: 09/2019
You and your family members or caregivers should read this Patient
Information leaflet before an opioid
emergency happens. This information does not take the place of talking
with your healthcare provider about
your medical condition or your treatment.
What is the most important information I should know about NARCAN
Nasal Spray?
NARCAN Nasal Spray is used to temporarily reverse the effects of
opioid medicines. The medicine in
NARCAN Nasal Spray has no effect in people who are not taking opioid
medicines. Always carry
NARCAN Nasal Spray with you in case of an opioid emergency.
1.
Use NARCAN Nasal Spray right away if you or your caregiver think signs
or symptoms of an opioid
emergency are present, even if you are not sure, because an opioid
emergency can cause severe
injury or death. Signs and symptoms of an opioid emergency may
include:
•
unusual sleepiness and you are not able to awaken the person with a
loud voice or by rubbing
firmly on the middle of their chest (sternum)
•
breathing problems including slow or shallow breathing in someone
difficult to awaken or
who looks like they are not breathing
•
the black circle in the center of the colored part of the eye (pupil)
is very small, sometimes
called "pinpoint pupils," in someone difficult to awaken
2.
Family members, caregivers, or other people who may have to use NARCAN
Nasal Spray in an
opioid emergency should know where NARCAN Nasal Spray is stored and
how to give NARCAN
before an opioid emergency happens.
3.
Get emergency medical help right away after giving the first dose of
NARCAN Nasal Spray. Rescue
breathing or CPR (cardiopulmonary resuscitation) may be given while
waiting for emergency
medical help.
4.
The signs and symptoms of an opioid emergency can return after NARCAN
Nasal Spray is given. If
this happens, give another dose after 2 to 3 min

Αρχείο Π.Χ.Π.

NARCAN- NALOXONE HYDROCHLORIDE SPRAY
EMERGENT DEVICES INC.
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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
•
•
•
•
•
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
•
•
•
•
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 EMERGENT DEVICES 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: 11/2020
®
®
®
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 ass