מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N)
A-S Medication Solutions
NASAL
PRESCRIPTION DRUG
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
Product: 50090-2422 NDC: 50090-2422-0 .1 mL in a VIAL, SINGLE-DOSE / 2 in a PACKAGE
New Drug Application
A-S Medication Solutions ---------- 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 קרא את המסמך השלם
NARCAN- NALOXONE HYDROCHLORIDE SPRAY A-S MEDICATION SOLUTIONS ---------- 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: 9/2023 ® ® ® 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 a קרא את המסמך השלם