Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N)
Proficient Rx LP
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 Error! Hyperlink reference not valid. ] . In animal reproduction studies, no embryotoxic o
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.
New Drug Application
NARCAN- NALOXONE HYDROCHLORIDE SPRAY PROFICIENT RX LP ---------- 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 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 ® ® ® 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 Přečtěte si celý dokument