Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
atropine (UNII: 7C0697DR9I) (atropine - UNII:7C0697DR9I)
Meridian Medical Technologies, LLC
atropine
atropine 2.1 mg in 0.7 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
ATNAA is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having anticholinesterase activity in adults. None. Risk Summary Atropine readily crosses the placental barrier and enters fetal circulation. There are no adequate data on the developmental risk associated with the use of atropine, pralidoxime chloride, or the combination in pregnant women. Adequate animal reproduction studies have not been conducted with atropine, pralidoxime chloride, or the combination. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Risk Summary Atropine has been reported to be excreted in human milk. It is not known whether pralidoxime chloride is excreted in human milk. There are no data on the effects of atropine or pralidoxime chloride on the breastfed infant or the effects of the drugs on milk production. The developmental and health benefits of breastfeeding should be
Each single-dose ATNAA autoinjector contains atropine (2.1 mg/0.7 mL; colorless to yellow solution, visible in front chamber) and pralidoxime chloride (600 mg/2mL, equivalent to pralidoxime 476.6 mg/2 mL; colorless to yellow solution, not visible in rear chamber). ATNAA, NDC-11704-777-01, is supplied through the Directorate of Medical Materiel, Defense Supply Center, Philadelphia. Each ATNAA is supplied in a pouch that provides protection from light. Store between 20ºC to 25ºC (68 ºF to 77ºF); excursions permitted between 15ºC and 30ºC (between 59ºF and 86ºF) [See USP Controlled Room Temperature]. Not made with natural rubber latex. Keep from freezing. Protect from light.
New Drug Application
ATNAA ATROPINE AND PRALIDOXIME CHLORIDE AUTO-INJECTOR- ATROPINE AND PRALIDOXIME CHLORIDE MERIDIAN MEDICAL TECHNOLOGIES, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ATNAA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ATNAA. ATNAA (ATROPINE AND PRALIDOXIME CHLORIDE INJECTION), FOR INTRAMUSCULAR USE INITIAL U.S. APPROVAL: 2002 INDICATIONS AND USAGE ATNAA, a combination of atropine, a cholinergic muscarinic antagonist, and pralidoxime chloride, a cholinesterase reactivator, is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having anticholinesterase activity in adults. (1) DOSAGE AND ADMINISTRATION ATNAA is intended as an initial treatment as soon as symptoms appear; definitive medical care should be sought immediately. (2.1) Dosage for Mild Symptoms: If a service member experiences some or all of the mild symptoms, they should self-administer one injection intramuscularly into the lateral thigh muscle or buttocks. If, at any time after the first dose, the service member develops any of the severe symptoms or if the mild symptoms are not relieved, a buddy should administer two additional injections intramuscularly in rapid succession. (2.2) Dosage for Severe Symptoms: If a service member has any of the severe symptoms, immediately buddy-administer three injections intramuscularly into the service member's lateral thigh muscle or buttocks in rapid succession. (2.2) DOSAGE FORMS AND STRENGTHS Injection: Each single-dose ATNAA autoinjector contains atropine (2.1 mg/0.7 mL) plus pralidoxime chloride (600 mg/2 mL). (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS _Cardiovascular (CV) Risks:_ Tachycardia, palpitations, premature ventricular contractions, flutter, fibrillation, etc. Use caution in individuals with known CV disease or conduction problems. (5.1) _Heat Injury:_ May inhibit sweating and lead to hyperthermia; avoid excessive exercising and heat exposure. (5.2) _Acute Glaucoma:_ Belgenin tamamını okuyun