ATNAA ATROPINE AND PRALIDOXIME CHLORIDE AUTO-INJECTOR- atropine and pralidoxime chloride kit

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

atropine (UNII: 7C0697DR9I) (atropine - UNII:7C0697DR9I)

Disponível em:

Meridian Medical Technologies, LLC

DCI (Denominação Comum Internacional):

atropine

Composição:

atropine 2.1 mg in 0.7 mL

Via de administração:

INTRAMUSCULAR

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

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.

Status de autorização:

New Drug Application

Características técnicas

ATNAA ATROPINE AND PRALIDOXIME CHLORIDE AUTO-INJECTOR- ATROPINE
AND PRALIDOXIME CHLORIDE
MERIDIAN MEDICAL TECHNOLOGIES, LLC
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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:_