ATROPEN AUTO-INJECTOR- atropine injection

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Meridian Medical Technologies LLC

DCI (Dénomination commune internationale):

Atropine sulfate

Composition:

Atropine sulfate 0.25 mg in 0.3 mL

Mode d'administration:

INTRAMUSCULAR

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

ATROPEN is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having cholinesterase activity as well as organophosphorus or carbamate insecticides in adult and pediatric patients. 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 in pregnant women. Adequate animal reproduction studies have not been conducted with atropine. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Risk Summary Atropine has been reported to be excreted in human milk. There are no data on the effects of atropine on the breastfed infant or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ATROPEN and any potential adverse effects on

Descriptif du produit:

ATROPEN is a prefilled single-dose autoinjector that contains a clear solution and is supplied in the following package configurations: Store between 20ºC to 25ºC (68ºF 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. After the ATROPEN autoinjector has been activated, the empty container should be disposed of properly. It cannot be refilled, nor can the protruding needle be retracted.

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

ATROPEN AUTO-INJECTOR- ATROPINE INJECTION
MERIDIAN MEDICAL TECHNOLOGIES LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ATROPEN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ATROPEN.
ATROPEN (ATROPINE INJECTION), FOR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 1960
INDICATIONS AND USAGE
ATROPEN is a cholinergic muscarinic antagonist indicated for the
treatment of poisoning by susceptible
organophosphorus nerve agents having cholinesterase activity as well
as organophosphorus or carbamate
insecticides in adult and pediatric patients. (1)
DOSAGE AND ADMINISTRATION
ATROPEN is a single-dose autoinjector intended as an initial treatment
of the muscarinic symptoms of
insecticide or nerve agent poisonings; definitive medical care should
be sought immediately. (2.1)
Dosage is dependent on weight. (2.2)
Dosage for Mild Symptoms: If the patient experiences two or more mild
symptoms, administer one
injection intramuscularly into the mid-lateral thigh. If, at any time
after the first dose, the patient
develops any of the severe symptoms, administer two additional
injections intramuscularly in rapid
succession. (2.2)
Dosage for Severe Symptoms: If the patient is either unconscious or
has any of the severe symptoms,
immediately administer three injections intramuscularly into the
patient's mid-lateral thigh in rapid
succession. (2.2)
DOSAGE FORMS AND STRENGTHS
Injection: Each prefilled single-dose autoinjector contains atropine
in a self-contained unit, and is available
in four strengths 0.25 mg/0.3 mL, 0.5 mg/0.7 mL, 1 mg/0.7 mL, and 2
mg/0.7 mL. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Cardiovascular (CV) Risks: Tachycardia, palpitations, premature
ventricular contractions, flutter,
fibrillation, etc. Use caution in patients 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: May precipitate in suscept