N/A- atropine injection, 2 mg injection N/A- atropine sulfate injection usp, 1 mg/0.7 ml injection N/A- atropine sulfate injec

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

ATROPINE (UNII: 7C0697DR9I) (ATROPINE - UNII:7C0697DR9I)

Disponible desde:

Rafa Laboratories, Ltd.

Designación común internacional (DCI):

ATROPINE

Composición:

ATROPINE 1 mg in 0.7 mL

Vía de administración:

INTRAMUSCULAR

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Atropine is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having anticholinesterase activity as well as organophosphorus or carbamate insecticides in adults and pediatric patients weighing more than 41 kg (90 pounds). None. Pregnancy 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. The background risk of major birth defects and miscarriage for the indicated population is unknown. Lactation 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.

Resumen del producto:

How Supplied The 2 mg Atropine autoinjector provides atropine base 1.67 mg/0.7 mL (equivalent to atropine sulfate 2 mg/0.7 mL) in a sterile solution for intramuscular injection. The 2 mg Atropine autoinjector is supplied as 480 self-contained single-dose autoinjectors per box (NDC 71053-592-01). Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do Not Freeze.

Estado de Autorización:

New Drug Application

Ficha técnica

N/A- ATROPINE INJECTION, 2 MG INJECTION
RAFA LABORATORIES, LTD.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ATROPINE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ATROPINE.
ATROPINE INJECTION, FOR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 1973
INDICATIONS AND USAGE
(1)
(1)
Atropine, a cholinergic muscarinic antagonist, is indicated for the
treatment of poisoning by susceptible
organophosphorus nerve agents having anticholinesterase activity as
well as organophosphorus or
carbamate insecticides in adults and pediatric patients weighing more
than 41 kg (90 pounds) (1). (1)
DOSAGE AND ADMINISTRATION
Atropine is intended as an initial treatment as soon as symptoms
appear; definitive medical care
should be sought immediately. (2.1)
Administer each dose of the 2 mg Atropine autoinjector into the
patient’s mid-lateral outer thigh (2.1).
_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 a patient 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: 1.67 mg/0.7 mL atropine base (equivalent to 2 MG atropine
sulfate) in a single-dose prefilled
autoinjector (3) (3)
CONTRAINDICATIONS
None (4) (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: