DUODOTE- atropine and pralidoxime chloride kit

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Meridian Medical Technologies® LLC

INN (Alþjóðlegt nafn):

atropine

Samsetning:

atropine 2.1 mg in 0.7 mL

Stjórnsýsluleið:

INTRAMUSCULAR

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

DuoDote is indicated for the treatment of poisoning by organophosphorus nerve agents as well as organophosphorus insecticides in adults and pediatric patients weighing more than 41 kg (90 pounds). 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, or the combination in pregnant women. Adequate animal reproduction studies have not been conducted with atropine, pralidoxime, 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 is excreted in human milk. There are no data on the effects of atropine or pralidoxime on the breastfed infant or the effects of the drugs on milk production. The developmental and health benefits

Vörulýsing:

Each single-dose DuoDote (atropine and pralidoxime chloride) autoinjector contains atropine (2.1 mg/0.7 mL; colorless to yellow solution, visible in front chamber) and pralidoxime chloride (600 mg/2 mL; colorless to yellow solution, not visible in rear chamber) and is available in a single unit carton, NDC-11704-620-01. Each DuoDote autoinjector is supplied in a pouch that provides protection from light. Store at 25ºC (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.

Leyfisstaða:

New Drug Application

Vara einkenni

DUODOTE- ATROPINE AND PRALIDOXIME CHLORIDE
MERIDIAN MEDICAL TECHNOLOGIES LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DUODOTE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DUODOTE.
DUODOTE (ATROPINE AND PRALIDOXIME CHLORIDE INJECTION), FOR
INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
DuoDote, a combination of atropine, a cholinergic muscarinic
antagonist, and pralidoxime chloride, a
cholinesterase reactivator, is indicated for the treatment of
poisoning by organophosphorus nerve agents
as well as organophosphorus insecticides in adults and pediatric
patients weighing more than 41 kg (90
pounds). (1)
DOSAGE AND ADMINISTRATION
DuoDote 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 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
Each single-dose DuoDote 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 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 susceptible individuals. (5.3)
_Urinary Retention_: Administer with caution in patient with bladder
outflow obstructio