Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
atropine (UNII: 7C0697DR9I) (atropine - UNII:7C0697DR9I)
Meridian Medical Technologies LLC
Atropine sulfate
Atropine sulfate 0.25 mg in 0.3 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
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
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.
New Drug Application
ATROPEN AUTO-INJECTOR- ATROPINE INJECTION MERIDIAN MEDICAL TECHNOLOGIES LLC ---------- 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 Belgenin tamamını okuyun