Application Nr Approved Date Route Status External Links
NDA017106 None Intramuscular None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage The Atropen ® Auto-Injector Is Indicated For The Treatment Of Poisoning By Susceptible Organophosphorous Nerve Agents Having Cholinesterase Activity As Well As Organophosphorous Or Carbamate Insecticides. The Atropen ® Auto-Injector Should Be Used By Persons Who Have Had Adequate Training In The Recognition And Treatment Of Nerve Agent Or Insecticide Intoxication. Pralidoxime Chloride May Serve As An Important Adjunct To Atropine Therapy. The Atropen ® Is Intended As An Initial Treatment Of The Muscarinic Symptoms Of Insecticide Or Nerve Agent Poisonings (Generally Breathing Difficulties Due To Increased Secretions); Definitive Medical Care Should Be Sought Immediately. The Atropen ® Auto-Injector Should Be Administered As Soon As Symptoms Of Organophosphorous Or Carbamate Poisoning Appear (Usually Tearing, Excessive Oral Secretions, Wheezing, Muscle Fasciculations, Etc.). In Moderate To Severe Poisoning, The Administration Of More Than One Atropen ® May Be Required Until Atropinization Is Achieved (Flushing, Mydriasis, Tachycardia, Dryness Of The Mouth And Nose). (See Dosage And Administration ) In Severe Poisonings, It May Also Be Desirable To Concurrently Administer An Anticonvulsant If Seizure Is Suspected In The Unconscious Individual Since The Classic Tonic-Clonic Jerking May Not Be Apparent Due To The Effects Of The Poison. In Poisonings Due To Organophosphorous Nerve Agents And Insecticides It May Also Be Helpful To Concurrently Administer A Cholinesterase Reactivator Such As Pralidoxime Chloride.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Atropine ATROPINE ZINC100009278

Comments