FDA Label for N/a
View Indications, Usage & Precautions
N/a Product Label
The following document was submitted to the FDA by the labeler of this product Rafa Laboratories, Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Indications & Usage
Atropine Sulfate Injection USP is indicated for the treatment of poisoning by susceptible organophosphorous nerve agents having cholinesterase activity as well as organophosphorous or carbamate insecticides. Atropine Sulfate Injection USP 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.
Atropine Sulfate Injection USP 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. Atropine Sulfate Injection USP 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 Atropine Sulfate Injection USP injection may be required until atropinization is achieved (flushing, mydriasis, tachycardia, dryness of the mouth and nose). 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.
Warnings
CAUTION! PRIMARY PROTECTION AGAINST EXPOSURE TO CHEMICAL NERVE AGENTS AND INSECTICIDE POISONING IS THE WEARING OF PROTECTIVE GARMENTS INCLUDING MASKS DESIGNED SPECIFICALLY FOR THIS USE.
INDIVIDUALS SHOULD NOT RELY SOLELY UPON ANTIDOTES SUCH AS ATROPINE AND PRALIDOXIME TO PROVIDE COMPLETE PROTECTION FROM CHEMICAL NERVE AGENTS AND INSECTICIDE POISONING.
Patients who have had previous anaphylactic reactions to atropine who have mild symptoms of organophosphorous or nerve agent poisoning should not be treated without adequate medical supervision.
While Atropine Sulfate Injection USP can be administered to all individuals with a life-threatening exposure to organophosphorous nerve agents and insecticides, it should be administered with extreme caution to individuals with the following disorders when the symptoms of nerve agent poisoning are less severe: individuals who are hypersensitive to any component of the product, disorders of heart rhythm such as atrial flutter, severe narrow angle glaucoma, pyloric stenosis, prostatic hypertrophy, significant renal insufficiency, or a recent myocardial infarction.
More than one dose of atropine of Atropine Sulfate Injection USP may be necessary initially, especially when exposure is massive or symptoms are severe. However, no more than three doses should be administered unless under the supervision of trained medical personnel. High doses of atropine may be required for many hours following high-dose exposure to maintain atropinization.
Children and the elderly may be more susceptible to the pharmacologic effects of atropine.
Severe difficulty in breathing requires artificial respiration in addition to the use of atropine since atropine is not dependable in reversing the weakness or paralysis of the respiratory muscles.
Dosage & Administration
Step 1: Determine which Rafa Atropine Auto-Injector is appropriate for the exposed individual based on weight/age.
The Rafa Atropine Auto-Injector is intended for use ONLY in adults and pediatric patients weighing 15 lbs [7 kg] or more (generally 6 months of age and over).
Do NOT administer the Rafa Atropine Auto-Injector to pediatric patients weighing weighing less than 15 lbs [7 kg] (generally younger than 6 months of age). Dose adjustment is not possible on an auto-injector.
Choose the correct dose of Atropine Auto-Injector for the exposed individual based on weight (or age if weight unknown) using Table 1 below.
Step 2: Determine the severity of symptoms using Table 2 below.
Note: Not all of these symptoms may be exhibited in an exposed person.
Step 3: Determine the number of Rafa Atropine Auto-Injectors to administer based on severity of symptoms. See Table 2 and Figure 1.
MILD SYMPTOMS (see Table 2)
One (1) Rafa Atropine Auto-Injector is recommended if two or more MILD symptoms of nerve agent or certain insecticide poisoning appear in situations when exposure is known or suspected.
Two (2) additional Rafa Atropine Auto-Injectors given in rapid succession are recommended 10 minutes after receiving the first Rafa Atropine Auto-Injector if the patient develops any of the SEVERE symptoms listed above. If possible, a person other than the patient should administer the second and third Rafa Atropine Auto-Injectors.
SEVERE SYMPTOMS (see Table 2)
If an individual is found either unconscious or has any of the SEVERE symptoms listed in Table 2 in the setting of suspected or known nerve agent or certain insecticide poisoning, immediately administer three (3) Rafa Atropine Auto-Injectors in rapid succession.
STEP 4: Instructions for administration of the Rafa Atropine Auto-Injector:
* Please review the disclaimer below.