12:08.08 Antimuscarinics/Antispasmodics
Generic Name
| Special Alerts:
December 21, 2023 TOPIC: 4.2% Sodium Bicarbonate Injection, 8.4% Sodium Bicarbonate Injection, and Atropine Sulfate Injection by Hospira: Recall - Due to the Potential Presence of Glass Particulate Matter ISSUE: Hospira is recalling the lots of 4.2% Sodium Bicarbonate Injection, USP ABBOJECT Glass Syringe, 5 mEq/10 mL; 8.4% Sodium Bicarbonate Injection, USP Lifeshield ABBOJECT Glass Syringe, 50 mEq/50 mL; and Atropine Sulfate Injection, USP Lifeshield ABBOJECT Glass Syringe, 1 mg/10 mL due to the potential for presence of glass particulate matter, identified during product inspection. For more information about this recall, see the full announcement on the FDA website: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-inc-issues-voluntary-nationwide-recall-42-sodium-bicarbonate-injection-84-sodium-bicarbonate. |
Atropine sulfate injection is available at concentrations of 0.4 mg/mL and 1 mg/mL in 1-mL single-dose (preservative-free) vials3448 and at a concentration of 0.4 mg/mL in 20-mL multiple-dose vials.3447; 3450 Sodium chloride is present for isotonicity, and sulfuric acid may have been used to adjust the pH.3447; 3448; 3450 Multiple-dose vials also contain benzyl alcohol as a preservative.3447; 3450
Atropine sulfate also is available in a concentration of 0.05 mg/mL in 5-mL single-dose prefilled syringes and 0.1 mg/mL in 5- and 10-mL single-dose prefilled syringes.3445; 3446; 3449 Sodium chloride is present for isotonicity.3445; 3446; 3449 Some syringes may contain sodium hydroxide and/or sulfuric acid to adjust the pH.3445; 3446 Some syringes contain citric acid and sodium citrate as buffers and may contain additional amounts of citric acid and/or sodium citrate to adjust the pH.3449
Atropine sulfate also is available in 0.25-, 0.5-, 1-, and 2-mg auto-injector syringes for self or caregiver intramuscular administration in the treatment of nerve agent and insecticide poisoning only.3451
pH
Single-dose vials: From 3 to 6.5.3448
Multiple-dose vials: From 3 to 3.8 (Fresenius Kabi)3447 or from 3 to 6.5 (West-Ward).3450
Prefilled syringes: From 3 to 6.5.3445; 3446; 3449
Auto-injector syringes: From 4 to 5.3451
Osmolarity
Atropine sulfate injection has a calculated osmolarity of 308 mOsm/L.3445; 3446
Atropine sulfate injection may be administered by the intravenous, subcutaneous, intramuscular, or intraosseous routes.3445; 3446; 3447; 3448; 3449; 3450 Specific product labeling should be consulted for details on the routes of administration that are recommended for each individual product.
Atropine sulfate injection should be stored at controlled room temperature.3445; 3446; 3447; 3448; 3449; 3450 One manufacturer states that multiple-dose vials should be stored at 20 to 25°C after initial use and should be discarded within 24 hours.3447
pH Effects
Minimum hydrolysis occurs at pH 3.5.1072
Temperature Effects
Atropine sulfate 0.1 mg/mL in auto-injector syringes (Abbott) was evaluated for stability over 45 days under use conditions in paramedic vehicles. Temperatures fluctuated with locations and conditions and ranged from 6.5°C (43.7 °F) to 52°C (125.6 °F) in high desert conditions. No visually apparent changes occurred, and little or no loss of atropine sulfate was found.2548
In another study, atropine sulfate injection under simulated summer conditions in paramedic vehicles was exposed to temperatures ranging from 26 to 38°C over 4 weeks. Analysis found no loss of the drug under these conditions.2562
Syringes
In 2015, reports of decreased potency of certain drugs (e.g., atropine sulfate) stored in Becton Dickinson syringes for extended periods (i.e., exceeding 24 hours) were confirmed by the manufacturer of these syringes; the cause of this change was later identified to be the inclusion of an alternate rubber stopper in the plunger of certain product lots of syringes.3029; 3036; 3037; 3039; 3041; 3042 Decreased potency was not observed when the syringes were filled and used promptly.3037 Use of the alternate stopper was later discontinued and use of the primary stopper in such syringes was resumed; however, Becton Dickinson states that its general-use syringes are cleared by FDA for immediate use in fluid aspiration and injection and that such syringes, regardless of the stopper material, have not been cleared by FDA for use as a closed-container system.3391
Atropine (salt unspecified) 1 mg/mL repackaged in polypropylene syringes exhibited little change in concentration after 4 weeks of storage at room temperature not exposed to direct light.2164
Extemporaneously compounded atropine sulfate 2-mg/mL injection in sodium chloride 0.9% for use in the event of a terrorist nerve gas attack was packaged in polypropylene syringes (Becton Dickinson) with sealed tips. The injection was adjusted to pH 3.5 with sulfuric acid during compounding. No visible changes were reported, and analysis found no loss of the drug over 364 days at 5°C protected from light, 364 days at 23°C exposed to light, and 28 days at 35°C exposed to light.2781
For a list of references cited in the text of this monograph, search the monograph titled References.