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handbook on injectable - Sample monograph

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ROBERTO CARLOS NIZAMA
ROBERTO CARLOS NIZAMA

Handbook on Injectable Drugs, 18th Edition - ASHP Author: American Society of Health-System Pharmacists - ASHP Publisher: American Society of Health-System Pharmacists - ASHP

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Name /bks_53475_hid/53475_special_request 07/14/2014 12:21PM Plate # 0-Composite pg 1 # 1 LEVETIRACETAM/1 LEVETIRACETAM AHFS 28:12.92 Products — Levetiracetam is available as a 100-mg/mL concentrate for injection in 5-mL single-use vials. (2833) The concentrate must be diluted before administration. (2833) Levetiracetam is also available as a single-use, ready-to-use solu- tion for intravenous infusion containing 500 mg, 1 g, or 1.5 g leve- tiracetam in 100 mL sodium chloride in dual-port plastic bags. (2834) Both the concentrate and the ready-to-use formulations contain wa- ter for injection and sodium chloride. (2833; 2834) pH — Levetiracetam concentrate and ready-to-use solutions for infusion have a pH adjusted to approximately 5.5 with glacial acetic acid and sodium acetate trihydrate. (2833; 2834) Osmolality — The osmolality of levetiracetam 100-mg/mL concentrate for injection was determined to be approximately 950 mOsm/kg. (2835) Following dilution of 500 mg of the concentrate in 100 mL of sodium chloride 0.9%, the osmolality of levetiracetam was deter- mined to be approximately 430 mOsm/kg. (2835) Sodium Content — Ready-to-use solutions of levetiracetam 500 mg, 1 g, and 1.5 g in 100 mL of sodium chloride injection contain 820, 750, and 540 mg of sodium, respectively. (2834) Trade Name(s) — Keppra. Administration — Single-use vials contain levetiracetam concentrate that is administered by intravenous infusion after dilution in 100 mL of a compatible diluent. (2833) Single-use, ready-to-use solutions of levetiracetam should not be further diluted prior to intravenous in- fusion. (2834) Levetiracetam is administered by intravenous infusion over 15 min- utes. (2833; 2834) Stability — Levetiracetam concentrate and diluted solutions should be clear and colorless. (2833; 2834) Intact vials of levetiracetam con- centrate and ready-to-use bags of levetiracetam in solution in their unopened aluminum overwrap should be stored at controlled room temperature. (2833; 2834) Discolored products or products containing particulate matter should not be used. (2833; 2834) Ready-to-use lev- etiracetam infusion bags should be used promptly once the aluminum overwrap has been removed. (2834) The unused contents of an opened vial or a partially used infusion bag should be discarded. (2833; 2834) The diluted contents of a vial of levetiracetam concentrate should be used within 24 hours. (2835) Compatibility Information Solution Compatibility Levetiracetam Solution Mfr Mfr Conc/L Remarks Ref C/I Dextrose 5% a UCB 5 and 40 g Physically compatible and chemically stable for 24 hours at controlled room temperature 2833; 2835 C Ringer’s injection lactated a UCB 1 and 8 g Physically compatible and chemically stable for 24 hours at controlled room temperature 2833; 2835 C Sodium chloride 0.9% a UCB 5 and 40 g Physically compatible and chemically stable for 24 hours at controlled room temperature 2833; 2835 C a Tested in PVC containers. Additive Compatibility Levetiracetam Drug Mfr Conc/L Mfr Conc/L Test Soln Remarks Ref C/I Diazepam 200 mg UCB 5 and 40 g D5W, NSa Physically compatible and chemically sta- ble for 24 hr at controlled room tempera- ture 2833; 2835 C 40 mg UCB 1 and 8 g LRa Physically compatible and chemically sta- ble for 24 hr at controlled room tempera- ture 2833; 2835 C
Name /bks_53475_hid/53475_special_request 07/14/2014 12:21PM Plate # 0-Composite pg 2 # 2 2/LEVETIRACETAM Additive Compatibility (Cont.) Levetiracetam Drug Mfr Conc/L Mfr Conc/L Test Soln Remarks Ref C/I Lorazepam 40 mg UCB 5 and 40 g D5W, NSa Physically compatible and chemically sta- ble for 24 hr at controlled room tempera- ture 2833; 2835 C 8 mg UCB 1 and 8 g LRa Physically compatible and chemically sta- ble for 24 hr at controlled room tempera- ture 2833; 2835 C Valproate sodium 12 g UCB 5 and 40 g D5W, NSa Physically compatible and chemically sta- ble for 24 hr at controlled room tempera- ture 2833; 2835 C 2.4 g UCB 1 and 8 g LRa Physically compatible and chemically sta- ble for 24 hr at controlled room tempera- ture 2833; 2835 C a Tested in PVC containers. á­§ Copyright, May 2013, American Society of Health-System Pharmacists, Inc.

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handbook on injectable - Sample monograph

  • 1. Name /bks_53475_hid/53475_special_request 07/14/2014 12:21PM Plate # 0-Composite pg 1 # 1 LEVETIRACETAM/1 LEVETIRACETAM AHFS 28:12.92 Products — Levetiracetam is available as a 100-mg/mL concentrate for injection in 5-mL single-use vials. (2833) The concentrate must be diluted before administration. (2833) Levetiracetam is also available as a single-use, ready-to-use solu- tion for intravenous infusion containing 500 mg, 1 g, or 1.5 g leve- tiracetam in 100 mL sodium chloride in dual-port plastic bags. (2834) Both the concentrate and the ready-to-use formulations contain wa- ter for injection and sodium chloride. (2833; 2834) pH — Levetiracetam concentrate and ready-to-use solutions for infusion have a pH adjusted to approximately 5.5 with glacial acetic acid and sodium acetate trihydrate. (2833; 2834) Osmolality — The osmolality of levetiracetam 100-mg/mL concentrate for injection was determined to be approximately 950 mOsm/kg. (2835) Following dilution of 500 mg of the concentrate in 100 mL of sodium chloride 0.9%, the osmolality of levetiracetam was deter- mined to be approximately 430 mOsm/kg. (2835) Sodium Content — Ready-to-use solutions of levetiracetam 500 mg, 1 g, and 1.5 g in 100 mL of sodium chloride injection contain 820, 750, and 540 mg of sodium, respectively. (2834) Trade Name(s) — Keppra. Administration — Single-use vials contain levetiracetam concentrate that is administered by intravenous infusion after dilution in 100 mL of a compatible diluent. (2833) Single-use, ready-to-use solutions of levetiracetam should not be further diluted prior to intravenous in- fusion. (2834) Levetiracetam is administered by intravenous infusion over 15 min- utes. (2833; 2834) Stability — Levetiracetam concentrate and diluted solutions should be clear and colorless. (2833; 2834) Intact vials of levetiracetam con- centrate and ready-to-use bags of levetiracetam in solution in their unopened aluminum overwrap should be stored at controlled room temperature. (2833; 2834) Discolored products or products containing particulate matter should not be used. (2833; 2834) Ready-to-use lev- etiracetam infusion bags should be used promptly once the aluminum overwrap has been removed. (2834) The unused contents of an opened vial or a partially used infusion bag should be discarded. (2833; 2834) The diluted contents of a vial of levetiracetam concentrate should be used within 24 hours. (2835) Compatibility Information Solution Compatibility Levetiracetam Solution Mfr Mfr Conc/L Remarks Ref C/I Dextrose 5% a UCB 5 and 40 g Physically compatible and chemically stable for 24 hours at controlled room temperature 2833; 2835 C Ringer’s injection lactated a UCB 1 and 8 g Physically compatible and chemically stable for 24 hours at controlled room temperature 2833; 2835 C Sodium chloride 0.9% a UCB 5 and 40 g Physically compatible and chemically stable for 24 hours at controlled room temperature 2833; 2835 C a Tested in PVC containers. Additive Compatibility Levetiracetam Drug Mfr Conc/L Mfr Conc/L Test Soln Remarks Ref C/I Diazepam 200 mg UCB 5 and 40 g D5W, NSa Physically compatible and chemically sta- ble for 24 hr at controlled room tempera- ture 2833; 2835 C 40 mg UCB 1 and 8 g LRa Physically compatible and chemically sta- ble for 24 hr at controlled room tempera- ture 2833; 2835 C
  • 2. Name /bks_53475_hid/53475_special_request 07/14/2014 12:21PM Plate # 0-Composite pg 2 # 2 2/LEVETIRACETAM Additive Compatibility (Cont.) Levetiracetam Drug Mfr Conc/L Mfr Conc/L Test Soln Remarks Ref C/I Lorazepam 40 mg UCB 5 and 40 g D5W, NSa Physically compatible and chemically sta- ble for 24 hr at controlled room tempera- ture 2833; 2835 C 8 mg UCB 1 and 8 g LRa Physically compatible and chemically sta- ble for 24 hr at controlled room tempera- ture 2833; 2835 C Valproate sodium 12 g UCB 5 and 40 g D5W, NSa Physically compatible and chemically sta- ble for 24 hr at controlled room tempera- ture 2833; 2835 C 2.4 g UCB 1 and 8 g LRa Physically compatible and chemically sta- ble for 24 hr at controlled room tempera- ture 2833; 2835 C a Tested in PVC containers. á­§ Copyright, May 2013, American Society of Health-System Pharmacists, Inc.