Neostigmine Methylsulfate

Neostigmine Methylsulfate Manufacturers

• Fresenius Kabi Usa, Llc
  

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  Neostigmine Methylsulfate | Fresenius Kabi Usa, Llc

  

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  2.1 Important Dosage and Administration Instructions Neostigmine should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents. Prior to Neostigmine Methylsulfate Injection administration and up until complete recovery of normal ventilation, the patient should be well ventilated and a patent airway maintained. Use a peripheral nerve stimulator capable of delivering a train-of-four (TOF) stimulus to evaluate the extent of recovery of neuromuscular function, and to determine the time of the first dose and the need for additional doses of Neostigmine Methylsulfate Injection. Prior to the administration of Neostigmine Methylsulfate Injection, there must be a twitch response to the first stimulus in the TOF of at least 10% of its baseline level (i.e., the response prior to NMBA administration). Dose selection should be based on the extent of spontaneous recovery at time of injection, half-life of the neuromuscular blocking agent (NMBA) to be reversed, and need for rapid NMBA reversal. Patients should continue to be monitored for adequacy of reversal of the effect of NMBAs for a period of time that would assure full recovery based on the patient’s medical condition and the pharmacokinetics of neostigmine and the NMBA used. Neostigmine Methylsulfate Injection is administered by intravenous bolus injection.  Additional, carefully adjusted bolus doses are administered according to the patient’s response. An anticholinergic agent (e.g., atropine or glycopyrrolate) should be administered prior to or concomitantly with Neostigmine Methylsulfate Injection [see Dosage and Administration (2.4), Warnings and Precautions (5.5)]. TOF monitoring alone should not be relied upon to determine the adequacy of reversal of neuromuscular blockade.  Satisfactory recovery should be judged by the patient’s ability to maintain a patent airway, adequacy of ventilation, and skeletal muscle tone. 2.2 Recommended Dosage in Adults The recommended dose range of Neostigmine Methylsulfate Injection is 0.03 mg/kg to 0.07 mg/kg administered as an intravenous bolus.  A dose less than 0.04 mg/kg is recommended for reversal of the effect of NMBAs with shorter half-lives (e.g., rocuronium), or when the first twitch response to the TOF stimulus is substantially greater than 10% of baseline, or when a second twitch is present.  A dose of 0.07 mg/kg is recommended for the reversal of the effect of NMBAs with longer half-lives (e.g., vecuronium or pancuronium), or when first twitch response is not substantially greater than 10% of baseline, or if there is need for more rapid recovery. Additional doses may be required. The recommended maximum total dose is 0.07 mg/kg or up to a total of 5 mg, whichever is less. 2.3 Recommended Dosage in Pediatric Patients including Neonates

  Adult guidelines should be followed when Neostigmine Methylsulfate Injection is administered to pediatric patients.  Pediatric patients require Neostigmine Methylsulfate Injection doses similar to those for adult patients.

  2.4 Concomitant or Pre-Administration of Anticholinergic Agents

  An anticholinergic agent (e.g., atropine sulfate or glycopyrrolate) should be administered intravenously several minutes prior to or with Neostigmine Methylsulfate Injection administration using separate syringes.  For bradycardic patients, the anticholinergic agent should be administered prior to Neostigmine Methylsulfate Injection.

  2.1 Important Dosage and Administration Instructions Neostigmine should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents. Prior to Neostigmine Methylsulfate Injection administration and up until complete recovery of normal ventilation, the patient should be well ventilated and a patent airway maintained. Use a peripheral nerve stimulator capable of delivering a train-of-four (TOF) stimulus to evaluate the extent of recovery of neuromuscular function, and to determine the time of the first dose and the need for additional doses of Neostigmine Methylsulfate Injection. Prior to the administration of Neostigmine Methylsulfate Injection, there must be a twitch response to the first stimulus in the TOF of at least 10% of its baseline level (i.e., the response prior to NMBA administration). Dose selection should be based on the extent of spontaneous recovery at time of injection, half-life of the neuromuscular blocking agent (NMBA) to be reversed, and need for rapid NMBA reversal. Patients should continue to be monitored for adequacy of reversal of the effect of NMBAs for a period of time that would assure full recovery based on the patient’s medical condition and the pharmacokinetics of neostigmine and the NMBA used. Neostigmine Methylsulfate Injection is administered by intravenous bolus injection.  Additional, carefully adjusted bolus doses are administered according to the patient’s response. An anticholinergic agent (e.g., atropine or glycopyrrolate) should be administered prior to or concomitantly with Neostigmine Methylsulfate Injection [see Dosage and Administration (2.4), Warnings and Precautions (5.5)]. TOF monitoring alone should not be relied upon to determine the adequacy of reversal of neuromuscular blockade.  Satisfactory recovery should be judged by the patient’s ability to maintain a patent airway, adequacy of ventilation, and skeletal muscle tone. 2.2 Recommended Dosage in Adults The recommended dose range of Neostigmine Methylsulfate Injection is 0.03 mg/kg to 0.07 mg/kg administered as an intravenous bolus.  A dose less than 0.04 mg/kg is recommended for reversal of the effect of NMBAs with shorter half-lives (e.g., rocuronium), or when the first twitch response to the TOF stimulus is substantially greater than 10% of baseline, or when a second twitch is present.  A dose of 0.07 mg/kg is recommended for the reversal of the effect of NMBAs with longer half-lives (e.g., vecuronium or pancuronium), or when first twitch response is not substantially greater than 10% of baseline, or if there is need for more rapid recovery. Additional doses may be required. The recommended maximum total dose is 0.07 mg/kg or up to a total of 5 mg, whichever is less. 2.3 Recommended Dosage in Pediatric Patients including Neonates

  Adult guidelines should be followed when Neostigmine Methylsulfate Injection is administered to pediatric patients.  Pediatric patients require Neostigmine Methylsulfate Injection doses similar to those for adult patients.

  2.4 Concomitant or Pre-Administration of Anticholinergic Agents

  An anticholinergic agent (e.g., atropine sulfate or glycopyrrolate) should be administered intravenously several minutes prior to or with Neostigmine Methylsulfate Injection administration using separate syringes.  For bradycardic patients, the anticholinergic agent should be administered prior to Neostigmine Methylsulfate Injection.

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• Cantrell Drug Company
  

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  Neostigmine Methylsulfate | Cantrell Drug Company

  

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  FOR SLOW INTRAVENOUS USE ONLY. PRESERVATIVE-FREE INJECTION SOLUTION.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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• American Regent, Inc.
  

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  Neostigmine Methylsulfate | American Regent, Inc.

  

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  Symptomatic control of myasthenia gravis: One mL of the 1:2000 solution (0.5 mg) subcutaneously or intramuscularly. Subsequent doses should be based on the individual patient's response. In most patients, however, oral treatment with Neostigmine Bromide tablets, 15 mg each, is adequate for control of symptoms.

  Prevention of postoperative distention and urinary retention: 0.25 mg subcutaneously or intramuscularly as soon as possible after operation; repeat every 4 to 6 hours for two or three days.

  Treatment of postoperative distention: One mL of the 1:2000 solution (0.5 mg) subcutaneously or intramuscularly, as required.

  Treatment of urinary retention: One mL of the 1:2000 solution (0.5 mg) subcutaneously or intramuscularly. If urination does not occur within an hour, the patient should be catheterized. After the patient has voided, or the bladder has been emptied, continue the 0.5 mg injections every three hours for at least 5 injections.

  Reversal of Effects of Non-depolarizing Blocking Agents: When Neostigmine Methylsulfate Injection, USP is administered intravenously, it is recommended that Atropine Sulfate (0.6 to 1.2 mg) also be given intravenously using separate syringes. Some authorities have recommended that the Atropine be injected several minutes before the Neostigmine rather than concomitantly. The usual dose is 0.5 to 2 mg Neostigmine Methylsulfate Injection, USP given by slow intravenous injection, repeated as required. Only in exceptional cases should the total dose of Neostigmine Methylsulfate exceed 5 mg. It is recommended that the patient be well ventilated and a patent airway maintained until complete recovery of normal respiration is assured. The optimum time for administration of the drug is during hyperventilation when the carbon dioxide level of the blood is low. It should never be administered in the presence of high concentrations of halothane or cyclopropane. In cardiac cases and severely ill patients, it is advisable to titrate the exact dose of Neostigmine Methylsulfate required, using a peripheral nerve stimulator device. In the presence of bradycardia, the pulse rate should be increased to about 80/minute with Atropine before administering Neostigmine.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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• West-ward Pharmaceutical Corp.
  

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  Neostigmine Methylsulfate | West-ward Pharmaceutical Corp.

  

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  Symptomatic control of myasthenia gravis: One mL of the 1:2000 solution (0.5 mg) subcutaneously or intramuscularly. Subsequent doses should be based on the individual patient's response. In most patients, however, oral treatment with neostigmine bromide tablets, 15 mg each, is adequate for control of symtoms.
  Prevention of postoperative distention and urinary retention: 0.25 mg subcutaneously or intramuscularly as soon as possible after operation; repeat every 4 to 6 hours for two or three days.
  Treatment of postoperative distention: One mL of 1:2000 solution (0.5 mg) subcutaneously or intramuscularly, as required.
  Treatment of urinary retention: One mL of the 1:2000 solution (0.5 mg) subcutaneously or intramuscularly. If urination does not occur within an hour, the patient should be catheterized. After the patient has voided, or the bladder has been emptied, continue the 0.5 mg injections every three hours for at least 5 injections.
  Reversal of Effects on Nondepolarizing Neuromuscular Blocking Agents: When Neostigmine Methylsulfate Injection is administered intravenously, it is recommended that atropine sulfate (0.6 to 1.2 mg) also be given intravenously using separate syringes. Some authorities have recommended that the atropine be injected several minutes before the neostigmine rather than concomitantly. The usual dose is 0.5 to 2 mg Neostigmine Methylsulfate Injection given by slow intravenous injection, repeated as required. Only in exceptional cases should the total dose neostigmine exceed 5 mg. It is recommended that the patient be well ventilated and a patent airway maintained until complete recovery of normal respiration is assured. The optimum time for administration of the drug is during hyperventilation when the carbon dioxide level of the blood is low. It should never be administered in the presence of high concentrations of halothane or cyclopropane. In cardiac cases and severely ill patients, it is advisable to titrate the exact dose of neostigmine required, using a peripheral nerve stimulator device. In the presence of bradycardia, the pulse rate should be increased to about 80/minute with atropine before administering neostigmine.
  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  

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• West-ward Pharmaceutical Corp.
  

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  Neostigmine Methylsulfate | West-ward Pharmaceutical Corp.

  

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  Symptomatic control of myasthenia gravis: One mL of the 1:2000 solution (0.5 mg) subcutaneously or intramuscularly. Subsequent doses should be based on the individual patient's response. In most patients, however, oral treatment with neostigmine bromide tablets, 15 mg each, is adequate for control of symtoms.
  Prevention of postoperative distention and urinary retention: 0.25 mg subcutaneously or intramuscularly as soon as possible after operation; repeat every 4 to 6 hours for two or three days.
  Treatment of postoperative distention: One mL of 1:2000 solution (0.5 mg) subcutaneously or intramuscularly, as required.
  Treatment of urinary retention: One mL of the 1:2000 solution (0.5 mg) subcutaneously or intramuscularly. If urination does not occur within an hour, the patient should be catheterized. After the patient has voided, or the bladder has been emptied, continue the 0.5 mg injections every three hours for at least 5 injections.
  Reversal of Effects on Nondepolarizing Neuromuscular Blocking Agents: When Neostigmine Methylsulfate Injection is administered intravenously, it is recommended that atropine sulfate (0.6 to 1.2 mg) also be given intravenously using separate syringes. Some authorities have recommended that the atropine be injected several minutes before the neostigmine rather than concomitantly. The usual dose is 0.5 to 2 mg Neostigmine Methylsulfate Injection given by slow intravenous injection, repeated as required. Only in exceptional cases should the total dose neostigmine exceed 5 mg. It is recommended that the patient be well ventilated and a patent airway maintained until complete recovery of normal respiration is assured. The optimum time for administration of the drug is during hyperventilation when the carbon dioxide level of the blood is low. It should never be administered in the presence of high concentrations of halothane or cyclopropane. In cardiac cases and severely ill patients, it is advisable to titrate the exact dose of neostigmine required, using a peripheral nerve stimulator device. In the presence of bradycardia, the pulse rate should be increased to about 80/minute with atropine before administering neostigmine.
  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  

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• Fresenius Kabi Usa, Llc
  

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  Neostigmine Methylsulfate | Fresenius Kabi Usa, Llc

  

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  Symptomatic Control of Myasthenia Gravis
  

  Symptomatic Control of Myasthenia Gravis One mL of the1:2000 solution (0.5 mg) IM or SC.  Subsequent doses should be based on the individual patient’s response.

  Prevention of Postoperative Distention and Urinary Retention
  

  One mL of the 1:4000 solution (0.25 mg) IM or SC as soon as possible after operation; repeat every four to six hours for two or three days.

  Treatment of Postoperative Distention
  

  One mL of the 1:2000 solution (0.5 mg) IM or SC, as required.

  Treatment of Urinary Retention
  

  One mL of the 1:2000 solution (0.5 mg) IM or SC.  If urination does not occur within an hour, the patient should be catheterized. After the patient has voided, or the bladder has been emptied, continue the 0.5 mg injections every three hours for at least five injections.

  Reversal of Effects of Nondepolarizing Neuromuscular Blocking Agents
  

  When neostigmine methylsulfate is administered IV, it is recommended that atropine sulfate (0.6 to 1.2 mg) also be given IV using separate syringes.  Some authorities have recommended that the atropine be injected several minutes before the neostigmine methylsulfate rather than concomitantly.  The usual dose is 0.5 to 2 mg neostigmine methylsulfate given by slow IV injection, repeated as required. Only in exceptional cases should the total dose of neostigmine methylsulfate exceed 5 mg.  It is recommended that the patient be well ventilated and a patent airway maintained until complete recovery of normal respiration is assured.  The optimum time for administration of the drug is during hyperventilation when the carbon dioxide level of the blood is low.  It should never be administered in the presence of high concentrations of halothane or cyclopropane.  In cardiac cases and severely ill patients, it is advisable to titrate the exact dose of neostigmine methylsulfate required, using a peripheral nerve stimulator device.  In the presence of bradycardia, the pulse rate should be increased to about 80/min with atropine before administering neostigmine methylsulfate. 

  Parenteral drug products should beinspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Symptomatic Control of Myasthenia Gravis
  

  Symptomatic Control of Myasthenia Gravis One mL of the1:2000 solution (0.5 mg) IM or SC.  Subsequent doses should be based on the individual patient’s response.

  Prevention of Postoperative Distention and Urinary Retention
  

  One mL of the 1:4000 solution (0.25 mg) IM or SC as soon as possible after operation; repeat every four to six hours for two or three days.

  Treatment of Postoperative Distention
  

  One mL of the 1:2000 solution (0.5 mg) IM or SC, as required.

  Treatment of Urinary Retention
  

  One mL of the 1:2000 solution (0.5 mg) IM or SC.  If urination does not occur within an hour, the patient should be catheterized. After the patient has voided, or the bladder has been emptied, continue the 0.5 mg injections every three hours for at least five injections.

  Reversal of Effects of Nondepolarizing Neuromuscular Blocking Agents
  

  When neostigmine methylsulfate is administered IV, it is recommended that atropine sulfate (0.6 to 1.2 mg) also be given IV using separate syringes.  Some authorities have recommended that the atropine be injected several minutes before the neostigmine methylsulfate rather than concomitantly.  The usual dose is 0.5 to 2 mg neostigmine methylsulfate given by slow IV injection, repeated as required. Only in exceptional cases should the total dose of neostigmine methylsulfate exceed 5 mg.  It is recommended that the patient be well ventilated and a patent airway maintained until complete recovery of normal respiration is assured.  The optimum time for administration of the drug is during hyperventilation when the carbon dioxide level of the blood is low.  It should never be administered in the presence of high concentrations of halothane or cyclopropane.  In cardiac cases and severely ill patients, it is advisable to titrate the exact dose of neostigmine methylsulfate required, using a peripheral nerve stimulator device.  In the presence of bradycardia, the pulse rate should be increased to about 80/min with atropine before administering neostigmine methylsulfate. 

  Parenteral drug products should beinspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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• Remedyrepack Inc.
  

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  Neostigmine Methylsulfate | Remedyrepack Inc.

  

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  Dosage

  Should be administered by trained healthcare providers (2.1) Recommend use of a peripheral nerve stimulator to determine whether neostigmine methylsulfate should be administered and to monitor recovery from neuromuscular blockade (2.1). Recommended dosage range is 0.03 mg/kg to 0.07mg/kg for reversing nondepolarizing neuromuscular block when administered with an anticholinergic agent (atropine or glycopyrrolate) (2.2, 2.3, 2.4) For reversal of NMBAs with shorter half-lives, when first twitch response is substantially greater than 10% of baseline, or when a second twitch is present:  0.03 mg/kg by intravenous route (2.2) For reversal of NMBAs with longer half-lives or when first twitch response is close to 10% of baseline:  0.07 mg/kg by intravenous route (2.2) Maximum total dosage is 0.07 mg/kg or up to a total of 5 mg (whichever is less) (2.2) An anticholinergic agent, e.g., atropine sulfate or glycopyrrolate, should be administered prior to or concomitantly with neostigmine methylsulfate (2.4)

  Dose of Anticholinergic Agent (atropine or glycopyrrolate)

  Administer atropine sulfate (~15 mcg/kg) or glycopyrrolate (~10 mcg/kg) intravenously either several minutes before or concomitantly with neostigmine methylsulfate (using separate syringes) (2.4)

   

  Neostigmine should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents. Prior to Neostigmine Methylsulfate Injection administration and up until complete recovery of normal ventilation, the patient should be well ventilated and a patent airway maintained. Use a peripheral nerve stimulator capable of delivering a train-of-four (TOF) stimulus to evaluate the extent of recovery of neuromuscular function, and to determine the time of the first dose and the need for additional doses of Neostigmine Methylsulfate Injection. Prior to the administration of Neostigmine Methylsulfate Injection, there must be a twitch response to the first stimulus in the TOF of at least 10% of its baseline level (i.e., the response prior to NMBA administration). Dose selection should be based on the extent of spontaneous recovery at time of injection, half-life of the neuromuscular blocking agent (NMBA) to be reversed, and need for rapid NMBA reversal. Patients should continue to be monitored for adequacy of reversal of the effect of NMBAs for a period of time that would assure full recovery based on the patient’s medical condition and the pharmacokinetics of neostigmine and the NMBA used. Neostigmine Methylsulfate Injection is administered by intravenous bolus injection.  Additional, carefully adjusted bolus doses are administered according to the patient’s response. An anticholinergic agent (e.g., atropine or glycopyrrolate) should be administered prior to or concomitantly with Neostigmine Methylsulfate Injection [see Dosage and Administration (2.4), Warnings and Precautions (5.5)]. TOF monitoring alone should not be relied upon to determine the adequacy of reversal of neuromuscular blockade.  Satisfactory recovery should be judged by the patient’s ability to maintain a patent airway, adequacy of ventilation, and skeletal muscle tone.

   

  The recommended dose range of Neostigmine Methylsulfate Injection is 0.03 mg/kg to 0.07 mg/kg administered as an intravenous bolus.  A dose less than 0.04 mg/kg is recommended for reversal of the effect of NMBAs with shorter half-lives (e.g., rocuronium), or when the first twitch response to the TOF stimulus is substantially greater than 10% of baseline, or when a second twitch is present.  A dose of 0.07 mg/kg is recommended for the reversal of the effect of NMBAs with longer half-lives (e.g., vecuronium or pancuronium), or when first twitch response is not substantially greater than 10% of baseline, or if there is need for more rapid recovery. Additional doses may be required. The recommended maximum total dose is 0.07 mg/kg or up to a total of 5 mg, whichever is less.

   

  Adult guidelines should be followed when Neostigmine Methylsulfate Injection is administered to pediatric patients.  Pediatric patients require Neostigmine Methylsulfate Injection doses similar to those for adult patients.

   

  An anticholinergic agent (e.g., atropine sulfate or glycopyrrolate) should be administered intravenously several minutes prior to or with Neostigmine Methylsulfate Injection administration using separate syringes.  For bradycardic patients, the anticholinergic agent should be administered prior to Neostigmine Methylsulfate Injection.

   

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