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Neostigmine

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Neostigmine Methylsulfate

INDICATIONS

Neostigmine Methylsulfate (neostigmine methylsulfate (neostigmine methylsulfate injection) injection) Injection, USP is indicated for:

- the symptomatic control of myasthenia gravis when oral therapy is impractical.
- the prevention and treatment of postoperative distention and urinary retention after mechanical obstruction has been excluded.
- reversal of effects of non-depolarizing neuromuscular blocking agents (e.g., tubocurarine, metocurine, gallamine or pancuronium) after surgery.

DOSAGE AND ADMINISTRATION

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 (neostigmine methylsulfate (neostigmine methylsulfate injection) injection) 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 (neostigmine methylsulfate (neostigmine methylsulfate injection) injection) Injection, USP given by slow intravenous injection, repeated as required.Only in exceptional cases should the total dose of Neostigmine Methylsulfate (neostigmine methylsulfate (neostigmine methylsulfate injection) injection) 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 (neostigmine methylsulfate (neostigmine methylsulfate injection) injection) 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.

HOW SUPPLIED

Neostigmine Methylsulfate (neostigmine methylsulfate (neostigmine methylsulfate injection) injection) Injection, USP 1:1000 (1 mg/mL)

NDC 0517-0033-25...............10 mL Multiple Dose Vials.............boxes of 25

Neostigmine Methylsulfate (neostigmine methylsulfate (neostigmine methylsulfate injection) injection) Injection, USP 1:2000 (0.5 mg/mL)

NDC 0517-0034-25...............10 mL Multiple Dose Vials. ...........boxes of 25

Store at controlled room temperature 15°-30°C (59°-86°F) (See USP). Protect from light.Store in carton until time of use.

AMERICAN REGENT LABORATORIES INC., SHIRELY, NY 11967. Rev.9/02. FDA Rev date: n/a

Last reviewed on RxList: 6/26/2008
This monograph has been modified to include the generic and brand name in many instances.

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Additional Neostigmine Methylsulfate Information

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