Pyridostigmine Bromide

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Pyridostigmine Bromide Recall

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Uses

Pyridostigmine bromide is indicated for pretreatment against the lethal effects of Soman nerve agent poisoning. Pyridostigmine is intended for use in conjunction with protective garments, including a mask. At the first sign of nerve agent poisoning, pyridostigmine should be stopped, and atropine and pralidoxime therapy started immediately.

The evidence for the effectiveness of pyridostigmine as pretreatment against Soman-induced toxicity was derived from animal studies alone [see Nonclinical Toxicology (13.2)].

FOR MILITARY MEDICAL USE ONLY

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History

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Other Information

Pyridostigmine bromide is an orally active, reversible cholinesterase inhibitor. Its chemical name is: 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate.

CAS registration number is 101-26-8.

Pyridostigmine bromide has a molecular formula of C9H13BrN202, a molecular weight of 261.12, and the following molecular structure:

Pyridostigmine bromide tablets, USP contain 30 mg pyridostigmine bromide for oral administration. The inactive ingredients included in the tablet formula are: lactose anhydrous, colloidal silicon dioxide, and stearic acid.

Sources

Pyridostigmine Bromide Manufacturers

Valeant Canada Limited

Pyridostigmine Bromide | Valeant Canada Limited

PYRIDOSTIGMINE BROMIDE IS FOR USE AS A PRETREATMENT FOR EXPOSURE TO THE CHEMICAL NERVE AGENT SOMAN. PYRIDOSTIGMINE ALONE WILL NOT PROTECT AGAINST EXPOSURE TO SOMAN. THE EFFICACY OF PYRIDOSTIGMINE IS DEPENDENT UPON THE RAPID USE OF ATROPINE AND PRALIDOXIME (2-PAM) AFTER SOMAN EXPOSURE.

PRIMARY PROTECTION AGAINST EXPOSURE TO CHEMICAL NERVE AGENTS IS THE WEARING OF PROTECTIVE GARMENTS INCLUDING MASKS, HOODS AND OVERGARMENTS DESIGNED SPECIFICALLY FOR THIS USE.

INDIVIDUALS MUST NOT RELY SOLELY UPON PRETREATMENT WITH PYRIDOSTIGMINE, AND THE ANTIDOTES ATROPINE AND PRALIDOXIME (2-PAM) TO PROVIDE COMPLETE PROTECTION FROM POISONING BY THE CHEMICAL NERVE AGENT SOMAN.

PYRIDOSTIGMINE MUST NOT BE TAKEN AFTER EXPOSURE TO SOMAN. IF PYRIDOSTIGMINE IS TAKEN IMMEDIATELY BEFORE EXPOSURE (E.G., WHEN THE GAS ATTACK ALARM IS GIVEN) OR AT THE SAME TIME AS POISONING BY SOMAN, IT IS NOT EXPECTED TO BE EFFECTIVE, AND MAY EXACERBATE THE EFFECTS OF A SUB-LETHAL EXPOSURE TO SOMAN [See Clinical Pharmacology (12.2)].

The dose of pyridostigmine is one 30 mg tablet every 8 hours, started at least several hours prior to exposure to Soman. At the first sign of nerve agent poisoning, pyridostigmine should be discontinued and treatment with atropine and pralidoxime should be instituted immediately.

There is no known advantage to taking pyridostigmine just prior to or concurrent with Soman exposure. According to the mechanism of action of pyridostigmine described below [See Clinical Pharmacology (12.2)], pyridostigmine should be effective when it is given sufficiently in advance of Soman poisoning to provide a pool of protected enzyme. Therefore, it is expected that pyridostigmine will not be effective if administered just prior to or during exposure to Soman.

The benefits and risks of use beyond 14 consecutive days have not been definitively established, therefore, continued use beyond 14 consecutive days should be evaluated in the context of the likelihood of exposure to Soman nerve agent.

No Recall
Kaiser Foundation Hospitals

Pyridostigmine Bromide | Kaiser Foundation Hospitals

DOSAGE AND ADMINISTRATION: Pyridostigmine Bromide Tablets are available as tablet form; each containing 60 mg pyridostigmine bromide.

Dosage: The size and frequency of the dosage must be adjusted to the needs of the individual patient.

The average dose is ten 60-mg tablets daily, spaced to provide maximum relief when maximum strength is needed. In severe cases as many as 25 tablets a day may be required, while in mild cases one to six tablets a day may suffice.

Note: For information on a diagnostic test for myasthenia gravis, and for the evaluation and stabilization of therapy, please see product literature on Tensilon® (edrophonium chloride).

No Recall
Remedyrepack Inc.

Pyridostigmine Bromide | Remedyrepack Inc.

Pyridostigmine bromide is available in tablets, each containing 60 mg pyridostigmine bromide.

Dosage
The size and frequency of the dosage must be adjusted to the needs of the individual patient. The average dose is ten 60-mg tablets daily, spaced to provide maximum relief when maximum strength is needed. In severe cases as many as 25 tablets a day may be required, while in mild cases one to six tablets a day may suffice.
Note: For information on a diagnostic test for myasthenia gravis, and for the evaluation and stabilization of therapy, please see product literature on Tensilon(edrophonium chloride).

No Recall
Remedyrepack Inc.

Pyridostigmine Bromide | Remedyrepack Inc.

Pyridostigmine bromide is available in tablets, each containing 60 mg pyridostigmine bromide.

The size and frequency of the dosage must be adjusted to the needs of the individual patient. The average dose is ten 60-mg tablets daily, spaced to provide maximum relief when maximum strength is needed. In severe cases as many as 25 tablets a day may be required, while in mild cases one to six tablets a day may suffice.

Note: For information on a diagnostic test for myasthenia gravis, and for the evaluation and stabilization of therapy, please see product literature on Tensilon® (edrophonium chloride).

No Recall
Corepharma, Llc

Pyridostigmine Bromide | Corepharma, Llc

Pyridostigmine bromide tablets are available as tablet form; each containing 60 mg pyridostigmine bromide.

Dosage: The size and frequency of the dosage must be adjusted to the needs of the individual patient.

The average dose is ten 60-mg tablets daily, spaced to provide maximum relief when maximum strength is needed. In severe cases as many as 25 tablets a day may be required, while in mild cases one to six tablets a day may suffice.

Note: For information on a diagnostic test for myasthenia gravis, and for the evaluation and stabilization of therapy, please see product literature on Tensilon® (edrophonium chloride).

No Recall
American Health Packaging

Pyridostigmine Bromide | American Health Packaging

Pyridostigmine bromide is available in tablets, each containing 60 mg pyridostigmine bromide.
Dosage
The size and frequency of the dosage must be adjusted to the needs of the individual patient. The average dose is ten 60-mg tablets daily, spaced to provide maximum relief when maximum strength is needed. In severe cases as many as 25 tablets a day may be required, while in mild cases one to six tablets a day may suffice.

Note: For information on a diagnostic test for myasthenia gravis, and for the evaluation and stabilization of therapy, please see product literature on Tensilon® (edrophonium chloride).

No Recall
Oceanside Pharmaceuticals

Pyridostigmine Bromide | Kosan Kozmetik Sanayi Ve Ticaret A.s.

Apply on the lips. Reapply when lips are exposed to strong sun for protection. Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses. Children under 6 months of age: Ask a doctor.

No Recall
Global Pharmaceuticals, Division Of Impax Laboratories Inc.

Pyridostigmine Bromide | Global Pharmaceuticals, Division Of Impax Laboratories Inc.

Pyridostigmine bromide is available in tablets, each containing 60 mg pyridostigmine bromide.
Dosage
The size and frequency of the dosage must be adjusted to the needs of the individual patient. The average dose is ten 60-mg tablets daily, spaced to provide maximum relief when maximum strength is needed. In severe cases as many as 25 tablets a day may be required, while in mild cases one to six tablets a day may suffice.

Note: For information on a diagnostic test for myasthenia gravis, and for the evaluation and stabilization of therapy, please see product literature on Tensilon® (edrophonium chloride).

No Recall
Oceanside Pharmaceuticals

Pyridostigmine Bromide | Oceanside Pharmaceuticals

Pyridostigmine Bromide Extended-release Tablets

each contain 180 mg pyridostigmine bromide. This form provides uniformly slow release, hence prolonged duration of drug action; it facilitates control of myasthenic symptoms with fewer individual doses daily. The immediate effect of a 180 mg Pyridostigmine Bromide Extended-release Tablet is about equal to that of a 60 mg Pyridostigmine Bromide Tablet; however, its duration of effectiveness, although varying in individual patients, averages 2 ½ times that of a 60 mg dose.

Dosage

The size and frequency of the dosage must be adjusted to the needs of the individual patient.

Pyridostigmine Bromide Extended-release Tablets

One to three 180 mg tablets, once or twice daily, will usually be sufficient to control symptoms; however, the needs of certain individuals may vary markedly from this average. The interval between doses should be at least 6 hours. For optimum control, it may be necessary to use the more rapidly acting regular tablets or syrup in conjunction with extended-release tablets therapy.

Note: For information on a diagnostic test for myasthenia gravis, and for the evaluation and stabilization of therapy, please see product literature on Tensilon (edrophonium chloride).

No Recall