Label: PYRIDOSTIGMINE BROMIDE tablet
- NDC Code(s): 0904-6622-61
- Packager: Major Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 68382-659
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 5, 2025
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- Official Label (Printer Friendly)
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DESCRIPTIONPyridostigmine bromide tablets, USP are an orally active cholinesterase inhibitor. Chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural ...
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CLINICAL PHARMACOLOGYPyridostigmine bromide inhibits the destruction of acetylcholine by cholinesterase and thereby permits freer transmission of nerve impulses across the neuromuscular junction. Pyridostigmine is an ...
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INDICATIONS AND USAGEPyridostigmine bromide tablets, USP are useful in the treatment of myasthenia gravis.
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CONTRAINDICATIONSPyridostigmine bromide tablets, USP are contraindicated in mechanical intestinal or urinary obstruction, and particular caution should be used in its administration to patients with bronchial ...
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WARNINGSAlthough failure of patients to show clinical improvement may reflect underdosage, it can also be indicative of overdosage. As is true of all cholinergic drugs, overdosage of pyridostigmine ...
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PRECAUTIONSPyridostigmine is mainly excreted unchanged by the kidney.6,7,8 Therefore, lower doses may be required in patients with renal disease, and treatment should be based on titration of drug dosage to ...
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ADVERSE REACTIONSThe side effects of pyridostigmine bromide are most commonly related to overdosage and generally are of two varieties, muscarinic and nicotinic. Among those in the former group are nausea ...
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DOSAGE AND ADMINISTRATIONPyridostigmine bromide tablets, USP is available as - Conventional Tablets - each containing 60 mg pyridostigmine bromide. Dosage: The size and frequency of the dosage must be adjusted to the ...
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HOW SUPPLIEDPyridostigmine Bromide Tablets USP, 60 mg having functional scoring. Pyridostigmine Bromide Tablets USP, 60 mg are white to off-white, round, flat, uncoated tablets with quadrisect breakline on ...
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REFERENCES1. Osserman KE, Genkins G. Studies in myasthenia gravis: Reduction in mortality rate after crisis. JAMA. Jan 1963; 183:97-101. 2. Osserman KE, Genkins G. Studies in myasthenia gravis. NY State J ...
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Package/Label Display Panel MAJOR® NDC 0904-6622-61 - Unit Dose - Pyridostigmine - Bromide - Tablets, USP - 60 mg - CAUTION: EXTREMELY MOISTURE - SENSITIVE. 100 TABLETS (10 x 10) Rx only
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INGREDIENTS AND APPEARANCEProduct Information