Drugplain

pyridostigmine bromide 60 mg/1

pyridostigmine bromide · TABLET · Golden State Medical Supply, Inc.

No Recall History
Plain English

pyridostigmine bromide is a tablet containing pyridostigmine bromide at 60 mg/1, taken oral. Manufactured by Golden State Medical Supply, Inc..

Key Facts

Brand Name
pyridostigmine bromide
Generic Name
pyridostigmine bromide
NDC Code (Product)
51407-590
Manufacturer
Golden State Medical Supply, Inc.
Strength
60 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA205650
Marketing Start
06/22/2015

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Pyridostigmine Bromide Tablets USP are useful in the treatment of myasthenia gravis.

Dosage & Administration

DOSAGE AND ADMINISTRATION Each Pyridostigmine Bromide Tablet contains 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 twenty-five 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).

Warnings

WARNINGS Although 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 bromide may result in cholinergic crisis, a state characterized by increasing muscle weakness which, through involvement of the muscles of respiration, may lead to death. Myasthenic crisis due to an increase in the severity of the disease is also accompanied by extreme muscle weakness, and thus may be difficult to distinguish from cholinergic crisis on a symptomatic basis. Such differentiation is extremely important, since increases in doses of pyridostigmine bromide or other drugs of this class in the presence of cholinergic crisis or of a refractory or "insensitive" state could have grave consequences. Osserman and Genkins 1 indicate that the differential diagnosis of the two types of crisis may require the use of Tensilon TM (edrophonium chloride) as well as clinical judgment. The treatment of the two conditions obviously differs radically. Whereas the presence of myasthenic crisis suggests the need for more intensive anticholinesterase therapy, the diagnosis of cholinergic crisis, a…

Contraindications

CONTRAINDICATIONS Pyridostigmine bromide tablets are contraindicated in mechanical intestinal or urinary obstruction, and particular caution should be used in its administration to patients with bronchial asthma. Care should be observed in the use of atropine for counteracting side effects, as discussed below.

Adverse Reactions

ADVERSE REACTIONS The 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, vomiting, diarrhea, abdominal cramps, increased peristalsis, increased salivation, increased bronchial secretions, miosis and diaphoresis. Nicotinic side effects are comprised chiefly of muscle cramps, fasciculation and weakness. Muscarinic side effects can usually be counteracted by atropine, but for reasons shown in the preceding section the expedient is not without danger. As with any compound containing the bromide radical, a skin rash may be seen in an occasional patient. Such reactions usually subside promptly upon discontinuance of the medication. To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Frequently Asked Questions

What is pyridostigmine bromide used for?

pyridostigmine bromide contains pyridostigmine bromide. It is a tablet taken oral. Consult your doctor for specific uses.

Is pyridostigmine bromide a controlled substance?

pyridostigmine bromide is not classified as a controlled substance by the DEA.

What is the generic name for pyridostigmine bromide?

The generic name for pyridostigmine bromide is pyridostigmine bromide. There are 11 other brand versions of pyridostigmine bromide.

What is the NDC code for pyridostigmine bromide 60 mg/1?

The NDC (National Drug Code) for pyridostigmine bromide 60 mg/1 is 51407-590, listed by Golden State Medical Supply, Inc..

Product NDC

51407-590

Package NDC

51407-590-30

Other pyridostigmine bromide Dosages

Other Pyridostigmine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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