Pyridostigmine Bromide 180 mg/1
Pyridostigmine Bromide · TABLET, EXTENDED RELEASE · Alvogen, Inc.
Pyridostigmine Bromide is a tablet, extended release containing pyridostigmine bromide at 180 mg/1, taken oral. Manufactured by Alvogen, Inc..
Key Facts
- Brand Name
- Pyridostigmine Bromide
- Generic Name
- Pyridostigmine Bromide
- NDC Code (Product)
47781-335- Manufacturer
- Alvogen, Inc.
- Strength
- 180 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA204737
- Marketing Start
- 06/29/2015
Recall History
VistaPharm, Inc.
cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Corepharma LLC
Failed Dissolution Specification: Corepharma Inc. is recalling Pyridostigmine Bromide Tablets USP 60 mg due to an out of specification dissolution test generated at the 30 month stability time point.
Core Pharma Llc
Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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, extended release 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 3 other brand versions of Pyridostigmine Bromide.
What is the NDC code for Pyridostigmine Bromide 180 mg/1?
The NDC (National Drug Code) for Pyridostigmine Bromide 180 mg/1 is 47781-335, listed by Alvogen, Inc..
Other Pyridostigmine Bromide Dosages
- Pyridostigmine Bromide30 mg/172458-128
- Pyridostigmine Bromide60 mg/5mL66689-406
- Pyridostigmine Bromide60 mg/168084-494
- Pyridostigmine Bromide60 mg/168682-302
- Pyridostigmine Bromide30 mg/10115-2134
- Pyridostigmine Bromide60 mg/5mL42192-626
- Pyridostigmine Bromide60 mg/5mL69238-1731
- Pyridostigmine Bromide60 mg/5mL72205-098
Other Pyridostigmine Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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