Pryidostigmine Bromide

Pryidostigmine Bromide is an FDA-registered drug product whose active ingredient is PYRIDOSTIGMINE BROMIDE. It is labelled by Rising Pharma Holdings, Inc. taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 16571-833, application ANDA208797, label effective 20220907. It is one of 10 FDA drug label records sharing the active ingredient PYRIDOSTIGMINE BROMIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing PYRIDOSTIGMINE BROMIDE are most often described in connection with: indication pyridostigmine, bromide oral, solution usp, treatment myasthenia. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATION Pyridostigmine bromide oral solution USP is useful in the treatment of myasthenia gravis.

Dosage and Administration Pyridostigmine bromide oral solution is available in the following dosage form: Oral Solution raspberry-flavored, containing 60 mg pyridostigmine bromide per teaspoonful (5 mL). This form permits accurate dosage adjustment for children and "brittle" myasthenic patients who require fractions of 60 mg doses. It is more easily swallowed, especially in the morning, by patients with bulbar involvement. Dosage The size and frequency of the dosage must be adjusted to the needs of the individual patient. Oral Solution The average dose is ten 5 mL teaspoonfuls daily, spaced to provide maximum relief when maximum strength is needed. In severe cases, as many as 25 teaspoonfuls a day may be required, while in mild cases one to six teaspoonfuls 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 TM (edrophonium chloride).

Contraindications Pyridostigmine bromide oral solution is 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.

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 oral solution 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 oral solution 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, according to Osserman and Genkins, 1 calls for the prompt withdrawal of all drugs of this type. The immediate use of atropine in cholinergic crisis is also recommended. Atropine may also be used to abolish or obtund gastrointestinal side effects or other muscarinic reactions; but such use, by masking signs of overdosage, can lead to inadvertent induction of cholinergic crisis. For detailed information on the management of patients with myasthenia gravis, the physician is referred to one of the excellent reviews such as those by Osserman and Genkins, 2 Grob 3 or Schwab. 4,5 Usage in Pregnancy The safety of pyridostigmine bromide oral solution during pregnancy or lactation in humans has not been established. Therefore, use of pyridostigmine bromide oral solution in women who may become pregnant requires weighing the drug's potential benefits against its possible hazards to mother and child.

Adverse Reactions The side effects of pyridostigmine bromide oral solution 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 Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

FDA lists 10 drug label records with PYRIDOSTIGMINE BROMIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Pryidostigmine Bromide used for?
INDICATION Pyridostigmine bromide oral solution USP is useful in the treatment of myasthenia gravis.

Who makes Pryidostigmine Bromide?
Rising Pharma Holdings, Inc. is the labeler of record for Pryidostigmine Bromide. 10 FDA label records share the active ingredient PYRIDOSTIGMINE BROMIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Pryidostigmine Bromide come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Pryidostigmine Bromide prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing PYRIDOSTIGMINE BROMIDE?
Yes. 10 FDA drug label records list PYRIDOSTIGMINE BROMIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Pryidostigmine Bromide been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.