Get your patient on Pyridostigmine Bromide - Pyridostigmine Bromide solution (Pyridostigmine Bromide)

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Pyridostigmine Bromide - Pyridostigmine Bromide solution prescribing information

Indications & Usage

INDICATION:

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

Dosage & Administration

DOSAGE AND ADMINISTRATION:

Pyridostigmine Bromide Oral Solution, USP is available in following 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 (edrophonium chloride).


Contraindications

CONTRAINDICATIONS:

Pyridostigmine bromide 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.

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 Novadoz Pharmaceuticals LLC at 1-855-668-2369 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


Description

DESCRIPTION:

Pyridostigmine bromide oral solution, USP is an orally active cholinesterase inhibitor. Chemically, pyridostigmine bromide, USP is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is:

Referenced Image

The molecular formula of pyridostigmine bromide, USP is C 9 H 13 BrN 2 O 2 having a molecular weight of 261.12.
Pyridostigmine bromide oral solution, USP contains 60 mg pyridostigmine bromide per teaspoonful in a vehicle containing 0.23% w/w alcohol, glycerin, lactic acid, sodium benzoate, sorbitol, sucrose, raspberry-flavor (propylene glycol, Nat & Art flavor) and water.

Pharmacology

CLINICAL PHARMACOLOGY:

Pyridostigmine bromide inhibits the destruction of acetylcholine by cholinesterase and thereby permits freer transmission of nerve impulses across the neuromuscular junction. Pyridostigmine is an analog of neostigmine (Prostigmin), but differs from it in certain clinically significant respects; for example, pyridostigmine is characterized by a longer duration of action and fewer gastrointestinal side effects.

How Supplied/Storage & Handling

HOW SUPPLIED:

Pyridostigmine Bromide Oral Solution USP, 60 mg pyridostigmine bromide per teaspoonful (5 mL) is available as a clear, raspberry flavored solution and 0.23% w/w alcohol.
It is supplied as follows:
Bottles of 16 fluid ounces, (1 pint, 473 mL)                NDC 72205-098-72
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59°to 86°F). [see USP Controlled Room Temperature].
Dispense in tight, light-resistant containers as defined by the USP.


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