PRYIDOSTIGMINE BROMIDE

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).

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.

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.

ACTIONS Pyridostigmine bromide oral solution 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 (Prostigmine TM ), 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.

DESCRIPTION Pyridostigmine bromide oral solution USP is an orally active cholinesterase inhibitor. Chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is: Pyridostigmine bromide oral soution USP is available in the following form: Oral solution containing 60 mg pyridostigmine bromide per teaspoonful in a vehicle containing 5% alcohol, glycerin, lactic acid, sodium benzoate, sorbitol, sucrose, FD&C Red No. 40, FD&C Blue No. 1, raspberry flavor and water. Pyridostigmine bromide_ structure

HOW SUPPLIED Oral Solution, 60 mg pyridostigmine bromide per teaspoonful (5 mL) and 5% alcohol — bottles of 16 fluid ounces (1 pint) (NDC: 24689-104-01). Store pyridostigmine bromide oral solution USP at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F). Brands mentioned are trademarks of their respective owners.