PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Pyridostigmine Bromide Oral Solution, USP

ADVERSE REACTIONS SECTION.


ADVERSE REACTIONS The side effects of Pyridostigmine Bromide Oral Solution are most commonly related to over dosage 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 Novitium Pharma LLC at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

INDICATIONS & USAGE SECTION.


INDICATIONS & USAGE Pyridostigmine Bromide Oral Solution, USPis useful in the treatment of myasthenia gravis.

DOSAGE & ADMINISTRATION SECTION.


DOSAGE & ADMINISTRATION Pyridostigmine Bromide Oral Solution is available in the following form: 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. 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).

SPL UNCLASSIFIED SECTION.


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.

HOW SUPPLIED SECTION.


HOW SUPPLIED Pyridostigmine Bromide Oral SolutionUSP,60 mg pyridostigmine bromide per teaspoonful (5 mL) and 5% alcohol - bottles of 16 fluid ounces (16 fl. oz.) (NDC 70954-148-10). Store at 20C to 25C (68F to 77F); excursions permitted to 15-30C (59-86F). [See USP Controlled Room Temperature]

DESCRIPTION SECTION.


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

PRECAUTIONS SECTION.


PRECAUTIONS GENERAL PRECAUTIONS Pyridostigmine is mainly excreted unchanged by the kidney.6,7,8 Therefore, lower doses may be required in patients with renal disease, and treatment should be based on titration of drug dosage to effect.6,7 PEDIATRIC USE Safety and effectiveness in pediatric patients have not been established.

REFERENCES SECTION.


REFERENCES Osserman KE, Genkins G. Studies in myasthenia gravis: Reduction in mortality rate after crisis. JAMA. Jan 1963; 183:97-101. Osserman KE, Genkins G. Studies in myasthenia gravis. NY State J Med. June 1961; 61:2076-2085. Grob D. Myasthenia gravis. A review of pathogenesis and treatment. Arch Intern Med. Oct 1961; 108:615-638. Schwab RS. Management of myasthenia gravis. New Eng J Med. Mar 1963; 268:596-597. Schwab RS. Management of myasthenia gravis. New Eng J Med. Mar 1963; 268:717-719. Cronnelly R, Stanski DR, Miller RD, Sheiner LB. Pyridostigmine kinetics with and without renal function. Clin Pharmacol Ther. 1980; 28:No 1, 78-81. Miller RD. Pharmacodynamics and pharmacokinetics of anticholinesterase. In: Ruegheimer E, Zindler M, ed. Anaesthesialagy. (Hamburg, Germany: Congress; Sep 14-21, 1980; 222-223.) (Int Congr. No. 538), Amsterdam, Netherlands: Excerpta Medica; 1981. Breyer-Pfaff U, Maier U, Brinkmann AM, Schumm F. Pyridostigmine kinetics in healthy subjects and patients with myasthenia gravis. Clin Pharmacol Ther. 1985;5:495-501 Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor New Jersey 08520 Revised: 01/2019

CONTRAINDICATIONS SECTION.


CONTRAINDICATIONS Pyridostigmine Bromide Oral Solutionis 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 SECTION.


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 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 Genkins1 indicate that the differential diagnosis of the two types of crisis may require the use of Tensilon (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 Genkins1, 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 Grob3 or Schwab.4,5