MESTINON- pyridostigmine bromide solution MESTINON- pyridostigmine bromide tablet MESTINON- pyridostigmine bromide tablet, ext

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

pyridostigmine bromide (UNII: KVI301NA53) (pyridostigmine - UNII:19QM69HH21)

Available from:

Bausch Health US, LLC

INN (International Name):

pyridostigmine bromide

Composition:

pyridostigmine bromide 60 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

MESTINON 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.

Product summary:

Oral Solution, 60 mg pyridostigmine bromide per teaspoonful (5 mL) and 5% alcohol - bottles of 1 pint (473 mL) (NDC 0187-3012-20). Tablets, are available as white, flat-faced tablets containing 60 mg pyridostigmine bromide in bottles of 100 (NDC 0187-3010-30). Each tablet is engraved “MESTINON 60 V” on one side and is quadrisect scored on the other. TIMESPAN tablets, are available as light straw-colored, capsule-shaped tablets containing 180 mg pyridostigmine bromide in bottles of 30 (NDC 0187-3013-30). Each tablet is engraved “MES V 180” on one side and is single-scored on the other. Note: Because of the hygroscopic nature of the TIMESPAN tablets, mottling may occur. This does not affect their efficacy. Store MESTINON (pyridostigmine bromide) Oral Solution, USP, MESTINON tablets, and TIMESPAN tablets at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Keep MESTINON tablets and TIMESPAN tablets in a dry place with the silica gel enclosed.

Authorization status:

New Drug Application

Summary of Product characteristics

MESTINON- PYRIDOSTIGMINE BROMIDE SOLUTION
MESTINON- PYRIDOSTIGMINE BROMIDE TABLET
MESTINON- PYRIDOSTIGMINE BROMIDE TABLET, EXTENDED RELEASE
BAUSCH HEALTH US, LLC
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MESTINON
(PYRIDOSTIGMINE BROMIDE)
ORAL SOLUTION, USP
ORAL SOLUTION
TABLETS
AND
TIMESPAN TABLETS
DESCRIPTION:
MESTINON (pyridostigmine bromide) is an orally active cholinesterase
inhibitor. Chemically,
pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide
dimethylcarbamate. Its structural
formula is:
MESTINON is available in the following forms: _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, flavors and
water. _Tablets_ containing 60 mg
pyridostigmine bromide; each tablet also contains lactose, silicon
dioxide and stearic acid. _TIMESPAN_
_tablets_ containing 180 mg pyridostigmine bromide; each tablet also
contains carnauba wax, corn-derived
proteins, isopropyl alcohol, magnesium stearate, silica gel, tribasic
calcium phosphate and water.
ACTIONS:
MESTINON 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.
INDICATION:
MESTINON is useful in the treatment of myasthenia gravis.
CONTRAINDICATIONS:
®
®
CONTRAINDICATIONS:
MESTINON 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,