MESTINON- pyridostigmine bromide syrup
MESTINON- pyridostigmine bromide tablet设备监理工程师
MESTINON- pyridostigmine bromide tablet, extended relea
Valeant Pharmaceuticals North America LLC
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MESTINON
软装设计师(pyridostigmine bromide)
SYRUP, TABLETS
and
TIMESPAN TABLETS春节活动图片
DESCRIPTION
Mestinon (pyridostigmine bromide) is an orally active cholinestera inhibitor. Chemically,
pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural
formula is:
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Mestinon is available in the following forms: Syrup containing 60 mg pyridostigmine bromide per teaspoonful in a vehicle containing 5% alcohol, glycerin, lactic acid, sodium benzoate, sorbitol,sucro, FD&C Red No. 40, FD&C Blue No. 1, flavors and water. Tablets containing 60 mg
pyridostigmine bromide; each tablet also contains lacto, silicon dioxide and stearic acid. Timespan Tablets containing 180 mg pyridostigmine bromide; each tablet also contains carnauba wax, corn-derived proteins, magnesium stearate, silica gel and tribasic calcium phosphate.
ACTIONS
记电话号码Mestinon inhibits the destruction of acetylcholine by cholinestera and thereby permits freer transmission of nerve impuls 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 uful in the treatment of myasthenia gravis.
CONTRAINDICATIONS
Mestinon is contraindicated in mechanical intestinal or urinary obstruction, and particular caution should be ud in its administration to patients with bronchial asthma. Care should be obrved in the u of ®®
atropine for counteracting side effects, as discusd below.
WARNINGS
如何瘦腰和肚子
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 Mestinon 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 increa in the verity of the dia 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 increas in dos of Mestinon or other drugs of this class in the prence of cholinergic crisis or of a
refractory or "innsitive" state could have grave conquences. Osrman and Genkins indicate that the differential diagnosis of the two types of crisis may require the u of Tensilon (edrophonium chloride) as well as clinical judgment. The treatment of the two conditions obviously differs radically.Whereas the prence of myasthenic crisis suggests the need for more intensive anticholinestera therapy, the diagnosis of cholinergic crisis, according to Osrman and Genkins, calls for the prompt withdrawal of all drugs of this type. The immediate u of atropine in cholinergic crisis is also recommended.
Atropine may also be ud to abolish or obtund gastrointestinal side effects or other muscarinic react
ions; but such u, 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 tho by Osrman and Genkins, Grob or Schwab.Usage in Pregnancy
The safety of Mestinon during pregnancy or lactation in humans has not been established. Therefore,u of Mestinon in women who may become pregnant requires weighing the drug's potential benefits against its possible hazards to mother and child.
PRECAUTION
Pyridostigmine is mainly excreted unchanged by the kidney. Therefore, lower dos may be required in patients with renal dia, and treatment should be bad on titration of drug dosage to effect.Pediatric U
Safety and effectiveness in pediatric patients have not been established.
ADVERSE REACTIONS
The side effects of Mestinon are most commonly related to overdosage and generally are of two varieties, muscarinic and nicotinic. Among tho in the former group are naua, vomiting, diarrhea,abdominal cramps, incread peristalsis, incread salivation, incread bronchial cretions, miosis and diaphoresis. Nicotinic side effects are comprid chiefly of muscle cramps, fasciculation and
weakness. Muscarinic side effects can usually be counteracted by atropine, but for reasons shown in the preceding ction the expedient is not without danger. As with any compound containing the bromide radical, a skin rash may be en in an occasional patient. Such reactions usually subside promptly upon discontinuance of the medication.
To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmacueticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or v/medwatch.11234,56,7,86,7
DOSAGE AND ADMINISTRATION
Mestinon is available in three dosage forms:
Syrup
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 dos. It is more easily swallowed, especially in the morning, by patients with bulbar involvement.
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Conventional Tablets
each containing 60 mg pyridostigmine bromide.
Timespan Tablets
each containing 180 mg pyridostigmine bromide. This form provides uniformly slow relea, hence prolonged duration of drug action; it facilitates control of myasthenic symptoms with fewer individual dos daily. The immediate effect of a 180 mg Timespan Tablet is about equal to that of a 60 mg Conventional Tablet; however, its duration of effectiveness, although varying in individual patients, averages 2½ times that of a 60 mg do.
Dosage
The size and frequency of the dosage must be adjusted to the needs of the individual patient.
Syrup and Conventional Tablets
The average do is ten 60 mg tablets or ten 5 mL teaspoonfuls daily, spaced to provide maximum relief when maximum strength is needed. In vere cas as many as 25 tablets or teaspoonfuls a day may be required, while in mild cas one to six tablets or teaspoonfuls a day may suffice.
Timespan Tablets
One to three 180 mg tablets, once or twice daily, will usually be sufficient to control symptoms; however, the needs of certain individuals may vary markedly from this average. The interval between dos should be at least 6 hours. For optimum control, it may be necessary to u the more rapidly acting regular tablets or syrup in conjunction with Timespan therapy.
NOTE: For information on a diagnostic test for myasthenia gravis, and for the evaluation and stabilization of therapy, plea e product literature on Tensilon (edrophonium chloride).
HOW SUPPLIED
Syrup, 60 mg pyridostigmine bromide per teaspoonful (5 mL) and 5% alcohol — bottles of 16 fluid ounces (1 pint) (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) and 500 (NDC 0187-3010-40). Each tablet is engraved "MESTINON 60 V" on one side and is quadrict 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: Becau of the hygroscopic nature of the Timespan Tablets, mottling may occur. This does not affect their efficacy.
Store Mestinon Tablets, Timespan Tablets and Syrup at 25°C (77°F); excursions permitted to 15° -30°C
(59° -86°F). Keep Mestinon Tablets and Timespan Tablets in a dry place with the silica gel enclod.REFERENCES
1.2.3.4.5.6.7.8.Manufactured by:
Valeant Pharmaceuticals International, Inc.
Laval, QC H7L 4A8 Canada
Distributed by:
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA
©Valeant Pharmaceuticals North America LLC
®/™ are trademarks of Valeant Pharmaceuticals
International, Inc. or its affiliates.
9549900 50104061B
Rev. August 2016
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
NDC 0187-3012-20
Rx Only
Syrup
Mestinon
(pyridostigmine
bromide syrup)
5 mL = 60 mg
1 Pint (473 mL)
5 mL
(1 teaspoonful)
contains 60 mg
pyridostigmine
bromide.
Alcohol 5%
VALEANT
Osrman KE, Genkins G. Studies in myasthenia gravis: Reduction in mortality rate after crisis.JAMA. Jan 1963; 183:97-101.
Osrman 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 anticholinestera. In: Ruegheimer E,Zindler M, ed. Anaesthesiology . (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.
®
Pharmaceuticals North America LLC
PRINCIPAL DISPLAY PANEL - 60 mg Tablets Bottle Label NDC 0187-3010-30
Rx Only
Pull here
®
Mestinon
(pyridostigmine bromide
新年游戏tablets, USP)
60 mg
Each tablet
contains 60 mg
pyridostigmine
bromide
100
Tablets
Valeant
VALEANT
Pharmaceuticals North America LLC
