Pyridostigmine extended-release

FDA label, Bausch Health US, LLC, oral, effective 2020-12-02. Full label on DailyMed

Other products: Pyridostigmine

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Preparation and administration

DOSAGE AND ADMINISTRATION: MESTINON is available in three dosage forms: 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 and Conventional tablets - The average dose is ten 60 mg tablets or ten 5 mL teaspoonfuls daily, spaced to provide maximum relief when maximum strength is needed. In severe cases as many as 25 tablets or teaspoonfuls a day may be required, while in mild cases 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 doses should be at least 6 hours. For optimum control, it may be necessary to use the more rapidly acting regular tablets or oral solution in conjunction with TIMESPAN therapy.

Drug interactions

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  • Pyridostigmine extended-release

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.

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for pyridostigmine extended-release. Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

Usage in Pregnancy : The safety of MESTINON during pregnancy or lactation in humans has not been established. Therefore, use of MESTINON in women who may become pregnant requires weighing the drug’s potential benefits against its possible hazards to mother and child.

Breastfeeding (LactMed)

Because of the low levels of pyridostigmine in breastmilk, amounts ingested by the infant are small and infant serum levels are very low. Pyridostigmine is not expected to cause any adverse effects in breastfed infants. Most mothers with myasthenia gravis are able to nurse successfully with pyridostigmine treatment, but occasionally breastfeeding must be discontinued to avoid excessive fatigue in the mother.

Alternatives LactMed suggests considering:
Source: LactMed: Pyridostigmine (NICHD, public domain)Revised Dec 19, 2022

Supply and cost

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