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Pyridostigmine Pregnancy and Breastfeeding Warnings

Pyridostigmine is also known as: Mestinon, Mestinon Timespan, Regonol

Medically reviewed by Drugs.com. Last updated on Nov 19, 2018.

Pyridostigmine Pregnancy Warnings

When this drug was administered to pregnant patients with myasthenia gravis no untoward effects on the fetus were reported.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

Benefit should outweigh risk.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned.

Risk Summary:

Comments:
-This drug crosses the placenta barrier.
-Excessive doses of this drug should be avoided during pregnancy and the newborn should be monitored for possible effects.
-IV administration of this drug can induce contraction of the uterus (especially in the last period of pregnancy).
-Because the severity of myasthenia gravis often fluctuates considerably, care is required to avoid cholinergic crisis, due to overdosage, but otherwise management is no different from that in nonpregnant patients.

See references

Pyridostigmine Breastfeeding Warnings

Safety has not been established.

Excreted into human milk: Yes (in negligible amounts)

Comments:
-The effects in the nursing infant are unknown.

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

See references

References for pregnancy information

  1. "Product Information. Regonol (pyridostigmine)." Organon, West Orange, NJ.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Mestinon (pyridostigmine)." ICN Pharmaceuticals Inc, Cost Mesa, CA.

References for breastfeeding information

  1. "Product Information. Mestinon (pyridostigmine)." ICN Pharmaceuticals Inc, Cost Mesa, CA.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Regonol (pyridostigmine)." Organon, West Orange, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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