Mexiletine use in specific populations
| Mexiletine |
|---|
| MEXILETINE HYDROCHLORIDE® FDA Package Insert |
| Indications and Usage |
| Dosage and Administration |
| Contraindications |
| Warnings and Precautions |
| Adverse Reactions |
| Drug Interactions |
| Use in Specific Populations |
| Overdosage |
| Description |
| Clinical Pharmacology |
| How Supplied/Storage and Handling |
| Labels and Packages |
| Clinical Trials on Mexiletine |
| ClinicalTrials.gov |
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Use in Specific Populations
Pregnancy
Teratogenic Effects
Pregnancy category C
Reproduction studies performed with mexiletine in rats, mice and rabbits at doses up to four times the maximum human oral dose (24 mg/kg in a 50 kg patient) revealed no evidence of teratogenicity or impaired fertility but did show an increase in fetal resorption. There are no adequate and well-controlled studies in pregnant women; this drug should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers
Mexiletine appears in human milk in concentrations similar to those observed in plasma. Therefore, if the use of mexiletine hydrochloride is deemed essential, an alternative method of infant feeding should be considered.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.[1]
References
- ↑ "MEXILETINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]". Retrieved 3 March 2014.