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i am a sales representative of pharmaceutical products. i have a query from one of my doctor regarding the profile of tizanidine during pregnancy. kindly advise. thanks

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PREGNANCY

Pregnancy Category C
Reproduction studies performed in rats at a dose of 3 mg/kg, equal to the
maximum recommended human dose on a mg/m2 basis, and in rabbits at 30
mg/kg, 16 times the maximum recommended human dose on a mg/m2 basis,
did not show evidence of teratogenicity. Tizanidine at doses that are equal to
and up to 8 times the maximum recommended human dose on a mg/m2 basis
increased gestation duration in rats. Prenatal and postnatal pup loss was
increased and developmental retardation occurred. Post-implantation loss was
increased in rabbits at doses of 1 mg/kg or greater, equal to or greater than 0.5
times the maximum recommended human dose on a mg/m2 basis. Tizanidine
has not been studied in pregnant women. Tizanidine should be given to
pregnant women only if clearly needed.

LABOR AND DELIVERY
The effect of tizanidine on labor and delivery in humans is unknown.

NURSING MOTHERS
It is not known whether tizanidine is excreted in human milk, although as a lipid
soluble drug, it might be expected to pass into breast milk.
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