Provigil/Pregnancy info

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http://www.rxlist.com/cgi/generic2/modafinil_wcp.htm

Patients Using Contraceptives

The effectiveness of steroidal contraceptives may be reduced when

used with PROVIGIL tablets and for one month after discontinuation of

therapy (See DRUG INTERACTIONS Potential Interactions with Drugs That

Inhibit or are Metabolized by Cytochrome P-450 Isoenzymes and Other

Hepatic Enzymes). Alternative or concomitant methods of contraception

are recommended for patients treated with PROVIGIL tablets, and for

one month after discontinuation of PROVIGIL.

Pregnancy

Animal studies to assess the effects of modafinil on reproduction and

the developing fetus were not conducted at adequately high doses or

according to guidelines which would ensure a comprehensive evaluation

of the potential of modafinil to adversely affect fertility, or cause

embryolethality or teratogenicity (see Impairment of Fertility and

Pregnancy, Pregnancy Catagory C below).

Patients should be advised to notify their physician if they become

pregnant or intend to become pregnant during therapy. Patients should

be cautioned regarding the potential increased risk of pregnancy when

using steroidal contraceptives (including depot or implantable

contraceptives) with PROVIGIL tablets and for one month after

discontinuation of therapy.

Impairment of Fertility

Oral administration of modafinil to male and female rats had no

effects on fertility when administered prior to and throughout

mating, and continued in females through day 7 of gestation, at doses

up to 480 mg/kg/day (23 times the recommended human dose of 200

mg/day on a mg/m2 basis).

Pregnancy

Pregnancy Category C: Modafinil administered orally to pregnant rats

throughout the period of organogenesis caused, in the absence of

maternal toxicity, an increase in resorptions and an increased

incidence of hydronephrosis and skeletal variations in the offspring

at a dose of 200 mg/kg/day (10 times the recommended human dose of

200 mg/day on a mg/m2 basis) but not at 100 mg/kg/day. However, in a

subsequent study of up to 480 mg/kg/day (23 times the recommended

human dose on a mg/m2 basis), which included maternally toxic doses,

no adverse effects on embryofetal development were seen.

Modafinil administered orally to pregnant rabbits throughout the

period of organogenesis at doses up to 100 mg/kg/day (10 times the

recommended human dose on a mg/m2 basis) had no effects on

embryofetal development.

However, in a subsequent study in pregnant rabbits, increased

resorptions, and increased alterations in fetuses from a single

litter (open eye lids, fused digits, rotated limbs), were observed at

180 mg/kg/day (17 times the recommended human dose on a mg/m2 basis),

a dose that was also maternally toxic.

Modafinil administered orally to rats throughout gestation and

lactation at doses up to 200 mg/kg/day (5 times the recommended human

dose on a mg/m2 basis), had no effects on the postnatal development

of the offspring.

There are no adequate and well-controlled studies in pregnant women.

Modafinil should be used during pregnancy only if the potential

benefit justifies the potential risk to the fetus.

http://www.rxlist.com/cgi/generic2/modafinil_ad.htm

Ethinyl Estradiol - Administration of modafinil to female volunteers

once daily at 200 mg/day for 7 days followed by 400 mg/day for 21

days resulted in a mean 11% decrease in Cmax and 18% decrease in AUC0-

24 of ethinyl estradiol (EE2; 0.035 mg; administered orally with

norgestimate). There was no apparent change in the elimination rate

of ethinyl estradiol.