Announcement

Collapse
No announcement yet.

pristiq

Collapse
X
 
  • Filter
  • Time
  • Show
Clear All
new posts

  • pristiq

    I suffered from ppd with my second son and was priscribed pristiq 50 mg once daily, i have taken the medication throughout my 3rd pregnancy (healthy full term baby) and am breastfeeding excusively that 3 month old baby... im looking for research associated with using this medication during pregnancy/breastfeeding....

  • #2
    Jem2125,

    Pristiq (desvenlafaxine) is rated an L3-limited data-probably compatible in breastfeeding. The amount passed into breast milk is 5.9-9.3% of your dose. Desvenlafaxine does enter the milk in moderate amounts, however no side-effects have been reported following exposure in lactation. Monitor your infant for s[COLOR=#333333][FONT=lucida grande]edation or irritability, not waking to feed/poor feeding and weight gain.[/FONT][/COLOR]


    [COLOR=#333333][FONT=lucida grande]There is some data on the transmission of desvenlafaxine into human milk following the use of its precursor, venlafaxine.[1,2] In a study of 6 women receiving an average of 244 mg/day venlafaxine, the mean maximum concentration of desvenlafaxine in milk was 796 ng/mL. Desvenlafaxine was detected in the plasma of 4 of the infants ranging from 3 to 38 ng/mL.[1] All the infants were healthy and unaffected. The milk/plasma ratio for venlafaxine and desvenlafaxine were 2.5 and 2.7 respectively. In a group of 13 women who consumed from 37.5 to 300 mg/day (mean=194.3 mg/day) of venlafaxine, levels of desvenlafaxine in milk ranged from 318 to 1912.7 ng/mL with a mean of 919 ng/mL.[2] The relative infant dose for desvenlafaxine using the highest levels reported (Cmax) ranged from 6.8% to 9.3%. The milk levels of desvanlafaxine were measured in a 35 year old breastfeeding mother who had been on 250 mg desvenlafaxine daily for 2 months prior to the initiation of this study.[3] Assuming a milk ingestion of 0.15 L/kg/day, the absolute infant dose was found to be 294 mcg/kg/day [COLOR=#333333][FONT=lucida grande]and the relative infant dose was calculated to be 7.8%. No untoward effects were noted or reported in the breastfed infant. Yet another study by Ilett and Hackett, of the transfer of desvenlafaxine into human milk was done in 10 women who were being treated with 50-150 mg daily dose of desvenlafaxine for postpartum depression.[4] The mean relative infant dose in this study was calculated to be 6.8% (5.5-8.1%), with a mean milk/plasma ratio of 2.24. Interestingly, in this study, it was found that the peak concentrations (Cmax) in milk occurred at 3.28 hours, which did not parallel with the Cmax in maternal plasma which is 7.5 hours. This suggests that milk concentration kinetics do not always co-relate with plasma concentration kinetics.[/FONT][/COLOR]

    1.##Ilett KF, Hackett LP, Dusci LJ, et al. Distribution and excretion of venlafaxine and O-desmethylvenlafaxine in human milk. British Journal of Clinical Pharmacology. 1998;45(5):459-462.
    2.##Newport DJ, Ritchie JC, Knight BT, Glover BA, Zach EB, Stowe ZN. Venlafaxine in human breast milk and nursing infant plasma: determination of exposure. J Clin Psychiatry. Sep 2009;70(9):1304-1310.
    3.##Ilett KF, Watt F, Hackett LP, Kohan R, Teoh S. Assessment of infant dose through milk in a lactating woman taking amisulpride and desvenlafaxine for treatment-resistant depression. Ther Drug Monit. 2010 Dec;32(6):704-7.
    4.##Rampono J, Teoh S, Hackett LP, Kohan R, Ilett KF. Estimation of desvenlafaxine transfer into milk and infant exposure during its use in lactating women withpostnatal depression. Arch Womens Ment Health. 2011 Feb;14(1):49-53.

    In pregnancy Pristiq is rated P3-unknown-risk to the fetus cannot be ruled out.

    From Package Insert

    Carcinogenesis

    Desvenlafaxine succinate administered by oral gavage to mice and rats for 2 years did not increase the incidence of tumors in either study.

    Mice received desvenlafaxine succinate at dosages up to 500/300 mg/kg/day (dosage lowered after 45 weeks of dosing). The 300 mg/kg/day dose is 15 times a human dose of 100 mg/day on a mg/m2 basis.

    Rats received desvenlafaxine succinate at dosages up to 300 mg/kg/day (males) or 500 mg/kg/day (females). The highest dose is 29 (males) or 48 (females) times a human dose of 100 mg/day on a mg/m2 basis.

    Mutagenesis

    Desvenlafaxine was not mutagenic in the in vitro bacterial mutation assay (Ames test) and was not clastogenic in an in vitro chromosome aberration assay in cultured CHO cells, an in vivo mouse micronucleus assay, or an in vivo chromosome aberration assay in rats. Additionally, desvenlafaxine was not genotoxic in the in vitro CHO mammalian cell forward mutation assay and was negative in the in vitro BALB/c-3T3 mouse embryo cell transformation assay.

    Impairment of fertility

    Reduced fertility was observed in a study in which both male and female rats received desvenlafaxine succinate. This effect was noted at oral doses approximately 10 times a human dose of 100 mg/day on a mg/m2 basis. There was no effect on fertility at oral doses approximately 3 times a human dose of 100 mg/day on a mg/m2 basis.

    Teratogenic effects Pregnancy Category C

    When desvenlafaxine succinate was administered orally to pregnant rats and rabbits during the period of organogenesis, there was no evidence of teratogenicity in rats at any doses tested, up to 10 times a human dose of 100 mg/day (on a mg/m2 basis) in rats, and up to 15 times a human dose of 100 mg/day (on a mg/m2 basis) in rabbits. However, fetal weights were decreased in rats, with a no-effect dose 10 times a human dose of 100 mg/day (on a mg/m2 basis).

    When desvenlafaxine succinate was administered orally to pregnant rats throughout gestation and lactation, there was a decrease in pup weights and an increase in pup deaths during the first four days of lactation. The cause of these deaths is not known. The no-effect dose for rat pup mortality was 10 times a human dose of 100 mg/day (on a mg/m2 basis). Post-weaning growth and reproductive performance of the progeny were not affected by maternal treatment with desvenlafaxine at a dose 29 times a human dose of 100 mg/day (on a mg/m2 basis).

    There are no adequate and well-controlled studies of PRISTIQ in pregnant women. Therefore, PRISTIQ should be used during pregnancy only if the potential benefits justify the potential risks.


    I hope this helps.

    Sandra Lovato R.N.
    InfantRisk Center
    806-352-2519
    Last edited by Sandra; 11-17-2015, 04:14 PM.

    Comment

    Working...
    X
    Muğla Escort Aydın Escort Çanakkale Escort Balıkesir Escort