Valganciclovir Hydrochloride | Mckesson Corporation Dba Sky Packaging while Breastfeeding

It is a well known fact that breastfeeding is best source of nutrition for infants. Breast milk provides minerals, vitamins and antibodies in most acceptable format when they need it. Nutrition taken by mother passes to breast-milk and same thing applies to medicines taken by mothers. Not all drugs cause problem for baby but some do. Lets analyze if Valganciclovir Hydrochloride | Mckesson Corporation Dba Sky Packaging is safe for baby while breastfed.

Valganciclovir tablets are a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for: Adult Patients (1.1) Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk. Pediatric Patients (1.2) Prevention of CMV disease in kidney and heart transplant patients at high risk. 1.1 Adult Patients Treatment of Cytomegalovirus (CMV) Retinitis: Valganciclovir tablets are indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies (14.1)]. Prevention of CMV Disease: Valganciclovir tablets are indicated for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]) [see Clinical Studies (14.1)]. 1.2 Pediatric Patients Prevention of CMV Disease: Valganciclovir tablets are indicated for the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk [see Clinical Studies (14.2)].

Statement of Manufacturer/Labeler about breastfeeding usage
8.3 Females and Males of Reproductive Potential Pregnancy Testing Females of reproductive potential should undergo pregnancy testing before initiation of valganciclovir hydrochloride [see Use in Specific Populations (8.1)]. Contraception Females Because of the mutagenic and teratogenic potential of valganciclovir hydrochloride, females of reproductive potential should be advised to use effective contraception during treatment and for at least 30 days following treatment with valganciclovir hydrochloride [see Dosage and Administration (2.6), Warnings and Precautions (5.4, 5.5), Nonclinical Toxicology (13.1)]. Males Because of its mutagenic potential, males should be advised to use condoms during and for at least 90 days following, treatment with valganciclovir hydrochloride [see Dosage and Administration (2.6), Warnings and Precautions (5.3 , 5.5) , Nonclinical Toxicology (13.1) ]. Infertility Valganciclovir hydrochloride at the recommended doses may cause temporary or permanent female and male infertility [see Warnings and Precautions (5.3 ) , Nonclinical Toxicology (13.1) ]. Data Human Data In a small, open-label, non-randomized clinical study, adult male renal transplant patients receiving valganciclovir hydrochloride for CMV prophylaxis for up to 200 days post-transplantation were compared to an untreated control group. Patients were followed-up for six months after valganciclovir hydrochloride discontinuation. Among 24 evaluable patients in the valganciclovir hydrochloride group, the mean sperm density at the end of treatment visit decreased by 11 million/mL from baseline; whereas, among 14 evaluable patients in the control group the mean sperm density increased by 33 million/mL. However, at the follow-up visit among 20 evaluable patients in the valganciclovir hydrochloride group the mean sperm density was comparable to that observed among 10 evaluable patients in the untreated control group (the mean sperm density at the end of follow-up visit increased by 41 million/mL from baseline in the valganciclovir hydrochloride group and by 43 million/mL in the untreated group).