Greeting from Ning Shao in Beijing,China. I am a mother of two months baby. Last week I was diagnosed as central retinal vein occlusion(CRVO) by the ophthalmologist and I have to recieve the treatment through OZURDEX (dexamethasone intravitreal implant) one week later. My ophthalmologist said he think it's safe to continune the breastfeeding during my treatment. But it's stated in the OZURDEX product labeling "8.3 Nursing Mothers:It is not known whether ocular administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when corticosteroids are administered to a nursing woman".
These days I am desperately sad and could not sleep day and night. I am not sure whether it's really safe for my baby to continue breastfeeding if I use the medication. Afterall OZURDEX is dexamethasone and it will be sustained-released, lasted for over 3 months as it is stated in the product labeling "12.3 Pharmacokinetics Plasma concentrations were obtained from 21 patients in two 6 month tudies prior to dosing and on Days 7, 30, 60, and 90 following the intravitreal implant containing 0.35 mg or 0.7 mg dexamethasone. In both studies, the majority of plasma dexamethasone concentrations were below the lower limit of uantitation (LLOQ = 50 pg/mL). Plasma dexamethasone concentrations from 10 of 73 samples in the 0.7 mg dose group and from 2 of 42 samples in the 0.35 mg dose group were above the LLOQ, ranging from 52 pg/mL to 94 pg/mL. The highest plasma concentration value of 94 pg/mL was observed in one subject from the 0.7 mg group. Plasma dexamethasone concentration did not appear to be related to age, body weight, or sex of patients.In an in vitro metabolism study, following the incubation of [14C]-dexamethasone with human cornea, iris-ciliary body, choroid,retina, vitreous humor, and sclera tissues for 18 hours, no metabolites were observed."
I woud be much appreciated if you could give me further advise on the safety of OZURDEX used in breastfeeding mother. Look forward to you prompt response.
These days I am desperately sad and could not sleep day and night. I am not sure whether it's really safe for my baby to continue breastfeeding if I use the medication. Afterall OZURDEX is dexamethasone and it will be sustained-released, lasted for over 3 months as it is stated in the product labeling "12.3 Pharmacokinetics Plasma concentrations were obtained from 21 patients in two 6 month tudies prior to dosing and on Days 7, 30, 60, and 90 following the intravitreal implant containing 0.35 mg or 0.7 mg dexamethasone. In both studies, the majority of plasma dexamethasone concentrations were below the lower limit of uantitation (LLOQ = 50 pg/mL). Plasma dexamethasone concentrations from 10 of 73 samples in the 0.7 mg dose group and from 2 of 42 samples in the 0.35 mg dose group were above the LLOQ, ranging from 52 pg/mL to 94 pg/mL. The highest plasma concentration value of 94 pg/mL was observed in one subject from the 0.7 mg group. Plasma dexamethasone concentration did not appear to be related to age, body weight, or sex of patients.In an in vitro metabolism study, following the incubation of [14C]-dexamethasone with human cornea, iris-ciliary body, choroid,retina, vitreous humor, and sclera tissues for 18 hours, no metabolites were observed."
I woud be much appreciated if you could give me further advise on the safety of OZURDEX used in breastfeeding mother. Look forward to you prompt response.
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