USE IN SPECIFIC POPULATIONS
Pregnancy
Risk Summary
There are no available data on the use of ASCOR® in pregnant
women to inform a drug-associated risk of adverse
developmental outcomes; however, ascorbic acid
(vitamin C) has been used during pregnancy for several
decades and no adverse developmental outcomes are
reported in the published literature [see Data]. There are dose adjustments for ascorbic acid (vitamin C) use during
pregnancy [see Clinical Considerations].
Animal reproduction studies have not been conducted with
ASCOR®.
The estimated background risk of major birth defects and
miscarriage for the indicated population is unknown. All
pregnancies have a background risk of birth defect, loss,
or other adverse outcomes. In the U.S. general population,
the estimated background risk of major birth defects and
miscarriage in clinically recognized pregnancies is 2-4% and
15-20%, respectively.
Clinical Considerations
Dose Adjustments During Pregnancy and Post-Partum Period
Follow the U.S. Recommended Dietary Allowances
(RDA) for pregnant women when considering use
of ASCOR® for treatment of scurvy [see Dosage and Administration].
Data
Human Data
There are no available data on use of ASCOR® or another
ascorbic acid injection in pregnant women. However, a
published meta–analysis of randomized studies evaluating
a large number of pregnant women who took oral ascorbic
acid (vitamin C) (through diet and supplementation) at
doses ranging from 500 to 1000 mg/day (2.5 to 5 times
the recommended daily intravenous dose, respectively)
[see Dosage and Administration] between the 9th and 16th weeks of pregnancy showed no increased risk
of adverse pregnancy outcomes such as miscarriage,
preterm premature rupture of membranes, preterm delivery
or pregnancy induced hypertension when compared to
placebo. These data cannot definitely establish or
exclude the absence of a risk with ascorbic acid (vitamin
C) during pregnancy.
Lactation
Risk Summary
There are no data on the presence of ascorbic acid (vitamin
C) in human milk following intravenous dosing in lactating
women. Ascorbic acid (vitamin C) is present in human
milk after maternal oral intake. Maternal oral intake of
ascorbic acid (vitamin C) exceeding the U.S. Recommended
Dietary Allowances (RDA) for lactation does not influence
the ascorbic acid (vitamin C) content in breast milk or the
estimated daily amount received by breastfed infants. There
are no data on the effect of ascorbic acid (vitamin C) on
milk production or the breastfed infant. The developmental
and health benefits of breastfeeding should be considered
along with the mother’s clinical need for ASCOR® and any
potential adverse effects on the breastfed child from ASCOR
or from the underlying maternal condition. Follow the U.S.
Recommended Dietary Allowances (RDA) for lactating
women when considering use of ASCOR® for treatment of
scurvy [see Dosage and Administration].
Pediatric Use
ASCOR® is indicated for the short term (up to 1 week)
treatment of scurvy in pediatric patients age 5 months
and older for whom oral administration is not possible,
insufficient or contraindicated. The safety profile of
ascorbic acid in pediatric patients is similar to adults;
however, pediatric patients less than 2 years of age may be
at higher risk of oxalate nephropathy following ascorbic
acid administration due to age-related decreased glomerular
filtration [see Warnings and Precautions].
ASCOR® is not indicated for use in pediatric patients less
than 5 months of age.
Geriatric Use
Glomerular filtration rate is known to decrease with age and
as such may increase risk for oxalate nephropathy following
ascorbic acid administration in elderly population [see Warnings and Precautions].
Renal Impairment
ASCOR® should be used with caution in scorbutic patients
with a history of or risk of developing renal oxalate stones or
evidence of renal impairment or other issues (e.g., patients
on dialysis, patients with diabetic nephropathy, and renal
transplant recipients). These patients may be at increased
risk of developing acute or chronic oxalate nephropathy
following high dose ascorbic acid administration [see Warnings and Precautions].
