ASCOR- ascorbic acid injection

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Nusipirk tai dabar

Parsisiųsti Prekės savybės (SPC)
25-01-2024

Veiklioji medžiaga:

ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)

Prieinama:

McGuff Pharmaceuticals, Inc.

INN (Tarptautinis Pavadinimas):

ASCORBIC ACID

Sudėtis:

ASCORBIC ACID 500 mg in 1 mL

Vartojimo būdas:

INTRAVENOUS

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

ASCOR is vitamin C indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated. Limitations of Use ASCOR is not indicated for treatment of vitamin C deficiency that is not associated with signs and symptoms of scurvy. None. USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Renal Impairment 8.1 Pregnancy Risk Summary There are no available data on use of ASCOR in pregnant women to inform a drug-associated risk of adverse developmental outcomes; however, use of 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 (2.3 )]. 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 to1000 mg/day (2.5 to 5 times the recommended daily intravenous dose, respectively) [ see Dosage and Administration (2.3) ] 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. 8.2 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 (2.3) ]. 8.4 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 (5.1 )]. Ascor is not indicated for use in pediatric patients less than 5 months of age. 8.5 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 (5.1 ) ]. 8.6 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 Warning and Precaution (5.1 ].

Produkto santrauka:

ASCOR for intravenous use is a colorless to pale yellow solution supplied as: Store in a refrigerator at 2° to 8°C (36° to 46°F). Protect from light. This product contains no preservative. See Dosage and Administration (2.1), for detailed instructions on preparation, dilution, and administration of ASCOR. Excursions to ambient conditions for up to 30 days during storage or shipping are acceptable.

Autorizacija statusas:

New Drug Application

Prekės savybės

                                ASCOR- ASCORBIC ACID INJECTION
MCGUFF PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
ASCOR HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ASCOR® SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ASCOR.
ASCOR (ASCORBIC ACID INJECTION), FOR INTRAVENOUS USE INITIAL U.S.
APPROVAL: 1947
INITIAL U.S. APPROVAL: 1947
INDICATIONS AND USAGE
ASCOR is vitamin C indicated for the short term (up to 1 week)
treatment of scurvy in adult and pediatric
patients age 5 months and older for whom oral administration is not
possible, insufficient or
contraindicated. (2)
Limitations of Use (2)
ASCOR is not indicated for treatment of vitamin C deficiency that is
not associated with signs and
symptoms of scurvy. (2)
DOSAGE AND ADMINISTRATION
Supplied in Pharmacy Bulk Package (PBP). Dispense single doses to
multiple patients in a pharmacy
admixture program; use within 4 hours of puncture. (2.1)
Must be diluted prior to use (2.1)
Administer as a slow intravenous infusion (2.1)
See Full Prescribing Information for important administration
instructions (2.1)
Maximum recommended duration is one week (2.2)
POPULATION ​ (2.2)
​RECOMMENDED DOSES
Pediatric patients age 5 months to less than 12 months
50 mg once daily
Pediatric patients age 1 year to less than 11 years
100 mg once daily
Adults and pediatric patients age 11 years and older
200 mg once daily
​SPECIFIC POPULATIONS ​(2.3, 8.1, 8.2)
Pregnant women, lactating women, patients with glucose-6-
phosphate dehydrogenase deficiency
Should not exceed the U.S. Recommended
Dietary Allowance (RDA)
DOSAGE AND ADMINISTRATION
ASCOR vials contain 25, 000 mg of ascorbic acid and the largest
recommended single dose is 200 mg. Do
not give the entire contents of the vial to a single patient.
Do not administer ASCOR as an undiluted intravenous sensitive.
Minimize exposure to light because ASCOR is light sensitive.
ASCOR is supplied as a Pharmacy Bulk Package (PBP) which is intended
for dispensing of single d
                                
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