Rx Item-Ascor 25MUMG 50 ML Inj -KEEP REFRIG- by Mcguff Pharma USA , Clinical Information:
Generic Code And Description: 77810 Ascorbic Acid Intravenous Vial 500 Mg/Ml
Strength: 500 Mg/Ml
Dose Form: Vial (Ml)
Product Category: : Rx Pharmaceuticals
Fine Line Class: 850085008510 All Rx Products
DEA Class: None Omp Family:
Drug Class: 88120000 Vitamin C
Active Ingredients: 1010 Ascorbic Acid 50817
Inactive Ingredients: 3785 Edetic Acid 60004
743 Sodium Bicarbonate 144558 Drug Class: Drug Class: 88120000 Vitamins N C, OMP Family: , Temparature Zone: 30 Refrige./DoNot Freez, Unit Dose Indicator: NO, Item Size: 50ML, Brand Label Flag: GENERICBRAND , Storage Temperature Zone: 30 Refrige./DoNot Freez, Item Size Code:50ML, Item Strength Code:25MUMG , Item Abbreviation: Ascor , Generic Form: Vial
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 doses to multiple patients in a pharmacy admixture program and is restricted to the preparation of admixtures for infusion: (3.1)
a. Use only in a suitable ISO Class 5 work area such as a laminar flow hood (or an equivalent clean air compounding area) (3.1)
b. Penetrate each PBP vial closure only one time with a suitable sterile transfer device or dispensing set that allows measured dispensing of the contents. Given that pressure may develop within the vial during storage, excercise caution when withdrawing contents from the vial. (3.1)
c. Once the closure system has been penetrated, complete all dispensing from the PBP vial within 4 hours. Each dose must be used immediately. Discard unused portion. (3.1)
d. Prior to administration, ASCOR must be diluted in a suitable infusion solution and the final solution for infusion must be isotonic (undiluted the osmolarity of ASCOR is approximately 5,900 mOsmol/L). Prior to preparing the admixture for infusion, calculate the osmolarity of the intended admixture for infusion. Add one daily dose of ASCOR directly to an appropriate volume of a suitable infusion solution (e.g., 5% Dextrose Injection, Sterile Water for Injection) and add appropriate solutes, as necessary, to make final solution isotonic. Sterile Water for Injection is highly hypotonic; adjust solute content, as necessary, to make thet final infusion solution isotonic prior to injection. Do not mix ASCOR with solutions containing elemental compounds that can be reduced (e.g., copper). The concentration of ascorbic acid in the final, admixture solution for infusion is to be the range of 1 to 25 mg of ascorbic acid per mL. For example, for the largest recommended dose: (3.1)
Add 200 mg of ascorbic acid (equivalent to 0.4 mL of ASCOR) to 7.5 mL of Sterile Water for Injection to produce an infusion solution having an approximate osmolarity of 290 mOsmol/L. In this specific example, addition of solute is NOT necessary because the solution is isotonic. (3.1)
e. Prepare the recommended dose based on the patient population [ see Dosage and Administration (2.2), (2.3)]. (3.1)
f. Visually inspect for particulate matter and discoloration prior to administration (the diluted ASCOR solution should appear colorless to pale yellow). (3.1)
g. Immediately administer the admixture for infusion as a slow intravenous infusion [ see Recommended Dosage, (2.2)] (3.1)
DOSAGE FORMS AND STRENGTHS
Injection: 25,000 mg /50 mL (500 mg/mL) supplied as a Pharmacy Bulk Package (clear, colorless to pale yellow solution)
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Oxalate nephropathy and Nephrolithiasis: Ascorbic acid has been associated with development of acute or chronic oxalate nephropathy following prolonged use of high doses of ascorbic acid infusion. Patients with renal disease including renal impairment, history of oxalate kidney stones, geriatric patients, and pediatric patients less than 2 years old may be at increased risk (5.1).
Hemolysis: Patients with glucose-6-phosphate dehydrogenase deficiency are at risk of severe hemolysis; a reduced is recommended (5.2).
Laboratory Test Interference: Ascorbic acid may interfere with laboratory tests based on oxidation-reduction reactions, including blood and urine glucose testing (5.3).
ADVERSE REACTIONS
Most common adverse reactions are pain and swelling at the site of infusion (6)
To report SUSPECTED ADVERSE REACTIONS, contact McGuff Pharmaceuticals, Inc., toll free at 1-800-603-4795 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Antibiotics: Ascorbic acid may decrease the activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Bleomycin is inactivated in vitro by ascorbic acid (7.1).
Amphetamine and Other Drugs Affected by Urine Acidification: Ascorbic acid may cause acidification of the urine and result in decreased amphetamine serum levels affect excretion and plasma concentrations of other drugs sensitive to urine pH (7.2).
Warfarin: Continue standard monitoring (7.3)
See 17 for PATIENT COUNSELING INFORMATION
DRUG INTERACTIONS
7.1 Antibiotics (8.1)
Ascorbic acid may decrease activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Bleomycin is inactivated in vitro by ascorbic acid. If the antibiotic efficacy is suspected to be decreased by concomitant administration of ASCOR, discontinue ASCOR administration. (8.1)
DRUG INTERACTIONS
7.2Amphetamine & Other Drugs Affected by Urine Acidification (8.2)
Ascorbic acid may acidify the urine and lower serum concentrations of amphetamine by increasing renal excretion (as reflected by changes in amphetamine urine recovery rates). In case of decreased amphetamine efficacy discontinue ASCOR administration. Standard monitoring of therapy is warranted. (8.2)
In addition, acidification of urine by ascorbic acid will alter the excretion of certain drugs affected by the pH of the urine (e.g., fluphenazine) when administered concurrently. It has been reported that concurrent administration of ascorbic acid and fluphenazine has resulted in decreased fluphenazine plasma concentrations. Standard monitoring of therapy is warranted. (8.2)
DRUG INTERACTIONS
7.3 Warfarin (8.3)
Limited case reports have suggested interference of ascorbic acid with the anticoagulation effects of warfarin, however, patients on warfarin therapy treated with ascorbic acid doses up to 1000 mg/day (5 times the largest recommended single dose) for 2 weeks (twice the maximum recommended duration), no effect was observed. Standard monitoring for anti-coagulation therapy should continue during ascorbic acid treatment, as per standard of care. (8.3)
DRUG INTERACTIONS
7.4 Laboratory Test Interference (8.4)
Because ascorbic acid is a strong reducing agent, it can interfere with numerous laboratory tests based on oxidation-reduction reactions (e.g., glucose, nitrite and bilirubin levels, leukocyte count, etc.). Chemical detecting methods based on colorimetric reactions are generally those tests affected. Ascorbic acid may lead to inaccurate results (false negatives) obtained for checking blood or urinary glucose levels, nitrite, bilirubin, and leukocytes if tested during or within 24 hours after infusion [see Warnings and Precautions (5.3)] . (8.4)
USE IN SPECIFIC POPULATIONS
USE IN SPECIFIC POPULATIONS (9)
8.1 Pregnancy (9)
8.2 Lactation (9)
8.4 Pediatric Use (9)
8.5 Geriatric Use (9)
8.6 Renal Impairment (9)
USE IN SPECIFIC POPULATIONS
8.1 Pregnancy (9.1)
Risk Summary (9.1)
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]. (9.1)
Animal reproduction studies have not been conducted with ASCOR. (9.1)
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. (9.1)
Clinical Considerations (9.1)
Dose Adjustments During Pregnancy and Post-Partum Period (9.1)
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)]. (9.1)
Data (9.1)
Human Data (9.1)
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. (9.1)
USE IN SPECIFIC POPULATIONS
8.2 Lactation (9.2)
Risk Summary (9.2)
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)]. (9.2)
USE IN SPECIFIC POPULATIONS
8.4 Pediatric Use (9.3)
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)]. (9.3)
(9.3)
Ascor is not indicated for use in pediatric patients less than 5 months of age. (9.3)
USE IN SPECIFIC POPULATIONS
8.5 Geriatric Use (9.4)
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) ]. (9.4)
USE IN SPECIFIC POPULATIONS
8.6 Renal Impairment (9.5)
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]. (9.5)
See 17 for FDA-approved patient labeling.
Revised: 7/2022
