ASCOR Solution for injection (2024)

Βιβλιογραφική αναφορά

Συγγραφείς

McGuff Pharmaceuticals, Inc.

Λέξεις κλειδιά

67157-101

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1. 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. 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 ...

3. Dosage Forms and Strengths

Injection: 25,000 mg/50 mL (500 mg/mL) - Pharmacy Bulk Package.

4. Contraindications

None.

5. Warnings and Precautions

5.1 Oxalate Nephropathy and Nephrolithiasis Acute and chronic oxalate nephropathy have been reported with prolonged administration of high doses of ascorbic acid. Acidification of the urine by ascorbic ...

6. Adverse Reactions

The following adverse reactions are discussed in greater detail in other sections of the labeling: Oxalate nephropathy and Nephrolithiasis [see Warnings and Precautions (5.1)]. Hemolysis in patients ...

7. 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). ...

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 ...

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 ...

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 ...

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 ...

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 ...

10. Overdosage

Overdose with ascorbic acid may cause nausea, vomiting, diarrhea, facial flushing, rash, headache, fatigue or disturbed sleep. If overdose of ASCOR occurs, immediately discontinue administration and treat ...

11. Description

ASCOR (ascorbic acid injection) for intravenous use is a colorless to pale yellow, preservative-free, hypertonic, sterile, non-pyrogenic solution of ascorbic acid. ASCOR must be diluted with an appropriate ...

12.1. Mechanism of Action

The exact mechanism of action of ascorbic acid for the treatment of symptoms and signs of scurvy (a disorder caused by severe deficiency in vitamin C) is unknown; however, administration of ascorbic acid ...

12.3. Pharmacokinetics

In a single pharmacokinetic study, healthy male and female adults (n=8) were given a single intravenous dose of 1000 mg ascorbic acid (5 times the largest recommended single dose) infused over a 30 minute ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and fertility studies have not been performed with ASCOR.

16.1. How Supplied

ASCOR for intravenous use is a colorless to pale yellow solution supplied as: NDC 67157-101-50 One 25,000 mg/50 mL (500 mg/mL) Pharmacy Bulk Package vial NDC 67157-101-51 Tray pack of twenty five 25,000 ...

16.2. Storage and Handling

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 ...

17. Patient Counseling Information

Inform patients that treatment with ASCOR may increase their risk of oxalate nephropathy [see Warnings and Precautions (5.1)]. Inform patients that treatment with ASCOR may impact laboratory results, ...