AVRO-C Drops

Ascorbic acid injection is 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 Ascorbic acid injection is not indicated for the treatment of vitamin C deficiency that is not associated with signs and symptoms of scurvy. Ascorbic acid injection 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. …

• Supplied in a Pharmacy Bulk Package (PBP)
• Dispense single doses to multiple patients in a pharmacy admixture program; use within 4 hours of puncture. • Must be diluted prior to use • Administer as a slow intravenous infusion • See Full Prescribing Information for important administration instructions • Maximum recommended duration is one week Population 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 Pregnant women, lactating women, patients with glucose-6-phosphate dehydrogenase deficiency Should not exceed the U.S
• Recommended Dietary Allowance (RDA) Important Preparation and Administration Instructions • Ascorbic acid injection 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 ascorbic acid injection as an undiluted intravenous injection. • Minimize exposure to light because ascorbic acid injection is light sensitive. • Ascorbic acid injection 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: a. Use only in a suitable ISO Class 5 work area such as a laminar flow hood (or an equivalent clean air compounding area). …

Injection: 25,000 mg per 50 mL (500 mg per mL) supplied as a Pharmacy Bulk Package (colorless to pale yellow solution) Injection: 25,000 mg per 50 mL (500 mg per mL) - Pharmacy Bulk Package

• Ascorbic acid injection 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 ]. …

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) ] .

• Inform patients that treatment with ascorbic acid injection may increase their risk of oxalate nephropathy [see Warnings and Precautions ]. • Inform patients that treatment with ascorbic acid injection may impact laboratory results, including blood and urine glucose tests, up to 24 hours after infusion [see Warnings and Precautions ]. • Inform patients with glucose-6-phosphate dehydrogenase deficiency that treatment with ascorbic acid injection may increase their risk of hemolysis [see Warnings and Precautions ]
• Manufactured by: Lake Zurich, IL 60047 www.fresenius-kabi.com/us 451857 Fresenius Kabi Logo

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• 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 and affect excretion and plasma concentrations of other drugs sensitive to urine pH ( 7.2 ). • Warfarin: Continue standard monitoring ( 7.3 ). 7.1 Antibiotics Ascorbic acid may decrease activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Bleomycin is inactivated in vitro by ascorbic acid. …

• 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 dose is recommended ( 5.2 ). …

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 with glucose-6-phosphate dehydrogenase deficiency [see Warnings and Precautions (5.2) ]. The following adverse reactions associated with the use of ascorbic acid were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure: Administration site reactions: pain and swelling. …

8.1 Pregnancy Risk Summary There are no available data on use of ascorbic acid injection 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]. …

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

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.