Ascorbic acid

Short-term, up to 1 week, scurvy treatment in adults and children ≥ 5 months when oral administration is impossible, insufficient or contraindicated. ASCOR is not indicated for vitamin C deficiency without scurvy signs/symptoms. FDA NDA 209112 currently lists it Prescription.

Vitamin C supports collagen synthesis and other physiological functions. Oral supplements can help supply nutritional intake, but FDA does not preapprove dietary supplements for safety/effectiveness. This reference supplies nutrient targets and approved ASCOR directions; it does not assert an approved infusion indication for immune enhancement, cancer or sepsis or a universal oral scurvy protocol.

Slow diluted IV once daily. Ordinary age-specific directions are shown; restricted populations below require lower RDA/AI limits.

Recommended maximum course is 7 days. If symptoms persist after a week, the label permits retreatment until resolution; repeat dosing is not recommended below 11 years. In pregnancy, breastfeeding or G6PD deficiency, do not exceed the age/condition-specific U.S. RDA or AI, even when the ordinary table shows a larger dose. The label supplies no fixed renal adjustment; renal/stone risk requires assessment.

Never administer undiluted or treat the entire vial as a patient dose. Dilute to 1–25 mg/mL using a suitable infusion solution such as D 5 W or sterile water, ensuring the final solution is isotonic; water alone does not guarantee tonicity. Avoid mixing with reducible elemental compounds such as copper. Inspect for particles/discoloration and minimize light exposure. Pharmacy bulk package: sterile transfer in an ISO 5 environment, single closure penetration, complete dispensing within 4 hours after entry; administer each prepared dose immediately and discard unused vial contents.

Daily RDA/AI in mg: 0–6 months 40 AI; 7–12 months 50 AI; ages 1–3:15,4–8:25,9–13:45. Ages 14–18: male 75, female 65, pregnancy 80, lactation 115. Adults≥ 19: male 90, female 75, pregnancy 85, lactation 120. Smokers need 35 mg extra daily. Healthy-population upper limits: ages 1–3:400,4–8:650,9–13:1,200,14–18:1,800, adults:2,000 mg/day. Infant UL is unestablished. These totals concern nutrition, not permission to exceed ASCOR’s restrictions.

The current ASCOR PI lists no formal contraindications. Its indication limitations, G6PD dose restrictions and renal/oxalate precautions still require clinical screening; “none” does not mean risk-free. Supplement ingredient restrictions are product-specific.

Current ASCOR has no boxed warning. Kidney injury, G6PD-associated hemolysis and laboratory interference remain significant warnings. Dietary supplements do not inherit an FDA-approved drug warning status.

ASCOR can cause infusion-site pain/swelling; rapid administration produces transient systemic symptoms. Overdose may cause nausea, vomiting, diarrhea, flushing, headache, fatigue or rash; stop administration and obtain medical assessment. Excess oral vitamin C commonly causes GI upset; high intake can aggravate iron overload in hereditary hemochromatosis. Serious hemolysis/oxalate injury are discussed above, with no invented incidence estimate.

ASCOR may reduce activity of erythromycin, kanamycin, streptomycin, doxycycline or lincomycin; bleomycin inactivation is reported in vitro. Monitor suspected diminished effectiveness and consider discontinuation with the treating team. Urine acidification can reduce amphetamine/fluphenazine concentrations and efficacy. Warfarin reports are limited and inconsistent; continue standard INR monitoring rather than invent a universal dose change. Redox laboratory interference needs method-specific review and, if feasible,24-hour testing delay.

ASCOR-specific human pregnancy and milk data are limited; oral supplementation findings cannot establish high-dose IV safety. Do not exceed age/condition-specific RDA/AI in pregnancy or breastfeeding. Review maternal need, infant exposure and alternative oral provision.

Indicated from 5 months; below 5 months is unestablished. Children< 2 have higher oxalate-nephropathy risk and repeat dosing is not recommended below 11. Older adults may have reduced kidney function and need renal monitoring; no automatic age-only dose formula is supplied.

Renal impairment, dialysis, diabetic nephropathy, transplantation or stone history heighten oxalate-nephropathy risk; assess and monitor rather than infer a fixed eGFR reduction. The PI gives no hepatic dose algorithm. G6PD deficiency requires at most RDA/AI and CBC/hemoglobin monitoring.

Vitamin C participates in collagen synthesis; ASCOR’s exact scurvy-treatment mechanism is not fully defined beyond restoration of body stores. Absorption from oral intake is dose-dependent and differs from IV delivery. The ASCOR PK study used 1,000 mg IV over 30 minutes—five times the ordinary maximum daily labeled dose—not an approved regimen. Renal elimination varies with concentration; metabolism includes oxalate. No universal half-life or oral-to-IV conversion is inferred from that study.

Confirm clinical scurvy and whether oral treatment is feasible. Review renal function, stone history, G6PD status and other vitamin C intake. Monitor kidney function; in G6PD deficiency monitor CBC/hemoglobin and hemolysis symptoms. Assess response at the end of the short course before any eligible repeat. Flag susceptible lab tests, infusion rate and site tolerance.

Explain that supplements and prescription IV treatment serve different purposes. Avoid extra unreviewed high-dose vitamin C. Report dark urine, reduced urination, flank pain, jaundice or marked fatigue promptly and tell testing staff about recent infusion. Pregnancy/breastfeeding/G6PD status affects the dose ceiling; only professionals prepare and administer ASCOR.

McGuff ASCOR injection:500 mg/mL,50 mL pharmacy bulk vial containing 25,000 mg; NDC 67157-101-50. It is an IV drug requiring dilution, not an oral supplement or direct undiluted injection.

FDA-approved selected ASCOR is 500 mg/mL IV solution in a 50 mL pharmacy bulk package, current NDA 209112 Prescription. Oral dietary supplements have varied forms/strengths and product-specific serving instructions; this review does not verify every supplement brand or establish an FDA-approved oral indication.

Refrigerate unopened ASCOR at 2–8°C, protect from light; label allows ambient-temperature excursions up to 30 days. This unopened excursion allowance does not extend the 4-hour pharmacy-bulk dispensing limit after penetration. No preservative; discard unused contents after the permitted window and administer diluted doses promptly. Follow an oral supplement’s own storage label rather than transferring injectable refrigeration directions.