Ascorbic acid

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Ascorbic Acid is used in the treatment of:

• Common Cold
• Methemoglobinemia
• Scurvy
• Tyrosinemias
• Wounds, Penetrating

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

When oral administration is not feasible or when malabsorption is suspected

IM preferred to IV

IV Compatibility

Compatible w/ most common diluents (dextrose solns, NS, LR, Ringer's, ½NS, dextrose-saline, dextrose-LR etc)

IV Preparation

Dilute with large volume of compatible fluid to minimize adverse reactions

IV ascorbic acid (Ascor) is supplied as a pharmacy bulk package (PBP)

Intended for dispensing of single doses to multiple patients in a pharmacy admixture program and is restricted to the preparation of admixtures for infusion

Use only in a suitable ISO Class 5 work area such as a laminar flow hood (or an equivalent clean air compounding area)

Open vials are to be used within 4 hr

Prior to administration, the final diluted solution for infusion must be isotonic (undiluted the osmolarity is ~5,900 mOsmol/L)

Calculate the osmolarity of the intended admixture for infusion

Add daily dose directly to an appropriate volume of a suitable infusion solution (eg, 5% Dextrose Injection)

Do not mix with solutions containing elemental compounds that cause reduction (eg, copper)

Final concentration of ascorbic acid admixture solution for infusion: 1-25 mg/mL

Visually inspect for particulate matter and discoloration prior to administration; solution should appear colorless to pale yellow

Immediately use as a slow IV infusion

IV Administration

Avoid rapid infusion

Infusion rate of diluted Ascor solution

• 5 months-12 months: 1.3 mg/minute
• 1-11 years: 3.3 mg/minute
• >11 years: 33 mg/minute

Oral Administration

Take with or without meals

Storage

Unopened IV vials: Store in refrigerator at 2-8°C (36-46°F); protect from light; contains no preservatives

Opened IV vials: Use within 4 hr of vial entry; discard remaining portion

Tablets: Store at room temperature at 15-30°C (59-86°F)

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

The recommended dietary allowance of vitamin C (ascorbic acid) increases with age. Follow your healthcare provider's instructions. You may also consult the Office of Dietary Supplements of the National Institutes of Health, or the U.S. Department of Agriculture (USDA) Nutrient Database (formerly "Recommended Daily Allowances") listings for more information.

Drink plenty of liquids while you are taking ascorbic acid.

The chewable tablet must be chewed before you swallow it.

Ascorbic acid gum may be chewed as long as desired and then thrown away.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Measure liquid medicine with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Keep the orally disintegrating tablet in the package until you are ready to take it. Use dry hands to remove the tablet and place it in your mouth. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. Swallow several times as the tablet dissolves.

Store ascorbic acid at room temperature away from moisture and heat.

Do not stop using ascorbic acid suddenly after long-term use at high doses, or you could have "conditional" vitamin C deficiency. Symptoms include bleeding gums, feeling very tired, and red or blue pinpoint spots around your hair follicles. Follow your doctor's instructions about tapering your dose. Conditional vitamin C deficiency can be difficult to correct without medical supervision.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using ascorbic acid and call your doctor at once if you have:

• joint pain, weakness or tired feeling, weight loss, stomach pain;

• chills, fever, increased urge to urinate, painful or difficult urination; or

• severe pain in your side or lower back, blood in your urine.

Common side effects may include:

• heartburn, upset stomach; or

• nausea, diarrhea, stomach cramps.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Storage

Oral

Cool dry place.d

Parenteral

Store in carton until time of use at room temperature (≤25°C).b Protect from light. b

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

• An essential water-soluble vitamin present in fresh fruits and vegetables.a Vitamin C refers to both ascorbic acid and dehydroascorbic acid (DHA); both compounds exhibit antiscorbutic activity.109

• An antioxidant and a cofactor in enzymatic and metabolic processes.109

• Required for collagen formation and tissue repair.b

• Acerola C 500 [OTC]
• Asco-Tabs-1000 [OTC]
• Ascocid [OTC]
• Ascocid-ISO-pH [OTC]
• BProtected Vitamin C [OTC]
• C-500 [OTC]
• C-Time [OTC]
• Cemill SR [OTC]
• Cemill [OTC]
• Chew-C [OTC]
• Fruit C 500 [OTC]
• Fruit C [OTC]
• Fruity C [OTC]
• Mega-C/A Plus
• Ortho-CS 250
• Vita-C [OTC]
• VitaChew Vit C Citrus Burst [OTC]

• Vitamin, Water Soluble

Ascorbic acid is an essential water soluble vitamin that acts as a cofactor and antioxidant. Ascorbic acid is an electron donor used for collagen hydroxylation, carnitine biosynthesis, and hormone/amino acid biosynthesis. It is required for connective tissue synthesis as well as iron absorption and storage (IOM, 2000).

Absorption

Oral: Readily absorbed in the intestine; an active process thought to be saturable and dose dependent (30 to 180 mg/day: 70% to 90%; >1,000 mg/day: ≤50%) (IOM, 2000)

Distribution

Pituitary and adrenal glands, leukocytes, eye tissues and humors, and brain; lower concentrations in the plasma and saliva (IOM, 2000)

Metabolism

Reversibly oxidized to dehydroascorbic acid (DHA); both ascorbic acid and DHA are active. Unabsorbed ascorbic acid is degraded in the intestine (IOM, 2000)

Excretion

Urine (with high serum concentrations) (IOM, 2000); there is an individual specific renal threshold for ascorbic acid; when blood levels are high, ascorbic acid is excreted in urine, whereas when the levels are subthreshold (doses up to 80 mg/day) very little if any ascorbic acid is excreted into urine

Reversal of scurvy symptoms: 2 days to 3 weeks

Half-Life Elimination

10 hours (Schwedhelm 2003). Biological half-life: 8 to 40 days (IOM, 2000)

Protein Binding

25%

There are no dosage adjustments provided in the manufacturer's labeling. Based on the pharmacokinetics of ascorbic acid, a water-soluble vitamin, a dosage adjustment does not seem necessary.

1% to 10%: Endocrine & metabolic: Hyperoxaluria (with large doses)

<1% (Limited to important or life-threatening): Dizziness, fatigue, flank pain, headache