Ascorbic Acid 500mg/5ml Fresenius Injection

ASCORBIC ACID FRESENIUS is administered by injection in severe deficiency states and where persistent vomiting, diarrhoea or other conditions prevent adequate utilisation by mouth.

Posology
Doses of up to 1 g daily in divided doses have been recommended.
Prophylactic: 25 to 75 mg daily
Therapeutic: 200 to 600 mg daily
Children up to 5 years: 50 mg daily.
Method of administration
ASCORBIC ACID FRESENIUS may be administered, as sodium ascorbate, by the intramuscular route, and by the intravenous or subcutaneous routes.

• Hypersensitivity to ascorbic acid or to any of the excipients listed in section 6.1.
• Hyperoxaluria and the formation of renal calcium oxalate calculi.

ASCORBIC ACID FRESENIUS should be given with care to patients with underlying renal failure due to the risk of formation of renal oxalate calculi. Tolerance may be induced in patients taking high doses. Large doses of ASCORBIC ACID FRESENIUS may result in haemolysis in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Very high doses of ASCORBIC ACID FRESENIUS may interfere with tests for sugar in the urine. Monitoring of cardiac function has also been recommended for patients receiving combined treatment with high doses of ASCORBIC ACID FRESENIUS and desferrioxamine. ASCORBIC ACID FRESENIUS contains 66 mg sodium per 5 ml, equivalent to 3,3 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Medicines which induce tissue desaturation of ascorbic acid include aspirin, nicotine from cigarettes, alcohol, several appetite suppressants, iron, phenytoin, some anticonvulsant medicines, the oestrogen component of oral contraceptives and tetracycline. Large doses of ASCORBIC ACID FRESENIUS may cause the urine to become acidic causing unexpected renal tubular reabsorption of acidic medicines, thus producing an exaggerated response. Conversely basic medicines may exhibit decreased reabsorption resulting in a decreased therapeutic effect. Large doses may reduce the response to oral anticoagulants. There is evidence that the overall effect of a large supplement of ASCORBIC ACID FRESENIUS is to convert a low-oestrogen oral contraceptive into a high-dose oral contraceptive. It has been reported that concurrent administration of ascorbic acid and fluphenazine has resulted in decreased fluphenazine plasma concentrations. Increased dosages of fluphenazine are necessary while under ASCORBIC ACID FRESENIUS treatment. ASCORBIC ACID FRESENIUS is a strong reducing agent and interferes with numerous laboratory tests based on oxidation-reduction reactions. Specialised references should be consulted for specific information on laboratory test interferences caused by ascorbic acid. ASCORBIC ACID FRESENIUS may increase the absorption of iron in iron-deficiency states. ASCORBIC ACID FRESENIUS given in addition to desferrioxamine in patients with iron overload to achieve better iron excretion may worsen iron toxicity, particularly to the heart, early on in the treatment when there is excessive tissue iron. Therefore, it is recommended that in patients with normal cardiac function ascorbic acid should not be given for the first month after starting desferrioxamine. ASCORBIC ACID FRESENIUS should not be given in conjunction with desferrioxamine in patients with cardiac dysfunction. Aspirin can reduce the absorption of ASCORBIC ACID FRESENIUS by approximately a third and decreases urinary excretion by about half. The clinical importance of this is uncertain. Patients with kidney failure given aluminium antacids and oral citrate can develop a potentially fatal encephalopathy due to marked rise in blood aluminium levels. There is evidence that vitamin C may interact similarly. Oral contraceptives lower serum levels of ascorbic acid.

Pregnancy
Healthy foetal growth and development depends on a steady supply of nutrients from mother to foetus. However, high dosage of ASCORBIC ACID FRESENIUS throughout pregnancy may harm the foetus.
Breastfeeding
ASCORBIC ACID FRESENIUS crosses the placenta and is distributed into the breast milk. High dosage of ASCORBIC ACID FRESENIUS while breastfeeding may be harmful to the baby and should be avoided.

ASCORBIC ACID FRESENIUS is unlikely to affect the patient's ability to drive a vehicle or use machinery.

After the administration of ASCORBIC ACID FRESENIUS, the following side effects may occur:
Blood and lymphatic system disorders
Frequency unknown: Reports of haemolysis in patients with glucose-6-phosphate dehydrogenase deficiency following large doses of ASCORBIC ACID FRESENIUS. High doses of ASCORBIC ACID FRESENIUS may cause certain blood problems.
Gastrointestinal disorders
Frequency unknown: Tolerance may be induced with prolonged use of large doses. Large doses are reported to cause diarrhoea and other gastrointestinal disturbances.
Renal and urinary disorders
Frequency unknown: Renal impairment associated with excessive oxalate excretion has been reported following the administration of large doses of ASCORBIC ACID FRESENIUS.
General disorders and administration site conditions
Frequency unknown: It has been stated that large doses may result in hyperoxaluria and the formation of renal calcium oxalate calculi.

In overdose, side effects can be precipitated and/or be of increased severity (See section 4.8). Treatment is symptomatic and supportive.