Ascorbic acid solution for injection 100 mg/ml Prefilled Syringe Taj Pharma.


Ascorbic acid solution   for injection/infusion

100 mg/ml Prefilled Syringe Taj Pharma.


1 ml of solution contains 100 mg ascorbic acid (Acidum ascorbicum).

Each Prefilled Syringe of 5 ml contains 500 mg ascorbic acid.

Excipients with known effect:

Each Prefilled Syringe of 5 ml contains 500mg sodium sulfite, anhydrous. For the full list of excipients, see section 6.1.


Solution for injection/infusion.

Clear, colourless to pale brownish-yellow solution free from visible particles, with a pH of 5.0-7.0. Osmolality: 1050-1200 mOsmol/kg, hypertonic solution.


4.1 Therapeutic indications

Ascorbic acid Prefilled Syringe100 mg/ml contains solution for injection/infusion is used for treatment of scurvy and for prophylaxis of ascorbic acid deficiency when oral use is not possible or absorption after oral intake is insufficient in all age groups.

4.2 Posology and method of administration


Adults (including elderly patients)

Treatment of scurvy

250 mg once or twice daily from 2 to 21 days (until skeletal changes and haemorrhagic disorders are reversed).

Prophylaxis of  ascorbic  acid  deficiency The usual dose is: from 50 to 200 mg daily.

Duration of treatment should be individualized, based on the therapeutic response and severity of the disease.

Patients (adults, including elderly patients) with renal impairment

In patients with recurrent renal stone  formation,  the  daily  dose  of vitamin C should not exceed 100 mg to 200 mg.

Patients with severe or terminal renal failure (dialysis patients) should  receive  no more  than 50 mg  to 100 mg daily (see section 4.4).

Paediatric population (neonates, infants, children and adolescents under 18 years of age)

Treatment of scurvy

The intramuscular/intravenous daily dose in children is from  100  mg  to  300  mg  in  divided doses, for 7-10 days.

Prophylaxis of ascorbic acid deficiency 25 – 75 mg daily.

Duration of treatment should be individualized, based on the therapeutic response.

Paediatric patients with renal impairment

Patients should be treated with lower individually adapted dose (see section 4.4).

Method of administration

Ascorbic acid Prefilled Syringe contains solution for injection/infusion is administered intramuscularly or  slowly intravenously. Intramuscular administration is recommended.

Preparation and administration of intramuscular injection

Withdraw the required dose of Ascorbic acid Prefilled Syringe100 mg/ml solution for injection/infusion.  Inject slowly high into the gluteal muscle, 5 cm below the iliac crest. Rotate injection sites for subsequent injection

Preparation and administration of intravenous injection

Rapid intravenous injection of the drug can cause temporary dizziness and should be avoided.

Since undiluted solution is hypertonic, it is recommended to dilute Vitamin  C  Sopharma  100  mg/ml solution for injection/infusion before intravenous  injection  in  at  least  an  equal  volume  of  diluent  such as 9 mg/ml (0.9%) sodium chloride solution or 50 mg/ml (5%) glucose solution and to inject slowly intravenously.

Preparation and administration of intravenous infusion

Withdraw the required Ascorbic acid Prefilled Syringe100 mg/ml solution for injection/infusion dose and add to

100 ml 9 mg/ml (0,9%) sodium chloride solution or 50 mg/ml (5%) glucose solution. Give by intravenous infusion over 15 – 30 minutes.

The solution should be administered immediately after mixing.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.


Oxalate urolithiasis.

4.4 Special warnings and precautions for use

Large dose of ascorbic acid elevates urinary oxalate levels and  may  precipitate  the  formation  of  calcium oxalate urinary calculi. Patients with impaired renal function and/or history of renal stones can be more susceptible to this effect (see section 4.2).

In case of glucose-6-phosphate dehydrogenase deficiency, high doses can induce haemolysis (see section 4.9).

Intravenous administration of ascorbic acid can be painful and rarely can cause thrombophlebitis due to chemical irritation. Rapid venous injection of ascorbic acid should be avoided and  care  should be taken to avoid extravasation during the infusion (see section 4.2).

In patients with disorders of the venous  vascular  system,  thrombophlebitis,  on  anticoagulant  therapy and with predisposition to thrombosis, intramuscular administration of the product is recommended.

Ascorbic acid should be administered with  caution  to  patients  with  iron overload  (e.g. hemochromatosis, thalassemia, sickle cell anaemia, sideroblastic anaemia).

High doses of ascorbic acid has been associated with sickle-cell crisis in patients with sickle-cell anaemia.

There are rare reports of scurvy due to tolerance or resistance following cessation after long-term high- dose use, such as in infants born to mothers taking 400 mg/day or  greater throughout  their  pregnancy  (see section 4.6).

The excessive dose of vitamin C may interrupt pregnancy. Excipients

This medicinal product contains sodium sulfite, anhydrous (E221) as an excipient, which may rarely

cause severe hypersensitivity reactions and bronchospasm.

This medicinal product contains less than 1 mmol sodium (23 mg) per dose of 100 mg (1ml),  i.e.  essentially sodium-free.

This medicinal product contains:

1,2 mmol (or 27,56 mg) sodium per dose of 200 mg (2ml);

1,8 mmol (or 41,3 mg) sodium per dose of 300 mg (3ml);

3 mmol (or 68,9 mg) sodium per dose of 500 mg (5 ml).

To be taken into consideration by patients on a controlled sodium diet.

4.5 Interaction with other medicinal products and other forms of interaction


In case of concomitant administration the amount of vitamin C in body  may  decrease  because  of possible reduced absorption of ascorbic acid and increased urinary excretion of it. Salicylates have been found to reduce the absorption of ascorbic acid by about a third.


Increase the oxidation of ascorbic acid.


Ascorbic acid may influence the intensity and duration of action  of  coumarin  anticoagulants  (for example, warfarin, bishydroxycoumarin).

Oral contraceptives

Oral contraceptives lower serum levels of ascorbic acid. When used concomitantly with estrogen containing medicinal products, ascorbic acid may increase estrogen concentration.

Iron-containing products

Ascorbic acid can increase iron absorption in the gastrointestinal tract.


Ascorbic acid may increase the excretion of iron when given concomitantly with desferrioxamine. However, cases of cardiomyopathy and congestive heart failure have occurred  in  patients  on concomitant treatment. It may be that ascorbic acid mobilises iron from spleen and other reticuloendothelial tissues resulting in increased iron deposition in visceral organs.


In concomitant administration with ascorbic acid, the chronotropic effect of isoprenaline decreases.


Alcohol reduces ascorbic acid levels.


Chronic use or high doses of ascorbic acid may interfere with the disulfiram  – alcohol interaction when used concurrently.


The use of large doses of ascorbic acid may accelerate the urinary excretion of mexiletine.

Barbiturates or primidon

May increase urinary excretion of ascorbic acid when administered together with barbiturates or primidone.

Fluphenazine, other phenothiazine derivatives

Concomitant administration of  ascorbic  acid  and  fluphenazine  and  other  phenothiazine  derivatives leads to reduction of phenothiazine derivatives therapeutic effect.

Amphetamines and tricyclic anti-depressants

Ascorbic acid decreased renal tubule reabsorption of amphetamines and tricyclic anti-depressants.

Aluminium containing medicinal products

Ascorbic acid may enhance the absorption of aluminium and potentiate undesirable effects.

Influence of ascorbic acid in laboratory parameters

Because ascorbic acid is a strong reducing agent, it interferes with numerous laboratory tests based on oxidation-reduction reactions. The degree of interference with laboratory tests  depends  on  several factors (e.g., the concentration of ascorbic acid, the resulting  pH,  the  specific  reagents  used). Specialized references should be consulted for specific information on laboratory test  interferences  caused by ascorbic acid.

Ascorbic acid at high doses can compromise the test results of transaminases, lactatdehydrogenase, bilirubin.

Ascorbic acid, as a redox-compound, affects various oxidative-reduction tests  for  determination  of glucose in urine and serum. Ascorbic acid administration should be  discontinued  1-2 days  before such test. Diabetic patients taking more than 500 mg vitamin C  daily  may  obtain  false  readings  of  their urinary glucose test.

Ascorbic acid has been reported to interfere with screening tests for acetaminophen in urine, causing negative screening tests to occur in the presence of acetaminophen. Acetaminophen screening tests employing methods which are not based upon hydrolysis and  formation  of  an  indophenol  blue  chromogen should be used in patients receiving ascorbic acid.  Alternatively,  the  addition  of  copper sulfate overcomes this interference.

Large doses of ascorbic acid (i.e., greater than 500 mg daily) may interfere in  carbamazepine  levels  when measured by the Ames ARIS(R) method. A method of carbamazepine assay other than the Ames ARIS(R) method should be used in patients receiving ascorbic acid.

Use of ascorbic acid (greater than 1 g daily) may cause a false negative guaiac fecal occult blood test. Ascorbic acid should be discontinued if an interference with a guaiac test is suspected.

4.6 Fertility, pregnancy and lactation


Ascorbic acid crosses the placenta.

With the ingestion of high doses (400 mg/day  or greater) of ascorbic acid during pregnancy, the  foetus can adapt and then develop a scorbutic illness after birth as a withdrawal reaction (see section 4.4).

Administration of Ascorbic acid Prefilled Syringe100 mg/ml solution for injection/infusion for pregnant  woman should be considered only when it is absolutely necessary.


Ascorbic acid is excreted into breast milk, but there is no evidence of any hazard for breastfed infant. Nevertheless, administration in breastfeeding mothers should be done with precaution.


There are no data about effect of ascorbic acid on fertility.

4.7 Effects on ability to drive and use machines

Ascorbic acid Prefilled Syringe100 mg/ml solution for injection/infusion has no influence on the  ability  to drive and use machines.

4.8 Undesirable effects

Undesirable effects are described below and are classified by organs and systems, and by frequency as follows: very common (³1/10), common (³1/100 to <1/10), uncommon (³1/1000 to <1/100), rare (³1/10000 to <1/1000), very rare (<1/10000) and not known (cannot be  estimated from the  available data).

Nervous system disorders

Not known: headache, insomnia, temporary faintness or dizziness as a result of too rapid intravenous administration.

Gastrointestinal disorders

Rare: nausea, vomiting, abdominal colic, diarrhoea.

Diarrhoea may occur after oral dosage of 1 g or more daily or greater.

Skin and subcutaneous tissue disorders

Rare: at high doses may provoke allergic reactions.

Renal and urinary disorders

Rare: polyuria,   nephrolithiasis   in  some  patient. Doses of 600 mg or more daily have a diuretic action.

Acidification of urine by large doses of ascorbic acid might cause precipitation  of  urate,  oxalate  or cystine stones or drugs in the urinary tract, especially since some ascorbate  is  metabolised to oxalate. Some patients with pre-existing renal disease have been reported to develop renal failure following treatment with high doses of ascorbic acid.

General disorders and administration site condition

Rare: transient mild soreness and hardening at the site of intramuscular injection.

Not known: hot flushes, fatigue, “rebound” effect in the form of vitamin C deficiency after discontinuation of high doses therapy.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.  It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.

4.9 Overdose


Overdosage of ascorbic acid may cause acidosis and haemolytic anaemia in predisposed individuals e.g., in patients with glucose-6-phosphate dehydrogenase deficiency. In massive ascorbic acid overdosage, renal failure may occur due to excessive oxalate excretion.

At high doses vitamin C may provoke allergic reactions.


In the event of severe or unusual untoward effects, ascorbic acid therapy should be terminated. Symptomatic or supportive measures should be taken.


5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Vitamins, ascorbic acid (vitamin C), plain.

Mechanism of action

Ascorbic acid, a water-soluble vitamin, is essential for formation of collagen and intercellular material, and therefore necessary for  the  development  of  cartilage, bone, teeth and for the  healing of wounds. It is also essential for the conversion from folic acid to folinic acid, facilitates iron absorption from the gastro-intestinal tract and influences haemoglobin formation and erythrocyte maturation.

5.2 Pharmacokinetic properties


Ascorbic acid is rapidly and completely absorbed after parenteral administration.


Ascorbic acid is distributed in all tissues with about 25% bound  to  plasma  proteins.  Ascorbic  acid crosses the placenta.

Large concentrations of the vitamin C are found in the liver, leukocytes, platelets, glandular tissues,

and the lens of the eye, while low levels are found in plasma and saliva.

A plasma ascorbate concentration of 50 μmol/l is indicative of adequate status  that corresponds  to a body pool of about 1,5 g with metabolic losses of about 3,0% per day (or 40-50 mg/day).

Catabolic turnover varies widely, about 10 to 45 mg/day, over a wide  range  of  dietary intakes  due  to body pool size.

Ascorbic acid plasma concentration below 10 μmol/l is associated with scurvy.


Ascorbic acid is metabolized in the  liver  to  dehydroascorbic  acid,  2-3-diketogulonic  acid  and  oxalic  acid which are excreted with urine.


Ascorbic acid is excreted with urine unchanged and in the form of metabolites. About  50%  of  the oxalates in urine are formed during ascorbic acid metabolism, but there are no data of oxalate concretion formation in the kidneys during prolonged therapy.

The quantity of unchanged ascorbic acid is dose-dependent – unmetabolized ascorbate is excreted with dietary intakes up to about 80 mg/day and that renal excretion of ascorbate  increases  proportionately with higher intakes.

Up to 40% of plasma ascorbic acid can be removed by haemodialysis.

5.3 Preclinical safety data

Non-clinical data do not reveal any specific risk for humans based on  conventional pharmacological studies of safety, repeated dose toxicity, genotoxicity, carcinogenic potential, reproductive toxicity.


6.1List of excipients

Sodium hydrogen carbonate Sodium sulfite, anhydrous, Edetic acid

Water for injections

6.2 Incompatibilities

Ascorbic acid is incompatible in solution with aminophyllyine, bleomycin, erythromycin, lactobionate, nafcillin, sodium nitrofurantoin,  conjugated  oestrogens,  sodium bicarbonate, sulfafurazole diethanolamine, chloramphenicol sodium succinate, chlorothiazide sodium and hydrocortisone sodium succinate.

Ascorbic acidis rapidly oxidised in alkaline media, in the  presence  of  copper  and iron ions as well as other oxidants.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Store below 25ºC. Do not freeze.

6.5 Nature and contents of container

5 ml solution in Prefilled Syringe of colourless glass  (Type  І), with  marking  for  Prefilled Syringe  opening (a colour dot/ring). A self-adhesive label is attached on each Prefilled Syringe.

. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Ascorbic acid Prefilled Syringe100 mg/ml solution for  injection/infusion  should  be  used  immediately after opening.

Ascorbic acid Prefilled Syringe100 mg/ml solution  for  injection/infusion  should  only  be  mixed  with  those infusion solutions which are recommended:

sodium chloride 9 mg/ml (0.9%) solution for infusion; glucose 50 mg/ml (5%) solution for infusion. For instructions on administration, see section 4.2.

Disposal: Any unused medicinal product or waste material should be  disposed of  in  accordance  with local requirements.

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