1. NAME OF THE MEDICINAL PRODUCT

Ascorbic Acid Injection USP 250mg/ 1ml – (2ml) Taj Pharma
Ascorbic Acid Injection USP 500mg/1ml – (50ml) Taj Pharma

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION
    a) Each ml of Injection contains:
    Ascorbic Acid USP………………….250mg
    For excipients, see 6.1

    b)Each ml of Injection contains:
    Ascorbic Acid USP………………….500mg
    For excipients, see 6.1

  1. PHARMACEUTICAL FORM

Solution for Injection

  1. Clinical particulars

4.1 Therapeutic indications

The prevention and treatment of scurvy, or other conditions requiring vitamin C supplementation, where the deficiency is acute or oral administration is difficult.

4.2 Posology and method of administration

Route of Administration: Parenteral

Adults

0.5 to 1g daily for scurvy, 200 to 500mg daily for preventative therapy.

Children

100 to 300mg daily for curative purposes, or 30mg daily for protective treatment.

Elderly

No special dosage requirements have been suggested.

4.3 Contraindications

Hyperoxaluria

4.4 Special warnings and precautions for use

Ascorbic acid 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 Injection USP 100mg/ml / 500mg/ml Taj Pharma have resulted in haemolysis in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency.

4.5 Interaction with other medicinal products and other forms of interaction

Drugs which induce tissue desaturation of ascorbic acid include aspirin, nicotine from cigarettes, alcohol, several appetite suppressants, iron, phenytoin, some anti-convulsant drugs, the oestrogen component of oral contraceptives and tetracycline. Large doses of ascorbic acid may cause the urine to become acidic causing unexpected renal tubular reabsorption of acidic drugs, thus producing an exaggerated response. Conversely basic drugs may exhibit decreased reabsorption resulting in a decreased therapeutic effect. Large doses may reduce the response to oral anticoagulants.

It has been reported that concurrent administration of ascorbic acid and fluphenazine has resulted in decreased fluphenazine plasma concentrations.

Ascorbic acid 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 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 should not be given in conjunction with desferrioxamine in patients with cardiac dysfunction.

Aspirin can reduce the absorption of ascorbic acid 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.

4.6 Fertility, pregnancy and lactation

Ascorbic acid in doses greater than 1g daily should not be taken during pregnancy since the effect of large doses on the foetus is unknown. Ascorbic acid is excreted in breast milk, but there is no evidence of any hazard.

4.7 Effects on ability to drive and use machines

Ascorbic acid injection is unlikely to affect the patient’s ability to drive or use machinery.

4.8 Undesirable effects

Large doses may cause gastrointestinal disorders including diarrhoea. Large doses may also result in hyperoxaluria and renal oxalate calculi may form if the urine becomes acidic. Doses of 600mg or more daily have a diuretic action. Induced tolerance with prolonged use of large doses can result in symptoms of deficiency when intake is reduced to normal.

4.9 Overdose

Large doses may cause gastrointestinal disorders including diarrhoea. Large doses may also result in hyperoxaluria and renal oxalate calculi may form if urine is acidic. Doses of 600mg or more daily have a diuretic action. Stop treatment and treat symptomatically.

  1. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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

Distribution – widely distributed in body tissues with about 25% bound to plasma proteins. Large amounts are present in leucocytes and platelets. Ascorbic acid crosses the placenta.

Metabolism – readily oxidised to dehydroascorbic acid where some is metabolised to oxalic acid and the inactive ascorbate – 2 – sulphate. Metabolic turnover appears to be greater in females than males.

Excretion – large doses are rapidly excreted in the urine when in excess of the requirements of the body and after an intravenous dose, about 40% is excreted in 8 hours, which is increased to about 70% after tissue saturation. The amount of unchanged drug is dose dependent; in women the excretion of ascorbic acid appears to vary with the stage of the menstrual cycle and it is decreased when taking oral contraceptives.

Ascorbic acid is excreted in breast milk.

Oxalic acid and ascorbate – 2 – sulphate are excreted in the urine.

5.3 Preclinical safety data

None stated

  1. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium Bicarbonate, Sodium Metabisulphite, Hydrochloric acid, Water for injections

6.2 Incompatibilities

Incompatible with ferric salts, oxidising agents, and salts of heavy metals, particularly copper.

Injections of ascorbic acid have been reported to be incompatible with aminophylline, bleomycin sulphate, erythromycin lactobionate, nafcillin sodium, nitrofurantoin sodium, conjugated oestrogens, sodium bicarbonate and sulphafurazole diethanolamine. Occasional incompatibility, depending on pH or concentration, has occurred with chloramphenicol sodium succinate.

6.3 Shelf life

12 months

6.4 Special precautions for storage

Do not store above 25°C

6.5 Nature and contents of container

5ml neutral glass (Type 1) ampoules. Pack size – 10.

6.6 Special precautions for disposal and other handling

None stated

  1. MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

PACKAGE LEAFLET: INFORMATION FOR PATIENT
ASCORBIC ACID INJECTION USP
500MG/1ML
TAJ PHARMA

Read all of this leaflet carefully before you are given this medicine.

  • Keep this leaflet. You may need to read it again
  • If you have any further questions, ask your doctor or nurse
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
  • In this leaflet, Ascorbic Acid Injection, 10 % w/v Solution for Injection will be called Ascorbic Acid Injection.

IN THIS LEAFLET:

  1. What Ascorbic Acid Injection is for
  2. Before you are given Ascorbic Acid Injection
  3. How Ascorbic Acid Injection will be given to you
  4. Possible side effects
  5. How to store Ascorbic Acid Injection
  6. Further information.|1. WHAT ASCORBIC ACID INJECTION IS FOR

Ascorbic acid is a nutritional supplement commonly called Vitamin C. It is used to prevent and treat scurvy or other conditions requiring extra vitamin C.

Ascorbic Acid Injection is used when the vitamin C deficiency is severe or taking tablets is difficult.

  1. BEFORE YOU ARE GIVEN ASCORBIC ACID INJECTION

Do not use Ascorbic Acid Injection if:

  • You have a condition called hyperoxaluria, where you have too much oxalate in your urine.

This can lead to kidney stones.

If this applies to you talk to your doctor or nurse.

Check with your doctor before you are given Ascorbic Acid Injection if:

  • You have kidney problems
  • You smoke
  • You have an enzyme deficiency called G6PD deficiency. Large doses of ascorbic acid can cause your blood cells to break up.

Tell your doctor if you are taking any of the following medicines:

  • Asprin
  • Desferrioxamine used to treat iron overload
  • Medicines used to treat epilepsy (e.g. phenytoin)
  • Appetite suppressants (e.g. fenfluramine)
  • Oral contraceptives which contains oestrogen (e.g. “the pill”)
  • antibiotics (e.g. tetracycline)
  • iron supplement
  • oral anticoagulants (e.g. Warfarin)
  • fluphenazine for mental disorders
  • Any other medicine, including medicines obtained without a prescription.

If any of the above applies to you talk to your doctor or nurse.

Having Ascorbic Acid Injection with food and drink Do not drink alcohol whilst you are having Ascorbic Acid injections.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, trying to become pregnant or breastfeeding. Large doses of ascorbic acid, i.e. greater than 1g daily, should not be taken during pregnancy since the effect of large doses on the foetus is unknown.

Ascorbic acid is excreted in breast milk but there is no evidence of any hazard to the baby.

  1. How Ascorbic Acid Injection will be given to you

Important:

Ascorbic Acid Injection will be given to you by a doctor or nurse. Your doctor will choose the dose that is right for you

Adults and the elderly

To treat scurvy the usual dose is 0.5 g to 1 g per day. To prevent scurvy the usual dose is 200 mg to 500 mg per day.

Children

To treat scurvy the usual dose is 100 mg to 300 mg per day.

To prevent scurvy the usual dose is 30 mg per day.

If you think you have been given more Ascorbic Acid Injection than you should

As this medicine will be given to you by a doctor or nurse, it is unlikely that you will be given too little or too much. However, if you think you have been given too much of this medicine, please tell your doctor.

Large doses of ascorbic acid may cause diarrhoea and kidney stones may form if your urine is acidic. Doses of 600 mg or more may lead to more frequent passing water.

If you have any further questions about the use of this medicine, ask your doctor or nurse.

  1. POSSIBLE SIDE EFFECTS

Like all medicines Ascorbic Acid Injection can cause side effects, although not everybody gets them.

  • Diarrhoea
  • Increased urination (passing water)
  • Formation of kidney stones if your urine is acidic.

If any of the side effects gets serious, or if you notice

any side effects not listed in this leaflet, please tell your doctor or nurse.

  1. HOW TO STORE ASCORBIC ACID INJECTION

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date on the carton and vial label. The expiry date refers to the last day of that month.

Store below 25°C.

Your doctor or nurse will make sure your medicine is correctly stored and disposed of.

  1. FURTHER INFORMATION

What Ascorbic Acid Injection contains

Each ml of Injection contains:
Ascorbic Acid USP………………….500mg

The other ingredients are: sodium bicarbonate, sodium metabisulphite, hydrochloric acid, ‘water for injections’.

What Ascorbic Acid Injection looks like

Ascorbic Acid Injection is a sterile solution in a 5 ml clear glass ampoule. It comes in packs of 10 ampoules.

  1. MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com