1. Name Of The Medicinal Product
ASCORBIC ACID TABLETS BP 500mg
2. Qualitative And Quantitative Composition
Each tablet contains 500mg ascorbic acid.
3. Pharmaceutical Form
White uncoated tablets.
White, circular, flat bevelled-edge uncoated tablets impressed “C” and the identifying letters “AN” on one face; or, as an alternative, plain tablets devoid of surface markings.
4. Clinical Particulars
4.1 Therapeutic Indications
1) Ascorbic acid is a synthetic vitamin C and is specific in the treatment of scurvy.
4.2 Posology And Method Of Administration
Tablets should be chewed before swallowing.
Adults including elderly: 500mg-1g two or three times daily.
Children over 12 years: 500mg two or three times daily.
Children 6-12 years: 500mg twice a day.
For oral administration.
4.3 Contraindications
Hyperoxaluria.
4.4 Special Warnings And Precautions For Use
Increased intake of ascorbic acid over a prolonged period may result in an increase in renal clearance and deficiency may result if it is withdrawn too rapidly.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Concomitant administration of aluminium-containing antacids may increase urinary aluminium elimination. Concurrent administration of antacids and ascorbic acid is not recommended, especially in patients with renal insufficiency.
Concomitant administration of aspirin and ascorbic acid may interfere with absorption of ascorbic acid. Renal excretion of salicylate is not affected and does not lead to reduced anti-inflammatory effects of aspirin.
Concurrent administration of ascorbic acid with desferrioxamine enhances urinary iron excretion. Cases of cardiomyopathy and congestive heart failure have been reported in patients with idiopathic haemochromatosis and thalassaemias receiving desferrioxamine who were subsequently given ascorbic acid. Ascorbic acid should be used with caution in these patients and cardiac function monitored.
Ascorbic acid may interfere with biochemical determinations of creatinine, uric acid and glucose in samples of blood and urine.
4.6 Pregnancy And Lactation
Ascorbic acid in doses greater than 1g should not be administered during pregnancy as the effect of large doses on the foetus is not known.
No problems are anticipated with the administration of ascorbic acid tablets during lactation.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
Nausea, vomiting and stomach cramps.
Flushing or redness of skin, headache, mild increase in urination with doses greater than 600mg per day.
Large doses of ascorbic acid (greater than 1g per day) may cause diarrhoea.
4.9 Overdose
Ascorbic acid may cause acidosis or haemolytic anaemia in certain individuals with a deficiency of glucose 6-phosphate dyhydrogenase. Renal failure can occur with massive ascorbic acid overdosage.
Gastric lavage may be given if ingestion is recent otherwise general supportive measures should be employed as required.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Ascorbic Acid is a synthetic vitamin C.
5.2 Pharmacokinetic Properties
Ascorbic acid is readily absorbed from the gastrointestinal tract and is widely distributed in the body tissues. Ascorbic acid in excess of the body's needs is rapidly eliminated in the urine.
The most established function of vitamin C in the body is the control of the formation of colloidal intercellular substances. Deficiency of vitamin C leads to scurvy and in the absence of this water-soluble vitamin, a typical nutritional anaemia develops; the vitamin acts directly on the blood-forming centres and is essential for the maturation of the red blood cells.
5.3 Preclinical Safety Data
Not applicable.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Also contains: stearic acid, E223, E460.
6.2 Incompatibilities
None known.
6.3 Shelf Life
Shelf-life
Three years from the date of manufacture.
Shelf-life after dilution/reconstitution
Not applicable.
Shelf-life after first opening
Not applicable.
6.4 Special Precautions For Storage
Store in a cool dry place. Protect from light. Avoid contact with metal.
6.5 Nature And Contents Of Container
The product containers are J & J standard securitainers or Wragby snap-secure containers with jayfilla or polyfoam wad headspace filler and snap-on lids; in case any supply difficulties should arise the alternative is amber glass containers with screw caps with polyfoam wad or cotton wool.
Pack sizes: 7s, 10s, 14s, 20s, 21s, 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s, 500s, 1000s
Polyethylene container with a polypropylene lid.
Pack size: 28
Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material.
Maximum size of bulk packs: 25,000.
6.6 Special Precautions For Disposal And Other Handling
Not applicable
Administrative Data
7. Marketing Authorisation Holder
Name or style and permanent address of registered place of business of the holder of the Marketing Authorisation:
Actavis UK Limited
(Trading style: Actavis)
Whiddon Valley
BARNSTAPLE
N Devon EX32 8NS
8. Marketing Authorisation Number(S)
PL 0142/6435 R
9. Date Of First Authorisation/Renewal Of The Authorisation
11.7.86
Renewed: 28.10.91; 14.3.02
10. Date Of Revision Of The Text
02/07/09
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