TRADE NAME: CEVAROL TABLETS GENERIC NAME: Ascorbic acid (vitamin C). COMPOSITION: Each tablet contains: Active ingredient: Ascorbic acid (vitamin C) 500 mg : Excipients Microcrystalline cellulose, Maize starch, Colloidal silicon dioxide, Magnesium stearate. PHARMACOLOGICAL ACTION: Ascorbic Acid is a synthetic vitamin C. PHARMACOKINETICS: 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. INDICATIONS: Ascorbic acid is a synthetic vitamin C and is specific in the treatment of scurvy. DOSAGE AND ADMINISTRATION: - 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. CONTRAINDICATIONS: Hyperoxaluria. WARNINGS AND PRECAUTIONS: 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ascorbic acid over a prolonged period may result in an increase in renal clearance and deficiency may result if it is withdrawn too rapidly. 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. PREGNANCY & 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. SIDE 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. OVERDOSAGE: 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. THERAPEUTIC CATEGORY: vitamin. LEGAL CATEGORY: O.T.C. STORAGE : Store at a temperature not exceeding 30˚C, in a dry place. PACKAGE : carton box containing (al/ transparent orange pvc) strips, each of 10 tablets+ inner leaflet
