TRADE NAME: Cevarol Ampoules GENERIC NAME: Vitamin C (Ascorbic acid) COMPOSITION: Each ampoule of 5 ml contains: Active ingredient: Vitamin C (Ascorbic acid) 1000 mg : Excipients Sodium bicarbonate, Sodium sulphite, Disodium edetate, Thioglycolic acid, Water for injection, Cysteine HCl. PHARMACEUTICAL FORM: Solution in ampoule for I.V.,I.M. injection. PHARMACOLOGICAL ACTION: PHARMACODYNAMICS: Pharmacotherapeutic group: vitamins, ascorbic acid (vitamin C). Cevarol contains ascorbic acid (vitamin C). The adequate intake of vitamin C through injection is necessary for human body, as the body cannot synthesize it. Vitamin C deficiency mainly affects mesenchyme and is associated with petechial hemorrhaging, ecchymosis, swelling and bleeding of the gingiva as well as symptoms of Sjögren's syndrome. Vitamin C affects many metabolic processes, for example: collagen synthesis or formation of hormones and is important for resistance to infectious diseases and for antibody production. Furthermore, the permeability of the blood vessels is influenced. In addition, vitamin C promotes the absorption of iron. PHARMACOKINETICS: The pharmacokinetics of ascorbic acid depend on the dose level and the method of administration. In increasing doses, bioavailability decreases. Distribution Ascorbic acid is ubiquitously distributed in all parts of the body. The highest levels are measured in adrenal cortex and pituitary gland, but the lowest levels in muscular system and adipose tissue. Biotransformation The most important metabolites of ascorbic acid are dehydroascorbic acid, 2,3-diketogluconic acid and oxalic acid. Elimination The excretion is predominantly renal. The daily excretion of ascorbic acid and its metabolites is about 3% of the total portion of vitamin C in body. INDICATIONS: * For the prevention and treatment of Vitamin C deficiency states. * In case of Methemoglobinemia. DOSAGE AND ADMINISTRATION: Dosage Adults For the prevention and treatment of Vitamin C deficiency states, adults receive 1 ampoule once a day. In case of Methemoglobinemia, adults receive 1 to 3 ampoules a day. Children and Teenagers For the treatment of Vitamin C deficiency states, children under the age of 12 years should not receive more than 5 to 7 mg ascorbic acid/ kg a day. There are no data available on the high-dose use in teenagers. In case of Methemoglobinemia, Children are injected once intravenously with 500 to 1000 mg of ascorbic acid. When needed, the dose should be repeated at the same dosage. During the treatment of Methemoglobinemia, Children should not exceed 100 mg ascorbic acid/ kg a day. Patients with renal insufficiency should be treated with lower individualized doses.
