Vitamin C SALF IM/IV 1000MG 5ML 5 ampoules

NAME VITAMIN C SALF PHARMACOTHERAPEUTIC CATEGORY Ascorbic acid (vit. C), including associations. ACTIVE PRINCIPLES Ascorbic acid. EXCIPIENTS Sodium hydroxide, sodium metabisulfite, water for injections. INDICATIONS Vitamin C deficiency states. CONTRAINDICATIONS/SECONDARY EFFECTS Individual hypersensitivity ascertained towards the product or towards any of the excipients; oxalic urolithiasis or hyperoxaluria; severe impairment of renal function or renal failure. In patients taking high doses of vitamin C, inadequacy of normal renal clearance mechanisms may result in very high plasma levels resulting in the possible development of crystals or kidney stones. DOSAGE 500 mg vial of injectable solution: the dosage is in relation to the indications and the severity of the condition. 1 vial of 500 mg is administered per day. 1 g vial of injectable solution: unless otherwise prescribed by the doctor, 1 vial every other day; in severe cases 1 vial per day. In subjects with rheumatic arthritis, as well as in cases of serious burns, the 1 g vials drug can also be used in combination with preparations based on adrenal hormone. STORAGE Store the medicine below 25 degrees C. Store in the original package to protect from light.

WARNINGS

Ascorbic acid should not be taken at higher doses or for longer periods than recommended, as overdose may cause calcium oxalate deposits and acute tubular necrosis and/or renal failure. Patients with kidney failure should consult a doctor before taking high doses of ascorbic acid. Vitamin C should be used with caution by subjects with a predisposition to calcium-oxal nephrolithiasis (kidney stones) or with recurrent nephrolithiasis, reducing the intake of ascorbic acid to 100-200 mg/day, and by those suffering from G6PD deficiency (glucose -6-phosphate dehydrogenase), hemochromatosis, thalassemia or sideroblastic anemia. Patients taking other mono- or multivitamin preparations or any other medicines or who are undergoing therapy should consult a doctor before using the product. The medicine contains sodium metabisulfite; and more than 1 mmol sodium per dose; to be taken into consideration in people with reduced renal function or who follow a low sodium diet. After a short period of treatment without appreciable results, consult your doctor. Interference with diagnostic tests: vitamin C can alter glycosuria values. It is therefore advisable to suspend the intake of vitamin C a few days before proceeding with the measurement of glucose in the urine.

INTERACTIONS

Vitamin C promotes intestinal absorption of iron. Deferoxamine: in patients with iron accumulation, simultaneous oral therapy with vitamin C and deferoxamine can increase the excretion of the iron complex. The association with vitamin C should only be carried out after 1-2 weeks of treatment with deferoxamine. In severe and chronic cases of iron accumulation, when deferoxamine is associated with high-dose treatment of vitamin C (more than 500 mg/day) an alteration of cardiac function is observed which is reversible after suspension of vitamin C. In the case of With this association it is advisable to monitor cardiac function. Cyclosporin: Some data suggest that ascorbic acid may reduce plasma levels of cyclosporine.

SIDE EFFECTS

Gastrointestinal disorders (frequency not known): diarrhoea, nausea, vomiting, abdominal pain, dyspepsia. Immune system disorders (frequency not known): allergic reaction, anaphylactic reaction, anaphylactic shock. Rare mild to moderate hypersensitivity reactions have been reported, including allergic asthma syndrome, reactions with cutaneous, respiratory, gastrointestinal and cardiovascular involvement, with symptoms such as rash, urticaria, allergic edema and angioedema, pruritus, cardio-respiratory distress and, very rarely, severe reactions up to anaphylactic shock. Systemic disorders and conditions relating to the administration site: reactions at the injection site.

PREGNANCY AND BREASTFEEDING

Vitamin C is generally considered safe during pregnancy, as long as it is taken at recommended doses. Since adequate controlled clinical studies have not been carried out to evaluate the risk of treatment with ascorbic acid during pregnancy, the use of the medicine should be considered only in cases of recognized and effective necessity, under medical supervision. During breastfeeding, the drug must be taken under the supervision of a doctor.