Product Name & Strength: Dexorange Hematinic Syrup, 200ml.
Indications (Approved Uses): Indicated for iron deficiency anaemia resulting from chronic blood loss, hookworm infestation, or inadequate iron intake; dimorphic anaemia due to deficiency of iron, folic acid, or cyanocobalamin; anaemia during pregnancy and lactation; and as a tonic for general weakness, lack of appetite, rundown conditions, convalescence, and post-surgical recovery.
Contraindications (Safety Warnings): Contraindicated in patients with primary or secondary iron storage diseases (e.g., haemochromatosis), anaemia associated with ineffective erythropoiesis, marrow hypoplasia, sideroblastic change, or uncomplicated cyanocobalamin/folate deficiency. It must not be used by patients with severe acute inflammatory intestinal disease (e.g., celiac sprue), porphyria cutanea tarda, uncontrolled parathyroid disease, or sickle cell disease. It is contraindicated in patients with known hypersensitivity to any of the ingredients. Iron compounds should not be given to patients receiving repeated blood transfusions unless iron deficiency is confirmed. Care should be taken in patients with hemoglobinopathies or existing gastrointestinal diseases such as inflammatory bowel disease, intestinal strictures, and diverticulae.
Side Effects (Adverse Reactions): Common adverse reactions include gastrointestinal irritation, abdominal pain, nausea, vomiting, diarrhoea, or constipation. High or toxic doses may lead to cardiovascular disorders (hypotension, tachycardia), metabolic changes (acidosis, hypoglycaemia), and CNS depression ranging from lethargy to coma. Allergic reactions to folic acid are rare.
Nutritional Information (per 15ml): Ferric Ammonium Citrate B.P. 160 mg (equivalent to elemental Iron 32.8mg), Cyanocobalamin B.P. 7.5 mcg, Folic Acid B.P. 0.5 mg, Alcohol U.S.P. 0.87 ml.
Instructions for Use / Dosage: For oral administration. Adults (therapeutic use): 1 tablespoonful (15ml) twice daily after meals. Children: As advised by a physician. Liquid iron preparations should be swallowed through a straw to prevent tooth discoloration.
Regulatory Information: NAFDAC Registration Number: 04-9708. Manufactured by: STP Pharmaceuticals Pvt. Ltd, India.
