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Medically reviewed by Oliinyk Elizabeth Ivanovna, PharmD. Last updated on 16.05.2022
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RANFERON-12 capsules are indicated for the treatment of Iron (Ranferon-12) and Folic Acid (Ranferon-12) deficiency anemia.
Adults and Adolescents: One to two capsules can be taken daily in single or in two divided dosages or as directed by physician.
RANFERON-12 capsules are contraindicated in those with hemochromatosis and hemosiderosis and in those who are hypersensitive to Iron (Ranferon-12), Folic Acid (Ranferon-12), vitamin B12, Vitamin C (Ranferon-12), Zinc (Ranferon-12), cobalt and to other components of RANFERON-12.
Iron (Ranferon-12) reduces the absorption of penicillamine. Iron (Ranferon-12) compounds impair the bioavailability of fluoroquinolones, levodopa, carbidopa, thyroxine and bisphosphonates.
Absorption of both Iron (Ranferon-12) and antibiotic may be reduced if Iron (Ranferon-12) is given with tetracycline.
Oral chloramphenicol delays plasma Iron (Ranferon-12) clearance, incorporation of Iron (Ranferon-12) into red blood cells and interferes with erythropoiesis. Neomycin may alter the absorption of Iron (Ranferon-12).
Administration of oral Iron (Ranferon-12) may increase blood pressure inpatients receiving methyldopa.
Concomitant intake of levothyroxine and Iron (Ranferon-12) may decrease the absorption of levothyroxine.
Absorption of both Iron (Ranferon-12) and Zinc (Ranferon-12) are reduced if taken concomitantly. Some inhibition of Iron (Ranferon-12) absorption may occur if it is taken with cholestyramine, trientine, tea, eggs or milk. Coffee may be a factor in reducing Iron (Ranferon-12) bioavailability. Aluminum- or magnesium-containing antacids may decrease the absorption of Iron (Ranferon-12) if used concomitantly.
Folic Acid (Ranferon-12) occasionally reduces plasma levels of anticonvulsants, particularly phenytoin.
Co-trimoxazole, chloramphenicol, sulphasalazine, aminopterin, methotrexate, pyrimethamine or sulphonamides may interfere with folate metabolism.
Absorption of vitamin B12 from the GI tract may be decreased by aminoglycoside antibiotics, colchicine, extended release potassium preparations, aminosalicylic acid and its salts, anticonvulsants (e.g., phenytoin, phenobarbital, primidone), cobalt irradiation of the small bowel, and by excessive alcohol intake lasting longer than 2 weeks.
Neomycin-induced malabsorption of vitamin B12 may be increased by concurrent administration of colchicine. Ascorbic acid may destroy substantial amounts of dietary vitamin B12 in vitro; this possibility should be considered when large doses of ascorbic acid are ingested within 1 hour of oral vitamin B12 administration.
Prednisone has been reported to increase the absorption of vitamin B12 and secretion of IF in a few patients with pernicious anemia, but not in patients with partial or total gastrectomy. The clinical importance of these findings is unknown.
Concurrent administration of chloramphenicol and vitamin B12 reportedly may antagonize the hematopoietic response to vitamin B12 in vitamin B12-deficient patients. The hematologic response to vitamin B12 in patients receiving both drugs should be carefully monitored and alternate anti-infectives should be considered.
Serum concentrations may be decreased by concurrent use of oral contraceptives. Many of these interactions are unlikely to be of clinical significance but should be taken into account when performing assays for blood concentrations.
The effect of ascorbic acid on following drugs: Desferrioxamine, hormonal contraceptives, fluphenazine, and warfarin have been reported. Ascorbic acid may increase the absorption of Iron (Ranferon-12) in Iron (Ranferon-12)-deficiency states.
The intake of large doses of Vitamin C (Ranferon-12) used at the same time as aluminum-containing antacids has been reported to increase urinary aluminum excretion, suggesting increased aluminum absorption from these antacids. However, this is not well documented.
Chronic use of high dose aspirin may lead to impaired Vitamin C (Ranferon-12) status.
Vitamin C (Ranferon-12) may potentiate the antineoplastic activity of cisplatin, doxorubicin and paclitaxel. It may also help ameliorate the cardiotoxic effect of doxorubicin and the nephrotoxic effect of cisplatin. This is based on in vitro and animal studies. There is a concern by some researchers that supplemental doses of Vitamin C (Ranferon-12) may diminish the efficacy of some chemotherapeutic agents.
Ascorbic acid may enhance 17 β-estradiol inhibition of oxidized LDL formation.
Vitamin C (Ranferon-12) used concomitantly with nonheme Iron (Ranferon-12) supplements may increase the uptake of Iron (Ranferon-12). This may cause problems in those with high Iron (Ranferon-12) stores or with propensity for Iron (Ranferon-12) overload, such as those with hemochromatosis, sideroblastic anemia, sickle cell anemia, thalassemia and erythrocyte G6PD deficiency.
Laboratory Tests: Ascorbic acid, a strong reducing agent, interferes with laboratory tests involving oxidation and reduction reactions. Falsely-elevated or false-negative test results may be obtained from plasma, faeces, or urine samples depending on such factors as the dose of ascorbic acid and specific method used. High intakes of Vitamin C (Ranferon-12) may cause falsely elevated bilirubin values. Large intakes of Vitamin C (Ranferon-12) may cause falsely elevated urine and serum creatinine levels. However, this is not well documented. Large intakes of Vitamin C (Ranferon-12) may cause false positive glucose readings measured by copper reduction methods (e.g., Clinitest) and false negative glucose results as measured by the oxidase methods (e.g., Clinistix and Tes-Tape). Intakes of Vitamin C (Ranferon-12) greater than 1 gram daily may cause a false negative guaiac test.
The absorption of Zinc (Ranferon-12) may be reduced by Iron (Ranferon-12) supplements, penicillamine, phosphorus-containing preparations, and tetracyclines. Zinc (Ranferon-12) supplements reduce the absorption of copper, fluoroquinolones, Iron (Ranferon-12), penicillamine and tetracyclines.
Concomitant intake of a bisphosphonate and Zinc (Ranferon-12) may decrease the absorption of both the bisphosphonate and Zinc (Ranferon-12).
The most common side effects are gastrointestinal ones and include nausea, vomiting, bloating and other abdominal discomfort, black stools, diarrhea, constipation and anorexia. Temporary staining of teeth occurs from Iron (Ranferon-12)-containing liquids. Rarely allergic reactions may occur.
Folic Acid (Ranferon-12) is generally well tolerated but gastrointestinal disturbances may occur occasionally.
Folic Acid (Ranferon-12) doses of up to 1 mg daily are well tolerated. There are more than 100 reported cases in which vitamin B12-deficient subjects who were receiving oral doses of Folic Acid (Ranferon-12) of 5 mg daily or more experienced progression of neurological symptoms and signs. There are very few such reports in those receiving doses of Folic Acid (Ranferon-12) less than 5 mg daily. There are rare reports of hypersensitivity reactions to oral Folic Acid (Ranferon-12). There is one report of a trial using oral doses of Folic Acid (Ranferon-12) of 15 mg daily for one month in which some subjects experienced sleep disturbances, mental changes and gastrointestinal effects.
Studies using comparable or higher doses, longer duration, or both, failed to confirm these findings.
Arrhythmias secondary to hypokalaemia have occurred at the beginning of parenteral treatment with hydroxocobalamin.
Intranasal cyanocobalamin may cause rhinitis, nausea, and headache.
In healthy adults, oral doses up to 3 grams daily of Vitamin C (Ranferon-12) are unlikely to cause adverse reactions. The most common adverse reaction in those who take oral doses greater than 3 grams daily are gastrointestinal and include nausea, abdominal cramps, diarrhea and flatulent distention. These reactions are attributed to the osmotic effect of unabsorbed Vitamin C (Ranferon-12) passing through the intestine. Some advocates of megadose Vitamin C (Ranferon-12) use recommend titrating the daily dose of Vitamin C (Ranferon-12) to what they refer to as "bowel tolerance", i.e., the point at which the user begins experiencing diarrhea. This is not recommended. Rare adverse reactions have been reported in healthy individuals taking high oral doses of Vitamin C (Ranferon-12). These include elevation of serum glucose in an adult male taking 4.5 grams daily, a gastrointestinal obstruction in a 66-year-old woman taking 4.5 grams daily of ascorbic acid and esophagitis in one person taking a single 500 milligram dose.
Doses of Zinc (Ranferon-12) up to 30 milligrams daily are generally well tolerated. Higher doses may cause adverse reactions. The most common adverse reactions are gastrointestinal and include abdominal pain, dyspepsia, nausea, vomiting, diarrhea, gastric irritation, gastritis and gastrointestinal discomfort. Other adverse reactions include a metallic taste, headache and drowsiness. There are some reports of decreased HDL-cholesterol in those taking high doses of Zinc (Ranferon-12).
Chronic intake of high doses of Zinc (Ranferon-12) can lead to copper deficiency and hypochromic, microcytic anemia secondary to Zinc (Ranferon-12)-induced copper deficiency. High doses of Zinc (Ranferon-12) may be immunosuppressive.
Each capsule contains ferrous fumarate BP 305 mg (equivalent to elemental Iron (Ranferon-12) 100 mg), Folic Acid (Ranferon-12) BP 0.75 mg, cyanocobalamin USP 5 mcg, ascorbic acid USP 75 mg and Zinc (Ranferon-12) sulphate BP 5 mg.