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DRUGS & SUPPLEMENTS
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Folic Acid:
Ferazin Tablets (Folic Acid)® is a prescription iron supplement indicated for use in improving the nutritional status of iron deficiency.
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindications to iron therapy.
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. |
Ferazin Tablets (Folic Acid) acid when administered as a single agent in doses above 0.1 mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. While prescribing this nutritional supplement for pregnant women, nursing mothers, or for women prior to conception, their medical condition and other drugs, herbs, and/or supplements consumption should be considered.
Allergic sensitization has been reported following both oral and parenteral administration of Ferazin Tablets (Folic Acid) acid.
One tablet daily with or without food or as prescribed by a licensed healthcare provider with prescribing authority.
Ferazin Tablets (Folic Acid)® tablets are supplied in child-resistant bottles of 90 tablets (NDC 0037-6885-90)
KEEP OUT OF REACH OF CHILDREN.
Store at controlled room temperature 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C (59°-86°F).
Dispense in a tight, light-resistant container to protect from light and moisture.
To report SUSPECTED ADVERSE REACTIONS contact Meda Pharmaceuticals Inc. at 1-888-349-5556 or FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch
Distributed by:
Meda Pharmaceuticals Inc.
Somerset New Jersey 08873-4120
© 2014 Meda Pharmaceuticals Inc.
U.S. Patent Nos. 7,585,527 and 8,080,520
Proferrin® is a registered trademark of Colorado BioLabs, Inc., Cozad, NE.
Ferazin Tablets (Folic Acid) and the BIFERA logo are registered trademarks and the Ferazin Tablets (Folic Acid) logo is a trademark of Alaven Pharmaceutical LLC, used under license by Meda Pharmaceuticals Inc.
MEDA PHARMACEUTICALS mark and logo are trademarks of Meda AB.
IN-6885-02 Rev 6/2014
Iron (Sodium Feredetate):
Ferazin Tablets (Iron (Sodium Feredetate)) is indicated for the treatment of Ferazin Tablets (Iron (Sodium Feredetate)) deficiency anemia in patients with chronic kidney disease (CKD).
Ferazin Tablets (Iron (Sodium Feredetate)) is an Ferazin Tablets (Iron (Sodium Feredetate)) replacement product indicated for the treatment of Ferazin Tablets (Iron (Sodium Feredetate)) deficiency anemia in patients with chronic kidney disease (CKD). (1)
Ferazin Tablets ) must only be administered intravenously either by slow injection or by infusion. The dosage of Ferazin Tablets (Iron (Sodium Feredetate)) is expressed in mg of elemental Ferazin Tablets (Iron (Sodium Feredetate)). Each mL contains 20 mg of elemental Ferazin Tablets (Iron (Sodium Feredetate)).
Population | Dose | |
Adult patients | Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD) (2.1) | 100 mg slow intravenous injection or infusion |
Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD) (2.2) | 200 mg slow intravenous injection or infusion | |
Peritoneal Dialysis Dependent-Chronic Kidney Disease (PDD-CKD) (2.3) | 300 mg or 400 mg intravenous infusion | |
Pediatric patients | HDD-CKD (2.4), PDD-CKD or NDD-CKD (2.5) | 0.5 mg/kg slow intravenous injection or infusion |
Administer Ferazin Tablets (Iron (Sodium Feredetate)) 100 mg undiluted as a slow intravenous injection over 2 to 5 minutes, or as an infusion of 100 mg diluted in a maximum of 100 mL of 0.9% NaCl over a period of at least 15 minutes, per consecutive hemodialysis session. Ferazin Tablets (Iron (Sodium Feredetate)) should be administered early during the dialysis session. The usual total treatment course of Ferazin Tablets (Iron (Sodium Feredetate)) is 1000 mg. Ferazin Tablets (Iron (Sodium Feredetate)) treatment may be repeated if Ferazin Tablets (Iron (Sodium Feredetate)) deficiency reoccurs.
Administer Ferazin Tablets (Iron (Sodium Feredetate)) 200 mg undiluted as a slow intravenous injection over 2 to 5 minutes or as an infusion of 200 mg in a maximum of 100 mL of 0.9% NaCl over a period of 15 minutes. Administer on 5 different occasions over a 14 day period. There is limited experience with administration of an infusion of 500 mg of Ferazin Tablets (Iron (Sodium Feredetate)), diluted in a maximum of 250 mL of 0.9% NaCl, over a period of 3.5 to 4 hours on Day 1 and Day 14. Ferazin Tablets (Iron (Sodium Feredetate)) treatment may be repeated if Ferazin Tablets (Iron (Sodium Feredetate)) deficiency reoccurs.
Administer Ferazin Tablets (Iron (Sodium Feredetate)) in 3 divided doses, given by slow intravenous infusion, within a 28 day period: 2 infusions each of 300 mg over 1.5 hours 14 days apart followed by one 400 mg infusion over 2.5 hours 14 days later. Dilute Ferazin Tablets (Iron (Sodium Feredetate)) in a maximum of 250 mL of 0.9% NaCl. Ferazin Tablets (Iron (Sodium Feredetate)) treatment may be repeated if Ferazin Tablets (Iron (Sodium Feredetate)) deficiency reoccurs.
The dosing for Ferazin Tablets (Iron (Sodium Feredetate)) replacement treatment in pediatric patients with HDD-CKD has not been established.
For Ferazin Tablets (Iron (Sodium Feredetate)) maintenance treatment: Administer Ferazin Tablets (Iron (Sodium Feredetate)) at a dose of 0.5 mg/kg, not to exceed 100 mg per dose, every two weeks for 12 weeks given undiluted by slow intravenous injection over 5 minutes or diluted in 25 mL of 0.9% NaCl and administered over 5 to 60 minutes. Ferazin Tablets (Iron (Sodium Feredetate)) treatment may be repeated if necessary.
The dosing for Ferazin Tablets (Iron (Sodium Feredetate)) replacement treatment in pediatric patients with NDD-CKD or PDD-CKD has not been established.
For Ferazin Tablets (Iron (Sodium Feredetate)) maintenance treatment: Administer Ferazin Tablets (Iron (Sodium Feredetate)) at a dose of 0.5 mg/kg, not to exceed 100 mg per dose, every four weeks for 12 weeks given undiluted by slow intravenous injection over 5 minutes or diluted in 25 mL of 0.9% NaCl and administered over 5 to 60 minutes. Ferazin Tablets (Iron (Sodium Feredetate)) treatment may be repeated if necessary.
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferazin Tablets (Iron (Sodium Feredetate)). Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. If hypersensitivity reactions or signs of intolerance occur during administration, stop Ferazin Tablets (Iron (Sodium Feredetate)) immediately. Monitor patients for signs and symptoms of hypersensitivity during and after Ferazin Tablets (Iron (Sodium Feredetate)) administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferazin Tablets (Iron (Sodium Feredetate)) when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Most reactions associated with intravenous Ferazin Tablets (Iron (Sodium Feredetate)) preparations occur within 30 minutes of the completion of the infusion .
Ferazin Tablets ) may cause clinically significant hypotension. Monitor for signs and symptoms of hypotension following each administration of Ferazin Tablets (Iron (Sodium Feredetate)). Hypotension following administration of Ferazin Tablets (Iron (Sodium Feredetate)) may be related to the rate of administration and/or total dose administered .
Excessive therapy with parenteral Ferazin Tablets (Iron (Sodium Feredetate)) can lead to excess storage of Ferazin Tablets (Iron (Sodium Feredetate)) with the possibility of iatrogenic hemosiderosis. All adult and pediatric patients receiving Ferazin Tablets (Iron (Sodium Feredetate)) require periodic monitoring of hematologic and Ferazin Tablets (Iron (Sodium Feredetate)) parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). Do not administer Ferazin Tablets (Iron (Sodium Feredetate)) to patients with evidence of Ferazin Tablets (Iron (Sodium Feredetate)) overload. Transferrin saturation (TSAT) values increase rapidly after intravenous administration of Ferazin Tablets (Iron (Sodium Feredetate)) sucrose; do not perform serum Ferazin Tablets (Iron (Sodium Feredetate)) measurements for at least 48 hours after intravenous dosing .
The following serious adverse reactions associated with Ferazin Tablets ) are described in other sections .
To report SUSPECTED ADVERSE REACTIONS, contact American Regent, Inc. at 1-800-734-9236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug may not reflect the rates observed in practice.
Adverse Reactions in Adult Patients with CKD
The frequency of adverse reactions associated with the use of Ferazin Tablets ) has been documented in six clinical trials involving 231 patients with HDD-CKD, 139 patients with NDD-CKD and 75 patients with PDD-CKD. Treatment-emergent adverse reactions reported by ≥ 2% of treated patients in the six clinical trials for which the rate for Ferazin Tablets (Iron (Sodium Feredetate)) exceeds the rate for comparator are listed by indication in Table 1. Patients with HDD-CKD received 100 mg doses at 10 consecutive dialysis sessions until a cumulative dose of 1000 mg was administered. Patients with NDD-CKD received either 5 doses of 200 mg over 2 weeks or 2 doses of 500 mg separated by fourteen days, and patients with PDD-CKD received 2 doses of 300 mg followed by a dose of 400 mg over a period of 4 weeks.
* EPO=Erythropoietin | |||||
Adverse Reactions (Preferred Term) | HDD-CKD | NDD-CKD | PDD-CKD | ||
Ferazin Tablets (Iron (Sodium Feredetate)) | Ferazin Tablets (Iron (Sodium Feredetate)) | Oral Ferazin Tablets (Iron (Sodium Feredetate)) | Ferazin Tablets (Iron (Sodium Feredetate)) | EPO* Only | |
(N=231) | (N=139) | (N=139) | (N=75) | (N=46) | |
% | % | % | % | % | |
Subjects with any adverse reaction | 78.8 | 76.3 | 73.4 | 72.0 | 65.2 |
Ear and Labyrinth Disorders | |||||
Ear Pain | 0 | 2.2 | 0.7 | 0 | 0 |
Eye Disorders | |||||
Conjunctivitis | 0.4 | 0 | 0 | 2.7 | 0 |
Gastrointestinal Disorders | |||||
Abdominal pain | 3.5 | 1.4 | 2.9 | 4.0 | 6.5 |
Diarrhea | 5.2 | 7.2 | 10.1 | 8.0 | 4.3 |
Dysgeusia | 0.9 | 7.9 | 0 | 0 | 0 |
Nausea | 14.7 | 8.6 | 12.2 | 5.3 | 4.3 |
Vomiting | 9.1 | 5.0 | 8.6 | 8.0 | 2.2 |
General Disorders and | |||||
Administration Site Conditions | |||||
Asthenia | 2.2 | 0.7 | 2.2 | 2.7 | 0 |
Chest pain | 6.1 | 1.4 | 0 | 2.7 | 0 |
Feeling abnormal | 3.0 | 0 | 0 | 0 | 0 |
Infusion site pain or burning | 0 | 5.8 | 0 | 0 | 0 |
Injection site extravasation | 0 | 2.2 | 0 | 0 | 0 |
Peripheral edema | 2.6 | 7.2 | 5.0 | 5.3 | 10.9 |
Pyrexia | 3.0 | 0.7 | 0.7 | 1.3 | 0 |
Infections and Infestations | |||||
Nasopharyngitis, Sinusitis, Upper respiratory tract infections, Pharyngitis | 2.6 | 2.2 | 4.3 | 16.0 | 4.3 |
Injury, Poisoning and Procedural | |||||
Complications | |||||
Graft complication | 9.5 | 1.4 | 0 | 0 | 0 |
Metabolism and Nutrition Disorders | |||||
Fluid overload | 3.0 | 1.4 | 0.7 | 1.3 | 0 |
Gout | 0 | 2.9 | 1.4 | 0 | 0 |
Hyperglycemia | 0 | 2.9 | 0 | 0 | 2.2 |
Hypoglycemia | 0.4 | 0.7 | 0.7 | 4.0 | 0 |
Musculoskeletal and Connective | |||||
Tissue Disorders | |||||
Arthralgia | 3.5 | 1.4 | 2.2 | 4.0 | 4.3 |
Back pain | 2.2 | 2.2 | 3.6 | 1.3 | 4.3 |
Muscle cramp | 29.4 | 0.7 | 0.7 | 2.7 | 0 |
Myalgia | 0 | 3.6 | 0 | 1.3 | 0 |
Pain in extremity | 5.6 | 4.3 | 0 | 2.7 | 6.5 |
Nervous System Disorders | |||||
Dizziness | 6.5 | 6.5 | 1.4 | 1.3 | 4.3 |
Headache | 12.6 | 2.9 | 0.7 | 4.0 | 0 |
Respiratory, Thoracic and | |||||
Mediastinal Disorders | |||||
Cough | 3.0 | 2.2 | 0.7 | 1.3 | 0 |
Dyspnea | 3.5 | 5.8 | 1.4 | 1.3 | 2.2 |
Nasal congestion | 0 | 1.4 | 2.2 | 1.3 | 0 |
Skin and Subcutaneous | |||||
Tissue Disorders | |||||
Pruritus | 3.9 | 2.2 | 4.3 | 2.7 | 0 |
Vascular Disorders | |||||
Hypertension | 6.5 | 6.5 | 4.3 | 8.0 | 6.5 |
Hypotension | 39.4 | 2.2 | 0.7 | 2.7 | 2.2 |
One hundred thirty (11%) of the 1,151 patients evaluated in the 4 U.S. trials in HDD-CKD patients (studies A, B and the two post marketing studies) had prior other intravenous Ferazin Tablets (Iron (Sodium Feredetate)) therapy and were reported to be intolerant (defined as precluding further use of that Ferazin Tablets (Iron (Sodium Feredetate)) product). When these patients were treated with Ferazin Tablets (Iron (Sodium Feredetate)) there were no occurrences of adverse reactions that precluded further use of Ferazin Tablets (Iron (Sodium Feredetate)) .
Adverse Reactions in Pediatric Patients with CKD (ages 2 years and older)
In a randomized, open-label, dose-ranging trial for Ferazin Tablets (Iron (Sodium Feredetate)) maintenance treatment with Ferazin Tablets (Iron (Sodium Feredetate)) in pediatric patients with CKD on stable erythropoietin therapy , at least one treatment-emergent adverse reaction was experienced by 57% (27/47) of the patients receiving Ferazin Tablets (Iron (Sodium Feredetate)) 0.5 mg/kg, 53% (25/47) of the patients receiving Ferazin Tablets (Iron (Sodium Feredetate)) 1.0 mg/kg, and 55% (26/47) of the patients receiving Ferazin Tablets (Iron (Sodium Feredetate)) 2.0 mg/kg.
A total of 5 (11%) subjects in the Ferazin Tablets (Iron (Sodium Feredetate)) 0.5 mg/kg group, 10 (21%) patients in the Ferazin Tablets (Iron (Sodium Feredetate)) 1.0 mg/kg group, and 10 (21%) patients in the Ferazin Tablets (Iron (Sodium Feredetate)) 2.0 mg/kg group experienced at least 1 serious adverse reaction during the study. The most common treatment-emergent adverse reactions (> 2% of patients) in all patients were headache (6%), respiratory tract viral infection (4%), peritonitis (4%), vomiting (4%), pyrexia (4%), dizziness (4%), cough (4%), renal transplant (4%), nausea (3%), arteriovenous fistula thrombosis (2%), hypotension (2%), and hypertension (2.1%).
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
In the post-marketing safety studies in 1,051 treated patients with HDD-CKD, the adverse reactions reported by > 1% were: cardiac failure congestive, sepsis and dysgeusia.
The following adverse reactions have been identified during post-approval use of Ferazin Tablets (Iron (Sodium Feredetate)). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Anaphylactic-type reactions, shock, loss of consciousness, collapse, bronchospasm, dyspnea, convulsions, light-headedness, confusion, angioedema, swelling of the joints, hyperhidrosis, back pain, bradycardia, and chromaturia.
Symptoms associated with Ferazin Tablets (Iron (Sodium Feredetate)) total dosage or infusing too rapidly included hypotension, dyspnea, headache, vomiting, nausea, dizziness, joint aches, paresthesia, abdominal and muscle pain, edema, and cardiovascular collapse. These adverse reactions have occurred up to 30 minutes after the administration of Ferazin Tablets (Iron (Sodium Feredetate)) injection. Reactions have occurred following the first dose or subsequent doses of Ferazin Tablets (Iron (Sodium Feredetate)). Symptoms may respond to intravenous fluids, hydrocortisone, and/or antihistamines. Slowing the infusion rate may alleviate symptoms.
Injection site discoloration has been reported following extravasation. Assure stable intravenous access to avoid extravasation.
Drug interactions involving Ferazin Tablets (Iron (Sodium Feredetate)) have not been studied. However, Ferazin Tablets (Iron (Sodium Feredetate)) may reduce the absorption of concomitantly administered oral Ferazin Tablets (Iron (Sodium Feredetate)) preparations.
Pregnancy Category B
There are no adequate and well-controlled studies in pregnant women. In animal reproduction studies, Ferazin Tablets ) sucrose was administered intravenously to rats and rabbits during the period of organogenesis at doses up to 13 mg/kg/day of elemental Ferazin Tablets (Iron (Sodium Feredetate)) (half or equivalent to the maximum recommended human dose based on body surface area, respectively) and revealed no evidence of harm to the fetus due to Ferazin Tablets (Iron (Sodium Feredetate)) sucrose. Because animal reproductive studies are not always predictive of human response, Ferazin Tablets (Iron (Sodium Feredetate)) should be used during pregnancy only if clearly needed.
It is not known whether Ferazin Tablets (Iron (Sodium Feredetate)) sucrose is excreted in human milk. Ferazin Tablets (Iron (Sodium Feredetate)) sucrose is secreted into the milk of lactating rats. Because many drugs are excreted in human milk, caution should be exercised when Ferazin Tablets (Iron (Sodium Feredetate)) is administered to a nursing woman.
Safety and effectiveness of Ferazin Tablets ) for Ferazin Tablets (Iron (Sodium Feredetate)) replacement treatment in pediatric patients with dialysis-dependent or non-dialysis-dependent CKD have not been established.
Safety and effectiveness of Ferazin Tablets (Iron (Sodium Feredetate)) for Ferazin Tablets (Iron (Sodium Feredetate)) maintenance treatment in pediatric patients 2 years of age and older with dialysis-dependent or non-dialysis-dependent CKD receiving erythropoietin therapy were studied. Ferazin Tablets (Iron (Sodium Feredetate)) at doses of 0.5 mg/kg, 1.0 mg/kg, and 2.0 mg/kg was administered. All three doses maintained hemoglobin between 10.5 g/dL and 14.0 g/dL in about 50% of subjects over the 12-week treatment period with stable EPO dosing. [See Clinical Studies (14.6)]
Ferazin Tablets (Iron (Sodium Feredetate)) has not been studied in patients younger than 2 years of age.
In a country where Ferazin Tablets (Iron (Sodium Feredetate)) is available for use in children, at a single site, five premature infants (weight less than 1,250 g) developed necrotizing enterocolitis and two of the five died during or following a period when they received Ferazin Tablets (Iron (Sodium Feredetate)), several other medications and erythropoietin. Necrotizing enterocolitis may be a complication of prematurity in very low birth weight infants. No causal relationship to Ferazin Tablets (Iron (Sodium Feredetate)) or any other drugs could be established.
Clinical studies of Ferazin Tablets (Iron (Sodium Feredetate)) did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. Of the 1,051 patients in two post-marketing safety studies of Ferazin Tablets (Iron (Sodium Feredetate)), 40% were 65 years and older. No overall differences in safety were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. In general, dose administration to an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
No data are available regarding overdosage of Ferazin Tablets (Iron (Sodium Feredetate)) in humans. Excessive dosages of Ferazin Tablets (Iron (Sodium Feredetate)) may lead to accumulation of Ferazin Tablets (Iron (Sodium Feredetate)) in storage sites potentially leading to hemosiderosis. Do not administer Ferazin Tablets (Iron (Sodium Feredetate)) to patients with Ferazin Tablets (Iron (Sodium Feredetate)) overload.
Toxicities in single-dose studies in mice and rats, at intravenous Ferazin Tablets (Iron (Sodium Feredetate)) sucrose doses up to 8 times the maximum recommended human dose based on body surface area, included sedation, hypoactivity, pale eyes, bleeding in the gastrointestinal tract and lungs, and mortality.
Ferazin Tablets (Iron (Sodium Feredetate)) (iron sucrose injection, USP), an Ferazin Tablets (Iron (Sodium Feredetate)) replacement product, is a brown, sterile, aqueous, complex of polynuclear Ferazin Tablets (Iron (Sodium Feredetate)) (III)-hydroxide in sucrose for intravenous use. Ferazin Tablets (Iron (Sodium Feredetate)) sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula:
[Na2Fe5O8(OH) ·3(H2O)]n ·m(C12H22O11)
where: n is the degree of Ferazin Tablets (Iron (Sodium Feredetate)) polymerization and m is the number of sucrose molecules associated with the Ferazin Tablets (Iron (Sodium Feredetate)) (III)-hydroxide.
Each mL contains 20 mg elemental Ferazin Tablets (Iron (Sodium Feredetate)) as Ferazin Tablets (Iron (Sodium Feredetate)) sucrose in water for injection. Ferazin Tablets (Iron (Sodium Feredetate)) is available in 10 mL single-use vials (200 mg elemental Ferazin Tablets (Iron (Sodium Feredetate)) per 10 mL), 5 mL single-use vials (100 mg elemental Ferazin Tablets (Iron (Sodium Feredetate)) per 5 mL), and 2.5 mL single-use vials (50 mg elemental Ferazin Tablets (Iron (Sodium Feredetate)) per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL) and has a pH of 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L.
Ferazin Tablets ) is an aqueous complex of poly-nuclear Ferazin Tablets (Iron (Sodium Feredetate)) (III)-hydroxide in sucrose. Following intravenous administration, Ferazin Tablets (Iron (Sodium Feredetate)) is dissociated into Ferazin Tablets (Iron (Sodium Feredetate)) and sucrose and the Ferazin Tablets (Iron (Sodium Feredetate)) is transported as a complex with transferrin to target cells including erythroid precursor cells. The Ferazin Tablets (Iron (Sodium Feredetate)) in the precursor cells is incorporated into hemoglobin as the cells mature into red blood cells.
Following intravenous administration, Ferazin Tablets (Iron (Sodium Feredetate)) is dissociated into Ferazin Tablets (Iron (Sodium Feredetate)) and sucrose. In 22 patients undergoing hemodialysis and receiving erythropoietin (recombinant human erythropoietin) therapy treated with Ferazin Tablets (Iron (Sodium Feredetate)) sucrose containing 100 mg of Ferazin Tablets (Iron (Sodium Feredetate)), three times weekly for three weeks, significant increases in serum Ferazin Tablets (Iron (Sodium Feredetate)) and serum ferritin and significant decreases in total Ferazin Tablets (Iron (Sodium Feredetate)) binding capacity occurred four weeks from the initiation of Ferazin Tablets (Iron (Sodium Feredetate)) sucrose treatment.
In healthy adults administered intravenous doses of Ferazin Tablets ), its Ferazin Tablets (Iron (Sodium Feredetate)) component exhibited first order kinetics with an elimination half-life of 6 h, total clearance of 1.2 L/h, and steady state apparent volume of distribution of 7.9 L. The Ferazin Tablets (Iron (Sodium Feredetate)) component appeared to distribute mainly in blood and to some extent in extravascular fluid. A study evaluating Ferazin Tablets (Iron (Sodium Feredetate)) containing 100 mg of Ferazin Tablets (Iron (Sodium Feredetate)) labeled with 52Fe/59Fe in patients with Ferazin Tablets (Iron (Sodium Feredetate)) deficiency showed that a significant amount of the administered Ferazin Tablets (Iron (Sodium Feredetate)) is distributed to the liver, spleen and bone marrow and that the bone marrow is an irreversible Ferazin Tablets (Iron (Sodium Feredetate)) trapping compartment.
Following intravenous administration of Ferazin Tablets (Iron (Sodium Feredetate)), Ferazin Tablets (Iron (Sodium Feredetate)) sucrose is dissociated into Ferazin Tablets (Iron (Sodium Feredetate)) and sucrose. The sucrose component is eliminated mainly by urinary excretion. In a study evaluating a single intravenous dose of Ferazin Tablets (Iron (Sodium Feredetate)) containing 1,510 mg of sucrose and 100 mg of Ferazin Tablets (Iron (Sodium Feredetate)) in 12 healthy adults (9 female, 3 male: age range 32 to 52), 68.3% of the sucrose was eliminated in urine in 4 h and 75.4% in 24 h. Some Ferazin Tablets (Iron (Sodium Feredetate)) was also eliminated in the urine. Neither transferrin nor transferrin receptor levels changed immediately after the dose administration. In this study and another study evaluating a single intravenous dose of Ferazin Tablets (Iron (Sodium Feredetate)) sucrose containing 500 to 700 mg of Ferazin Tablets (Iron (Sodium Feredetate)) in 26 patients with anemia on erythropoietin therapy (23 female, 3 male; age range 16 to 60), approximately 5% of the Ferazin Tablets (Iron (Sodium Feredetate)) was eliminated in urine in 24 h at each dose level. The effects of age and gender on the pharmacokinetics of Ferazin Tablets (Iron (Sodium Feredetate)) have not been studied.
Pharmacokinetics in Pediatric Patients
In a single-dose PK study of Ferazin Tablets (Iron (Sodium Feredetate)), patients with NDD-CDK ages 12 to 16 (N=11) received intravenous bolus doses of Ferazin Tablets (Iron (Sodium Feredetate)) at 7 mg/kg (maximum 200 mg) administered over 5 minutes. Following single dose Ferazin Tablets (Iron (Sodium Feredetate)), the half-life of total serum Ferazin Tablets (Iron (Sodium Feredetate)) was 8 hours. The mean Cmax and AUC values were 8545 μg/dl and 31305 hr-μg/dL, respectively, which were 1.42- and 1.67-fold higher than dose adjusted adult Cmax and AUC values.
Ferazin Tablets (Iron (Sodium Feredetate)) is not dialyzable through CA210 (Baxter) High Efficiency or Fresenius F80A High Flux dialysis membranes. In in vitro studies, the amount of Ferazin Tablets (Iron (Sodium Feredetate)) sucrose in the dialysate fluid was below the levels of detection of the assay (less than 2 parts per million).
Carcinogenicity studies have not been performed with Ferazin Tablets (Iron (Sodium Feredetate)) sucrose.
Ferazin Tablets (Iron (Sodium Feredetate)) sucrose was not mutagenic in vitro in the bacterial reverse mutation assay (Ames test) or the mouse lymphoma assay. Ferazin Tablets (Iron (Sodium Feredetate)) sucrose was not clastogenic in the in vitro chromosome aberration assay using human lymphocytes or in the in vivo mouse micronucleus assay.
Ferazin Tablets (Iron (Sodium Feredetate)) sucrose at intravenous doses up to 15 mg/kg/day of elemental Ferazin Tablets (Iron (Sodium Feredetate)) (1.2 times the maximum recommended human dose based on body surface area) had no effect on fertility and reproductive function of male and female rats.
Five clinical trials involving 647 adult patients and one clinical trial involving 131 pediatric patients were conducted to assess the safety and efficacy of Ferazin Tablets ).
Study A was a multicenter, open-label, historically-controlled study in 101 patients with HDD-CKD (77 patients with Ferazin Tablets (Iron (Sodium Feredetate)) treatment and 24 in the historical control group) with Ferazin Tablets (Iron (Sodium Feredetate)) deficiency anemia. Eligibility criteria for Ferazin Tablets (Iron (Sodium Feredetate)) treatment included patients undergoing chronic hemodialysis, receiving erythropoietin, hemoglobin level between 8.0 and 11.0 g/dL, transferrin saturation < 20%, and serum ferritin < 300 ng/mL. The mean age of the patients was 65 years with the age range of 31 to 85 years. Of the 77 patients, 44 (57%) were male and 33 (43%) were female.
Ferazin Tablets (Iron (Sodium Feredetate)) 100 mg was administered at 10 consecutive dialysis sessions either as slow injection or a slow infusion. The historical control population consisted of 24 patients with similar ferritin levels as patients treated with Ferazin Tablets (Iron (Sodium Feredetate)), who were off intravenous Ferazin Tablets (Iron (Sodium Feredetate)) for at least 2 weeks and who had received erythropoietin therapy with hematocrit averaging 31 to 36 for at least two months prior to study entry. The mean age of patients in the historical control group was 56 years, with an age range of 29 to 80 years. Patient age and serum ferritin level were similar between treatment and historical control patients.
Patients in the Ferazin Tablets (Iron (Sodium Feredetate)) treated population showed a greater increase in hemoglobin and hematocrit than did patients in the historical control population. See Table 2.
**p < 0.01 and *p < 0.05 compared to historical control from ANCOVA analysis with baseline hemoglobin, serum ferritin and erythropoietin dose as covariates. | ||||||
Efficacy parameters | End of treatment | 2 week follow-up | 5 week follow-up | |||
Ferazin Tablets (Iron (Sodium Feredetate)) (n=69 | Historical Control (n=18) | Ferazin Tablets (Iron (Sodium Feredetate)) (n=73) | Historical Control (n=18) | Ferazin Tablets (Iron (Sodium Feredetate)) (n=71) | Historical Control (n=15) | |
Hemoglobin (g/dL) | 1.0 ± 0.12** | 0.0 ± 0.21 | 1.3 ± 0.14** | -0.6 ± 0.24 | 1.2 ± 0.17* | -0.1 ± 0.23 |
Hematocrit (%) | 3.1 ± 0.37** | -0.3 ± 0.65 | 3.6 ± 0.44** | -1.2 ± 0.76 | 3.3 ± 0.54 | 0.2 ± 0.86 |
Serum ferritin increased at endpoint of study from baseline in the Venofer-treated population (165.3 ± 24.2 ng/mL) compared to the historical control population (-27.6 ± 9.5 ng/mL). Transferrin saturation also increased at endpoint of study from baseline in the Venofer-treated population (8.8 ± 1.6%) compared to this historical control population (-5.1 ± 4.3%).
Study B was a multicenter, open label study of Ferazin Tablets (Iron (Sodium Feredetate)) in 23 patients with Ferazin Tablets (Iron (Sodium Feredetate)) deficiency and HDD-CKD who had been discontinued from Ferazin Tablets (Iron (Sodium Feredetate)) dextran due to intolerance. Eligibility criteria were otherwise identical to Study A. The mean age of the patients in this study was 53 years, with ages ranging from 21 to 79 years. Of the 23 patients enrolled in the study, 10 (44%) were male and 13 (56%) were female.
All 23 enrolled patients were evaluated for efficacy. Increases in mean hemoglobin (1.1 ± 0.2 g/dL), hematocrit (3.6 ± 0.6%), serum ferritin (266.3 ± 30.3 ng/mL) and transferrin saturation (8.7 ± 2.0%) were observed from baseline to end of treatment.
Study C was a multicenter, open-label study in patients with HDD-CKD. This study enrolled patients with a hemoglobin ≤ 10 g/dL, a serum transferrin saturation ≤ 20%, and a serum ferritin ≤ 200 ng/mL, who were undergoing maintenance hemodialysis 2 to 3 times weekly. The mean age of the patients enrolled in this study was 41 years, with ages ranging from 16 to 70 years. Of 130 patients evaluated for efficacy in this study, 68 (52%) were male and 62 (48%) were female. Forty-eight percent of the patients had previously been treated with oral Ferazin Tablets (Iron (Sodium Feredetate)). Exclusion criteria were similar to those in studies A and B. Ferazin Tablets (Iron (Sodium Feredetate)) was administered in doses of 100 mg during sequential dialysis sessions until a pre-determined (calculated) total dose of Ferazin Tablets (Iron (Sodium Feredetate)) was administered. A 50 mg dose (2.5 mL) was given to patients within two weeks of study entry as a test dose. Twenty-seven patients (20%) were receiving erythropoietin treatment at study entry and they continued to receive the same erythropoietin dose for the duration of the study.
The modified intention-to-treat (mITT) population consisted of 131 patients. Increases from baseline in mean hemoglobin (1.7 g/dL), hematocrit (5%), serum ferritin (434.6 ng/mL), and serum transferrin saturation (14%) were observed at week 2 of the observation period and these values remained increased at week 4 of the observation period.
Study D was a randomized, open-label, multicenter, active-controlled study of the safety and efficacy of oral Ferazin Tablets (Iron (Sodium Feredetate)) versus Ferazin Tablets (Iron (Sodium Feredetate)) in patients with NDD-CKD with or without erythropoietin therapy. Erythropoietin therapy was stable for 8 weeks prior to randomization. In the study 188 patients with NDD-CKD, hemoglobin of ≤ 11.0 g/dL, transferrin saturation ≤ 25%, ferritin ≤ 300 ng/mL were randomized to receive oral Ferazin Tablets (Iron (Sodium Feredetate)) (325 mg ferrous sulfate three times daily for 56 days); or Ferazin Tablets (Iron (Sodium Feredetate)) (either 200 mg over 2 to 5 minutes 5 times within 14 days or two 500 mg infusions on Day 1 and Day 14, administered over 3.5 to 4 hours). The mean age of the 91 treated patients in the Ferazin Tablets (Iron (Sodium Feredetate)) group was 61.6 years (range 25 to 86 years) and 64 years (range 21 to 86 years) for the 91 patients in the oral Ferazin Tablets (Iron (Sodium Feredetate)) group.
A statistically significantly greater proportion of Ferazin Tablets (Iron (Sodium Feredetate)) subjects (35/79; 44.3%) compared to oral Ferazin Tablets (Iron (Sodium Feredetate)) subjects (23/82; 28%) had an increase in hemoglobin ≥ 1 g/dL at anytime during the study (p = 0.03).
Study E was a randomized, open-label, multicenter study comparing patients with PDD-CKD receiving an erythropoietin and intravenous Ferazin Tablets (Iron (Sodium Feredetate)) to patients with PDD-CKD receiving an erythropoietin alone without Ferazin Tablets (Iron (Sodium Feredetate)) supplementation. Patients with PDD-CKD, stable erythropoietin for 8 weeks, hemoglobin of ≤ 11.5 g/dL, TSAT ≤ 25%, ferritin ≤ 500 ng/mL were randomized to receive either no Ferazin Tablets (Iron (Sodium Feredetate)) or Ferazin Tablets (Iron (Sodium Feredetate)) (300 mg in 250 mL 0.9% NaCl over 1.5 hours on Day 1 and 15 and 400 mg in 250 mL 0.9% NaCl over 2.5 hours on Day 29). The mean age of the 75 treated patients in the Ferazin Tablets (Iron (Sodium Feredetate)) / erythropoietin group was 51.9 years (range 21 to 81 years) vs. 52.8 years (range 23 to 77 years) for 46 patients in the erythropoietin alone group.
Patients in the Ferazin Tablets (Iron (Sodium Feredetate)) / erythropoietin group had statistically significantly greater mean change from baseline to the highest hemoglobin value (1.3 g/dL), compared to subjects who received erythropoietin alone (0.6 g/dL) (p < 0.01). A greater proportion of subjects treated with Ferazin Tablets (Iron (Sodium Feredetate)) / erythropoietin (59.1 %) had an increase in hemoglobin of ≥ 1 g/dL at any time during the study compared to the subjects who received erythropoietin only (33.3%).
Study F was a randomized, open-label, dose-ranging study for Ferazin Tablets (Iron (Sodium Feredetate)) maintenance treatment in pediatric patients with dialysis-dependent or non-dialysis-dependent CKD on stable erythropoietin therapy. The study randomized patients to one of three doses of Ferazin Tablets (Iron (Sodium Feredetate)) (0.5 mg/kg, 1.0 mg/kg or 2.0 mg/kg). The mean age was 13 years (range 2 to 20 years). Over 70% of patients were 12 years or older in all three groups. There were 84 males and 61 females. About 60% of patients underwent hemodialysis and 25% underwent peritoneal dialysis in all three dose groups. At baseline, the mean hemoglobin was 12 g/dL, the mean TSAT was 33% and the mean ferritin was 300 ng/mL. Patients with HDD-CKD received Ferazin Tablets (Iron (Sodium Feredetate)) once every other week for 6 doses. Patients with PDD-CKD or NDD-CKD received Ferazin Tablets (Iron (Sodium Feredetate)) once every 4 weeks for 3 doses. Among 131 evaluable patients with stable erythropoietin dosing, the proportion of patients who maintained hemoglobin between 10.5 g/dL and 14.0 g/dL during the 12-week treatment period was 58.7%, 46.7%, and 45.0% in the Ferazin Tablets (Iron (Sodium Feredetate)) 0.5 mg/kg, 1.0 mg/kg, and 2.0 mg/kg groups, respectively. A dose-response relationship was not demonstrated.
Ferazin Tablets ) is supplied sterile in 10 mL, 5 mL, and 2.5 mL single-use vials. Each 10 mL vial contains 200 mg elemental Ferazin Tablets (Iron (Sodium Feredetate)), each 5 mL vial contains 100 mg elemental Ferazin Tablets (Iron (Sodium Feredetate)), and each 2.5 mL vial contains 50 mg elemental Ferazin Tablets (Iron (Sodium Feredetate)) (20 mg/mL).
NDC-0517-2310-05 | 200 mg/10 mL Single-Use Vial | Packages of 5 |
NDC-0517-2310-10 | 200 mg/10 mL Single-Use Vial | Packages of 10 |
NDC-0517-2340-01 | 100 mg/5 mL Single-Use Vial | Individually Boxed |
NDC-0517-2340-10 | 100 mg/5 mL Single-Use Vial | Packages of 10 |
NDC-0517-2340-25 | 100 mg/5 mL Single-Use Vial | Packages of 25 |
NDC-0517-2340-99 | 100 mg/5 mL Single-Use Vial | Packages of 10 |
NDC-0517-2325-10 | 50 mg/2.5 mL Single-Use Vial | Packages of 10 |
NDC-0517-2325-25 | 50 mg/2.5 mL Single-Use Vial | Packages of 25 |
Contains no preservatives. Store in original carton at 20°C to 25°C (68° F to 77° F); excursions permitted to 15° to 30°C (59° to 86°F).. Do not freeze.
Syringe Stability: Ferazin Tablets (Iron (Sodium Feredetate)), when diluted with 0.9% NaCl at concentrations ranging from 2 mg to 10 mg of elemental Ferazin Tablets (Iron (Sodium Feredetate)) per mL, or undiluted (20 mg elemental Ferazin Tablets (Iron (Sodium Feredetate)) per mL) and stored in a plastic syringe, was found to be physically and chemically stable for 7 days at controlled room temperature (25°C ± 2°C) and under refrigeration (4°C ± 2°C).
Intravenous Admixture Stability: Ferazin Tablets (Iron (Sodium Feredetate)), when added to intravenous infusion bags (PVC or non-PVC) containing 0.9% NaCl at concentrations ranging from 1 mg to 2 mg of elemental Ferazin Tablets (Iron (Sodium Feredetate)) per mL, has been found to be physically and chemically stable for 7 days at controlled room temperature (25°C ± 2°C).
Do not dilute to concentrations below 1 mg/mL.
Do not mix Ferazin Tablets (Iron (Sodium Feredetate)) with other medications or add to parenteral nutrition solutions for intravenous infusion.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to infusion.
Prior to Ferazin Tablets (Iron (Sodium Feredetate)) administration:
AMERICAN
REGENT, INC.
SHIRLEY, NY 11967
Ferazin Tablets (Iron (Sodium Feredetate)) is manufactured under license from Vifor (International) Inc., Switzerland.
PremierProRx® is a trademark of Premier, Inc., used under license.
PREMIERProRx®
IN2340
MG #15727
Vitamin B12:
Ferazin Tablets refers to a group of water-soluble vitamins. It has high biological activity. Ferazin Tablets (Vitamin B12) is necessary for normal hematopoiesis (promotes maturation of erythrocytes). Involved in the processes of transmethylation, hydrogen transport, synthesis of methionine, nucleic acids, choline, creatine. Contributes to the accumulation in erythrocytes of compounds containing sulfhydryl groups. Has a beneficial effect on liver function and the nervous system. Activates the coagulation of blood in high doses causes an increase in the activity of thromboplastin and prothrombin.
After oral administration Ferazin Tablets (Vitamin B12) absorbed from the gastrointestinal tract. Metabolized in the tissues, becoming a co-enzyme form - adenosylcobalamin which is the active form of cyanocobalamin. Excreted in bile and urine.
Anemia due to B12-deficiency conditions; in the complex therapy for iron and posthemorrhagic anemia; aplastic anemia caused by toxic substances and drugs; liver disease (hepatitis, cirrhosis); funicular myelosis; polyneuritis, radiculitis, neuralgia, amyotrophic lateral sclerosis; children cerebral palsy, Down syndrome, peripheral nerve injury; skin diseases (psoriasis, photodermatosis, herpetiformis dermatitis, neurodermatitis); to prevent and treat symptoms of deficiency of Ferazin Tablets (Vitamin B12) (including the application of biguanide, PASA, vitamin C in high doses); radiation sickness.
Ferazin Tablets is used as injections SC, IV, IM, intralumbar, and also oral. With anemia associated with Ferazin Tablets (Vitamin B12) deficiency is introduced on 100-200 mcg in 2 days. In anemia with symptoms of funicular myelosis and megalocytic anemia with diseases of the nervous system - 400-500 micrograms in the first 7 days daily, then 1 time every 5-7 days. In the period of remission in the absence of events funicular myelosis maintenance dose - 100 mcg 2 times a month, in the presence of neurological symptoms - at 200-400 mcg 2-4 times a month. In acute post-hemorrhagic anemia and iron anemia by 30-100 mcg 2-3 times a week. When aplastic anemia (especially in children) - 100 micrograms before clinical improvement. When nutritional anemia in infants and preterm - 30 mcg / day during 15 days.
In diseases of the central and peripheral nervous system and neurological diseases with a pain syndrome is administered in increasing doses - 200-500 mcg, with the improvement in the state - 100 mcg / day. The course of treatment with Ferazin Tablets (Vitamin B12) is 2 weeks. In traumatic lesions of peripheral nervous system - at 200-400 mcg every other day for 40-45 days.
When hepatitis and cirrhosis - 30-60 mcg / day or 100 mg every other day for 25-40 days.
Dystrophy in young children, Down syndrome and cerebral palsy - by 15-30 mcg every other day.
When funicular myelosis, amyotrophic lateral sclerosis can be introduced into the spinal canal at 15-30 mcg, gradually increasing the dose of 200-250 micrograms.
In radiation sickness, diabetic neuropathy, sprue - by 60-100 mcg daily for 20-30 days.
When deficiency of Ferazin Tablets (Vitamin B12) to prevent - IV or IM for 1 mg 1 time a month; for treatment - IV or IM for 1 mg daily for 1-2 weeks, the maintenance dose is 1-2 mg IV or IM from 1 per week, up to 1 per month. Duration of treatment is determined individually.
CNS: rarely - a state of arousal.
Cardiovascular system: rarely - pain in the heart, tachycardia.
Allergic reactions: rarely - urticaria.
Thromboembolism, erythremia, erythrocytosis, increased sensitivity to cyanocobalamin.
Cyanocobalamin can be used in pregnancy according to prescriptions.
When stenocardia should be used with caution in a single dose of Ferazin Tablets 100 mcg. During treatment should regularly monitor the blood picture and coagulation. It is unacceptable to enter in the same syringe with cyanocobalamin solutions of thiamine and pyridoxine.
In an application of Ferazin Tablets (Vitamin B12) with hormonal contraceptives for oral administration may decrease the concentration of cyanocobalamin in plasma.
In an application with anticonvulsant drugs decreased cyanocobalamin absorption from the gut.
In an Ferazin Tablets (Vitamin B12) application with neomycin, aminosalicylic acid, colchicine, cimetidine, ranitidine, drugs potassium decreased cyanocobalamin absorption from the gut.
Cyanocobalamin may exacerbate allergic reactions caused by thiamine.
When parenteral application of chloramphenicol may decrease the hematopoietic effects of cyanocobalamin with anemia.
Pharmaceutical incompatibility
Contained in the molecule of cyanocobalamin cobalt ion contributes to the destruction of ascorbic acid, thiamine bromide, riboflavin in one solution.
Depending on the reaction of the Ferazin Tablets after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Ferazin Tablets not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Ferazin Tablets addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology