DRUGS & SUPPLEMENTS

Ferro Syrup

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Ferro Syrup uses

Ferro Syrup consists of Folic Acid, Iron (Iron III Hydroxide Polymaltose Complex), Vitamin B12.

Folic Acid:


INDICATIONS AND USAGE

Ferro Syrup (Folic Acid)® is a prescription iron supplement indicated for use in improving the nutritional status of iron deficiency.

CONTRAINDICATIONS

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.

PRECAUTIONS

Ferro Syrup (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.

ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of Ferro Syrup (Folic Acid) acid.

DOSAGE AND ADMINISTRATION

One tablet daily with or without food or as prescribed by a licensed healthcare provider with prescribing authority.

HOW SUPPLIED

Ferro Syrup (Folic Acid)® tablets are supplied in child-resistant bottles of 90 tablets (NDC 0037-6885-90)

KEEP OUT OF REACH OF CHILDREN.

STORAGE

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.

Ferro Syrup (Folic Acid) and the BIFERA logo are registered trademarks and the Ferro Syrup (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 (Iron III Hydroxide Polymaltose Complex):


1 INDICATIONS AND USAGE

Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) is indicated for the treatment of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) deficiency anemia in patients with chronic kidney disease (CKD).

Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) is an Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) replacement product indicated for the treatment of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) deficiency anemia in patients with chronic kidney disease (CKD). (1)

2 DOSAGE AND ADMINISTRATION

Ferro Syrup ) must only be administered intravenously either by slow injection or by infusion. The dosage of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) is expressed in mg of elemental Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)). Each mL contains 20 mg of elemental Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)).

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

2.1 Adult Patients with Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD)

Administer Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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. Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) should be administered early during the dialysis session. The usual total treatment course of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) is 1000 mg. Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) treatment may be repeated if Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) deficiency reoccurs.

2.2 Adult Patients with Non-Dialysis Dependent-Chronic Kidney Disease

Administer Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)), 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. Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) treatment may be repeated if Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) deficiency reoccurs.

2.3 Adult Patients with Peritoneal Dialysis Dependent-Chronic Kidney Disease

Administer Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) in a maximum of 250 mL of 0.9% NaCl. Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) treatment may be repeated if Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) deficiency reoccurs.

2.4 Pediatric Patients with HDD-CKD for Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) maintenance treatment

The dosing for Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) replacement treatment in pediatric patients with HDD-CKD has not been established.

For Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) maintenance treatment: Administer Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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. Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) treatment may be repeated if necessary.

2.5 Pediatric Patients with NDD-CKD or PDD-CKD who are on erythropoietin therapy for Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) maintenance treatment

The dosing for Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) replacement treatment in pediatric patients with NDD-CKD or PDD-CKD has not been established.

For Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) maintenance treatment: Administer Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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. Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) treatment may be repeated if necessary.

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3 DOSAGE FORMS AND STRENGTHS

  • 10 mL single-use vial / 200 mg elemental Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) (20 mg/mL)
  • 5 mL single-use vial / 100 mg elemental Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) (20 mg/mL)
  • 2.5 mL single-use vial / 50 mg elemental Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) (20 mg/mL)
  • 10 mL single-use vial / 200 mg elemental Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) (20 mg/mL) (3)
  • 5 mL single-use vial / 100 mg elemental Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) (20 mg/mL) (3)
  • 2.5 mL single-use vial / 50 mg elemental Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) (20 mg/mL) (3)

4 CONTRAINDICATIONS

  • Known hypersensitivity to Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex))
  • Known hypersensitivity to Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) (4)

5 WARNINGS AND PRECAUTIONS

  • Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after Ferro Syrup ) administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. (5.1)
  • Hypotension: Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) may cause hypotension. Monitor for signs and symptoms of hypotension during and following each administration of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)). (5.2)
  • Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) Overload: Regularly monitor hematologic responses during Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) therapy. Do not administer Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) to patients with Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) overload. (5.3)

5.1 Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)). 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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) immediately. Monitor patients for signs and symptoms of hypersensitivity during and after Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Most reactions associated with intravenous Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) preparations occur within 30 minutes of the completion of the infusion .

5.2 Hypotension

Ferro Syrup ) may cause clinically significant hypotension. Monitor for signs and symptoms of hypotension following each administration of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)). Hypotension following administration of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) may be related to the rate of administration and/or total dose administered .

5.3 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) Overload

Excessive therapy with parenteral Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) can lead to excess storage of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) with the possibility of iatrogenic hemosiderosis. All adult and pediatric patients receiving Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) require periodic monitoring of hematologic and Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). Do not administer Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) to patients with evidence of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) overload. Transferrin saturation (TSAT) values increase rapidly after intravenous administration of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) sucrose; do not perform serum Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) measurements for at least 48 hours after intravenous dosing .

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6 ADVERSE REACTIONS

The following serious adverse reactions associated with Ferro Syrup ) are described in other sections .

  • The most common adverse reactions (≥2%) following the administration of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) are diarrhea, nausea, vomiting, headache, dizziness, hypotension, pruritus, pain in extremity, arthralgia, back pain, muscle cramp, injection site reactions, chest pain, and peripheral edema. (6.1)

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 .

6.1 Adverse Reactions in Clinical Trials

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 Adults Patients with CKD

Adverse Reactions in Adult Patients with CKD

The frequency of adverse reactions associated with the use of Ferro Syrup ) 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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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
Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) Oral Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) therapy and were reported to be intolerant (defined as precluding further use of that Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) product). When these patients were treated with Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) there were no occurrences of adverse reactions that precluded further use of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) .

Adverse Reactions in Pediatric Patients with CKD (ages 2 years and older)

Adverse Reactions in Pediatric Patients with CKD (ages 2 years and older)

In a randomized, open-label, dose-ranging trial for Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) maintenance treatment with Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 0.5 mg/kg, 53% (25/47) of the patients receiving Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 1.0 mg/kg, and 55% (26/47) of the patients receiving Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 2.0 mg/kg.

A total of 5 (11%) subjects in the Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 0.5 mg/kg group, 10 (21%) patients in the Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 1.0 mg/kg group, and 10 (21%) patients in the Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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%).

6.2 Adverse Reactions from Post-Marketing Experience

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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)). 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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) injection. Reactions have occurred following the first dose or subsequent doses of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)). 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.

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7 DRUG INTERACTIONS

Drug interactions involving Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) have not been studied. However, Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) may reduce the absorption of concomitantly administered oral Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) preparations.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category B

Pregnancy Category B

There are no adequate and well-controlled studies in pregnant women. In animal reproduction studies, Ferro Syrup ) sucrose was administered intravenously to rats and rabbits during the period of organogenesis at doses up to 13 mg/kg/day of elemental Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) (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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) sucrose. Because animal reproductive studies are not always predictive of human response, Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) should be used during pregnancy only if clearly needed.

8.3 Nursing Mothers

It is not known whether Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) sucrose is excreted in human milk. Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) sucrose is secreted into the milk of lactating rats. Because many drugs are excreted in human milk, caution should be exercised when Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) is administered to a nursing woman.

8.4 Pediatric Use

Safety and effectiveness of Ferro Syrup ) for Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) replacement treatment in pediatric patients with dialysis-dependent or non-dialysis-dependent CKD have not been established.

Safety and effectiveness of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) for Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) maintenance treatment in pediatric patients 2 years of age and older with dialysis-dependent or non-dialysis-dependent CKD receiving erythropoietin therapy were studied. Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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)]

Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) has not been studied in patients younger than 2 years of age.

In a country where Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)), several other medications and erythropoietin. Necrotizing enterocolitis may be a complication of prematurity in very low birth weight infants. No causal relationship to Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) or any other drugs could be established.

8.5 Geriatric Use

Clinical studies of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)), 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.

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10 OVERDOSAGE

No data are available regarding overdosage of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) in humans. Excessive dosages of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) may lead to accumulation of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) in storage sites potentially leading to hemosiderosis. Do not administer Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) to patients with Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) overload.

Toxicities in single-dose studies in mice and rats, at intravenous Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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.

11 DESCRIPTION

Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) (iron sucrose injection, USP), an Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) replacement product, is a brown, sterile, aqueous, complex of polynuclear Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) (III)-hydroxide in sucrose for intravenous use. Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) polymerization and m is the number of sucrose molecules associated with the Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) (III)-hydroxide.

Each mL contains 20 mg elemental Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) as Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) sucrose in water for injection. Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) is available in 10 mL single-use vials (200 mg elemental Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) per 10 mL), 5 mL single-use vials (100 mg elemental Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) per 5 mL), and 2.5 mL single-use vials (50 mg elemental Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Ferro Syrup ) is an aqueous complex of poly-nuclear Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) (III)-hydroxide in sucrose. Following intravenous administration, Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) is dissociated into Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) and sucrose and the Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) is transported as a complex with transferrin to target cells including erythroid precursor cells. The Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) in the precursor cells is incorporated into hemoglobin as the cells mature into red blood cells.

12.2 Pharmacodynamics

Following intravenous administration, Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) is dissociated into Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) and sucrose. In 22 patients undergoing hemodialysis and receiving erythropoietin (recombinant human erythropoietin) therapy treated with Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) sucrose containing 100 mg of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)), three times weekly for three weeks, significant increases in serum Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) and serum ferritin and significant decreases in total Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) binding capacity occurred four weeks from the initiation of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) sucrose treatment.

12.3 Pharmacokinetics

In healthy adults administered intravenous doses of Ferro Syrup ), its Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) component appeared to distribute mainly in blood and to some extent in extravascular fluid. A study evaluating Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) containing 100 mg of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) labeled with 52Fe/59Fe in patients with Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) deficiency showed that a significant amount of the administered Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) is distributed to the liver, spleen and bone marrow and that the bone marrow is an irreversible Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) trapping compartment.

Following intravenous administration of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)), Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) sucrose is dissociated into Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) and sucrose. The sucrose component is eliminated mainly by urinary excretion. In a study evaluating a single intravenous dose of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) containing 1,510 mg of sucrose and 100 mg of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) sucrose containing 500 to 700 mg of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) in 26 patients with anemia on erythropoietin therapy (23 female, 3 male; age range 16 to 60), approximately 5% of the Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) was eliminated in urine in 24 h at each dose level. The effects of age and gender on the pharmacokinetics of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) have not been studied.

Pharmacokinetics in Pediatric Patients

Pharmacokinetics in Pediatric Patients

In a single-dose PK study of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)), patients with NDD-CDK ages 12 to 16 (N=11) received intravenous bolus doses of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) at 7 mg/kg (maximum 200 mg) administered over 5 minutes. Following single dose Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)), the half-life of total serum Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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.

Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) is not dialyzable through CA210 (Baxter) High Efficiency or Fresenius F80A High Flux dialysis membranes. In in vitro studies, the amount of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) sucrose in the dialysate fluid was below the levels of detection of the assay (less than 2 parts per million).

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies have not been performed with Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) sucrose.

Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) sucrose was not mutagenic in vitro in the bacterial reverse mutation assay (Ames test) or the mouse lymphoma assay. Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) sucrose was not clastogenic in the in vitro chromosome aberration assay using human lymphocytes or in the in vivo mouse micronucleus assay.

Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) sucrose at intravenous doses up to 15 mg/kg/day of elemental Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) (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.

14 CLINICAL STUDIES

Five clinical trials involving 647 adult patients and one clinical trial involving 131 pediatric patients were conducted to assess the safety and efficacy of Ferro Syrup ).

14.1 Study A: Hemodialysis Dependent-Chronic Kidney Disease (HDD–CKD)

Study A was a multicenter, open-label, historically-controlled study in 101 patients with HDD-CKD (77 patients with Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) treatment and 24 in the historical control group) with Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) deficiency anemia. Eligibility criteria for Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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.

Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)), who were off intravenous Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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
Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) (n=69 Historical Control (n=18) Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex))

(n=73)

Historical Control

(n=18)

Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex))

(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%).

14.2 Study B: Hemodialysis Dependent-Chronic Kidney Disease

Study B was a multicenter, open label study of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) in 23 patients with Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) deficiency and HDD-CKD who had been discontinued from Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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.

14.3 Study C: Hemodialysis Dependent-Chronic Kidney Disease

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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)). Exclusion criteria were similar to those in studies A and B. Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) was administered in doses of 100 mg during sequential dialysis sessions until a pre-determined (calculated) total dose of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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.

14.4 Study D: Non-Dialysis Dependent-Chronic Kidney Disease

Study D was a randomized, open-label, multicenter, active-controlled study of the safety and efficacy of oral Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) versus Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) (325 mg ferrous sulfate three times daily for 56 days); or Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) (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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) group.

A statistically significantly greater proportion of Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) subjects (35/79; 44.3%) compared to oral Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) subjects (23/82; 28%) had an increase in hemoglobin ≥ 1 g/dL at anytime during the study (p = 0.03).

14.5 Study E: Peritoneal Dialysis Dependent-Chronic Kidney Disease

Study E was a randomized, open-label, multicenter study comparing patients with PDD-CKD receiving an erythropoietin and intravenous Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) to patients with PDD-CKD receiving an erythropoietin alone without Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) or Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) (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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) / 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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) / 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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) / 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%).

14.6 Study F: Ferro Syrup ) Maintenance Treatment Dosing in Pediatric Patients Ages 2 years and Older with Chronic Kidney Disease

Study F was a randomized, open-label, dose-ranging study for Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) (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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) once every other week for 6 doses. Patients with PDD-CKD or NDD-CKD received Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 0.5 mg/kg, 1.0 mg/kg, and 2.0 mg/kg groups, respectively. A dose-response relationship was not demonstrated.

16 HOW SUPPLIED/storage and handling

16.1 How Supplied

Ferro Syrup ) is supplied sterile in 10 mL, 5 mL, and 2.5 mL single-use vials. Each 10 mL vial contains 200 mg elemental Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)), each 5 mL vial contains 100 mg elemental Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)), and each 2.5 mL vial contains 50 mg elemental Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) (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

16.2 Stability and Storage

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: Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)), when diluted with 0.9% NaCl at concentrations ranging from 2 mg to 10 mg of elemental Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) per mL, or undiluted (20 mg elemental Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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: Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)), 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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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 Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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.

17 PATIENT COUNSELING INFORMATION

Prior to Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) administration:

  • Question patients regarding any prior history of reactions to parenteral Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) products
  • Advise patients of the risks associated with Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex))
  • Advise patients to report any symptoms of hypersensitivity that may develop during and following Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) administration, such as rash, itching, dizziness, light-headedness, swelling, and breathing problems [see Warnings and Precautions (5)]

AMERICAN

REGENT, INC.

SHIRLEY, NY 11967

Ferro Syrup (Iron (Iron III Hydroxide Polymaltose Complex)) 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:


Pharmacological action

Ferro Syrup refers to a group of water-soluble vitamins. It has high biological activity. Ferro Syrup (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.

Pharmacokinetics

After oral administration Ferro Syrup (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.

Why is Ferro Syrup prescribed?

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 Ferro Syrup (Vitamin B12) (including the application of biguanide, PASA, vitamin C in high doses); radiation sickness.

Dosage and administration

Ferro Syrup is used as injections SC, IV, IM, intralumbar, and also oral. With anemia associated with Ferro Syrup (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 Ferro Syrup (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 Ferro Syrup (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.

Ferro Syrup (Vitamin B12) side effects, adverse reactions

CNS: rarely - a state of arousal.

Cardiovascular system: rarely - pain in the heart, tachycardia.

Allergic reactions: rarely - urticaria.

Ferro Syrup contraindications

Thromboembolism, erythremia, erythrocytosis, increased sensitivity to cyanocobalamin.

Ferro Syrup using during pregnancy and breastfeeding

Cyanocobalamin can be used in pregnancy according to prescriptions.

Special instructions

When stenocardia should be used with caution in a single dose of Ferro Syrup 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.

Ferro Syrup (Vitamin B12) drug interactions

In an application of Ferro Syrup (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 Ferro Syrup (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.

Ferro Syrup pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Ferro Syrup available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Ferro Syrup destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Ferro Syrup Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Ferro Syrup pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."FOLIC ACID INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "folic acid". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Ferro Syrup?

Depending on the reaction of the Ferro Syrup after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Ferro Syrup 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 Ferro Syrup 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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Review

sDrugs.com conducted a study on Ferro Syrup, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Ferro Syrup consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

One visitor reported useful

How is the drug Ferro Syrup useful in reducing or relieving the symptoms? How useful is it?
According to the survey conducted by the website sDrugs.com, there are variable results and below are the percentages of the users that say the medicine is useful to them and that say it is not helping them much. It is not ideal to continue taking the medication if you feel it is not helping you much. Contact your healthcare provider to check if there is a need to change the medicine or if there is a need to re-evaluate your condition. The usefulness of the medicine may vary from patient to patient, depending on the other diseases he is suffering from and slightly depends on the brand name.
Visitors%
Not useful1
100.0%

One visitor reported frequency of use

How often in a day do you take the medicine?
Are you taking the Ferro Syrup drug as prescribed by the doctor?

Few medications can be taken Twice in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sDrugs.com website users about the frequency of taking the drug Ferro Syrup is mentioned below.
Visitors%
Twice in a day1
100.0%

Three visitors reported age

Visitors%
16-292
66.7%
6-151
33.3%

Visitor reviews


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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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