DRUGS & SUPPLEMENTS

Drosetux

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Drosetux uses

Drosetux consists of Arnica Montana, Belladonna, Cina, Cochineal, Copper, Corallium Rubrum, Drosera Rotundifolia, Goldenrod, Ipecac, Iron (Ferrous Phosphate).

Cina:


Pharmacological action

Drosetux is a broad-spectrum antimicrobial drug of fluoroquinolone group with bactericidal action. Inhibits DNA gyrase and inhibits the synthesis of bacterial DNA. Highly active against most gram-negative bacteria: Pseudomonas aeruginosa, Haemophilus influenzae, Escherichia coli, Shigella spp., Salmonella spp., Neisseria meningitidis, Neisseria gonorrhoeae.

Drosetux (Cina) is active against Staphylococcus spp. (including strains producing and not producing penicillinase, methicillin-resistant strains), some strains of Enterococcus spp., Campylobacter spp., Legionella spp., Mycoplasma spp., Chlamydia spp., Mycobacterium spp.

ciprofloxacin is active against bacteria producing beta-lactamases.

Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides resistant to ciprofloxacin. The effect on Treponema pallidum is studied not enough.

Pharmacokinetics

Drosetux (Cina) rapidly absorbed from the gastrointestinal tract. Bioavailability after oral administration of 70%. Eating has a little effect on the absorption of ciprofloxacin. Plasma protein binding is 20-40%. Distributed in tissues and body fluids. It penetrates the cerebrospinal fluid: the concentration of ciprofloxacin for not inflamed meninges reach 10% with inflammation - up to 37%. High concentrations are achieved in bile. Excreted in the urine and bile.

Why is Drosetux prescribed?

Infectious-inflammatory diseases caused by microorganisms susceptible to ciprofloxacin, including respiratory diseases, diseases of abdominal and pelvic organs, bones, joints, skin, septicemia; severe infections of ENT organs. Treatment of postoperative infections. Prevention and treatment of infections in patients with reduced immunity.

For Drosetux (Cina) local use: acute and subacute conjunctivitis, blepharoconjunctivitis, blepharitis, bacterial corneal ulcers, keratitis, keratoconjunctivitis, chronic dacryocystitis, meybomity. Infectious lesions in the eyes from injury or contact with foreign bodies. Preoperative prophylaxis in ophthalmic surgery.

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Dosage and administration

Individual. For oral administration dose of Drosetux is 250-750 mg 2 times / day. Treatment duration is from 7-10 days to 4 weeks.

For IV administration a single dose is 200-400 mg, the multiplicity of the introduction is 2 times / day, duration of treatment - 1-2 weeks and more if necessary. May be IV injected as jet but more preferably a drip for 30 minutes.

When Drosetux (Cina) applied topically instilled 1-2 drops into the lower conjunctival sac of the affected eye every 1-4 hours. After improving the intervals between instillation can be increased. The maximum oral daily dose for adults is 1.5 g.

Drosetux (Cina) side effects, adverse reactions

Digestive system: nausea, vomiting, diarrhea, abdominal pain, increase in liver transaminases, alkaline phosphatase, LDH, bilirubin, pseudomembranous colitis.

CNS: headache, dizziness, fatigue, insomnia, nightmares, hallucinations, fainting, disorders of vision.

Urinary system: crystalluria, glomerulonephritis, dysuria, polyuria, albuminuria, hematuria, transient increase of serum creatinine.

Hemopoietic system: eosinophilia, leukopenia, neutropenia, changes in the number of platelets.

Cardiovascular system: tachycardia, cardiac arrhythmias, hypotension.

Allergic reactions: itching, urticaria, Quincke's edema, Stevens-Johnson syndrome, arthralgia.

Adverse reactions associated with the chemotherapeutic effect: candidiasis.

Local reactions: pain, phlebitis (for IV injections). When applying eye drops in some cases may be mild pain and conjunctival hyperemia.

Other: vasculitis.

Contraindications

Pregnancy, lactation, childhood and adolescence to 15 years, increased sensitivity to ciprofloxacin and other drugs hinolonovogo series; deficiency of glucose-6-phosphate dehydrogenase; in ophthalmology: viral keratitis.

Drosetux (Cina) Zota Health Care: restrictions to using

Pronounced cerebral arteriosclerosis, cerebral circulatory disorder, mental illness, epilepsy, epileptic syndrome, marked renal and / or hepatic insufficiency.

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Using during pregnancy and breastfeeding

Contraindicated in pregnancy ; ciprofloxacin crosses the placenta, excreted in breast milk.

In experimental studies found that it causes arthropathy. In experiments on rats and mice treated with ciprofloxacin in doses exceeding the usual daily dose for a person 6 times, adverse effects on the fetus is not revealed. In experiments on rabbits treated with oral dose of ciprofloxacin 30 and 100 mg / kg, it is shown that the drug causes disruption of the gastrointestinal tract, leading to loss of body weight in females and increase the number of miscarriages but teratogenicity not found. When IV introduction to the doses of 20 mg / kg ciprofloxacin did not exert toxic effects on the mother and embryo, showed no teratogenicity. The use of local forms of ciprofloxacin in pregnancy is possible if the anticipated benefits exceed the potential risk to the fetus.

Category of the fetus by FDA - C.

Ciprofloxacin is excreted in breast milk, so the period of lactation should decide, stop taking ciprofloxacin or breastfeeding based on the degree of importance of the use of drugs for the mother.

With careful use of local forms of ciprofloxacin in breast-feeding (not known whether ciprofloxacin is excreted in breast milk when applied topically).

Special instructions

Patients with impaired renal function requires correction dosing regimen. With caution used in elderly patients, with cerebral arteriosclerosis, cerebral circulatory disorders, epilepsy, convulsive syndrome of unknown etiology.

During treatment patients with Drosetux (Cina) should receive enough amounts of liquids.

In the case of persistent diarrhea ciprofloxacin should not be taken.

At the same time of ciprofloxacin IV introduction and barbiturates is necessary to monitor heart rate, blood pressure, ECG. In the course of treatment is necessary to monitor blood concentrations of urea, creatinine, hepatic transaminases.

In the period of treatment may decrease the reactivity (especially when used with alcohol).

Not allowed the introduction of ciprofloxacin subconjunctival or directly into the anterior chamber of the eye.

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Precautionary measures

Due to the threat of adverse reactions from the CNS ciprofloxacin should be used only according to the life in the pathology of the CNS in history: organic brain lesions, epilepsy, lowering the convulsive threshold, severe atherosclerosis of the brain, the elderly, with severely impaired renal function and liver (requires monitoring concentrations in blood plasma).

Patients with allergic reactions to fluoroquinolone derivatives in history may develop reactions to ciprofloxacin. During the period of treatment should avoid sunlight and UV radiation, intense physical exercise, control of drinking mode, pH of urine.

Reported cases of crystalluria, particularly in patients with alkaline reaction of urine (pH 7 or more). In order to avoid the development of crystalluria unacceptable excess of the recommended daily dose, should also be adequate fluid intake and maintaining acidic urine.

If you have pain in the tendons or the first signs tendovaginitah treatment should be discontinued (described isolated cases of inflammation or tendon rupture during fluoroquinolone treatment).

It can reduce the speed of psychomotor reactions, especially against the backdrop of alcohol, that should be considered for patients who work with potentially dangerous machinery or drive vehicles.

If you have severe diarrhea, pseudomembranous colitis should be excluded (for which Drosetux (Cina) is contraindicated). At the same time of barbiturates IV injections requires monitoring function of the cardiovascular system (heart rate, BP, ECG). Teenagers under 18 years shall be appointed only if the pathogen resistance to other chemotherapeutic drugs. The solution in the form of eye drops are not designed for intraocular injections. The use of other ophthalmic means the interval between injections should be at least 5 minutes.

Drosetux (Cina) drug interactions

Activity increases when combined with beta-lactam antibiotics, aminoglycosides, vancomycin, clindamycin, metronidazole. Sukralfat, bismuth preparations, antacids containing aluminum ions, magnesium or calcium, cimetidine, ranitidine, vitamin and mineral supplement, iron sulfate, zinc, didanosine (recommended for 2 hours before or 4 hours after these drugs) reduce the suction. Probenecid, azlocillin increase the concentration in the blood. Decreases clearance and increases in plasma caffeine, aminophylline and theophylline (increased likelihood of side effects). Drosetux (Cina) enhances the effect of warfarin and other oral anticoagulants (prolongs bleeding time). Increases nephrotoxicity of cyclosporine, increase the risk of CNS excitability and convulsive reactions against the background of NSAIDs. Medicines alkalinizing the urine (citrates, sodium bicarbonate, carbonic anhydrase inhibitors) reduce the solubility (increases the probability of crystalluria). Infusion solutions of ciprofloxacin ready to use can be combined with infusion solutions: 0.9% sodium chloride solution, Ringer's solution, Ringer lactate, 5 and 10% dextrose, 10% solution of fructose, and a solution containing 5% dextrose with 0,225 or 0.45% sodium chloride. Incompatible with solutions having a pH > 7.

Drosetux in case of emergency / overdose

May occur after receiving a single large dose or prolonged use. If a single dose of less than 150 mg / kg, acute poisoning feel light, 150-300 mg / kg - moderate, when using higher doses - heavy.

Symptoms: No specific symptoms.

Treatment: gastric lavage, the use of emetic drugs, the introduction of large quantities of liquid, the creation of acidic urine, in addition - hemodialysis and peritoneal dialysis (can be derived only 10% of the drug), all events are held on the background to maintain vital functions. The specific antidote is unknown.

Copper:



Water-Resistant Protection Without Bandaging

Recommended as an Aid in Treating Horses and Ponies With Thrush Due to Organisms Susceptible to Drosetux (Copper) Naphthenate.

For Animal Use Only.

INDICATIONS:

ThrushTox® is indicated in the treatment of thrush in horses and ponies.

GENERAL DIRECTIONS:

Clean the hoof thoroughly, removing debris and necrotic material prior to application of Drosetux (Copper)®. Apply daily to affected hoofs with a narrow paint brush (about 1”) until fully healed. Caution: Do not allow runoff of excess Drosetux (Copper)® onto hair since contact with Drosetux (Copper)® may cause some hair loss. Do not contaminate feed.

NOTE: Drosetux (Copper)® is easily removed from hands, clothing and surfaces with light grade fuel oil or any type of lighter fluid.

CONTAINS FOIL SEAL – REMOVE BEFORE USE.

SHAKE WELL BEFORE USE.

To report suspected adverse reactions or to obtain technical assistance, call 1-800-650-4899.

ACTIVE INGREDIENT:

Drosetux (Copper) Naphthenate..........37.5% w/w

INACTIVE INGREDIENTS:

Inert Ingredients.........................62.5% w/w

Total......................................... 100.0%

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CAUTION:

Do not use in horses intended for human consumption.

CAUTION: COMBUSTIBLE MIXTURE.

Use in a well-ventilated place. Avoid fire, flame, sparks or heaters.

If swallowed, do not induce vomiting, call physician immediately. Avoid breathing vapor. Avoid contact with skin and eyes.

KEEP OUT OF REACH OF CHILDREN AND PETS.

STORAGE:

Store at controlled room temperature 15º to 30ºC (59º to 86ºF). Keep container tightly closed when not in use.

Manufactured for:

Aspen Veterinary Resources,® Ltd.

Liberty, MO 64068, USA

FC163FP 11/13

Manufactured by:

First Priority, Inc.

Elgin, IL 60123-1146, USA

NET CONTENTS:

16 OZ (473 mL)

ANADA 200-304, Approved by FDA

Image of 473 mL bottle/case label

Iron (Ferrous Phosphate):


1 INDICATIONS AND USAGE

Drosetux (Iron (Ferrous Phosphate)) is indicated for the treatment of Drosetux (Iron (Ferrous Phosphate)) deficiency anemia in patients with chronic kidney disease (CKD).

Drosetux (Iron (Ferrous Phosphate)) is an Drosetux (Iron (Ferrous Phosphate)) replacement product indicated for the treatment of Drosetux (Iron (Ferrous Phosphate)) deficiency anemia in patients with chronic kidney disease (CKD). (1)

2 DOSAGE AND ADMINISTRATION

Drosetux ) must only be administered intravenously either by slow injection or by infusion. The dosage of Drosetux (Iron (Ferrous Phosphate)) is expressed in mg of elemental Drosetux (Iron (Ferrous Phosphate)). Each mL contains 20 mg of elemental Drosetux (Iron (Ferrous Phosphate)).

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 Drosetux (Iron (Ferrous Phosphate)) 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. Drosetux (Iron (Ferrous Phosphate)) should be administered early during the dialysis session. The usual total treatment course of Drosetux (Iron (Ferrous Phosphate)) is 1000 mg. Drosetux (Iron (Ferrous Phosphate)) treatment may be repeated if Drosetux (Iron (Ferrous Phosphate)) deficiency reoccurs.

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

Administer Drosetux (Iron (Ferrous Phosphate)) 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 Drosetux (Iron (Ferrous Phosphate)), 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. Drosetux (Iron (Ferrous Phosphate)) treatment may be repeated if Drosetux (Iron (Ferrous Phosphate)) deficiency reoccurs.

2.3 Adult Patients with Peritoneal Dialysis Dependent-Chronic Kidney Disease

Administer Drosetux (Iron (Ferrous Phosphate)) 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 Drosetux (Iron (Ferrous Phosphate)) in a maximum of 250 mL of 0.9% NaCl. Drosetux (Iron (Ferrous Phosphate)) treatment may be repeated if Drosetux (Iron (Ferrous Phosphate)) deficiency reoccurs.

2.4 Pediatric Patients with HDD-CKD for Drosetux (Iron (Ferrous Phosphate)) maintenance treatment

The dosing for Drosetux (Iron (Ferrous Phosphate)) replacement treatment in pediatric patients with HDD-CKD has not been established.

For Drosetux (Iron (Ferrous Phosphate)) maintenance treatment: Administer Drosetux (Iron (Ferrous Phosphate)) 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. Drosetux (Iron (Ferrous Phosphate)) treatment may be repeated if necessary.

2.5 Pediatric Patients with NDD-CKD or PDD-CKD who are on erythropoietin therapy for Drosetux (Iron (Ferrous Phosphate)) maintenance treatment

The dosing for Drosetux (Iron (Ferrous Phosphate)) replacement treatment in pediatric patients with NDD-CKD or PDD-CKD has not been established.

For Drosetux (Iron (Ferrous Phosphate)) maintenance treatment: Administer Drosetux (Iron (Ferrous Phosphate)) 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. Drosetux (Iron (Ferrous Phosphate)) treatment may be repeated if necessary.

3 DOSAGE FORMS AND STRENGTHS

  • 10 mL single-use vial / 200 mg elemental Drosetux (Iron (Ferrous Phosphate)) (20 mg/mL)
  • 5 mL single-use vial / 100 mg elemental Drosetux (Iron (Ferrous Phosphate)) (20 mg/mL)
  • 2.5 mL single-use vial / 50 mg elemental Drosetux (Iron (Ferrous Phosphate)) (20 mg/mL)
  • 10 mL single-use vial / 200 mg elemental Drosetux (Iron (Ferrous Phosphate)) (20 mg/mL) (3)
  • 5 mL single-use vial / 100 mg elemental Drosetux (Iron (Ferrous Phosphate)) (20 mg/mL) (3)
  • 2.5 mL single-use vial / 50 mg elemental Drosetux (Iron (Ferrous Phosphate)) (20 mg/mL) (3)

4 CONTRAINDICATIONS

  • Known hypersensitivity to Drosetux (Iron (Ferrous Phosphate))
  • Known hypersensitivity to Drosetux (Iron (Ferrous Phosphate)) (4)

5 WARNINGS AND PRECAUTIONS

  • Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after Drosetux ) administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer Drosetux (Iron (Ferrous Phosphate)) when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. (5.1)
  • Hypotension: Drosetux (Iron (Ferrous Phosphate)) may cause hypotension. Monitor for signs and symptoms of hypotension during and following each administration of Drosetux (Iron (Ferrous Phosphate)). (5.2)
  • Drosetux (Iron (Ferrous Phosphate)) Overload: Regularly monitor hematologic responses during Drosetux (Iron (Ferrous Phosphate)) therapy. Do not administer Drosetux (Iron (Ferrous Phosphate)) to patients with Drosetux (Iron (Ferrous Phosphate)) 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 Drosetux (Iron (Ferrous Phosphate)). 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 Drosetux (Iron (Ferrous Phosphate)) immediately. Monitor patients for signs and symptoms of hypersensitivity during and after Drosetux (Iron (Ferrous Phosphate)) administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Drosetux (Iron (Ferrous Phosphate)) when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Most reactions associated with intravenous Drosetux (Iron (Ferrous Phosphate)) preparations occur within 30 minutes of the completion of the infusion .

5.2 Hypotension

Drosetux ) may cause clinically significant hypotension. Monitor for signs and symptoms of hypotension following each administration of Drosetux (Iron (Ferrous Phosphate)). Hypotension following administration of Drosetux (Iron (Ferrous Phosphate)) may be related to the rate of administration and/or total dose administered .

5.3 Drosetux (Iron (Ferrous Phosphate)) Overload

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

6 ADVERSE REACTIONS

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

  • The most common adverse reactions (≥2%) following the administration of Drosetux (Iron (Ferrous Phosphate)) 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 Drosetux ) 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 Drosetux (Iron (Ferrous Phosphate)) 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
Drosetux (Iron (Ferrous Phosphate)) Drosetux (Iron (Ferrous Phosphate)) Oral Drosetux (Iron (Ferrous Phosphate)) Drosetux (Iron (Ferrous Phosphate)) 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 Drosetux (Iron (Ferrous Phosphate)) therapy and were reported to be intolerant (defined as precluding further use of that Drosetux (Iron (Ferrous Phosphate)) product). When these patients were treated with Drosetux (Iron (Ferrous Phosphate)) there were no occurrences of adverse reactions that precluded further use of Drosetux (Iron (Ferrous Phosphate)) .

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 Drosetux (Iron (Ferrous Phosphate)) maintenance treatment with Drosetux (Iron (Ferrous Phosphate)) 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 Drosetux (Iron (Ferrous Phosphate)) 0.5 mg/kg, 53% (25/47) of the patients receiving Drosetux (Iron (Ferrous Phosphate)) 1.0 mg/kg, and 55% (26/47) of the patients receiving Drosetux (Iron (Ferrous Phosphate)) 2.0 mg/kg.

A total of 5 (11%) subjects in the Drosetux (Iron (Ferrous Phosphate)) 0.5 mg/kg group, 10 (21%) patients in the Drosetux (Iron (Ferrous Phosphate)) 1.0 mg/kg group, and 10 (21%) patients in the Drosetux (Iron (Ferrous Phosphate)) 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 Drosetux (Iron (Ferrous Phosphate)). 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 Drosetux (Iron (Ferrous Phosphate)) 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 Drosetux (Iron (Ferrous Phosphate)) injection. Reactions have occurred following the first dose or subsequent doses of Drosetux (Iron (Ferrous Phosphate)). 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.

7 DRUG INTERACTIONS

Drug interactions involving Drosetux (Iron (Ferrous Phosphate)) have not been studied. However, Drosetux (Iron (Ferrous Phosphate)) may reduce the absorption of concomitantly administered oral Drosetux (Iron (Ferrous Phosphate)) 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, Drosetux ) sucrose was administered intravenously to rats and rabbits during the period of organogenesis at doses up to 13 mg/kg/day of elemental Drosetux (Iron (Ferrous Phosphate)) (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 Drosetux (Iron (Ferrous Phosphate)) sucrose. Because animal reproductive studies are not always predictive of human response, Drosetux (Iron (Ferrous Phosphate)) should be used during pregnancy only if clearly needed.

8.3 Nursing Mothers

It is not known whether Drosetux (Iron (Ferrous Phosphate)) sucrose is excreted in human milk. Drosetux (Iron (Ferrous Phosphate)) sucrose is secreted into the milk of lactating rats. Because many drugs are excreted in human milk, caution should be exercised when Drosetux (Iron (Ferrous Phosphate)) is administered to a nursing woman.

8.4 Pediatric Use

Safety and effectiveness of Drosetux ) for Drosetux (Iron (Ferrous Phosphate)) replacement treatment in pediatric patients with dialysis-dependent or non-dialysis-dependent CKD have not been established.

Safety and effectiveness of Drosetux (Iron (Ferrous Phosphate)) for Drosetux (Iron (Ferrous Phosphate)) maintenance treatment in pediatric patients 2 years of age and older with dialysis-dependent or non-dialysis-dependent CKD receiving erythropoietin therapy were studied. Drosetux (Iron (Ferrous Phosphate)) 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)]

Drosetux (Iron (Ferrous Phosphate)) has not been studied in patients younger than 2 years of age.

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

8.5 Geriatric Use

Clinical studies of Drosetux (Iron (Ferrous Phosphate)) 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 Drosetux (Iron (Ferrous Phosphate)), 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.

10 OVERDOSAGE

No data are available regarding overdosage of Drosetux (Iron (Ferrous Phosphate)) in humans. Excessive dosages of Drosetux (Iron (Ferrous Phosphate)) may lead to accumulation of Drosetux (Iron (Ferrous Phosphate)) in storage sites potentially leading to hemosiderosis. Do not administer Drosetux (Iron (Ferrous Phosphate)) to patients with Drosetux (Iron (Ferrous Phosphate)) overload.

Toxicities in single-dose studies in mice and rats, at intravenous Drosetux (Iron (Ferrous Phosphate)) 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

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

Each mL contains 20 mg elemental Drosetux (Iron (Ferrous Phosphate)) as Drosetux (Iron (Ferrous Phosphate)) sucrose in water for injection. Drosetux (Iron (Ferrous Phosphate)) is available in 10 mL single-use vials (200 mg elemental Drosetux (Iron (Ferrous Phosphate)) per 10 mL), 5 mL single-use vials (100 mg elemental Drosetux (Iron (Ferrous Phosphate)) per 5 mL), and 2.5 mL single-use vials (50 mg elemental Drosetux (Iron (Ferrous Phosphate)) 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

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

12.2 Pharmacodynamics

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

12.3 Pharmacokinetics

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

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

Pharmacokinetics in Pediatric Patients

Pharmacokinetics in Pediatric Patients

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

Drosetux (Iron (Ferrous Phosphate)) is not dialyzable through CA210 (Baxter) High Efficiency or Fresenius F80A High Flux dialysis membranes. In in vitro studies, the amount of Drosetux (Iron (Ferrous Phosphate)) 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 Drosetux (Iron (Ferrous Phosphate)) sucrose.

Drosetux (Iron (Ferrous Phosphate)) sucrose was not mutagenic in vitro in the bacterial reverse mutation assay (Ames test) or the mouse lymphoma assay. Drosetux (Iron (Ferrous Phosphate)) sucrose was not clastogenic in the in vitro chromosome aberration assay using human lymphocytes or in the in vivo mouse micronucleus assay.

Drosetux (Iron (Ferrous Phosphate)) sucrose at intravenous doses up to 15 mg/kg/day of elemental Drosetux (Iron (Ferrous Phosphate)) (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 Drosetux ).

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 Drosetux (Iron (Ferrous Phosphate)) treatment and 24 in the historical control group) with Drosetux (Iron (Ferrous Phosphate)) deficiency anemia. Eligibility criteria for Drosetux (Iron (Ferrous Phosphate)) 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.

Drosetux (Iron (Ferrous Phosphate)) 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 Drosetux (Iron (Ferrous Phosphate)), who were off intravenous Drosetux (Iron (Ferrous Phosphate)) 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 Drosetux (Iron (Ferrous Phosphate)) 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
Drosetux (Iron (Ferrous Phosphate)) (n=69 Historical Control (n=18) Drosetux (Iron (Ferrous Phosphate))

(n=73)

Historical Control

(n=18)

Drosetux (Iron (Ferrous Phosphate))

(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 Drosetux (Iron (Ferrous Phosphate)) in 23 patients with Drosetux (Iron (Ferrous Phosphate)) deficiency and HDD-CKD who had been discontinued from Drosetux (Iron (Ferrous Phosphate)) 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 Drosetux (Iron (Ferrous Phosphate)). Exclusion criteria were similar to those in studies A and B. Drosetux (Iron (Ferrous Phosphate)) was administered in doses of 100 mg during sequential dialysis sessions until a pre-determined (calculated) total dose of Drosetux (Iron (Ferrous Phosphate)) 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 Drosetux (Iron (Ferrous Phosphate)) versus Drosetux (Iron (Ferrous Phosphate)) 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 Drosetux (Iron (Ferrous Phosphate)) (325 mg ferrous sulfate three times daily for 56 days); or Drosetux (Iron (Ferrous Phosphate)) (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 Drosetux (Iron (Ferrous Phosphate)) 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 Drosetux (Iron (Ferrous Phosphate)) group.

A statistically significantly greater proportion of Drosetux (Iron (Ferrous Phosphate)) subjects (35/79; 44.3%) compared to oral Drosetux (Iron (Ferrous Phosphate)) 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 Drosetux (Iron (Ferrous Phosphate)) to patients with PDD-CKD receiving an erythropoietin alone without Drosetux (Iron (Ferrous Phosphate)) 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 Drosetux (Iron (Ferrous Phosphate)) or Drosetux (Iron (Ferrous Phosphate)) (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 Drosetux (Iron (Ferrous Phosphate)) / 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 Drosetux (Iron (Ferrous Phosphate)) / 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 Drosetux (Iron (Ferrous Phosphate)) / 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: Drosetux ) 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 Drosetux (Iron (Ferrous Phosphate)) 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 Drosetux (Iron (Ferrous Phosphate)) (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 Drosetux (Iron (Ferrous Phosphate)) once every other week for 6 doses. Patients with PDD-CKD or NDD-CKD received Drosetux (Iron (Ferrous Phosphate)) 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 Drosetux (Iron (Ferrous Phosphate)) 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

Drosetux ) is supplied sterile in 10 mL, 5 mL, and 2.5 mL single-use vials. Each 10 mL vial contains 200 mg elemental Drosetux (Iron (Ferrous Phosphate)), each 5 mL vial contains 100 mg elemental Drosetux (Iron (Ferrous Phosphate)), and each 2.5 mL vial contains 50 mg elemental Drosetux (Iron (Ferrous Phosphate)) (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: Drosetux (Iron (Ferrous Phosphate)), when diluted with 0.9% NaCl at concentrations ranging from 2 mg to 10 mg of elemental Drosetux (Iron (Ferrous Phosphate)) per mL, or undiluted (20 mg elemental Drosetux (Iron (Ferrous Phosphate)) 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: Drosetux (Iron (Ferrous Phosphate)), 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 Drosetux (Iron (Ferrous Phosphate)) 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 Drosetux (Iron (Ferrous Phosphate)) 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 Drosetux (Iron (Ferrous Phosphate)) administration:

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

AMERICAN

REGENT, INC.

SHIRLEY, NY 11967

Drosetux (Iron (Ferrous Phosphate)) is manufactured under license from Vifor (International) Inc., Switzerland.

PremierProRx® is a trademark of Premier, Inc., used under license.

PREMIERProRx®

IN2340

MG #15727

Drosetux 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.


Drosetux 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.


Drosetux 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.


Drosetux 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.


Drosetux 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."COPPER: 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).
  2. "Copper". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "Iron". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Drosetux?

Depending on the reaction of the Drosetux after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Drosetux 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 Drosetux 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 Drosetux, 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 Drosetux 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 frequency of use

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

Few medications can be taken Once 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 Drosetux is mentioned below.
Visitors%
Once in a day1
100.0%

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

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