Decan

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Decan uses

Decan consists of Chromium (Chromium Chloride Hexahydrate), Cobalt (Cobalt Gluconate Dihydrate), Copper (Copper Gluconate), Fluorine (Sodium Fluoride), Iodine (Sodium Iodide), Iron (Ferrous Gluconate Dihydrate), Manganese (Manganese Gluconate), Molybdenum (Ammonium Molybdate Tetrahydrate), Selenium (Sodium Selenite Pentahydrate), Zinc (Zinc Gluconate Trihydrate).

Copper (Copper Gluconate):



Water-Resistant Protection Without Bandaging

Recommended as an Aid in Treating Horses and Ponies With Thrush Due to Organisms Susceptible to Decan (Copper (Copper Gluconate)) 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 Decan (Copper (Copper Gluconate))®. Apply daily to affected hoofs with a narrow paint brush (about 1”) until fully healed. Caution: Do not allow runoff of excess Decan (Copper (Copper Gluconate))® onto hair since contact with Decan (Copper (Copper Gluconate))® may cause some hair loss. Do not contaminate feed.

NOTE: Decan (Copper (Copper Gluconate))® 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:

Decan (Copper (Copper Gluconate)) 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

Fluorine (Sodium Fluoride):


This medication is used to prevent cavities. It makes teeth stronger and more resistant to decay caused by acid and bacteria. This medication is not recommended for use in infants less than 6 months of age. This medication is not recommended for use in areas where the fluoride content in the water supply is greater than 0.6 parts per million. See Notes section for more information.

Iodine (Sodium Iodide):


Decan ) Tincture 7%

Directions:


Topical Antiseptic

Use full Strength for superficial cuts, wounds, abrasions, insect bites and bruises on the skin of animals. Apply Decan (Iodine (Sodium Iodide)) with a swab.

If necessary, clip hair around the area being treated and clean with soap and water.

Apply Decan (Iodine (Sodium Iodide)) Tincture 7% only once daily. Dilute product 3 to 1 if repeating application.

Do not apply under bandage.

Irritation may occur if used on tender skin areas. If redness, irritation, or swelling persists or increases, discontinue use and consult a veterinarian.


Storage:

Store at 2-30 degrees C (36-86 degrees F).

Keep container away from heat and out of sunlight. Rinse empty container thoroughly and discard.


DANGER - Poison


Caution:

If swallowed, give starch paste, milk, bread, egg white, or

activated charcoal. A 5% solutions of sodium thiosulfate

(Photographic (“hypc”) may be administered orally at a

rate of 10 ml per kilogram of body weight.


Eye irritant: Use only as directed. Avoid contact with eyes. In case of contact, flush eyes immediately with tepid water for at least 15 minutes. Consult a physician.


Avoid contamination of food.


Not for use on burns, deep cuts, or body cavities.

Decan ) Tincture 7%

image description

Iron (Ferrous Gluconate Dihydrate):


1 INDICATIONS AND USAGE

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

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

2 DOSAGE AND ADMINISTRATION

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

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

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

Administer Decan (Iron (Ferrous Gluconate Dihydrate)) 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 Decan (Iron (Ferrous Gluconate Dihydrate)), 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. Decan (Iron (Ferrous Gluconate Dihydrate)) treatment may be repeated if Decan (Iron (Ferrous Gluconate Dihydrate)) deficiency reoccurs.

2.3 Adult Patients with Peritoneal Dialysis Dependent-Chronic Kidney Disease

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

2.4 Pediatric Patients with HDD-CKD for Decan (Iron (Ferrous Gluconate Dihydrate)) maintenance treatment

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

For Decan (Iron (Ferrous Gluconate Dihydrate)) maintenance treatment: Administer Decan (Iron (Ferrous Gluconate Dihydrate)) 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. Decan (Iron (Ferrous Gluconate Dihydrate)) treatment may be repeated if necessary.

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

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

For Decan (Iron (Ferrous Gluconate Dihydrate)) maintenance treatment: Administer Decan (Iron (Ferrous Gluconate Dihydrate)) 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. Decan (Iron (Ferrous Gluconate Dihydrate)) treatment may be repeated if necessary.

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3 DOSAGE FORMS AND STRENGTHS

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

4 CONTRAINDICATIONS

  • Known hypersensitivity to Decan (Iron (Ferrous Gluconate Dihydrate))
  • Known hypersensitivity to Decan (Iron (Ferrous Gluconate Dihydrate)) (4)

5 WARNINGS AND PRECAUTIONS

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

5.2 Hypotension

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

5.3 Decan (Iron (Ferrous Gluconate Dihydrate)) Overload

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

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6 ADVERSE REACTIONS

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

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

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

A total of 5 (11%) subjects in the Decan (Iron (Ferrous Gluconate Dihydrate)) 0.5 mg/kg group, 10 (21%) patients in the Decan (Iron (Ferrous Gluconate Dihydrate)) 1.0 mg/kg group, and 10 (21%) patients in the Decan (Iron (Ferrous Gluconate Dihydrate)) 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 Decan (Iron (Ferrous Gluconate Dihydrate)). 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 Decan (Iron (Ferrous Gluconate Dihydrate)) 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 Decan (Iron (Ferrous Gluconate Dihydrate)) injection. Reactions have occurred following the first dose or subsequent doses of Decan (Iron (Ferrous Gluconate Dihydrate)). 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 Decan (Iron (Ferrous Gluconate Dihydrate)) have not been studied. However, Decan (Iron (Ferrous Gluconate Dihydrate)) may reduce the absorption of concomitantly administered oral Decan (Iron (Ferrous Gluconate Dihydrate)) 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, Decan ) sucrose was administered intravenously to rats and rabbits during the period of organogenesis at doses up to 13 mg/kg/day of elemental Decan (Iron (Ferrous Gluconate Dihydrate)) (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 Decan (Iron (Ferrous Gluconate Dihydrate)) sucrose. Because animal reproductive studies are not always predictive of human response, Decan (Iron (Ferrous Gluconate Dihydrate)) should be used during pregnancy only if clearly needed.

8.3 Nursing Mothers

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

8.4 Pediatric Use

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

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

Decan (Iron (Ferrous Gluconate Dihydrate)) has not been studied in patients younger than 2 years of age.

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

8.5 Geriatric Use

Clinical studies of Decan (Iron (Ferrous Gluconate Dihydrate)) 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 Decan (Iron (Ferrous Gluconate Dihydrate)), 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 Decan (Iron (Ferrous Gluconate Dihydrate)) in humans. Excessive dosages of Decan (Iron (Ferrous Gluconate Dihydrate)) may lead to accumulation of Decan (Iron (Ferrous Gluconate Dihydrate)) in storage sites potentially leading to hemosiderosis. Do not administer Decan (Iron (Ferrous Gluconate Dihydrate)) to patients with Decan (Iron (Ferrous Gluconate Dihydrate)) overload.

Toxicities in single-dose studies in mice and rats, at intravenous Decan (Iron (Ferrous Gluconate Dihydrate)) 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

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

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

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

12.2 Pharmacodynamics

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

12.3 Pharmacokinetics

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

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

Pharmacokinetics in Pediatric Patients

Pharmacokinetics in Pediatric Patients

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

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

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

Decan (Iron (Ferrous Gluconate Dihydrate)) sucrose at intravenous doses up to 15 mg/kg/day of elemental Decan (Iron (Ferrous Gluconate Dihydrate)) (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 Decan ).

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 Decan (Iron (Ferrous Gluconate Dihydrate)) treatment and 24 in the historical control group) with Decan (Iron (Ferrous Gluconate Dihydrate)) deficiency anemia. Eligibility criteria for Decan (Iron (Ferrous Gluconate Dihydrate)) 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.

Decan (Iron (Ferrous Gluconate Dihydrate)) 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 Decan (Iron (Ferrous Gluconate Dihydrate)), who were off intravenous Decan (Iron (Ferrous Gluconate Dihydrate)) 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 Decan (Iron (Ferrous Gluconate Dihydrate)) 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
Decan (Iron (Ferrous Gluconate Dihydrate)) (n=69 Historical Control (n=18) Decan (Iron (Ferrous Gluconate Dihydrate))

(n=73)

Historical Control

(n=18)

Decan (Iron (Ferrous Gluconate Dihydrate))

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

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

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

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

AMERICAN

REGENT, INC.

SHIRLEY, NY 11967

Decan (Iron (Ferrous Gluconate Dihydrate)) is manufactured under license from Vifor (International) Inc., Switzerland.

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

PREMIERProRx®

IN2340

MG #15727

Manganese (Manganese Gluconate):


INDICATIONS AND USAGE

Decan (Manganese (Manganese Gluconate)) 0.1 mg/mL (Manganese Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN).

Administration helps to maintain Decan (Manganese (Manganese Gluconate)) serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.

CONTRAINDICATIONS

None known.

WARNINGS

Direct intramuscular or intravenous injection of Decan (Manganese (Manganese Gluconate)) 0.1 mg/mL (Manganese Chloride Injection, USP) is contraindicated as the acidic pH of the solution (pH 2.0) may cause considerable tissue irritation.

Liver and/or biliary tract dysfunction may require omission or reduction of copper and Decan (Manganese (Manganese Gluconate)) doses because these elements are primarily eliminated in the bile.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS

General

Do not use unless solution is clear and seal is intact.

Decan ) 0.1 mg/mL (Manganese Chloride Injection, USP) should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. Solution contains no preservatives; discard unused portion immediately after admixture procedure is completed.

Laboratory Tests

Serum Decan (Manganese (Manganese Gluconate)) levels can be measured periodically at the discretion of the investigator. Because of the low serum concentration normally present, samples will usually be analyzed by a reference laboratory.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies to evaluate the carcinogenic potential of Decan ) 0.1 mg/mL (Manganese Chloride Injection, USP) have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Decan (Manganese (Manganese Gluconate)) 0.1 mg/mL (Manganese Chloride Injection, USP) additive is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Pregnancy Category C.

Animal reproduction studies have not been conducted with Decan (Manganese (Manganese Gluconate)) chloride. It is also not known whether Decan (Manganese (Manganese Gluconate)) chloride can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Decan (Manganese (Manganese Gluconate)) chloride should be given to a pregnant woman only if clearly indicated.

Geriatric Use

An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS

None known.

DRUG ABUSE AND DEPENDENCE

None known.

OVERDOSAGE

Decan (Manganese (Manganese Gluconate)) toxicity in TPN patients has not been reported.

DOSAGE AND ADMINISTRATION

Decan (Manganese (Manganese Gluconate)) 0.1 mg/mL (Manganese Chloride Injection, USP) contains 0.1 mg manganese/mL and is administered intravenously only after dilution. The additive should be administered in a volume of fluid not less than 100 mL. For the adult receiving TPN, the suggested additive dosage for Decan (Manganese (Manganese Gluconate)) is 0.15 to 0.8 mg/day (1.5 to 8 mL/day). For pediatric patients, a dosage of 2 to 10 mcg manganese/kg/day (0.02 to 0.1 mL/kg/day) is recommended.

Periodic monitoring of Decan (Manganese (Manganese Gluconate)) plasma levels is suggested as a guideline for subsequent administration.

Parenteral products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS .)

HOW SUPPLIED

Decan (Manganese (Manganese Gluconate)) 0.1 mg/mL (Manganese Chloride Injection, USP) is supplied in 10 mL Plastic Vials (NDC No. 0409-4091-01).

Store at 20 to 25°C (68 to 77°F)

Revised: November, 2009

Printed in USA EN-2320

Hospira, Inc., Lake Forest, IL 60045 USA

RL-0104


Selenium (Sodium Selenite Pentahydrate):



Rx Only

TRACE ELEMENT ADDITIVE FOR IV USE AFTER DILUTION

DESCRIPTION

Decan (Selenium (Sodium Selenite Pentahydrate)) Injection is a sterile, nonpyrogenic solution for use as an additive to solutions for Total Parenteral Nutrition (TPN).

Each mL contains Selenious Acid 65.4 mcg (equivalent to elemental Decan (Selenium (Sodium Selenite Pentahydrate)) 40 mcg/mL) and Water for Injection q.s. pH may be adjusted with nitric acid to 1.8 to 2.4.

CLINICAL PHARMACOLOGY

Decan (Selenium (Sodium Selenite Pentahydrate)) is part of glutathione peroxidase which protects cell components from oxidative damage due to peroxides produced in cellular metabolism.

Prolonged TPN support in humans has resulted in Decan (Selenium (Sodium Selenite Pentahydrate)) deficiency symptoms which include muscle pain and tenderness. The symptoms have been reported to respond to supplementation of TPN solutions with Decan (Selenium (Sodium Selenite Pentahydrate)).

Pediatric conditions, Keshan disease, and Kwashiorkor, have been associated with low dietary intake of Decan (Selenium (Sodium Selenite Pentahydrate)). The conditions are endemic to geographical areas with low Decan (Selenium (Sodium Selenite Pentahydrate)) soil content. Dietary supplementation with Decan (Selenium (Sodium Selenite Pentahydrate)) salts has been reported to reduce the incidence of the conditions among affected children.

Normal blood levels of Decan (Selenium (Sodium Selenite Pentahydrate)) in different human populations have been found to vary and depend on the Decan (Selenium (Sodium Selenite Pentahydrate)) content of the food consumed. Results of surveys carried out in some countries are tabulated below:



COUNTRY


Number of

Samples

Decan (Selenium (Sodium Selenite Pentahydrate)) (mcg/100 mL) (a)

Whole Blood


Blood Cells

Plasma/

Serum

(a) Mean values with or without standard deviation in parentheses, all other ranges.
(b) Age group unknown.
(c) Three children recovered from Kwashiorkor and the other six under treatment for other diseases.
(d) Low selenium-content soil area.
(e) Well nourished children, three recovered from Kwashiorkor and the other six under treatment for other diseases.
(f) Mean values from seven subjects.
Canada 254 Adults (37.9 ± 7.8) (23.6 ± 6.0) (14.4 ± 2.9)
England 8 (b) 26-37 (32) -- --
Guatemala &

Southern USA

10 Adults

9 Children (c)

19-28 (22)

(23 ± 5)

--

(36 ± 12)

--

(15 ± 5)

New Zealand (d) 113 Adults (5.4 ± 0.1) (6.6 ± 0.3) (4.3 ± 0.1)
Thailand 3 Adults

9 Children (e)

14.4-20.2

(12.0 ± 3.6) (f)

17.8-35.8

(19.5 ± 8.2)

8.1-12.5

(8.3 ± 2.2)

USA 210 Adults 15.7-25.6

(20.6)

-- --

Plasma Decan (Selenium (Sodium Selenite Pentahydrate)) levels of 0.3 and 0.9 mcg/100 mL have been reported to produce deficiency symptoms in humans.

Decan (Selenium (Sodium Selenite Pentahydrate)) is eliminated primarily in urine. However, significant endogenous losses through feces also occur. The rate of excretion and the relative importance of two routes varies with the chemical form of Decan (Selenium (Sodium Selenite Pentahydrate)) used in supplementation. Ancillary routes of elimination are lungs and skin.

INDICATIONS AND USAGE

Decan (Selenium (Sodium Selenite Pentahydrate)) Injection is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN). Administration of Decan (Selenium (Sodium Selenite Pentahydrate)) in TPN solutions helps to maintain plasma Decan (Selenium (Sodium Selenite Pentahydrate)) levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.

CONTRAINDICATIONS

Decan (Selenium (Sodium Selenite Pentahydrate)) Injection should not be given undiluted by direct injection into a peripheral vein because of the potential for infusion phlebitis.

WARNINGS

Decan (Selenium (Sodium Selenite Pentahydrate)) Injection can be toxic if given in excessive amounts. Supplementation of TPN solution with Decan (Selenium (Sodium Selenite Pentahydrate)) should be immediately discontinued if toxicity symptoms are observed. Frequent determination of plasma Decan (Selenium (Sodium Selenite Pentahydrate)) levels during TPN support and close medical supervision is recommended.

Decan (Selenium (Sodium Selenite Pentahydrate)) Injection is a hypotonic solution and should be administered in admixtures only.

This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS

As Decan ) is eliminated in urine and feces, Decan (Selenium (Sodium Selenite Pentahydrate)) supplements may be adjusted, reduced or omitted in renal dysfunction and/or gastrointestinal malfunction. In patients receiving blood transfusions, contribution from such transfusions should also be considered. Frequent Decan (Selenium (Sodium Selenite Pentahydrate)) plasma level determinations are suggested as a guideline.

In animals, Decan (Selenium (Sodium Selenite Pentahydrate)) has been reported to enhance the action of Vitamin E and decrease the toxicity of mercury, cadmium and arsenic.

Pregnancy

Teratogenic Effects

Pregnancy Category C: Decan (Selenium (Sodium Selenite Pentahydrate)) at high dose levels (15-30 mcg/egg) has been reported to have adverse embryological effects among chickens. There are however, no adequate and wellcontrolled studies in pregnant women. Decan (Selenium (Sodium Selenite Pentahydrate)) Injection should be used during pregnancy only if potential benefit justifies the potential risk to the fetus.

Presence of Decan (Selenium (Sodium Selenite Pentahydrate)) in placenta and umbilical cord blood has been reported in humans.

ADVERSE REACTIONS

The amount of Decan (Selenium (Sodium Selenite Pentahydrate)) present in Decan (Selenium (Sodium Selenite Pentahydrate)) Injection is small. Symptoms of toxicity from Decan (Selenium (Sodium Selenite Pentahydrate)) are unlikely to occur at the recommended dosage level.

OVERDOSAGE

Chronic toxicity in humans resulting from exposure to Decan (Selenium (Sodium Selenite Pentahydrate)) in industrial environments, intake of foods grown in seleniferous soils, use of selenium-contaminated water, and application of cosmetics containing Decan (Selenium (Sodium Selenite Pentahydrate)) has been reported in literature. Toxicity symptoms include hair loss, weakened nails, dermatitis, dental defects, gastrointestinal disorders, nervousness, mental depression, metallic taste, vomiting, and garlic odor of breath and sweat. Acute poisoning due to ingestion of large amounts of Decan (Selenium (Sodium Selenite Pentahydrate)) compounds has resulted in death with histopathological changes including fulminating peripheral vascular collapse, internal vascular congestion, diffusely hemorrhagic, congested and edematus lungs, brick-red color gastric mucosa. The death was preceded by coma.

No effective antidote to Decan (Selenium (Sodium Selenite Pentahydrate)) poisoning in humans is known. Animal studies have shown casein and linseed oil in feeds, reduced glutathione, arsenic, magnesium sulfate, and bromobenzene to afford limited protection.

DOSAGE AND ADMINISTRATION

Decan (Selenium (Sodium Selenite Pentahydrate)) Injection provides 40 mcg selenium/mL. For metabolically stable adults receiving TPN, the suggested additive dosage level is 20 to 40 mcg selenium/day. For pediatric patients, the suggested additive dosage level is 3 mcg/kg/day.

In adults, Decan (Selenium (Sodium Selenite Pentahydrate)) deficiency states resulting from long-term TPN support, Decan (Selenium (Sodium Selenite Pentahydrate)) as selenomethionine or selenious acid, administered intravenously at 100 mcg/day for a period of 24 and 31 days, respectively, has been reported to reverse deficiency symptoms without toxicity.

Aseptic addition of Decan (Selenium (Sodium Selenite Pentahydrate)) Injection to the TPN solution under laminar flow hood is recommended. Decan (Selenium (Sodium Selenite Pentahydrate)) is physically compatible with the electrolytes and other trace elements usually present in amino-acid/dextrose solution used for TPN. Frequent monitoring of plasma Decan (Selenium (Sodium Selenite Pentahydrate)) levels is suggested as a guideline for subsequent administration. The normal whole blood range for Decan (Selenium (Sodium Selenite Pentahydrate)) is approximately 10 to 37 mcg/100 mL.

Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.

HOW SUPPLIED

Decan (Selenium (Sodium Selenite Pentahydrate)) Injection containing selenious acid 65.4 mcg/mL (equivalent to elemental Decan (Selenium (Sodium Selenite Pentahydrate)) 40 mcg/mL).

NDC 0517-6510-25 10 mL Single Dose Vial Packaged in boxes of 25

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).

AMERICAN

REGENT, INC.

SHIRLEY, NY 11967

IN6510

Rev. 11/15

PRINCIPAL DISPLAY PANEL - Container

NDC 0517-6510-25

Decan (Selenium (Sodium Selenite Pentahydrate)) INJECTION

Decan (Selenium (Sodium Selenite Pentahydrate)) 400 mcg/10 mL

(40 mcg/mL)

10 mL

SINGLE DOSE VIAL

Trace Element Additive

FOR IV USE AFTER DILUTION

PRESERVATIVE FREE

Rx Only

AMERICAN REGENT, INC.

SHIRLEY, NY 11967

PRINCIPAL DISPLAY PANEL - Carton

Decan (Selenium (Sodium Selenite Pentahydrate)) INJECTION

Decan (Selenium (Sodium Selenite Pentahydrate)) 400 mcg/10 mL

(40 mcg/mL)

Trace Element Additive

NDC 0517-6510-25

25 x 10 mL

SINGLE DOSE VIALS

FOR INTRAVENOUS USE AFTER DILUTION PRESERVATIVE FREE Rx Only

Each mL contains: Selenious Acid 65.4 mcg, Water for Injection q.s.

pH adjusted with Nitric Acid. Sterile, nonpyrogenic.

WARNING: DISCARD UNUSED PORTION. Store at 20°-25°C (68°-77°F); excursions

permitted to 15°-30°C (59°-86°F).

Directions for Use: See Package Insert.

AMERICAN REGENT, INC.

SHIRLEY, NY 11967

Rev. 11/05

Container Carton

Zinc (Zinc Gluconate Trihydrate):


INDICATIONS AND USAGE

Decan (Zinc (Zinc Gluconate Trihydrate)) 1 mg/mL (Zinc Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain Decan (Zinc (Zinc Gluconate Trihydrate)) serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms.

CONTRAINDICATIONS

None known.

WARNINGS

Direct intramuscular or intravenous injection of Decan (Zinc (Zinc Gluconate Trihydrate)) 1 mg/mL (Zinc Chloride Injection, USP) is contraindicated as the acidic pH of the solution (2) may cause considerable tissue irritation.

Severe kidney disease may make it necessary to reduce or omit chromium and Decan (Zinc (Zinc Gluconate Trihydrate)) doses because these elements are primarily eliminated in the urine.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS

General

Do not use unless the solution is clear and the seal is intact.

Zinc 1 mg/mL should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. Solution contains no preservatives; discard unused portion immediately after admixture procedure is completed.

Zinc should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential for increased excretory loss of Decan (Zinc (Zinc Gluconate Trihydrate)) from a bolus injection. Administration of Decan (Zinc (Zinc Gluconate Trihydrate)) in the absence of copper may cause a decrease in serum copper levels.

Laboratory Tests

Periodic determinations of serum copper as well as Decan (Zinc (Zinc Gluconate Trihydrate)) are suggested as a guideline for subsequent Decan (Zinc (Zinc Gluconate Trihydrate)) administration.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies to evaluate the carcinogenic potential of Decan ) 1 mg/mL (Zinc Chloride Injection, USP) have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Decan (Zinc (Zinc Gluconate Trihydrate)) 1 mg/mL (Zinc Chloride Injection, USP) is administered to a nursing woman.

Pediatric Use

Pregnancy Category C. Animal reproduction studies have not been conducted with Decan ) chloride. It is also not known whether Decan (Zinc (Zinc Gluconate Trihydrate)) chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Decan (Zinc (Zinc Gluconate Trihydrate)) chloride should be given to a pregnant woman only if clearly needed.

Geriatric Use

An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS

None known.

DRUG ABUSE AND DEPENDENCE

None known.

OVERDOSAGE

Single intravenous doses of 1 to 2 mg zinc/kg body weight have been given to adult leukemic patients without toxic manifestations. However, acute toxicity was reported in an adult when 10 mg Decan (Zinc (Zinc Gluconate Trihydrate)) was infused over a period of one hour on each of four consecutive days. Profuse sweating, decreased level of consciousness, blurred vision, tachycardia (140/min), and marked hypothermia (94.2° F) on the fourth day were accompanied by a serum Decan (Zinc (Zinc Gluconate Trihydrate)) concentration of 207 mcg/dl. Symptoms abated within three hours.

Hyperamylasemia may be a sign of impending Decan (Zinc (Zinc Gluconate Trihydrate)) overdosage; patients receiving an inadvertent overdose (25 mg zinc/liter of TPN solution, equivalent to 50 to 70 mg zinc/day) developed hyperamylasemia (557 to 1850 Klein units; normal: 130 to 310).

Death resulted from an overdosage in which 1683 mg Decan (Zinc (Zinc Gluconate Trihydrate)) was delivered intravenously over the course of 60 hours to a 72 year old patient.

Symptoms of Decan (Zinc (Zinc Gluconate Trihydrate)) toxicity included hypotension (80/40 mm Hg), pulmonary edema, diarrhea, vomiting, jaundice, and oliguria, with a serum Decan (Zinc (Zinc Gluconate Trihydrate)) level of 4184 mcg/dl.

Calcium supplements may confer a protective effect against Decan (Zinc (Zinc Gluconate Trihydrate)) toxicity.

DOSAGE AND ADMINISTRATION

Decan (Zinc (Zinc Gluconate Trihydrate)) 1 mg/mL (Zinc Chloride Injection, USP) contains 1 mg zinc/mL and is administered intravenously only after dilution. The additive should be diluted prior to administration in a volume of fluid not less than 100 mL. For the metabolically stable adult receiving TPN, the suggested intravenous dosage is 2.5 to 4 mg zinc/day (2.5 to 4 mL/day). An additional 2 mg zinc/day (2 mL/day) is suggested for acute catabolic states. For the stable adult with fluid loss from the small bowel, an additional 12.2 mg zinc/liter of small bowel fluid lost (12.2 mL/liter of small bowel fluid lost), or an additional 17.1 mg zinc/kg of stool or ileostomy output (17.1 mL/kg of stool or ileostomy output) is recommended. Frequent monitoring of Decan (Zinc (Zinc Gluconate Trihydrate)) blood levels is suggested for patients receiving more than the usual maintenance dosage level of Decan (Zinc (Zinc Gluconate Trihydrate)).

For full term infants and children up to 5 years of age, 100 mcg zinc/kg/day (0.1 mL/kg/day) is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg zinc/kg/day (0.3 mL/kg/day) is suggested.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

HOW SUPPLIED

Decan (Zinc (Zinc Gluconate Trihydrate)) 1 mg/mL (Zinc Chloride Injection, USP) is supplied in 10 mL Plastic Vials (List No. 4090).

Store at 20 to 25°C (68 to 77°F).

Revised: October, 2004


© Hospira 2004 EN-0488 Printed in USA

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

10 mL Vial

Decan (Zinc (Zinc Gluconate Trihydrate))

1 mg/mL

Decan (Zinc (Zinc Gluconate Trihydrate)) Chloride Inj., USP

Rx only

FOR I.V. USE ONLY AFTER DILUTION.

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

Decan pharmaceutical active ingredients containing related brand and generic drugs:

Active 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.


Decan available forms, composition, doses:

Form 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.


Decan destination | category:

Destination 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.


Decan Anatomical Therapeutic Chemical codes:

A 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.


Decan pharmaceutical companies:

Pharmaceutical 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. "Iodine". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "Selenium". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Decan?

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

Visitor reported useful

No survey data has been collected yet

Two visitors reported side effects

Did you get side effects while taking the Decan drug, or were there no side effects?
According to the survey conducted by website sdrugs.com users, the below-mentioned percentages indicate the number of people experiencing the side effects and the number of people not experiencing the side effects when taking Decan medicine. Every drug produces minimal side effects, and they are negligible most times, when compared to the desired effect [use] of the medicine. Side effects depend on the dose you are taking, any drug interactions that happen when you are on other medications, if the patient is sensitive, and other associated conditions. If you cannot tolerate the side effects, consult your doctor immediately, so he can either adjust the dose or change the medication.
Visitors%
No side effects2
100.0%

One visitor reported price estimates

What is your opinion about drug cost? Did you feel the cost is apt, or did you feel it is expensive?
The report given by the sdrugs.com website users shows the following figures about several people who felt the medicine Decan is expensive, and the medicine is not expensive. The results are mixed. The perception of the cost of the medicine to be expensive or not depends on the brand name of the medicine, country, and place where it is sold, and the affordability of the patient. You can choose a generic drug in the place of the branded drug to save the cost. The efficiency of the medicine will not vary if it is generic or a branded one.
Visitors%
Not expensive1
100.0%

One visitor reported frequency of use

How often in a day do you take the medicine?
Are you taking the Decan 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 Decan is mentioned below.
Visitors%
Twice in a day1
100.0%

One visitor reported doses

What is the dose of Decan drug you are taking?
According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 201-500mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
201-500mg1
100.0%

Two visitors reported time for results

What is the time duration Decan drug must be taken for it to be effective or for it to reduce the symptoms?
Most chronic conditions need at least some time so the dose and the drug action gets adjusted to the body to get the desired effect. The stastistics say sdrugs.com website users needed 3 month to notice the result from using Decan drug. The time needed to show improvement in health condition after using the medicine Decan need not be same for all the users. It varies based on other factors.
Visitors%
3 month1
50.0%
1 day1
50.0%

Visitor reported administration

No survey data has been collected yet

Four visitors reported age

Visitors%
16-292
50.0%
46-602
50.0%

Visitor reviews


There are no reviews yet. Be the first to write one!


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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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