Doctor's Choice Multivitamins and Minerals for Eyes

Folic Acid:

• Indications and usage
• Contraindications
• Precautions
• Adverse reactions
• Dosage and administration
• How supplied
• Storage
• Doctor's Choice Multivitamins and Minerals for Eyes (Folic Acid) reviews

INDICATIONS AND USAGE

Doctor's Choice Multivitamins and Minerals for Eyes (Folic Acid)^® is a prescription iron supplement indicated for use in improving the nutritional status of iron deficiency.

CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindications to iron therapy.

PRECAUTIONS

Doctor's Choice Multivitamins and Minerals for Eyes (Folic Acid) acid when administered as a single agent in doses above 0.1 mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. While prescribing this nutritional supplement for pregnant women, nursing mothers, or for women prior to conception, their medical condition and other drugs, herbs, and/or supplements consumption should be considered.

ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of Doctor's Choice Multivitamins and Minerals for Eyes (Folic Acid) acid.

DOSAGE AND ADMINISTRATION

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

HOW SUPPLIED

Doctor's Choice Multivitamins and Minerals for Eyes (Folic Acid)^® tablets are supplied in child-resistant bottles of 90 tablets (NDC 0037-6885-90)

KEEP OUT OF REACH OF CHILDREN.

STORAGE

Store at controlled room temperature 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C (59°-86°F).

Dispense in a tight, light-resistant container to protect from light and moisture.

To report SUSPECTED ADVERSE REACTIONS contact Meda Pharmaceuticals Inc. at 1-888-349-5556 or FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch

Distributed by:

Meda Pharmaceuticals Inc.

Somerset New Jersey 08873-4120

© 2014 Meda Pharmaceuticals Inc.

U.S. Patent Nos. 7,585,527 and 8,080,520

Proferrin® is a registered trademark of Colorado BioLabs, Inc., Cozad, NE.

Doctor's Choice Multivitamins and Minerals for Eyes (Folic Acid) and the BIFERA logo are registered trademarks and the Doctor's Choice Multivitamins and Minerals for Eyes (Folic Acid) logo is a trademark of Alaven Pharmaceutical LLC, used under license by Meda Pharmaceuticals Inc.

MEDA PHARMACEUTICALS mark and logo are trademarks of Meda AB.

IN-6885-02 Rev 6/2014

Garlic:

• Doctor's Choice Multivitamins and Minerals for Eyes (Garlic) reviews

Ginkgo Biloba Leaf:

• Doctor's Choice Multivitamins and Minerals for Eyes (Ginkgo Biloba Leaf) reviews

Indication: Appears to be effective in: alleviating age-related memory impairment in some elderly people with mild to moderate age-related memory or cognitive impairment; improving cognitive function in healthy young to middle-aged people; improving symptoms of Alzheimer's, vascular or mixed dementia; improving damage to the visual field in patients with normal tension glaucoma; decreasing the number of painful attacks in patients with Raynaud's syndrome; and may improve symptoms of vertigo and dizziness in some patients.

The mechanism by which Doctor's Choice Multivitamins and Minerals for Eyes (Ginkgo Biloba Leaf) is thought to be effective for these conditions appears to be in part through active "ginkgolides" terpenoids and flavinoids that appear to inhibit platelet aggregation, neutrophil degranulation, and the induction of oxygen-free radical production

Iron:

• Indications and usage
• Dosage and administration
• Dosage forms and strengths
• Contraindications
• Warnings and precautions
• Adverse reactions
• Drug interactions
• Use in specific populations
• Overdosage
• Description
• Clinical pharmacology
• Nonclinical toxicology
• Clinical studies
• How supplied/storage and handling
• Patient counseling information
• Doctor's Choice Multivitamins and Minerals for Eyes (Iron) reviews

1 INDICATIONS AND USAGE

Doctor's Choice Multivitamins and Minerals for Eyes (Iron) is indicated for the treatment of Doctor's Choice Multivitamins and Minerals for Eyes (Iron) deficiency anemia in patients with chronic kidney disease (CKD).

Doctor's Choice Multivitamins and Minerals for Eyes (Iron) is an Doctor's Choice Multivitamins and Minerals for Eyes (Iron) replacement product indicated for the treatment of Doctor's Choice Multivitamins and Minerals for Eyes (Iron) deficiency anemia in patients with chronic kidney disease (CKD). (1)

2 DOSAGE AND ADMINISTRATION

Doctor's Choice Multivitamins and Minerals for Eyes must only be administered intravenously either by slow injection or by infusion. The dosage of Doctor's Choice Multivitamins and Minerals for Eyes (Iron) is expressed in mg of elemental Doctor's Choice Multivitamins and Minerals for Eyes (Iron). Each mL contains 20 mg of elemental Doctor's Choice Multivitamins and Minerals for Eyes (Iron).

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

Administer Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 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. Doctor's Choice Multivitamins and Minerals for Eyes (Iron) should be administered early during the dialysis session. The usual total treatment course of Doctor's Choice Multivitamins and Minerals for Eyes (Iron) is 1000 mg. Doctor's Choice Multivitamins and Minerals for Eyes (Iron) treatment may be repeated if Doctor's Choice Multivitamins and Minerals for Eyes (Iron) deficiency reoccurs.

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

Administer Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 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 Doctor's Choice Multivitamins and Minerals for Eyes (Iron), 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. Doctor's Choice Multivitamins and Minerals for Eyes (Iron) treatment may be repeated if Doctor's Choice Multivitamins and Minerals for Eyes (Iron) deficiency reoccurs.

2.3 Adult Patients with Peritoneal Dialysis Dependent-Chronic Kidney Disease

Administer Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 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 Doctor's Choice Multivitamins and Minerals for Eyes (Iron) in a maximum of 250 mL of 0.9% NaCl. Doctor's Choice Multivitamins and Minerals for Eyes (Iron) treatment may be repeated if Doctor's Choice Multivitamins and Minerals for Eyes (Iron) deficiency reoccurs.

2.4 Pediatric Patients with HDD-CKD for Doctor's Choice Multivitamins and Minerals for Eyes (Iron) maintenance treatment

The dosing for Doctor's Choice Multivitamins and Minerals for Eyes (Iron) replacement treatment in pediatric patients with HDD-CKD has not been established.

For Doctor's Choice Multivitamins and Minerals for Eyes (Iron) maintenance treatment: Administer Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 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. Doctor's Choice Multivitamins and Minerals for Eyes (Iron) treatment may be repeated if necessary.

2.5 Pediatric Patients with NDD-CKD or PDD-CKD who are on erythropoietin therapy for Doctor's Choice Multivitamins and Minerals for Eyes (Iron) maintenance treatment

The dosing for Doctor's Choice Multivitamins and Minerals for Eyes (Iron) replacement treatment in pediatric patients with NDD-CKD or PDD-CKD has not been established.

For Doctor's Choice Multivitamins and Minerals for Eyes (Iron) maintenance treatment: Administer Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 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. Doctor's Choice Multivitamins and Minerals for Eyes (Iron) treatment may be repeated if necessary.

3 DOSAGE FORMS AND STRENGTHS

• 10 mL single-use vial / 200 mg elemental Doctor's Choice Multivitamins and Minerals for Eyes (Iron) (20 mg/mL)
• 5 mL single-use vial / 100 mg elemental Doctor's Choice Multivitamins and Minerals for Eyes (Iron) (20 mg/mL)
• 2.5 mL single-use vial / 50 mg elemental Doctor's Choice Multivitamins and Minerals for Eyes (Iron) (20 mg/mL)

• 10 mL single-use vial / 200 mg elemental Doctor's Choice Multivitamins and Minerals for Eyes (Iron) (20 mg/mL) (3)
• 5 mL single-use vial / 100 mg elemental Doctor's Choice Multivitamins and Minerals for Eyes (Iron) (20 mg/mL) (3)
• 2.5 mL single-use vial / 50 mg elemental Doctor's Choice Multivitamins and Minerals for Eyes (Iron) (20 mg/mL) (3)

4 CONTRAINDICATIONS

• Known hypersensitivity to Doctor's Choice Multivitamins and Minerals for Eyes (Iron)

• Known hypersensitivity to Doctor's Choice Multivitamins and Minerals for Eyes (Iron) (4)

5 WARNINGS AND PRECAUTIONS

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

5.2 Hypotension

Doctor's Choice Multivitamins and Minerals for Eyes may cause clinically significant hypotension. Monitor for signs and symptoms of hypotension following each administration of Doctor's Choice Multivitamins and Minerals for Eyes (Iron). Hypotension following administration of Doctor's Choice Multivitamins and Minerals for Eyes (Iron) may be related to the rate of administration and/or total dose administered .

5.3 Doctor's Choice Multivitamins and Minerals for Eyes (Iron) Overload

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

6 ADVERSE REACTIONS

The following serious adverse reactions associated with Doctor's Choice Multivitamins and Minerals for Eyes are described in other sections .

• The most common adverse reactions (≥2%) following the administration of Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 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 Doctor's Choice Multivitamins and Minerals for Eyes 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 Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 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.

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 Doctor's Choice Multivitamins and Minerals for Eyes (Iron) therapy and were reported to be intolerant (defined as precluding further use of that Doctor's Choice Multivitamins and Minerals for Eyes (Iron) product). When these patients were treated with Doctor's Choice Multivitamins and Minerals for Eyes (Iron) there were no occurrences of adverse reactions that precluded further use of Doctor's Choice Multivitamins and Minerals for Eyes (Iron) .

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 Doctor's Choice Multivitamins and Minerals for Eyes (Iron) maintenance treatment with Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 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 Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 0.5 mg/kg, 53% (25/47) of the patients receiving Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 1.0 mg/kg, and 55% (26/47) of the patients receiving Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 2.0 mg/kg.

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

8.3 Nursing Mothers

It is not known whether Doctor's Choice Multivitamins and Minerals for Eyes (Iron) sucrose is excreted in human milk. Doctor's Choice Multivitamins and Minerals for Eyes (Iron) sucrose is secreted into the milk of lactating rats. Because many drugs are excreted in human milk, caution should be exercised when Doctor's Choice Multivitamins and Minerals for Eyes (Iron) is administered to a nursing woman.

8.4 Pediatric Use

Safety and effectiveness of Doctor's Choice Multivitamins and Minerals for Eyes for Doctor's Choice Multivitamins and Minerals for Eyes (Iron) replacement treatment in pediatric patients with dialysis-dependent or non-dialysis-dependent CKD have not been established.

Safety and effectiveness of Doctor's Choice Multivitamins and Minerals for Eyes (Iron) for Doctor's Choice Multivitamins and Minerals for Eyes (Iron) maintenance treatment in pediatric patients 2 years of age and older with dialysis-dependent or non-dialysis-dependent CKD receiving erythropoietin therapy were studied. Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 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)]

Doctor's Choice Multivitamins and Minerals for Eyes (Iron) has not been studied in patients younger than 2 years of age.

In a country where Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 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 Doctor's Choice Multivitamins and Minerals for Eyes (Iron), several other medications and erythropoietin. Necrotizing enterocolitis may be a complication of prematurity in very low birth weight infants. No causal relationship to Doctor's Choice Multivitamins and Minerals for Eyes (Iron) or any other drugs could be established.

8.5 Geriatric Use

Clinical studies of Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 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 Doctor's Choice Multivitamins and Minerals for Eyes (Iron), 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 Doctor's Choice Multivitamins and Minerals for Eyes (Iron) in humans. Excessive dosages of Doctor's Choice Multivitamins and Minerals for Eyes (Iron) may lead to accumulation of Doctor's Choice Multivitamins and Minerals for Eyes (Iron) in storage sites potentially leading to hemosiderosis. Do not administer Doctor's Choice Multivitamins and Minerals for Eyes (Iron) to patients with Doctor's Choice Multivitamins and Minerals for Eyes (Iron) overload.

Toxicities in single-dose studies in mice and rats, at intravenous Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 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

Doctor's Choice Multivitamins and Minerals for Eyes (Iron) (iron sucrose injection, USP), an Doctor's Choice Multivitamins and Minerals for Eyes (Iron) replacement product, is a brown, sterile, aqueous, complex of polynuclear Doctor's Choice Multivitamins and Minerals for Eyes (Iron) (III)-hydroxide in sucrose for intravenous use. Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 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 Doctor's Choice Multivitamins and Minerals for Eyes (Iron) polymerization and m is the number of sucrose molecules associated with the Doctor's Choice Multivitamins and Minerals for Eyes (Iron) (III)-hydroxide.

Each mL contains 20 mg elemental Doctor's Choice Multivitamins and Minerals for Eyes (Iron) as Doctor's Choice Multivitamins and Minerals for Eyes (Iron) sucrose in water for injection. Doctor's Choice Multivitamins and Minerals for Eyes (Iron) is available in 10 mL single-use vials (200 mg elemental Doctor's Choice Multivitamins and Minerals for Eyes (Iron) per 10 mL), 5 mL single-use vials (100 mg elemental Doctor's Choice Multivitamins and Minerals for Eyes (Iron) per 5 mL), and 2.5 mL single-use vials (50 mg elemental Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 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

Doctor's Choice Multivitamins and Minerals for Eyes is an aqueous complex of poly-nuclear Doctor's Choice Multivitamins and Minerals for Eyes (Iron) (III)-hydroxide in sucrose. Following intravenous administration, Doctor's Choice Multivitamins and Minerals for Eyes (Iron) is dissociated into Doctor's Choice Multivitamins and Minerals for Eyes (Iron) and sucrose and the Doctor's Choice Multivitamins and Minerals for Eyes (Iron) is transported as a complex with transferrin to target cells including erythroid precursor cells. The Doctor's Choice Multivitamins and Minerals for Eyes (Iron) in the precursor cells is incorporated into hemoglobin as the cells mature into red blood cells.

12.2 Pharmacodynamics

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

12.3 Pharmacokinetics

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

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

Pharmacokinetics in Pediatric Patients

Pharmacokinetics in Pediatric Patients

In a single-dose PK study of Doctor's Choice Multivitamins and Minerals for Eyes (Iron), patients with NDD-CDK ages 12 to 16 (N=11) received intravenous bolus doses of Doctor's Choice Multivitamins and Minerals for Eyes (Iron) at 7 mg/kg (maximum 200 mg) administered over 5 minutes. Following single dose Doctor's Choice Multivitamins and Minerals for Eyes (Iron), the half-life of total serum Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 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.

Doctor's Choice Multivitamins and Minerals for Eyes (Iron) is not dialyzable through CA210 (Baxter) High Efficiency or Fresenius F80A High Flux dialysis membranes. In in vitro studies, the amount of Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 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 Doctor's Choice Multivitamins and Minerals for Eyes (Iron) sucrose.

Doctor's Choice Multivitamins and Minerals for Eyes (Iron) sucrose was not mutagenic in vitro in the bacterial reverse mutation assay (Ames test) or the mouse lymphoma assay. Doctor's Choice Multivitamins and Minerals for Eyes (Iron) sucrose was not clastogenic in the in vitro chromosome aberration assay using human lymphocytes or in the in vivo mouse micronucleus assay.

Doctor's Choice Multivitamins and Minerals for Eyes (Iron) sucrose at intravenous doses up to 15 mg/kg/day of elemental Doctor's Choice Multivitamins and Minerals for Eyes (Iron) (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 Doctor's Choice Multivitamins and Minerals for Eyes.

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 Doctor's Choice Multivitamins and Minerals for Eyes (Iron) treatment and 24 in the historical control group) with Doctor's Choice Multivitamins and Minerals for Eyes (Iron) deficiency anemia. Eligibility criteria for Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 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.

Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 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 Doctor's Choice Multivitamins and Minerals for Eyes (Iron), who were off intravenous Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 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 Doctor's Choice Multivitamins and Minerals for Eyes (Iron) treated population showed a greater increase in hemoglobin and hematocrit than did patients in the historical control population. See Table 2.

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

A statistically significantly greater proportion of Doctor's Choice Multivitamins and Minerals for Eyes (Iron) subjects (35/79; 44.3%) compared to oral Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 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 Doctor's Choice Multivitamins and Minerals for Eyes (Iron) to patients with PDD-CKD receiving an erythropoietin alone without Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 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 Doctor's Choice Multivitamins and Minerals for Eyes (Iron) or Doctor's Choice Multivitamins and Minerals for Eyes (Iron) (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 Doctor's Choice Multivitamins and Minerals for Eyes (Iron) / 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 Doctor's Choice Multivitamins and Minerals for Eyes (Iron) / 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 Doctor's Choice Multivitamins and Minerals for Eyes (Iron) / 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: Doctor's Choice Multivitamins and Minerals for Eyes 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 Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 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 Doctor's Choice Multivitamins and Minerals for Eyes (Iron) (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 Doctor's Choice Multivitamins and Minerals for Eyes (Iron) once every other week for 6 doses. Patients with PDD-CKD or NDD-CKD received Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 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 Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 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

Doctor's Choice Multivitamins and Minerals for Eyes is supplied sterile in 10 mL, 5 mL, and 2.5 mL single-use vials. Each 10 mL vial contains 200 mg elemental Doctor's Choice Multivitamins and Minerals for Eyes (Iron), each 5 mL vial contains 100 mg elemental Doctor's Choice Multivitamins and Minerals for Eyes (Iron), and each 2.5 mL vial contains 50 mg elemental Doctor's Choice Multivitamins and Minerals for Eyes (Iron) (20 mg/mL).

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: Doctor's Choice Multivitamins and Minerals for Eyes (Iron), when diluted with 0.9% NaCl at concentrations ranging from 2 mg to 10 mg of elemental Doctor's Choice Multivitamins and Minerals for Eyes (Iron) per mL, or undiluted (20 mg elemental Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 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: Doctor's Choice Multivitamins and Minerals for Eyes (Iron), 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 Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 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 Doctor's Choice Multivitamins and Minerals for Eyes (Iron) 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 Doctor's Choice Multivitamins and Minerals for Eyes (Iron) administration:

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

AMERICAN

REGENT, INC.

SHIRLEY, NY 11967

Doctor's Choice Multivitamins and Minerals for Eyes (Iron) is manufactured under license from Vifor (International) Inc., Switzerland.

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

PREMIERProRx^®

IN2340

MG #15727

Selenium:

• Description
• Clinical pharmacology
• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) reviews

Rx Only

TRACE ELEMENT ADDITIVE FOR IV USE AFTER DILUTION

DESCRIPTION

Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) 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 Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) 40 mcg/mL) and Water for Injection q.s. pH may be adjusted with nitric acid to 1.8 to 2.4.

CLINICAL PHARMACOLOGY

Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) 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 Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) deficiency symptoms which include muscle pain and tenderness. The symptoms have been reported to respond to supplementation of TPN solutions with Doctor's Choice Multivitamins and Minerals for Eyes (Selenium).

Pediatric conditions, Keshan disease, and Kwashiorkor, have been associated with low dietary intake of Doctor's Choice Multivitamins and Minerals for Eyes (Selenium). The conditions are endemic to geographical areas with low Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) soil content. Dietary supplementation with Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) salts has been reported to reduce the incidence of the conditions among affected children.

Normal blood levels of Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) in different human populations have been found to vary and depend on the Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) content of the food consumed. Results of surveys carried out in some countries are tabulated below:

Plasma Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) levels of 0.3 and 0.9 mcg/100 mL have been reported to produce deficiency symptoms in humans.

Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) 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 Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) used in supplementation. Ancillary routes of elimination are lungs and skin.

INDICATIONS AND USAGE

Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) Injection is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN). Administration of Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) in TPN solutions helps to maintain plasma Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.

CONTRAINDICATIONS

Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) Injection should not be given undiluted by direct injection into a peripheral vein because of the potential for infusion phlebitis.

WARNINGS

Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) Injection can be toxic if given in excessive amounts. Supplementation of TPN solution with Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) should be immediately discontinued if toxicity symptoms are observed. Frequent determination of plasma Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) levels during TPN support and close medical supervision is recommended.

Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) 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 Doctor's Choice Multivitamins and Minerals for Eyes is eliminated in urine and feces, Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) 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 Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) plasma level determinations are suggested as a guideline.

In animals, Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) 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: Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) 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. Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) Injection should be used during pregnancy only if potential benefit justifies the potential risk to the fetus.

Presence of Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) in placenta and umbilical cord blood has been reported in humans.

ADVERSE REACTIONS

The amount of Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) present in Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) Injection is small. Symptoms of toxicity from Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) are unlikely to occur at the recommended dosage level.

OVERDOSAGE

Chronic toxicity in humans resulting from exposure to Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) in industrial environments, intake of foods grown in seleniferous soils, use of selenium-contaminated water, and application of cosmetics containing Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) 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 Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) 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 Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) 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

Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) 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, Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) deficiency states resulting from long-term TPN support, Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) 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 Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) Injection to the TPN solution under laminar flow hood is recommended. Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) is physically compatible with the electrolytes and other trace elements usually present in amino-acid/dextrose solution used for TPN. Frequent monitoring of plasma Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) levels is suggested as a guideline for subsequent administration. The normal whole blood range for Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) 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

Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) Injection containing selenious acid 65.4 mcg/mL (equivalent to elemental Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) 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

Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) INJECTION

Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) 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

Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) INJECTION

Doctor's Choice Multivitamins and Minerals for Eyes (Selenium) 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

Vitamin A:

• Dosage and administration
• Warning
• Clinical pharmacology
• Dietary supplementation
• Warnings
• Precautions
• Adverse reactions
• Dosage and administration
• How supplied
• Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin A) reviews

DOSAGE AND ADMINISTRATION

One tablet daily or as directed by a physician.

WARNING

KEEP OUT OF THE REACH OF CHILDREN.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Other Ingredients: Artificial cherry flavor, artificial grape flavor, ascorbic acid, cholecalciferol, compressible sugar, D&C Red #7 calcium lake, FD&C Blue #1 aluminum lake, FD&C Yellow #6 aluminum lake, folic acid, magnesium stearate, microcrystalline cellulose, natural and artificial orange flavor, niacinamide, polyethylene glycol, pyridoxine HCl, riboflavin, sodium ascorbate, sodium fluoride, stearic acid, sucralose, thiamine HCl, Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin A) acetate, vitamin B12 and vitamin E acetate.

Active ingredient for caries prophylaxis: Fluoride as sodium fluoride.

CLINICAL PHARMACOLOGY

Significant decrease in the incidence of dental caries can be linked to the fluoridation of the water supply (1ppm fluoride) during the period of tooth development.

Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin A) Tablets provide sodium fluoride and ten essential vitamins in a chewable tablet. Because the tablets are chewable, they provide a topical as well as systemic source of fluoride. Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the Hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite.

The reaction may be expressed by the equation:

Three stages of fluoride deposition in tooth enamel can be distinguished:

• Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.
• After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted.
• After eruption, the surface enamel acquires fluoride from the water, food, supplementary fluoride and smaller amounts of saliva.

DIETARY SUPPLEMENTATION

Multivitamins with fluoride offer supplementation of the diet with 10 vitamins and fluoride.

WARNINGS

AS IN THE CASE OF ALL MEDICATIONS, KEEP OUT OF THE REACH OF CHILDREN. This tablet should be chewed. This product, as with all chewable tablets are not recommended for children under the age of 4 due to risk of choking.

PRECAUTIONS

The suggested dose of Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin A) Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.

Before recommending Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin A) Tablets

• Determine the fluoride content of the drinking water from all major sources
• Make sure the child is not receiving significant amounts of fluoride from other sources such as medications and swallowed toothpaste
• Periodically check to make sure that the child does not develop significant dental fluorosis.

ADVERSE REACTIONS

Allergic rash and other idiosyncrasies have been rarely reported.

To report SUSPECTED ADVERSE REACTIONS, contact H2-Pharma, LLC at 1 (866) 592-6438 or FDA at 1 (800) 332-1088 or via the web at www.fda.gov/medwatch/index.html for voluntary reporting of adverse reactions.

DOSAGE AND ADMINISTRATION

One tablet daily or as directed by a physician.

HOW SUPPLIED

Doctor's Choice Multivitamins and Minerals for Eyes Tablets 0.25 mg are available as orange, red and purple chewable tablets imprinted with "151" in 100 tablet bottles.

Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin A) Tablets 0.5 mg are available as orange, red and purple chewable tablets imprinted with "152" in 100 tablet bottles.

Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin A) Tablets 1.0 mg are available as orange, red and purple chewable tablets imprinted with "153" in 100 tablet bottles.

STORAGE

Store at controlled room temperature 20ºC-25ºC (68º-77ºF), excursions permitted between 15º-30ºC (59º-86ºF).

Distributed by:

H2-Pharma, LLC

2010 Berry Chase Place

Montgomery, AL 36117

www.h2-pharma.com

1067084

61269-151-01

MultiVitamin

with Fluoride

Chewable Tablets

Rx

0.25 mg

MultiVitamin and Fluoride Supplement

Dietary Supplement

100 Tablets

H²pharma

Vitamin B12:

• Pharmacological action
• Pharmacokinetics
• Why is Doctor's Choice Multivitamins and Minerals for Eyes prescribed?
• Dosage and administration
• Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin B12) side effects, adverse reactions
• Doctor's Choice Multivitamins and Minerals for Eyes contraindications
• Doctor's Choice Multivitamins and Minerals for Eyes using during pregnancy and breastfeeding
• Special instructions
• Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin B12) drug interactions
• Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin B12) reviews

Pharmacological action

Doctor's Choice Multivitamins and Minerals for Eyes refers to a group of water-soluble vitamins. It has high biological activity. Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin B12) is necessary for normal hematopoiesis (promotes maturation of erythrocytes). Involved in the processes of transmethylation, hydrogen transport, synthesis of methionine, nucleic acids, choline, creatine. Contributes to the accumulation in erythrocytes of compounds containing sulfhydryl groups. Has a beneficial effect on liver function and the nervous system. Activates the coagulation of blood in high doses causes an increase in the activity of thromboplastin and prothrombin.

Pharmacokinetics

After oral administration Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin B12) absorbed from the gastrointestinal tract. Metabolized in the tissues, becoming a co-enzyme form - adenosylcobalamin which is the active form of cyanocobalamin. Excreted in bile and urine.

Why is Doctor's Choice Multivitamins and Minerals for Eyes prescribed?

Anemia due to B12-deficiency conditions; in the complex therapy for iron and posthemorrhagic anemia; aplastic anemia caused by toxic substances and drugs; liver disease (hepatitis, cirrhosis); funicular myelosis; polyneuritis, radiculitis, neuralgia, amyotrophic lateral sclerosis; children cerebral palsy, Down syndrome, peripheral nerve injury; skin diseases (psoriasis, photodermatosis, herpetiformis dermatitis, neurodermatitis); to prevent and treat symptoms of deficiency of Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin B12) (including the application of biguanide, PASA, vitamin C in high doses); radiation sickness.

Dosage and administration

Doctor's Choice Multivitamins and Minerals for Eyes is used as injections SC, IV, IM, intralumbar, and also oral. With anemia associated with Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin B12) deficiency is introduced on 100-200 mcg in 2 days. In anemia with symptoms of funicular myelosis and megalocytic anemia with diseases of the nervous system - 400-500 micrograms in the first 7 days daily, then 1 time every 5-7 days. In the period of remission in the absence of events funicular myelosis maintenance dose - 100 mcg 2 times a month, in the presence of neurological symptoms - at 200-400 mcg 2-4 times a month. In acute post-hemorrhagic anemia and iron anemia by 30-100 mcg 2-3 times a week. When aplastic anemia (especially in children) - 100 micrograms before clinical improvement. When nutritional anemia in infants and preterm - 30 mcg / day during 15 days.

In diseases of the central and peripheral nervous system and neurological diseases with a pain syndrome is administered in increasing doses - 200-500 mcg, with the improvement in the state - 100 mcg / day. The course of treatment with Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin B12) is 2 weeks. In traumatic lesions of peripheral nervous system - at 200-400 mcg every other day for 40-45 days.

When hepatitis and cirrhosis - 30-60 mcg / day or 100 mg every other day for 25-40 days.

Dystrophy in young children, Down syndrome and cerebral palsy - by 15-30 mcg every other day.

When funicular myelosis, amyotrophic lateral sclerosis can be introduced into the spinal canal at 15-30 mcg, gradually increasing the dose of 200-250 micrograms.

In radiation sickness, diabetic neuropathy, sprue - by 60-100 mcg daily for 20-30 days.

When deficiency of Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin B12) to prevent - IV or IM for 1 mg 1 time a month; for treatment - IV or IM for 1 mg daily for 1-2 weeks, the maintenance dose is 1-2 mg IV or IM from 1 per week, up to 1 per month. Duration of treatment is determined individually.

Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin B12) side effects, adverse reactions

CNS: rarely - a state of arousal.

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

Allergic reactions: rarely - urticaria.

Doctor's Choice Multivitamins and Minerals for Eyes contraindications

Thromboembolism, erythremia, erythrocytosis, increased sensitivity to cyanocobalamin.

Doctor's Choice Multivitamins and Minerals for Eyes using during pregnancy and breastfeeding

Cyanocobalamin can be used in pregnancy according to prescriptions.

Special instructions

When stenocardia should be used with caution in a single dose of Doctor's Choice Multivitamins and Minerals for Eyes 100 mcg. During treatment should regularly monitor the blood picture and coagulation. It is unacceptable to enter in the same syringe with cyanocobalamin solutions of thiamine and pyridoxine.

Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin B12) drug interactions

In an application of Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin B12) with hormonal contraceptives for oral administration may decrease the concentration of cyanocobalamin in plasma.

In an application with anticonvulsant drugs decreased cyanocobalamin absorption from the gut.

In an Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin B12) application with neomycin, aminosalicylic acid, colchicine, cimetidine, ranitidine, drugs potassium decreased cyanocobalamin absorption from the gut.

Cyanocobalamin may exacerbate allergic reactions caused by thiamine.

When parenteral application of chloramphenicol may decrease the hematopoietic effects of cyanocobalamin with anemia.

Pharmaceutical incompatibility

Contained in the molecule of cyanocobalamin cobalt ion contributes to the destruction of ascorbic acid, thiamine bromide, riboflavin in one solution.

Vitamin C:

• Pharmacological action
• Pharmacokinetics
• Why is Doctor's Choice Multivitamins and Minerals for Eyes prescribed?
• Dosage and administration
• Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin C) side effects, adverse reactions
• Doctor's Choice Multivitamins and Minerals for Eyes contraindications
• Using during pregnancy and breastfeeding
• Special instructions
• Doctor's Choice Multivitamins and Minerals for Eyes drug interactions
• Doctor's Choice Multivitamins and Minerals for Eyes in case of emergency / overdose
• Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin C) reviews

Pharmacological action

Ascorbic acid is essential for the formation of intracellular collagen, is required to strengthen the structure of teeth, bones, and the capillary walls. Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin C) participates in redox reactions, the metabolism of tyrosine, converting folic acid into folinic acid, metabolism of carbohydrates, the synthesis of lipids and proteins, iron metabolism, processes of cellular respiration. Reduces the need for vitamins B1, B2, A, E, folic acid, pantothenic acid, enhances the body's resistance to infections; enhances iron absorption, contributing to its sequestration in reduced form. Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin C) has antioxidant properties.

With intravaginal application of ascorbic acid lowers the vaginal pH, inhibiting the growth of bacteria and helps to restore and maintain normal pH and vaginal flora (Lactobacillus acidophilus, Lactobacillus gasseri).

Pharmacokinetics

After oral administration ascorbic acid is completely absorbed from the gastrointestinal tract. Widely distributed in body tissues.

The concentration of ascorbic acid in blood plasma in normal amounts to approximately 10-20 mg / ml.

The concentration of ascorbic acid in white blood cells and platelets is higher than in erythrocytes and plasma. When deficient state of concentration in leucocytes is reduced later and more slowly and is regarded as the best criterion for evaluating the deficit than the concentration in plasma.

Plasma protein binding is about 25%.

Ascorbic acid is reversibly oxidized to form dehydroascorbic acid, is metabolized with the formation of ascorbate-2-sulphate which is inactive and oxalic acid which is excreted in the urine.

Ascorbic acid taken in excessive quantities is rapidly excreted unchanged in urine, it usually happens when exceeding a daily dose is 200 mg.

Why is Doctor's Choice Multivitamins and Minerals for Eyes prescribed?

For systemic use of Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin C) Kimia Farma: prevention and treatment of hypo- and avitaminosis of Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin C); providing increased need for Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin C) during growth, pregnancy, lactation, with heavy loads, fatigue and during recovery after prolonged severe illness; in winter with an increased risk of infectious diseases.

For intravaginal use: chronic or recurrent vaginitis (bacterial vaginosis, nonspecific vaginitis) caused by the anaerobic flora (due to changes in pH of the vagina) in order to normalize disturbed vaginal microflora.

Dosage and administration

This medication administered orally, IM, IV, intravaginally.

For the prevention of deficiency conditions Doctor's Choice Multivitamins and Minerals for Eyes dose is 25-75 mg / day, for the treatment - 250 mg / day or more in divided doses.

For intravaginal used ascorbic acid drugs in appropriate dosage forms.

Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin C) side effects, adverse reactions

CNS: headache, fatigue, insomnia.

Digestive system: stomach cramps, nausea and vomiting.

Allergic reaction: describes a few cases of skin reactions and manifestations of the respiratory system.

Urinary system: when used in high doses - hyperoxaluria and the formation of kidney stones of calcium oxalate.

Local reactions: with intravaginal application - a burning or itching in the vagina, increased mucous discharge, redness, swelling of the vulva. Other: sensation of heat.

Doctor's Choice Multivitamins and Minerals for Eyes contraindications

Increased sensitivity to ascorbic acid.

Using during pregnancy and breastfeeding

The minimum daily requirement of ascorbic acid in the II and III trimester of pregnancy is about 60 mg.

Ascorbic acid crosses the placental barrier. It should be borne in mind that the fetus can adapt to high doses of ascorbic acid, which takes a pregnant woman, and then a newborn baby may develop the ascorbic disease as the reaction of cancel. Therefore, during pregnancy should not to take ascorbic acid in high doses, except in cases where the expected benefit outweighs the potential risk.

The minimum daily requirement during lactation is 80 mg. Ascorbic acid is excreted in breast milk. A mother's diet that contains adequate amounts of ascorbic acid, is sufficient to prevent deficiency in an infant. It is unknown whether dangerous to the child's mother use of ascorbic acid in high doses. Theoretically it is possible. Therefore, it is recommended not to exceed the maximum daily nursing mother needs to ascorbic acid, except when the expected benefit outweighs the potential risk.

Special instructions

Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin C) is used with caution in patients with hyperoxaluria, renal impairment, a history of instructions on urolithiasis. Because ascorbic acid increases iron absorption, its use in high doses can be dangerous in patients with hemochromatosis, thalassemia, polycythemia, leukemia, and sideroblastic anemia.

Patients with high content body iron should apply ascorbic acid in minimal doses.

Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin C) is used with caution in patients with deficiency of glucose-6-phosphate dehydrogenase.

The use of ascorbic acid in high doses can cause exacerbation of sickle cell anemia.

Data on the diabetogenic action of ascorbic acid are contradictory. However, prolonged use of ascorbic acid should periodically monitor your blood glucose levels.

It is believed that the use of ascorbic acid in patients with rapidly proliferating and widely disseminated tumors may worsen during the process. It should therefore be used with caution in ascorbic acid in patients with advanced cancer.

Absorption of ascorbic acid decreased while use of fresh fruit or vegetable juices, alkaline drinking.

Doctor's Choice Multivitamins and Minerals for Eyes drug interactions

In an application with barbiturates, primidone increases the excretion of ascorbic acid in the urine.

With the simultaneous use of oral contraceptives reduces the concentration of ascorbic acid in blood plasma.

In an application of Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin C) with iron preparations ascorbic acid, due to its regenerative properties, transforms ferric iron in the bivalent, which improves its absorption.

Ascorbic acid in high doses can decrease urine pH that while the application reduces the tubular reabsorption of amphetamine and tricyclic antidepressants.

With the simultaneous use of aspirin reduces the absorption of ascorbic acid by about a third.

Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin C) in an application with warfarin may decrease effects of warfarin.

With the simultaneous application of ascorbic acid increases the excretion of iron in patients receiving deferoxamine. In the application of ascorbic acid at a dose of 500 mg / day possibly left ventricular dysfunction.

In an application with tetracycline is increased excretion of ascorbic acid in the urine.

There is a described case of reducing the concentration of fluphenazine in plasma in patients treated with ascorbic acid 500 mg 2 times / day.

May increase the concentration of ethinyl estradiol in the blood plasma in its simultaneous application in the oral contraceptives.

Doctor's Choice Multivitamins and Minerals for Eyes in case of emergency / overdose

Symptoms: long-term use of large doses (more than 1 g) - headache, increased CNS excitability, insomnia, nausea, vomiting, diarrhea, gastritis giperatsidnyh, ultseratsiya gastrointestinal mucosa, inhibition of the function insular apparatus of the pancreas (hyperglycemia, glycosuria), hyperoxaluria, nephrolithiasis (calcium oxalate), damage to the glomerular apparatus of the kidneys, moderate thamuria (when receiving a dose of 600 mg / day).

Decrease capillary permeability (possibly deteriorating trophic tissues, increased blood pressure, hypercoagulability, the development of microangiopathy).

When IV administration in high doses - the threat of termination of pregnancy (due to estrogenemia), hemolysis of red blood cells.

Vitamin E:

• Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin E) reviews

Indication: Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin E), known for its antioxidant activities, is protective against cardiovascular disease and some forms of cancer and has also demonstrated immune-enhancing effects. It may be of limited benefit in some with asthma and rheumatoid arthritis. It may be helpful in some neurological diseases including Alzheimer's, some eye disorders including cataracts, and diabetes and premenstrual syndrome. It may also help protect skin from ultraviolet irradiation although claims that it reverses skin aging, enhances male fertility and exercise performance are poorly supported. It may help relieve some muscle cramps.

Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin E) has antioxidant activity. It may also have anti-atherogenic, antithrombotic, anticoagulant, neuroprotective, antiviral, immunomodulatory, cell membrane-stabilizing and antiproliferative actions. Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin E) is a collective term used to describe eight separate forms, the best-known form being alpha-tocopherol. Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin E) is a fat-soluble vitamin and is an important antioxidant. It acts to protect cells against the effects of free radicals, which are potentially damaging by-products of the body's metabolism. Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin E) is often used in skin creams and lotions because it is believed to play a role in encouraging skin healing and reducing scarring after injuries such as burns. There are three specific situations when a Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin E) deficiency is likely to occur. It is seen in persons who cannot absorb dietary fat, has been found in premature, very low birth weight infants (birth weights less than 1500 grams, or 3½ pounds), and is seen in individuals with rare disorders of fat metabolism. A Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin E) deficiency is usually characterized by neurological problems due to poor nerve conduction. Symptoms may include infertility, neuromuscular impairment, menstrual problems, miscarriage and uterine degradation. Preliminary research has led to a widely held belief that Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin E) may help prevent or delay coronary heart disease. Antioxidants such as Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin E) help protect against the damaging effects of free radicals, which may contribute to the development of chronic diseases such as cancer. It also protects other fat-soluble vitamins (A and B group vitamins) from destruction by oxygen. Low levels of Doctor's Choice Multivitamins and Minerals for Eyes (Vitamin E) have been linked to increased incidence of breast and colon cancer.

Zinc:

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Drug abuse and dependence
• Overdosage
• Dosage and administration
• How supplied
• Doctor's Choice Multivitamins and Minerals for Eyes (Zinc) reviews

INDICATIONS AND USAGE

Doctor's Choice Multivitamins and Minerals for Eyes (Zinc) 1 mg/mL (Zinc Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain Doctor's Choice Multivitamins and Minerals for Eyes (Zinc) serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms.

CONTRAINDICATIONS

None known.

WARNINGS

Direct intramuscular or intravenous injection of Doctor's Choice Multivitamins and Minerals for Eyes (Zinc) 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 Doctor's Choice Multivitamins and Minerals for Eyes (Zinc) 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 Doctor's Choice Multivitamins and Minerals for Eyes (Zinc) from a bolus injection. Administration of Doctor's Choice Multivitamins and Minerals for Eyes (Zinc) in the absence of copper may cause a decrease in serum copper levels.

Laboratory Tests

Periodic determinations of serum copper as well as Doctor's Choice Multivitamins and Minerals for Eyes (Zinc) are suggested as a guideline for subsequent Doctor's Choice Multivitamins and Minerals for Eyes (Zinc) administration.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies to evaluate the carcinogenic potential of Doctor's Choice Multivitamins and Minerals for Eyes 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 Doctor's Choice Multivitamins and Minerals for Eyes (Zinc) 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 Doctor's Choice Multivitamins and Minerals for Eyes chloride. It is also not known whether Doctor's Choice Multivitamins and Minerals for Eyes (Zinc) chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Doctor's Choice Multivitamins and Minerals for Eyes (Zinc) 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 Doctor's Choice Multivitamins and Minerals for Eyes (Zinc) 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 Doctor's Choice Multivitamins and Minerals for Eyes (Zinc) concentration of 207 mcg/dl. Symptoms abated within three hours.

Hyperamylasemia may be a sign of impending Doctor's Choice Multivitamins and Minerals for Eyes (Zinc) 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 Doctor's Choice Multivitamins and Minerals for Eyes (Zinc) was delivered intravenously over the course of 60 hours to a 72 year old patient.

Symptoms of Doctor's Choice Multivitamins and Minerals for Eyes (Zinc) toxicity included hypotension (80/40 mm Hg), pulmonary edema, diarrhea, vomiting, jaundice, and oliguria, with a serum Doctor's Choice Multivitamins and Minerals for Eyes (Zinc) level of 4184 mcg/dl.

Calcium supplements may confer a protective effect against Doctor's Choice Multivitamins and Minerals for Eyes (Zinc) toxicity.

DOSAGE AND ADMINISTRATION

Doctor's Choice Multivitamins and Minerals for Eyes (Zinc) 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 Doctor's Choice Multivitamins and Minerals for Eyes (Zinc) blood levels is suggested for patients receiving more than the usual maintenance dosage level of Doctor's Choice Multivitamins and Minerals for Eyes (Zinc).

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

Doctor's Choice Multivitamins and Minerals for Eyes (Zinc) 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

Doctor's Choice Multivitamins and Minerals for Eyes (Zinc)

1 mg/mL

Doctor's Choice Multivitamins and Minerals for Eyes (Zinc) Chloride Inj., USP

Rx only

FOR I.V. USE ONLY AFTER DILUTION.

HOSPIRA, INC., LAKE FOREST, IL 60045 USA