IROSPAN® 24/6 Iron / Folic Acid / Supplement Tablets

Iron deficiency is the most common known form of nutritional deficiency. Its prevalence is highest among young children
and women of childbearing age (particularly pregnant women). In children, iron deficiency causes developmental delays
and behavioral disturbances, and in pregnant women, it increases the risk for a preterm delivery and delivering a
low-birthweight baby. In the past three decades, increased iron intake among infants has resulted in a decline in
childhood iron-deficiency anemia in the United States. For women of childbearing age, iron deficiency has remained
prevalent.
IROSPAN® 24/6 Iron / Folic Acid / Supplement Tablets and Succinic Acid Tablets provide a 30 day oral iron supplement therapy
IROSPAN TABLET DESCRIPTION: Each light blue capsule-shaped film
coated tablet has a pleasant sweet flavor with WC002 imprinted on one
side.
INGREDIENTS
DOSE
%DV*
Vitamin C (Sodium Ascorbate) ....................................100 mg
Formical® (Calcium Formate) ......................................155 mg
B1 (Thiamine HCL)..........................................................5 mg
B2 (Riboflavin).................................................................5 mg
B3 (Niacin).....................................................................25 mg
B6 (Pyridoxine HCL)......................................................30 mg
Folic Acid .................................................................1000 mcg
B12 (Cyanocobalamin)................................................10 mcg
B7 (Biotin)..................................................................300 mcg
B5 (d-Calcium Pantothenate) ..........................................7 mg
Iron (Ferrous bisGlycinate Chelate)...............................65 mg
Iron (Polysaccharide Iron Complex) ..............................65 mg
167%
16%
333%
294%
125%
1500%
250%
167%
100%
70%
361%
361%
*% Daily Value based on a 2000 Calorie Diet
OTHER INGREDIENTS: Microcrystalline Cellulose, Magensium Stearate,
Povidone, Polyvinyl Alcohol-Partially Hydrolyzed, PEG 3350, Titanium
Dioxide, Talc, and FD&C Blue #1, Saccharin, Carnauba Wax.
SUCCINIC ACID TABLET DESCRIPTION: Each white round film coated
tablet has a pleasant sweet flavor with WC imprinted on one side.
INGREDIENTS
DOSE
%DV*
Vitamin C (as Sodium Ascorbate)................................100 mg
Calcium (Calcium Carbonate) ....................................100 mg
B1 (Thiamine HCL)..........................................................5 mg
B2 (Riboflavin).................................................................5 mg
B3 (Niacin).....................................................................25 mg
B6 (Pyridoxine HCL)......................................................30 mg
Folic Acid .................................................................1000 mcg
B12 (Cyanocobalamin)................................................10 mcg
B7 (Biotin)..................................................................300 mcg
B5 (d-Calcium Pantothenate) ..........................................7 mg
Succinic Acid ...............................................................150 mg
167%
10%
333%
294%
125%
1500%
250%
167%
100%
70%
†
*% Daily Value based on a 2000 Calorie Diet
†DV not established
INACTIVE INGREDIENTS: Microcrystalline Cellulose, Magensium
Stearate, Povidone, Polyvinyl Alcohol-Partially Hydrolyzed, PEG 3350,
Titanium Dioxide, Talc, Saccharin, Carnauba Wax.
WARNING: Accidental overdose of iron-containing products is
a leading cause of fatal poisoning in children under 6.
KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN.
In case of accidental overdose, call a doctor or poison control
center immediately.
REFERENCES
1 Garcia-Casal MN, Layrisse M. The effect of change in pH on solubility of iron bis-glycinate chelate and other iron
compounds. Arch Latinoam Nutr. 2001;51(suppl 1):35-36.
2 Bovell-Benjamin AC, Viteri FE, Allen LH, Iron absorption from ferrous bisGlycinate and ferric triglycinate in whole
maize is regulated by iron status. Am J Clin Nutr. 2000;71(6):1563-1569.
3 Lynch SR, Stoltzfus RJ, Iron and ascorbic acid: proposed fortification levels and recommended iron compounds. J
Nutr. 2003;133:2978S-2984S.
4 Brise H, Hallberg L, Effect of ascorbic acid on iron absorption. Acta Med Scan. 1962;171(suppl 376):51-58.
5 Zijp IM, Korver O, Tijburg LB. Effect of tea and other dietary factors on iron absorption. Crit Rev Food Sci Nutr.
2000;40(5):371-398.
6 Atanasova BD, Li AC, Bjarnason I, Tzatchev KN, Simpson Rj. Duodenal ascorbate and ferric reductase in human
iron deficiency. Am J Clin Nutr. 2005;81:130-133.
7 Hallberg L, Norrby A, Solvell L. Oral iron with succinic acid in the treatment of iron deficiency anaemia. Scand J
Haematol. 1971;8:104-111.
8 Careddu P, Scotti A. Controlled, double-blind, multicenter clinical trial of iron protein succinylate in the treatment of
iron deficiency in children. Int J Clin Pharmocol Ther Toxicol. 1993;31(4):157-169
9 Pineda O. Ashmead HD. Effectiveness of treatment of iron-deficiency anemia in infants and young children with
ferrous bis-glycinate chelate. Nutrition. 2001;17:381-384.
10 Hallberg L, Solvell. Succinic acid as absorption promoter in iron tablets. Acta Med Scand Suppl. 1966;459:23-35.
PHARMACEUTICALS
CLINICAL PHARMACOLOGY: Iron is an essential component in the
formation of hemoglobin. Adequate amounts of iron are necessary for
effective erythropoiesis. Iron also serves as a cofactor of several
essential enzymes, including cytochromes that are involved in electron
transport.
Folic acid is required for nucleoprotein synthesis and the maintenance of
normal erythropoiesis. Folic acid is converted in the liver and plasma to
its metabolically active form, tetrahydrofolic acid, by dihydrofolate
reductase.
Vitamin B12 is required for the maintenance of normal erythropoiesis,
nucleoprotein and myelin synthesis, cell reproduction and normal growth.
Intrinsic factor, a glycoprotein secreted by the gastric mucosa, is required
for active absorption of Vitamin B12 from the gastrointestinal tract.
INDICATIONS AND USAGE: IROSPAN® 24/6 is indicated for the
treatment of all anemias that are responsive to oral iron therapy. These
include: hypochromic anemia associated with pregnancy, chronic and/or
acute blood loss, metabolic disease, post-surgical convalescence, and
dietary needs.
CONTRAINDICATIONS: This product is contraindicated in patients with a
known hypersensitivity to any of the ingredients. Hemolytic anemia,
hemochromatosis, and hemosiderosis are contraindications to iron
therapy.
WARNINGS: Folic acid alone is improper therapy in the treatment of
pernicious anemia and other megaloblastic anemias where vitamin B12 is
deficient.
PRECAUTIONS: Folic acid in doses above 0.1mg daily may obscure
pernicious anemia in that hematologic remission can occur while
neurological manifestations remain progressive.
ADVERSE REACTIONS: Adverse reactions with iron therapy may include
constipation, diarrhea, nausea, vomiting, dark stools, and abdominal pain.
Adverse reactions with iron therapy are usually transient. Allergic
sensitization has been reported following both oral and parenteral
administration of folic acid.
DOSAGE AND ADMINISTRATION:
Usual adult dosage is 1 tablet daily or as directed by a physician. The
IROSPAN® 24/6 carton contains a 30 day course of iron therapy that
consists of 24 light blue tablets and 6 white tablets. Take 1 light blue
tablet daily for 24 days, followed by 1 white tablet daily for 6 days. After
the 30 tablets have been taken, a new course may be started if
prescribed.
HOW SUPPLIED: IROSPAN® 24/6 tablets for oral administration are
available in four child resistant blister cards containing 30 tablets (24 light
blue tablets and 6 white tablets) (NDC 50967-126-30)
Samples are in blister cards containing 3 light blue tablets (NDC
50967-126-03)
Store at controlled room temperature 15°-30°(59°-86°F) RX only
Distributed by:
Women’s Choice Pharmaceuticals • Gilbert, AZ 85233 • (877) 774-4949
24/6
TABLETS
Formical® is a registered trademark of Nephro-Tech 1, LLC
US Patent #6,528,542, #6,489,361, #6,160,016
IROSPAN® is a registered trademark of Women’s Choice
Pharmaceuticals, LLC
Gilbert, AZ 85233 • (877) 774-4949 • www.wcpharma.com
IRO – 01/11
Iron therapy the way duodenal enterocytes deserve!
Complementary Iron Formulation for Optimal Result
Ascorbic
Acid
24/6
Fe
Ascorbic
Acid
TABLETS
Fe
POLYSAC Iron
Succinic
Acid
Fe
Fe
Fe
Chelated Iron
Fe
Fe
Ascorbic
Acid
IROSPAN® 24/6 is an innovative formula and
dosing regimen developed specifically for
women to maximize iron absorption and
tolerability.
IROSPAN® 24/6 Formulation
Two uniquely different forms of Iron for
maximized Absorption
—Ferrous bisGlycinate Chelate
• Absorbed more evenly throughout the entire
GI tract and not affected by higher pH.1,2,3
• More resistant to interference from food and
liquid substances.1,2,3
—Polysaccharide Iron Complex
• Non-ionic delivery system allows the ionic iron
to be delivered to the bloodstream without
coming into contact with the stomach or upper
GI tract.
—Complex B-vitamins to promote energy
—Irospan® contains Formical®, a patented
source of calcium formate.
24/6 Dosing Regimen
Twenty four days of combination iron therapy
with ascorbic acid providing 130 mg of
elemental iron
• Ascorbic acid promotes efficient absorption by
pushing iron into duodenal enterocyte cells,
blocking binding phytates, tannins, and
polyphenols that normally interfere with iron
absorption.4-5
Six days of succinic acid therapy
• Stimulates iron transmission by pulling iron
from intestinal enterocyte cells into the
bloodstream, which promotes iron absorption
even when oral iron is not being
administered.2,4
Fe
Unique combination of complementary
and easily absorbable irons
A unique push/pull mechanism promotes
superior absorption
Irospan’s dual iron formulations, ferrous
bisGlycinate chelate and polysaccharide iron
complex, are absorbed in different intestinal sites
The ascorbic acid contained in Irospan® pushes the iron
into duodenal cells and blocks substances that interfere
with iron absorption. The succinic acid therapy pulls iron
from those cells into the bloodstream during the 6 days
that iron is not administered.
Chelated iron has been shown to be absorbed
up to 3.4 times more than ferrous sulfate.9
Research has shown that ascorbic and succinic
acids can enhance absorption by 33% and 30%,
respectively, without a rise in side effects.4,10
• The 6 day iron-free period allows for the regeneration of the body’s cells. This enables the cells to
“rest” for the next cycle of iron therapy.
Benefits of 24/6 therapy
Maximum Iron absorption… Highest absorption of iron has been shown to occur in the first 20-24 days
of therapy7
• Active Iron is only administered when the body is capable of absorbing it efficiently7
Fewer Iron related side effects…Research indicates iron absorption decreases after 20-24 days of
continuous therapy.7 Continuous iron only therapy may lead to chronic irritation of the epithelial cells
lining the gastrointestinal (GI) tract, which may explain common iron related side effects.8
• In addition to enhancing tolerability, the unique regimen and formula promotes continued iron absorption
during the 6 day succinic acid period.
Comparable Iron Therapies Report:
• 2-gram hemoglobin increase in first month of therapy, and a 3.5-gram increase by month three
24/6
TABLETS