CONTENTS:   Each blue soft gelatin capsule, imprinted images/77/36001501.jpg0331 contains:

Calcium (as calcium carbonate)...........200 mg
Vitamin C (ascorbic acid)......................60 mg
Iron (as ferrous fumarate)......................28 mg
Docusate Calcium. mg
Vitamin E ( d -alpha tocopherol)...............30 IU
Vitamin B 6 (pyridoxine hydrochloride)...20 mg
Vitamin B 2 (riboflavin)..........................1.8 mg
Vitamin B 1 (thiamine mononitrate)..........1.6 mg
Folic Acid. mg
Vitamin B 12 (cyanocobalamin)..............12 mcg
Vitamin D (cholecalciferol)....................400 IU

ACTIVE INGREDIENT:   Each gelcap contains 1 mg folic acid.

DISCUSSION:   The amount of elemental iron and the absorption of the iron components of commercial iron preparations vary widely. Certain accessory components enhance absorption and utilization of iron. Chromagen® OB gelcaps are formulated to provide the essential factors for a complete, versatile vitamin and mineral supplement.

ACTIONS

HIGH ELEMENTAL IRON CONTENT: Ferrous fumarate, used in Chromagen® OB gelcaps, is an organic iron complex which has the highest elemental iron content of any hematinic salt--33%. This compares with 20% for ferrous sulfate (heptahydrate) and 13% for ferrous gluconate.

MORE COMPLETE ABSORPTION: It has been shown that ascorbic acid, when given in sufficient amounts, can increase the absorption of ferrous iron from the gastrointestinal tract. The effect of ascorbic acid may be related both to its reducing effect, preventing the formation of insoluble ferric hydroxide, and to its ability to form soluble complexes with ferric iron, which preserve the iron solubility at the more alkaline duodenal pH. Studies indicate that 60 mg of ascorbic acid can increase iron absorption. Each Chromagen® OB gelcap contains 60 mg of ascorbic acid.

PROMOTES MOVEMENT OF PLASMA IRON: Ascorbic acid also plays a role in the movement of plasma iron to storage depots in the tissues. The action, which leads to the transport of plasma iron to ferritin, presumably involves its reducing effect, converting transferrin iron from the ferric to the ferrous state. There is also evidence that ascorbic acid improves iron utilization, presumably as a further result of its reducing action. It may also have a direct effect upon erythropoiesis. Ascorbic acid is further alleged to enhance the conversion of folic acid to a more physiologically active form, folinic acid, necesssary for erythropoiesis.

EXCELLENT ORAL TOLERATION:   Ferrous fumarate is used in Chromagen® OB gelcaps because it is less likely to cause gastric disturbances. Ferrous fumarate has a low ionization constant and high solubility in the entire pH range of the gastrointestinal tract. It does not precipitate proteins or have the astringency of ionizable forms of iron, and does not interfere with proteolytic or diastatic activities of the digestive system.

TOXICITY:   Ferrous fumarate is the least toxic of three popular iron salts.

INDICATIONS

Chromagen® OB is a vitamin and mineral nutritional supplement indicated for use in women prior to, throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. It is also useful for improving the nutritional status of women prior to conception.

CONTRAINDICATIONS

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

Supplemental vitamins should also not be prescribed for patients with Wilson' disease.

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient.

WARNING:   Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Average gelcap doses in sensitive individuals or excessive dosage may cause nausea, skin rash, vomiting, diarrhea, precordial pain, or flushing of the face and extremities.

PRECAUTIONS

General:

Folic acid, in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

Information for Patients:

Patients should not exceed the recommended dosage unless directed by the physician. Patients should be informed that iron therapy can cause black or dark stools.

ADVERSE REACTIONS

The following adverse reactions, normally associated with iron products such as Chromagen® OB, may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions are usually transient.

Dispense in a tight, light resistant container with a child resistant closure.

Store at controlled room temperature 15°-30°C (59°-86°F). Avoid excessive heat 40°C (104°F). Avoid freezing.

ULTRAFORT™

CONTENTS:   Each maroon soft gelatin capsule, imprinted images/77/36001501.jpg0260 contains: Vitamin C (ascorbic acid), 250 mg, Ferrous fumarate USP, 200 mg, Zinc (as Zinc Sulfate USP), 25 mg, Vitamin B 12 (cyanocobalamin), 10 mcg.

DISCUSSION:   The amount of elemental iron and the absorption of the iron components of commercial iron preparations vary widely. It is further established that certain "accessory components" may be included to enhance absorption and utilization of iron. UltraFort™ gelcaps are formulated to provide the essential factors for a complete, versatile hematinic.

ACTIONS

HIGH ELEMENTAL IRON CONTENT: Ferrous fumarate, used in UltraFort™ gelcaps, is an organic iron complex which has the highest elemental iron content of any hematinic salt--33%. This compares with 20% for ferrous sulfate (heptahydrate) and 13% for ferrous gluconate. 1,2

MORE COMPLETE ABSORPTION: It has been repeatedly shown that ascorbic acid, when given in sufficient amounts, can increase the absorption of ferrous iron from the gastrointestinal tract. 3,4,5,6,7,8,9 The absorption-promoting effect is mainly due to the reducing action of ascorbic acid within the gastrointestinal lumen, which helps to prevent or delay the formation of insoluble or less dissociated ferric compounds. 3

Iron absorption has been shown to increase sharply with increasing amounts of ascorbic acid, showing a gain in absorption of approximately 40% at 250 mg. Above 250 mg, the gain becomes insignificant, with an additional gain of only approximately 8% at 500 mg. 3 Each UltraFort™ gelcap contains 250 mg of ascorbic acid, believed to be the optimal amount.

PROMOTES MOVEMENT OF PLASMA IRON: Ascorbic acid also plays an important role in the movement of plasma iron to storage depots in the tissues. 10 The action, which leads to the transport of plasma iron to ferritin, presumably involves its reducing effect, converting transferrin iron from the ferric to the ferrous state. 5 There is also evidence that ascorbic acid improves iron utilization, presumably as a further result of its reducing action, 6,9 and some evidence that it may have a direct effect upon erythropoiesis. Ascorbic acid is further alleged to enhance the conversion of folic acid to a more physiologically active form, folinic acid, which would make it even more important in the treatment of anemia since it would aid in the utilization of dietary folic acid. 11

EXCELLENT ORAL TOLERATION:   Ferrous fumarate is used in UltraFort™ gelcaps because it is less likely to cause the gastric disturbances so often associated with oral iron therapy. Ferrous fumarate has a low ionization constant and high solubility in the entire pH range of the gastrointestinal tract. It does not precipitate proteins or have the astringency of more ionizable forms of iron, and does not interfere with proteolytic or diastatic activities of the digestive system. Because of excellent oral toleration, UltraFort™ can usually be administered between meals when iron absorption is maximal.

ZINC SUPPLEMENTATION:   Zinc is a necessary catalyst for over 200 enzymes functioning at the cellular level. Physiologic functions facilitated by zinc include wound healing, tissue repair, recovery from prolonged stress or trauma, and facilitation of host immunity, among others. These and other actions of zinc are beneficial in iron deficiency anemia. 12 Daily zinc supplementation, during pregnancy, is associated with improved infant birth weights and head circumference, in women with low zinc blood plasma levels. 13 During pregnancy low zinc plasma levels are also associated with an increased risk of low birth weight of infants, preterm labor, preterm delivery, placental ablation, perinatal death, abnormal labor, and other pregnancy complications. 14-17

TOXICITY:   Ferrous fumarate was found to be the least toxic of three popular oral iron salts, with an oral LD 50 of 630 mg/kg. In the same report, the LD 50 of ferrous gluconate was reported to be 320 mg/kg and ferrous sulfate 230 mg/kg. 1,18

INDICATIONS

For the treatment of all anemias responsive to oral iron therapy, such as hypochromic anemia associated with pregnancy, chronic or acute blood loss, dietary restriction, metabolic disease and post-surgical convalescence.

CONTRAINDICATIONS

Hemochromatosis and hemosiderosis are contraindications to iron therapy.

WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

SIDE EFFECTS

Average capsule doses in sensitive individuals or excessive dosage may cause nausea, skin rash, vomiting, diarrhea, precordial pain, or flushing of the face and extremities.

USUAL ADULT DOSAGE: Chromagen® OB--one soft gelatin capsule in the morning with food and a full glass of water.

UltraFort™--one soft gelatin capsule at night.

HOW SUPPLIED

Prenatal ComboPak 30 Day Supply, NDC 0281-0338-30

Prenatal ComboPak 100 Day Supply, NDC 0281-0338-18

Store at controlled room temperature 15°-30°C (59°-86°F). Avoid excessive heat 40°C (104°F). Avoid freezing.

BIBLIOGRAPHY

1 Berk, M.S. and Novich, M.A.: "Treatment of Iron Deficiency Anemia With Ferrous Fumarate," Am. J. Obst. & Gynec., 203-206, 1962. 2 Shapleigh, J.B. and Montgomery, A.: Am. Pract. & Dig. Treat. 10-461, 1959. 3 Brise, H. and Hallberg, L.: "Effect of Ascorbic Acid on Iron Absorption," Acta. Med. Scand., 171:376, 51-58, 1962. 4 New Drugs, p. 309, AMA, Chicago, 1966. 5 Mazur, A., Green, S. and Carleton, A.: "Mechanism of Plasma Iron Incorporation into Hepatic Ferritin," J. Bio. Chem., 3:595-603, 1960. 6 Greenberg, S.M., Tucker, A.E., Mathues, H. and J.D.: "Iron Absorption and Metabolism I. Interrleationship of Ascorbic Acid and Vitamin E," J. Nutrition, 63:19-31, 1957. 7 Moore, C.V. and Dubach, R.: "Observations on the Absorption of Iron from Foods Tagged with Radioiron," Trans. Assoc. Amer. Physic. 64:245, 1951. 8 Steinkamp, R., Dubach, R. and Moore, C.V.: "Studies in Iron Transportation and Metabolism," Arch. Int. Med., 95:181, 1955. 9 Gorten, M.K. and Bradley, J.E.: "The Treatment of Nutritional Anemia in Infancy and Childhood with Oral Iron and Ascorbic Acid," J. Pediatrics, 45:1, 1954. 10 Mazur, A.: "Role of Ascorbic Acid in the Incorporation of Plasma Iron into Ferritin," Ann. N.Y. Acad. Sci., 92:223-229, 1961. 11 Cox, E.V., et al: "The Anemia of Scurvy," Amer. J. Med., 42:220-227, 1967. 12 "Drug Information for the Health Care Professional," U.S. Pharmacopeial Conven., Rockville, P. 2826-2828, 1995. 13 Goldenberg, R.L., Tamura, T., Neggers, Y., Copper, R.L., Johston, K.E., DuBard, M.B., Hauth, J.C.: "The effect of zinc supplementation on pregnancy outcome," JAMA, 274:463-468, 1995. 14 Jameson, S.: "Zinc status in pregnancy: The effects of zinc therapy on perinatal mortality, prematurity and placental ablation," Ann. N.Y. Acad. Sci., 678:178-192, 1993. 15 Lazebnik, N., Kuhnert, B.R., Kuhnert, P.M. and Thompson, K.L.: "Zinc status, pregnancy complications, and labor abnormalities", Am. J. Obstet. Gynecol., 158:161-66, 1988. 16 Sikorski, R., Juszkiewicz, T. and Paszkowski, P.: "Zinc status in women with premature rupture of the membranes at term." Obstet. Gynecol., 76:675-677, 1990. 17 Cherry, F., Sandstead, H.H., Rojas, P., Johnson, L.K., Batson, H.K. and Wang, X.B., "Adolescent pregnancy: Associations among body weight, zinc nutriture, and pregnancy outcome", Am. J. Clin. Nutr., 50: 945-954, 1989. 18 Berenbaum, M.C., et al.: Blood, 15:540, 1960.

Manufactured for:

SAVAGE LABORATORIES®

a division of Altana Inc. IF338A

Melville, New York 11747    R 6/00

by: R.P. Scherer Corporation, St. Petersburg, Florida 33702

PRODUCT PHOTO(S):

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug' identity should be verified by chemical analysis.

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