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Iron/Chromagen Forte/Ferrous Fumerate

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Yanno , I got to thinking about all this Iron discussion today so after

I got my private " I toed ja so " from Mother I went to the medicine

cabinet to inventory the Ferro Sequel supply. This is ferrous fumerate I

bought at one of the chain drug stores, 50mg per tab. Lo and behold I had

none! So I rummaged in the drawer where I toss things for later and found

the prescription Iron my surgeon (heart surgeon) had prescribed when leaving

the hospital last year. I had tried it and it had indeed turned my stools

tarry black like you mentioned and the package also mentions. I also

thought at the time that it had constipated me into oblivion and for some

unknown reason I thought it was ferrous gluconate. I think that is the

reason I stopped taking it. Duh!

I thought about all this because you mentioned some type that had been

prescribed for you and it crossed my mind that perhaps it may have been

Chromagen Forte, which is what I have, and when I went to the mfg's site I

found to my great amazement that I was wrong! This is ferrous fumerate in

the liquid form and really very good size dosages in each capsule. For

general info I will attach the prescribing info from their web site just in

case this is what you have. Sounds like good stuff to me. I am gonna risk

the constipation (something I rarely have ever had to deal with in life) and

do it for the next few weeks until next labs to see it if sets me aright.

Dan Slone

Surgery 5/2/2000

CHROMAGEN FORTE

DESCRIPTION [PARA]CONTENTS:[NL]Each brown soft gelatin capsule contains:

ferrous fumarate USP, 460 mg (151 mg elemental iron), ascorbic acid USP, 60

mg, folic acid USP, 1 mg, cyanocobalamin USP, 10 mcg. [PARA]DISCUSSION:

[NL]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. Chromagen® Forte Capsules are formulated to provide

the essential factors for a complete, versatile hematinic. [PARA]ACTIONS

[PARA]HIGH ELEMENTAL IRON CONTENT: [NL]Ferrous fumarate, used in

Chromagen® Forte Capsules, 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 Chromagen® Forte contains 151 mg of elemental iron.

[PARA]MORE COMPLETE ABSORPTION:[NL]It has been repeatedly shown that

ascorbic acid, when given in sufficient amounts, can increase the absorption

of ferrous iron from the gastrointestinal tract.3-9 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 [PARA]PROMOTES MOVEMENT OF

PLASMA IRON: [NL]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 [PARA]EXCELLENT ORAL TOLERATION: [NL]Ferrous

fumarate is used in Chromagen® Forte Capsules 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, Chromagen® Forte Capsules

can usually be administered between meals when iron absorption is maximal.

[PARA]FOLIC ACID SUPPLEMENTATION: [NL]The use of supplemental folic acid may

be indicated in patients with increased requirements for this vitamin, such

as iron deficiency anemia. Folic acid administration may reduce the risk of

neural tube defects in the developing fetus.12 Folic acid has also been

shown to reduce circulating homocysteine levels in the blood.13,14 Folate as

5-methyltetrahydrofolate and B12 as methylcobalamin are involved in the

remethylation reaction of homocysteine to methionine.15,16 Elevated

homocysteine plasma levels are associated with increased risk of

preeclampsia, neural tube defects, myocardial infarction and

artherosclerosis.17-21 [PARA]TOXICITY: [NL]Ferrous fumarate was found to be

the least toxic of three popular oral iron salts, with an oral LD50 of 630

mg/kg. In the same report, the LD50 of ferrous gluconate was reported to be

320 mg/kg and ferrous sulfate 230 mg/kg.1,22 [PARA]INDICATIONS[NL]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.

[PARA]CONTRAINDICATIONS[NL]Hemochromatosis and hemosiderosis are

contraindications to iron therapy. Folic acid is contraindicated in patients

with pernicious anemia (see PRECAUTIONS). [PARA]WARNING[NL]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.

[PARA]PRECAUTIONS[NL]Folic acid should not be prescribed until the diagnosis

of pernicious anemia has been eliminated, since it can alleviate the

hematologic manifestations, while allowing neurological damage to continue

undetected.23 [PARA]ADVERSE REACTIONS[NL]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.

[PARA]DOSAGE AND ADMINISTRATION[NL]Usual adult dose is 1-2 soft gelatin

capsules daily, or as directed by a physician. [PARA]HOW

SUPPLIED[NL]Capsules: NDC 0281-0262-18, Unit Dose Box 100

[PARA]CAUTION:[NL]Federal law prohibits dispensing without prescription.

[PARA]BIBLIOGRAPHY[NL]1. Berk, M.S. and Novich, M.A.: " Treatment of Iron

Deficiency Anemia With Ferrous Fumarate, " Am. J. Obst. & Gynec., 203-206,

1962.[NL]2. Shapleigh, J.B., and Montgomery, A.:Am. Pract. & Dig. Treat.

10-461, 1959. [NL]3. Brise, H. and Hallberg, L.: " Effect of Ascorbic Acid on

Iron Absorption, " Acta. Med. Scand.171:376, 51-58, 1962.[NL]4. New Drugs, p.

309, AMA, Chicago, 1966.[NL]5. Mazur, A., Green, S. and Carleton, A,:

" Mechanism of Plasma Iron Incorporation into Hepatic Ferritin, " J. Bio.

Chem. 3:595-603, 1960. [NL]6. Greenberg, S.M., Tucker, A. E., Mathues, H and

J.D.: " Iron Absorption and Metabolism, I. Interrelationship of Ascorbic Acid

and Vitamin E, " J. Nutrition 63:19-31, 1957.[NL]7. , C.V. and Dubach,

R. " Observations on the Absorption of Iron from Foods Tagged with Radioiron "

Trans. Assoc. Amer. Physic. 64:245, 1951.[NL]8. Steinkamp, R. Dubach, R. and

, C.V.: " Studies in Iron Transportation and Metabolism, " Arch. Int. Med.

95:181, 1955. [NL]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.[NL]10. Mazur, A.: " Role of Ascorbic Acid

in the Incorporation of Plasma Iron into Ferritin, " Ann. N.Y. Acad. Sci,

92:223-229, 1961. [NL]11. , E.V. et al.: " The Anemia of Scurvy, " Amer. J.

Med. 42:220-227, 1967. [NL]12. McEvoy, G.K., Ed.: AHFS Drug Information, p.

2667-2669, Am. Soc. Hosp. Pharm., Bethesda, 1996. [NL]13. en DG, Boers

GH, Blom HJ, Trijbels JM. " Effect of various regimens of vitamin B6 and

folic acid on mild hyperhomocysteinemia in vascular patients. " J. Inherit.

Metab. Dis. 1994; 17:159-62. [NL]14. Brattstrom L, Israelsson B, Norrving B,

et al. " Impaired homocysteine metabolism in early-onset cerebral and

peripheral occlusive disease - effects of pyridoxine and folic acid

treatment. " Atherosclerosis 1990; 81: 2004-6. [NL]15. Kang S. Wong PWK,

Norusis M. " Homocysteinemia due to folate deficiency. " Metabolism 1987; 36:

458-62. [NL]16. RH, Stabler SP, Savage DG, Lindernbaum J. " Diagnosis

of cobalamin deficiency. " IL usefulness of serum methylmalonic acid and

total homocysteine concentrations. Am. J. Hematol. 1990; 34: 90-98. [NL]17.

Dekker GA, de Vries JI, Doelitzsch PM, Huijgens PC, von Blomberg BM, Jakobs,

C, van Geijn HP. 1985. " Underlying disorder associated with severe

early-onset preeclampsia. " Am. J. Obstet. Gynecol. 173: 1042-1048. [NL]18.

Mills JL, McPartlin JM, Kirke PN, Lee YJ, Conley MR, Weir DG, JM.

1995. " Homocysteine metabolism in pregnancies complicated by neural-tube

defects. " Lancet. 345: 149-151. [NL]19. Steegers-Theunissen RP, Boers GH,

Blom HJ, Nijhuis JG, CM, Borm GF, Eskes TK. 1995. " Neural tube

defects and elevated homocysteine levels in amniotic fluid. " Am. J. Obstet.

Gynecol. 172: 1436-1441. [NL]20. Landgren F, Israelsson B, Lindgren A,

Hultberg B, Andersson A, Brattstrom L. 1995. " Plasma homocysteine in acute

myocardial infarction: Homocysteine-lowering effect of folic acid. " J.

Intern. Med. 237: 381-388. [NL]21. Mayer EL, sen DW, K. 1996.

" Homocysteine and Coronary Atherosclerosis. " J. Am. Coll. Cardiol. 27:

517-27. [NL]22. Berenbaum, M.C. et al.: Blood, 15:540, 1960. [NL]23. Drug

Information for the Health Care Professional, p.1365-1368, U. S.

Pharmacopeial Conven., Rockville, 1995. [PARA]REFERENCES[NL]1. Drug Facts

and Comparisons ®. 1993 Facts and Comparisons St. Louis, Mo; 208-236.

[NL]2. Dunea G, Swagel MA, Bodiwala U, et al, Intradialytic oral iron

therapy. Int J Artif Organs. 1994;17:261-264. [NL]3. Kirlin LF. Case

management of the anemic patient epoetin alfa-focus on iron supplementation.

ANNA Journal. 1993; 20:678-681. [NL]4. Wingard RL, RA, Ismail N. et

al. Efficacy of oral iron therapy in patients receiving recombinant human

erythropoietin. Am J Kidney Dis. 1995;25:433-439. [NL]5. Data on file,

Savage Laboratories. [PARA]Niferex-150 Forte is a registered trademark of

Central Pharmaceuticals, Inc. [NL]Trinisicon is a registered trademark of

UCB Pharma, Inc. [NL]Hemocyte Plus is a registered trademark of U.S.

Pharmaceutical Corp. [NL]Nephro-Fer Rx is a registered trademark of R & D

Laboratories. [NL]Iberet-Folic 500 and Fero-Folic 500 are registered

trademarks of Abbott Laboratories. [NL]Feosol is a registered trademark of

Kline Beecham Consumer Healthcare. [NL]Slow Fe is a registered

trademark of Ciba Self-Medication, Inc. [NL]Ferro-Sequels© is a registered

trademark of Lederle Consumer Health, A Division of Whitehall-Robins

Healthcare. [NL]Fergon is a registered trademark of Winthrop Consumer

Products.[NL]Ferro-Sequels is a registered trademark of Lederle Consumer

Health, A Division of Whitehall-Robins Healthcare. [NL]Fergon is a

registered trademark of Winthrop Consumer Products.

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