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PALAFER®
SmithKline Beecham
Ferrous Fumarate
Anemia Therapy
 
Indications And Clinical Uses: Increased iron requirements as in childhood, adolescence, and pregnancy; blood losses, overt or occult. Characterized microcytic hypochromic anemia; faulty iron absorption following gastrectomy; iron loss due to menstruation, sub-clinical iron deficiencies in adolescent girls due to precarious iron balance, and geriatrics.

Contra-Indications: Hemosiderosis, hemochromatosis. Iron compounds are also contraindicated in the treatment of hemolytic anemias unless an iron-deficient state also exists, since storage of iron with a possible exogenous hemosiderosis can result.

Precautions: Where anemia exists, its nature should be established and underlying causes determined.

Prolonged administration of iron should be avoided except in patients with continued bleeding or repeated pregnancies. In infants, large chronic doses of iron may so interfere with the assimilation of phosphorus as to cause severe rickets.

Orally administered iron salts may aggravate existing disorders, such as peptic ulcer, regional enteritis and ulcerative colitis. They may not be absorbed in patients with steatorrhea and those who have had a partial gastrectomy.

Before initiating parenteral iron therapy, it is advisable to give test doses to help detect sensitivity. Iron overload can occur in patients given an excess of parenteral iron, as well as those with hemoglobinopathies or other refractory anemias which might be erroneously diagnosed as iron-deficiency anemia.

Do not administer oral iron preparations concomitantly with parenteral iron.

Iron binds with tetracyclines in equal molecular ratio thus preventing absorption of tetracyclines.

Warn patients that iron is toxic when overdoses are ingested by children. Severe reactions, including fatalities, have resulted.

Concomitant administration of antacids containing aluminum and magnesium salts may impair the absorption of iron.

Adverse Reactions: Oral ingestion of iron preparations may be associated with gastrointestinal discomfort (such as nausea) and dose-related bowel effects (such as constipation or diarrhea). Untoward effects usually subside with continuation of therapy or by administration with or after meals.

There is a possibility that liquid dosage forms of iron may stain teeth. To reduce this possibility, mix each dose with water or fruit juice. If staining occurs, remove by brushing with baking soda (sodium bicarbonate).

Parenteral iron administration can cause nausea, vomiting and such acute allergic reactions as chills and fever, arthralgia, urticaria and asthma. Occasional pain and staining of the skin at the site of injection may occur. Severe anaphylactoid reactions with some deaths have been reported in the literature. Although i.m. administration of iron dextran injections have caused sarcoma in laboratory animals, induced malignanacy in man has never been observed.

Symptoms And Treatment Of Overdose: Iron poisoning is rare in adults but serious acute poisoning in children can result from ingestion of doses in excess of 1 g. Doses of 1 g should be considered as toxic in children and therapy instituted as soon as possible. Serum iron levels above 500 µg/100 mL can be taken as presumptive evidence of poisoning; severe poisoning is usually associated with levels well above 1 000 µg/100 mL.Symptoms: Symptoms may occur within about 30 minutes or may be delayed several hours. They are largely those of gastrointestinal irritation and necrosis with vomiting, diarrhea, tarry stools, hematemesis, fast and weak pulse, lethargy, low blood pressure, coma and signs of peripheral circulatory collapse. There may be a transient period of apparent recovery after 4 to 6 hours, followed by a second crisis characterized by cyanosis, pulmonary edema, circulatory collapse, convulsion and coma may then occur followed by death in 12 to 48 hours. tag_Treatment

Treatment: Milk should be given immediately and vomiting induced. Eggs and milk should then be fed (to form iron-protein complexes) until it is possible to perform gastric lavage with 1% sodium bicarbonate solution (to convert the iron to a less soluble form). Gastric lavage should not be performed after the first hour of iron ingestion because of the danger of perforation due to gastric necrosis. If an iron-chelating agent such as deferoxamine mesylate is available, it should be utilized. BAL (dimercaprol) should not be used because it may form a toxic complex. Measures to combat shock, dehydration, blood loss and respiratory failure may be necessary.

Dosage And Administration: Capsules: Adults and children over 12 years: 1 capsule daily on an empty stomach preferably at bedtime. Ferrous fumarate is well tolerated by most patients, however for patients sensitive to any form of iron: 1 capsule twice a day with meals is recommended. Characterized iron deficiency anemia: 24 weeks minimum. In pregnancy, 1 capsule daily throughout gestation. Iron supplementation in clinical cases, 12 weeks minimum.

Suspension: Children 0 to 2 years: Preventive: 0 to 6 months: 0.25 mL once daily (5 mg/day of elemental iron). 6 months to 2 years: 0.75 mL once daily (15 mg/day elemental iron).

Therapeutic: 0 to 6 months: 0.25 mL t.i.d. (15 mg/day of elemental iron). 6 months to 2 years: 0.75 mL t.i.d. (45 mg/day of elemental iron). Administer between meals with water or fruit juice.

Children 2 to 6 years: 2.5 mL (1/2 teaspoonful) daily at bedtime. 6 years of age and over: 5 mL (1 teaspoonful) daily at bedtime.

Availability And Storage: Capsules: Each scarlet capsule, printed "PALAFER" in white ink on the body and cap, contains: ferrous fumarate M.D.I. (micro dispersible form) 300 mg representing 100 mg of elemental iron. Nonmedicinal ingredients: D&C yellow No. 10, FD&C red No. 2, FD&C red No. 3, FD&C yellow No. 6, gelatin, lactose, povidone, sucrose, talc, titanium dioxide, silicon dioxide and sodium lauryl sulfate. Energy: 0.2 kJ (0.06 kcal). Cartons of 30 and bottles of 500.

Suspension: Each 5 mL of brown colored suspension contains: ferrous fumarate 300 mg equivalent to 100 mg elemental iron. Nonmedicinal ingredients: artificial cherry flavor, caramel carrageen, glycerin, methylparaben, propylparaben, sorbitol solution, sugar and water. Energy: 28.57 kJ (6.83 kcal)/5 mL. Bottles of 100 mL.