PureFe OB Plus

PureTek Corporation

Prescribing Information

FULL PRESCRIBING INFORMATION: CONTENTS*

• CLINICAL PHARMACOLOGY:
• INDICATIONS:
• PUREFE OB PLUS CONTRAINDICATIONS:
• WARNING:
• PRECAUTIONS:
  • Pediatric Use:
  • Geriatric Use:
  • Adverse Reactions:
• OVERDOSE:
• PUREFE OB PLUS DOSAGE AND ADMINISTRATION:
• HOW SUPPLIED:
• Label

FULL PRESCRIBING INFORMATION

CLINICAL PHARMACOLOGY:

PureFe OB Plus supplies important prenatal vitamins and minerals in a formulation that was especially designed to supplement the nutritional needs of pregnant women, before, during and after pregnancy. In PureFe OB Plus, patients receive the balanced support of 13 essential vitamins and minerals, including 1 mg of folic acid. The essential role of iron supplementation for pregnant women has long been recognized. PureFe OB Plus is unique in that it utilizes two (2) different forms of iron, i.e., Ferrous Fumarate and Polysaccharide Iron Complex (as cell-contracted akaganeite), making available a total of 106 mg of elemental iron per capsule as follows:

Ferrous Fumarate (anhydrous)          162 mg
Polysaccharide Iron Complex (PIC)   115.2 mg

Ferrous Fumarate: Provides about 53 mg of elemental iron per dose. Ferrous Fumarate is an anhydrous  salt of a combination of ferrous iron and fumaric acid, containing 33% of iron per weight. The acute toxicity in experimental animals is low and Ferrous Fumarate is well tolerated clinically. As a ferrous salt, it is more efficiently absorbed in the duodenum. Ferrous Fumarate contrasts very favorably with the availability of the 20% of elemental iron of ferrous sulfate, and the 13% of elemental iron of ferrous gluconate.

Polysaccharide Iron Complex: Provides about 53 mg of elemental iron, as a cell-contracted akaganeite. It is a product of ferric iron complexed to a low molecular weight polysaccharide. This polysaccharide is produced by extensive hydrolysis of starch and is a dark brown powder that dissolves in water to form a very dark brown solution, which is virtually odorless and tasteless.

The most frequent cause of anemia in pregnant women is iron deficiency. Because of the continuous loss of iron due to monthly menstruation, most women enter pregnancy with less than optimal iron stores. Supplementation of iron must suffice to meet the need for maternal and fetal erythropoisis, and account for daily maternal gastrointestinal losses and obligate fetal transfer and growth. Iron requirements during pregnancy usually cannot be met with the average diet (ACOG technical bulletin (1993): Nutrition during Pregnancy. p.4 Number 179-April 1993: The American College of Obstetricians and Gynecologists, Washington, D.C. 20024-2188).

PureFe OB Plus does not contain calcium, as calcium may inhibit iron absorption because of the binding or conversion of ferrous salts by calcium and other minerals. Calcium salts can always be prescribed separately for women at high nutritional risk, including those who do not eat adequate amounts of dairy products. The recommendation of the National Academy of Sciences Tenth Ed. 1989 National Academy Press, Washington, D.C., suggests the supplementation of 1200 mg of calcium for pregnant and lactating women for the prevention of calcium deficiency.

Folic acid is a hematopoetic vitamin and has been used extensively for the prevention of neural tube defects (NTD). The need for folic acid in pregnancy, with its increased demands of the fetus, or lactation, is not being met by normal dietary sources. PureFe OB Plus capsules contain 1 mg of folic acid. NTD are the most common birth defects that result in infant mortality and serious disability. For women with a previous pregnancy that resulted in a child with a neural tube malformation, the use of 4 mg/d of folic acid has been reported to be effective in preventing a recurrence (MRC Vitamin Study Research Group, 1991). However, earlier studies from the United Kingdom suggested that lower daily doses, for example 0.36 mg might result in a comparable reduction of a recurrence of NTD. Since neural tube closure is complete by four weeks following conception, beginning folic acid supplementation after that time is not likely to be of any value. It should be noted that a daily 4 mg dose of folic acid did not prevent all NTD in the MRC study. Patients should be cautioned that folic acid supplementation does not preclude the need for consideration for prenatal testing for NTD (ACOG Committee Opinion, Number 120, March 1993: The American College of Obstetricians and Gynecologists, Washington D.C. 20024-2188). The U.S. Public Health Service has recommended that all women of childbearing age in the United States who are capable of becoming pregnant should consume 0.4 mg of folic acid per day for reducing their risk of having a pregnancy affected with spina bifida or other NTD (Center of Disease Control, 1992). Recommendation for the use of folic acid to reduce the number of cases of spina bifida and other neural tube defects: MMWR 1992: 41(RR14): 1-7).

INDICATIONS:

PureFe OB Plus is a prenatal vitamin-mineral preparation designed to supply nutritional supplementation for women throughout pregnancy and during the postnatal period to lactating and non-lactating mothers. PureFe OB Plus may also be used to improve the nutritional status of women before conception.

CONTRAINDICATIONS:

PureFe OB Plus is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.

WARNING:

Accidental overdose of Iron-containing products is the leading cause of fatal poisoning of children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately.

Folic acid alone is improper therapy in the treatment for pernicious anemias and other megaloblastic anemias where Vitamin B₁₂ is deficient.

PRECAUTIONS:

General: Folic acid in doses above 0.1 mg - 0.4 mg daily may obscure pernicious anemia, in that hematological remission can occur while neurological manifestations, remain progressive.

Pediatric Use:

Safety and effectiveness of this product have not been established in pediatric patients.

Geriatric Use:

No clinical studies have been performed in patients age 65 and over to determine whether older patients respond differently from younger patients. Dosage should always begin at the low end of the dosage scale and should consider that elderly patients may have decreased hepatic, renal, or cardiac function and/or concomitant diseases.

Side Effects:

Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid.

Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving PureFe OB Plus after meals may control occasional gastrointestinal disturbances. PureFe OB Plus is best absorbed when taken at bedtime.

Call your doctor for medical advice about side effects. You may report suspected side effects to the FDA at 1-800-FDA-1088.

OVERDOSE:

Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness and coma. The estimated overdose of orally ingested iron is 300 mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities, have resulted. PureFe OB Plus should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this and all drugs out of reach of children.

Treatment: For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxgen.

DOSAGE AND ADMINISTRATION:

Adults (persons over 12 years of age), One (1) capsule daily, orally, between meals, or as prescribed by a physician. Do not exceed recommended dosage. Do not administer to children under the age of 12.

HOW SUPPLIED:

PureFe OB Plus are red and white capsules imprinted horizontally "P-113", bottles of 90 capsules NDC 59088-113-66. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.

Stored at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Keep in a cool, dry place.

Label