Docosavit

Generic Name: ascorbic acid, pyridoxine hydrochloride, folic acid, ferrous fumarate and iron
Dosage Form: tablet

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Docosavit

INGREDIENTS:

Ferrous Fumarate: Provides about 15 mg of elemental iron per dose. Ferrous Fumarate is an anhydrous salt of a combination of ferrous iron and fumaric acid containing 33% or iron by 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 15 mg elemental iron, as a cell0contracted akageneite. It is a product of ferric iron complexed to a low molecular weight polysaccharide. This polysaccharide is produced by the 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 needs for maternal and fetal erythropoiesis and account for daily maternal gastrointestinal losses and obligate fetal transfer and growth. Iron requirement during pregnancy usually cannot be met with the average diet.(1)(2) Docosavit 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 suggests the supplementation of 1,200 mg of calcium for pregnant and lactating women for the prevention of calcium deficiency.(3)

Folic Acid: Neural tube defects occur in approximately 0.6 of 1,000 live births in the United States (i.e., approximately 6 of 10,000 live births; about 2,500 cases among 4 million live births annually). Neural tube defects are believed to be caused by many factors. The single greatest risk factor for a neural tube defect-affected pregnancy is a personal or family history of a pregnancy affected with such a defect. However, about 90 percent of infants with a neural tube defect are born to women who do not have a family history of these defects. The available evidence shows that diets adequate in folate (folic acid) may reduce the risk of neural tube defects but not of other birth defects.(4)

Vitamin C: An extra 15 mg of vitamin C is recommended daily for pregnant women (60 mg daily). While vitamin C deficiency has not been shown to affect the course or outcome of pregnancy in humans, questions have arisen about its possible association with low plasma levels of vitamin C, which have been reported to be associated with premature rupture of the membranes and preeclampsia.

Vitamin B6: Vitamin B6 may help for the treatment of nausea and vomiting during pregnancy. According to one clinical trial, thirty-one patients receiving vitamin B6 at 25 mg experienced significant reductions of severe nausea. (5)

Omega 3 Fatty Acids: The omega-3 fatty acids EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) are considered essential fatty acids because they must be supplied from the diet. The essential fatty acid (EFA) status of the developing fetus depends on that of its mother. Pregnancy is associated with a decrease in the biochemical EFA status and normalization after delivery is slow. This is particularly true for DHA because, on the basis of the current habitual diet, birth spacing appears to be insufficient for the maternal DHA status to normalize completely. Because of the decrease in EFA status during pregnancy, the neonatal EFA status may not be optimal. The neonatal EFA status can be increased by maternal EFA supplementation during pregnancy. (6)

INDICATIONS AND USAGE:

Docosavit is a prescription prenatal vitamin-mineral-nutrient preparation formulated to provide dietary supplementation for women throughout pregnancy and during the postnatal period (during lactation). Docosavit can also be used to improve the nutritional status of women prior to conception.

DOSAGE AND ADMINISTARTION:

Adult women (over 12 years of age), take one (1) softgel daily (orally), between meals or as prescribed by a physician. Do not exceed the recommended dosage. Do not administer to children under 12 years of age, or persons age 65 or older.

CONTRAINDICATIONS:

Docosavit is contraindicated in patients with known hypersensitivity to any of the ingredients including fish oil and soy. Iron is contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. This product is contraindicated for persons with pernicious anemia, as folic acid may obscure its signs and symptoms.

WARNING:

Folic acid alone is improper therapy in the treatment of pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive.

Ingestion of omega-3 fatty acids of more than 3 grams per day may present antithrombotic effects, including increased bleeding time. Omega-3 fatty acids including DHA and EPA should be avoided in patients with inherited or acquired bleeding diatheses. Patients taking anticoagulant drug products should consult with their physician prior to ingesting omega-3 fatty acids.

PRECAUTIONS:

Folic acid in dosages above 400 mcg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive.

ADVERSE REACTIONS:

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

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

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

USE IN SPECIFIC POPULATIONS:

Docosavit is not advocated for pediatric or geriatric use.

OVERDOSE:

Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting. In severe cases, iron overdose can cause 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, server reactions, including fatalities have resulted. Docosavit should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this and all other drugs out of the 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 oxygen.

HOW SUPPLIED:

Docosavit is available as a dark brown softgel capsule: bottles of 90 softgels NDC 68032-280-90. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. Store at controlled room temperature 15 – 30 C (59 – 86 F). Keep in a cool, dry place.

CAUTION:

Rx Only

RESERVED FOR PROFESSIONAL RECOMMENDATION: Made in the USA excelusively for River’s Ege Pharmaceuticals, LLC, Suwanee, GA 30024. All rights reserved. Copyright by River’s Edge Pharmaceuticals.

REFERENCES
(1) Worthington-Roberts BS, Williams SR. Nutrition in Pregnancy and Lactation, 6th Edition, Pg 168. 1977.
(2) Bothwell TH. Iron requirements in pregnancy and strategies to meet them. Am Jour Clin Tutr; 2000: 72(1), 257S-264S.
(3) National Academy of Science, 11th Edition, National Academy Press, Wash, D.C., 1997
(4) 21 CFR 101.79 Health claims: Folate and neural tube defects.
(5) Sahakian V et al Vitamin B6 is effective therapy for nausea and vomiting in pregnancy: a randomized double-blind placebo-controlled study. Obstet Gynecol 78:33. 1991.
(6) Hornstra B. Essential fatty acids in mothers and their neonates. Am Jour Clin Nutr. 2000;71(suppl):1262S-9S.

PACKAGING:

Docosavit  
ascorbic acid, pyridoxine hydrochloride, folic acid, ferrous fumarate, iron tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68032-280
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 25 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
FERROUS FUMARATE (IRON) FERROUS FUMARATE 15 mg
IRON (IRON) IRON 15 mg
DOCONEXENT (DOCONEXENT) DOCONEXENT 215.12 mg
ICOSAPENT (ICOSAPENT) ICOSAPENT 53.46 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN  
WATER  
GLYCERIN  
POLYSORBATE 80  
YELLOW WAX  
LECITHIN, SOYBEAN  
Product Characteristics
Color brown Score no score
Shape OVAL Size 20mm
Flavor Imprint Code RE;280
Contains         
Packaging
# Item Code Package Description
1 NDC:68032-280-90 90 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/16/2008 10/31/2012
Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 04/2011
 
River's Edge Pharmaceuticals, LLC



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