CitraNatal Bloom Prescribing Information
Package insert / product label
Generic name: iron, folic acid, cyanocobalamin, ascorbic acid, and docusate sodium
Dosage form: tablet, film coated
Drug classes: Iron products, Vitamin and mineral combinations
Medically reviewed by Drugs.com. Last updated on Mar 25, 2024.
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Warning: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.
| Iron (Carbonyl iron, ferrous gluconate) | 90 | mg |
| Folic Acid | 1 | mg |
| Vitamin B12 (Cyanocobalamin) | 12 | mcg |
| Vitamin C (Ascorbic acid) | 119 | mg |
| Docusate sodium | 50 | mg |
Related/similar drugs
ferrous sulfate, ergocalciferol, folic acid, thiamine, Zinc, pyridoxine, FeroSul
CitraNatal Bloom - Clinical Pharmacology
Oral iron is absorbed most efficiently when administered between meals. Iron is critical for normal hemoglobin synthesis to maintain oxygen transport for energy production and proper function of cells. Adequate amounts of iron are necessary for effective erythropolesis. Iron also serves as a cofactor of several essential enzymes, Including cytochromes, which are involved in electron transport. Folic acid is required for nucleoprotein synthesis and the maintenance of normal erytropolesis. Folic acid is the precursor of tetrahydrofolic acid, which is involved as a cofactor for transformylation reactions in the biosynthesis of purines and thymidylates of nucleic acids. Deficiency of folic acid may account for the defective deoxyribonucleic acid (DNA) synthesis that leads to megaloblast formation and megaloblastic macrocytic anemias. Vitamin B12 is essential to growth, cell reproduction, hematopolesis, nucleic acid, and myelin synthesis. Deficiency may result in megaloblastic anemia or pernicious anemia.
Indications and Usage for CitraNatal Bloom
CitraNatal Bloom is indicated for the treatment of all anemias that are responsive to oral iron therapy. These include: hypochromic anemia associated with pregnancy, chronic and/or acute blood loss, metabolic disease, post-surgical convalescence, and dietary needs.
Contraindications
Hypersensitivity to any of the ingredients. Hemolytic anemia, hemochromatosis, and hemosiderosis are contraindications to iron therapy.
Warnings
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemia where vitamin B12 is deficient.
Precautions
General:
Take 2 hours after meals. Do not exceed recommended dose. Discontinue use if symptoms of intolerance appear. The type of anemia and underlying cause or causes should be determined before starting therapy with CitraNatal Bloom tablets. Ensure Hgb, Hct, and reticulocyte count are determined before starting therapy to determine if it needs to be continued without change or if a dose change is indicated. This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
Folic Acid:
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using these products since folic acid may mask the symptoms of pernicious anemia.
Adverse Reactions/Side Effects
Adverse reactions with iron therapy may include GI irritation, constipation, diarrhea, nausea, vomiting, and dark stools. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Drug Interactions
Prescriber should be aware of a number of iron/drug interactions, including antacids, tetracyclines, or fluoroquinolones.
Overdosage
Symptoms: abdominal pain, metabolic acidosis, anuria, CNS damage, coma, convulsions, death, dehydration, diffuse vascular congestion, hepatic cirrhosis, hypotension, hypothermia, lethargy, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, tachycardia, hyperglycemia, drowsiness, pallor, cyanosis, lassitude, seizures, and shock
CitraNatal Bloom Dosage and Administration
One tablet daily or as directed by a physician.
Do not chew tablet.
Storage and Handling
Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C and 30°C (between 59°F and 86°F). (See USP Controlled Room Temperature.)
How is CitraNatal Bloom supplied
CitraNatal Bloom (NDC 0178-0088-90) is a green, modified rectangle shaped, film-coated tablet, debossed with “F7” on one side and blank on the other, and packaged in bottles of 90.
| CITRANATAL BLOOM
iron, folic acid, cyanocobalamin, ascorbic acid, and docusate sodium tablet, film coated |
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| Labeler - Mission Pharmacal Company (008117095) |
| Registrant - Mission Pharmacal Company (927726893) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Mission Pharmacal Company | 927726893 | MANUFACTURE(0178-0088) | |
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