PRENATAL/POSTNATAL Prescription Folic Acid-Containing
Dietary Supplement

69543-237-90

Rx

DESCRIPTION

VP-HEME OB is an orally administered PRENATAL / POSTNATAL prescription dietary supplement and should be administered under the supervision of a licensed medical practitioner.

DIRECTIONS FOR USE

Before, during and/or after pregnancy, regardless of lactation status: one tablet daily or as directed by a licensed healthcare practitioner. Supplements containing iron should not be taken on an empty stomach. Notice: Contact with moisture may produce surface discoloration or erosion.

Other Ingredients: Microcrystalline Cellulose, Pregelatinized Starch, Di Calcium Phosphate, Purple Coating (hydroxypropylmethylcellulose, titanium dioxide, polyvinyl alcohol, polyethylene glycol, talc, FD&C red #40 lake, FD&C blue #1 lake), Croscarmellose Sodium, Magnesium Stearate, Fumed Silica, Silicon Dioxide, Stearic Acid, Tripotassium Citrate, Citric Acid.

Contains FD&C Red #40 Lake and FD&C Blue #1 Lake

Potential allergens: Contains FD&C Red #40 and FD&C Blue #1. This product is manufactured in a facility that also manufactures products containing tree nuts, peanuts, fish, egg, wheat, milk, soy and shellfish.

VP-HEME OB Tabs should be administered under the supervision of a licensed medical practitioner.

CONTRAINDICATIONS

VP-HEME OB is contraindicated in patients with a known hypersensitivity to any of its ingredients.

CAUTION

High levels of folic acid may, especially in older adults, hide signs of vitamin B-12 deficiency (such as pernicious anemia, a condition that can cause nerve damage).

SIDE EFFECTS

Allergic sensitization has been reported following oral administration of folic acid. Paresthesia, somnolence, nausea and headaches have been reported with pyridoxine hydrochloride (vitamin B6). Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with vitamin B12. Iron can cause mild gastrointestinal side effects, particularly when taken on an empty stomach. Iodine supplementation in excess of 500 µg per day are associated with increased thyroid stimulating hormone levels.

DRUG INTERACTIONS

Drugs that may interact with folate include:

•

Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, fosphenytoin, valproate, phenobarbital and lamotrigine have been shown to impair folate absorption and increase the metabolism of circulating folate. Additionally, concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the level of the AED in the blood and allowing breakthrough seizures to occur. Caution should be used when prescribing this product among patients who are receiving treatment with phenytoin or other anticonvulsants.

•

Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of capecitabine.

•

Cholestyramine: Reduces folic acid absorption and reduces serum folate levels.

•

Colestipol: Reduces folic acid absorption and reduces serum folate levels.

•

Cycloserine: Reduces folic acid absorption and reduces serum folate levels.

•

Dihydrofolate Reductase Inhibitors (DHFRI): DHFRIs block the conversion of folic acid to its active forms, and lower plasma and red blood cell folate levels. DHFRIs include aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim.

•

Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine.

•

Isotretinoin: Reduced folate levels have occurred in some patients taking isotretinoin.

•

L-dopa, triamterene, colchicine, and trimethoprim may decrease plasma folate levels.

•

Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs have been shown to inhibit some folate dependent enzymes in laboratory experiments. NSAIDs include ibuprofen, naproxen, indomethacin and sulindac.

•

Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy.

•

Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylprednisolone.

•

Pancreatic Enzymes: Reduced folate levels have occurred in some patients taking pancreatic extracts, such as pancreatin and pancrelipase.

•

Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine.

•

Pyrimethamine: High levels of folic acid may result in decreased serum levels of pyrimethamine.

•

Smoking and Alcohol: Reduced serum folate levels have been noted.

•

Sulfasalazine: Inhibits the absorption and metabolism of folic acid.

•

Metformin treatment in patients with type 2 diabetes decreases serum folate.

•

Warfarin can produce significant impairment in folate status after a 6-month course of therapy.

•

Heme-iron: Can compete for transport and reduce folate absorption. Ensure adequate medical supervision to ensure proper iron levels.

•

Folinic acid may enhance the toxicity of fluorouracil.

•

Concurrent administration of chloramphenicol and folinic acid in folate-deficient patients may result in antagonism of the hematopoietic response to folate.

•

Exercise caution with the concomitant use of folinic acid and trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection as it is associated with increased rates of treatment failure and mortality in a placebo controlled study.

Drugs that interact with vitamin B12:

•

Antibiotics, cholestyramine, colchicines, colestipol, metformin, para-aminosalicylic acid, and potassium chloride may decrease the absorption of vitamin B12.

•

Nitrous oxide can produce a functional vitamin B12 deficiency.

Drugs that interact with vitamin B6:

•

Vitamin B6 should not be given to patients receiving the drug levodopa because the action of levodopa is antagonized by vitamin B6. However, vitamin B6 may be used concurrently in patients receiving a preparation containing both carbidopa and devodopa.

•

Isoniazid can produce a vitamin B6 deficiency.

Drugs that may interact with vitamin D3:

•

Certain thiazide diuretics, such as hydrochlorothiazide, as well as antacids, bile acid sequestrants (such as cholestyramine), mineral oil, orlistat, olestra, cimetidine, and anticonvulsant medications may reduce the absorption or increase the catabolism of vitamin D.

•

Vitamin D supplementation should not be given with calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.

Drugs that interact with iron:

•

Iron supplements might reduce the amounts of levodopa available to the body and diminish its clinical effectiveness.

•

Levothyroxine ingested simultaneously with iron can result in clinically significant reductions in levothyroxine efficacy.

•

Proton pump inhibitors reduce the acidity of stomach contents and can reduce iron absorption.

Drugs that interact with iodine:

•

Anti-thyroid medications, such as methimazole, are used to treat hyperthyroidism. Taking high doses of iodine can produce an additive effect and cause hyperthyroidism.

•

Taking potassium iodide with angiotensin-converting enzyme (ACE) inhibitors increases the risk of hyperkalemia.

•

Potassium-sparing diuretics such as spironolactone and amiloride can increase the risk of hyperkalemia when taken with potassium iodide.

PREGNANT/NURSING WOMEN

VP-HEME OB is a prescription folate dietary supplement intended for use before, during, and after pregnancy, regardless of lactation status.

VP-HEME OB should be used ony under licensed medical supervision.

HEALTH CLAIM

Adequate folate in healthful diet may reduce a woman's risk of having a child with a brain or spinal cord birth defect.

HOW SUPPLIED

VP-HEME OB is supplied as oval, purple film-coated tablets imprinted "VPHEME" on one side and a bisect on the other side, dispensed in bottles of 90 tablets.

STORAGE

Store at room temperature 15° to 30°C (59° to 86°F). Protect from light and moisture. Dispense in a tight, light-resistant container. Contact with moisture may produce surface discoloration or erosion.

69543-237-90

Call your licensed medical practitioner about side effects. You may report side effects by calling Virtus at 1-888-848-3593 or FDA at 1-800-FDA-1088.

KEEP THIS OUT OF REACH OF CHILDREN.

Rx

Manufactured for
Virtus Pharmaceuticals, LLC
Tampa, Florida 33619
1-888-848-3593

MADE IN CANADA
Rev. 07/15

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

 

VIRTUS
PHARMACEUTICALS

69543-237-90

VP-HEME OB
Tabs

PRENATAL/POSTNATAL

Prescription Folic Acid-Containing
Dietary Supplement

Rx
90 Tablets