VP-HEME One

Virtus Pharmaceuticals LLC

VP-HEME OnePrenatal/Postnatal Multivitamin/Multimineral/DHA softgel

FULL PRESCRIBING INFORMATION: CONTENTS*

• Inactive Ingredients
• VP-HEME ONE INDICATIONS AND USAGE
• VP-HEME ONE CONTRAINDICATIONS
• WARNING
• WARNING
• PRECAUTIONS
• INTERACTIONS
• VP-HEME ONE ADVERSE REACTIONS
• VP-HEME ONE DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• STORAGE
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

Rx Only

DESCRIPTION: VP-HEME One is a prescription prenatal/postnatal multivitamin/ multimineral nutritional supplement with Omega-3 fatty acid. VP-HEME One is an oblong shaped, opaque purple colored softgel, imprinted with V240 in white ink on one side and plain on the other.

Each VP-HEME One Softgel contains:
Vitamin C (as ascorbic acid)	25 mg
Vitamin D3 (as cholecalciferol)	400 IU
Vitamin E (as dl-alpha tocopheryl acetate)	10 IU
Vitamin B3 (niacin as niacinamide)	17 mg
Vitamin B6 (as pyridoxine HCI)	50 mg
Folic Acid	1 mg
Vitamin B12 (as cyanocobalamin)	12 mcg
Biotin	30 mcg
Vitamin B5 (as d-calcium pantothenate)	10 mg
Iron as Polysaccharide Iron Complex	22 mg
as heme iron	6 mg
Iodine (as potassium iodide)	175 mcg
Zinc (as zinc oxide)	15 mg
Docosahexaenoic Acid (DHA)	200 mgThe DHA is derived from ultra-purified fish oil that contains less than 1% EPA.

Inactive Ingredients

Carmine, ethyl vanillin, FD&C blue #1, FD&C red #40, gelatin, glycerin, natural creamy orange flavor, purified water, soybean oil, soy lecithin, titanium dioxide, and yellow beeswax.

Contains: Soy, Shellfish, Fish, and Bovine.

VP-HEME ONE INDICATIONS AND USAGE

VP-HEME One is a prescription multivitamin/ multimineral nutritional supplement with Omega-3 fatty acid indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. VP-HEME One is also beneficial in improving the nutritional status of women prior to conception.

VP-HEME ONE CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNING

Ingestion of more than 3 grams of Omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of Omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding diathesis.

PRECAUTIONS

Folic acid when administered as a single agent in doses above 0.1 mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. Pregnant women and nursing mothers should avoid supplemental doses of vitamin E higher than RDA amounts. While prescribing this nutritional supplement for pregnant women, nursing mothers, or for women prior to conception, their medical condition and other drugs, herbs, and/or supplements consumption should be considered.

INTERACTIONS

Drugs which may interact with folate include:

• First generation anticonvulsants: High dose folic acid may result in decreased serum levels for first generation anticonvulsants (carbamazepine, fosphenytoin, phenytoin, phenobarbital, primidone, valproic acid, valproate). This may possibly reduce the effectiveness of first generation anticonvulsants and/or increase the frequency of seizures in susceptible patients. Caution should be used when prescribing folates among patients who are receiving treatment with first generation anticonvulsants.
• Second-generation anticonvulsants: Information on second-generation anticonvulsants' (including, but not limited to, lamotrigine) effect on folate levels is limited and cannot be ruled out.
• 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.
• Colchicine: Colchicine may decrease folate plasma levels.
• L-dopa: L-dopa may decrease folate plasma 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. Caution should be exercised when using folate with folate antagonists. Patients, typically, should not be given folate simultaneously with a folate antagonist, for the purpose of reducing or preventing clinical toxicity, as the therapeutic effect of the antagonist may be nullified.
• 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.
• 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, including, but not limited to pancreatin and pancrelipase: Reduced folate levels have occurred in some patients taking pancreatic extracts.
• Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine.
• 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 therapy.
• Folate may enhance the toxicity of fluorouracil.
• Concurrent administration of chloramphenicol and folate in folate-deficient patients may result in antagonism of the haematopoietic response to folate.
• Caution should be exercised with the concomitant use of folate 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 which may interact with pyridoxine hydrochloride: Pyridoxine hydrochloride should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine hydrochloride. However, pyridoxine hydrochloride may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.

VP-HEME ONE ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

VP-HEME ONE DOSAGE AND ADMINISTRATION

One softgel daily with or without food, or as prescribed by a licensed health care provider with prescribing authority.

HOW SUPPLIED

VP-HEME One is supplied in child-resistant blister packs of 30 softgels (NDC 76439-240-30).

KEEP OUT OF REACH OF CHILDREN.

STORAGE

Store at controlled room temperature 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C (59°-86°F). [See current USP].

To protect from light, dispense in carton provided. Once open, blisters should be stored in carton.

To report suspected adverse reactions, contact Virtus Pharmaceuticals at 813-283-1344 or FDA at 1-800-FDA-1088 or www.FDA.gov/safety/medwatch

Manufactured for:
Virtus Pharmaceuticals
Tampa, FL. 33619

VIRTUS
PHARMACEUTICALS

Rev. 03/13

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VIRTUS
Pharmaceuticals

NDC* 76439-240-30

VP-HEME-One

PRENATAL / POSTNATAL

Pre/Post-Natal Nutritional Supplement with DHA

12 Essential Vitamins and minerals including:

• 50mg of vitamiin B₆
• 1mg of folic acid

Plus Omega-3

30 Softgels

R_x

Virtus
PHARMACEUTICALS