V-Natal

Virtus Pharmaceuticals

V-Natal Tabs

FULL PRESCRIBING INFORMATION: CONTENTS*

• V-NATAL DESCRIPTION
  • Other Ingredients
• FOLATE REGULATION
• V-NATAL INDICATIONS AND USAGE
• V-NATAL CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • General
  • PATIENT INFORMATION
  • DRUG INTERACTIONS
  • PREGNANCY and NURSING MOTHERS
• V-NATAL ADVERSE REACTIONS
• V-NATAL DOSAGE AND ADMINISTRATION
• STORAGE
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

FULL PRESCRIBING INFORMATION

Rx

PRENATAL / POSTNATAL

Prescription Folate

V-NATAL DESCRIPTION

V-Natal Tabs is an orally administered PRENATAL / POSTNATAL prescription folate specifically formulated for the dietary management of patients with unique nutritional needs requiring increased folate levels.

V-Natal Tabs should be administered under the supervision of a licensed medical practitioner.

Each oval, pink film-coated tablet contains the following dietary ingredients:

Other Ingredients

Acacia, Citric Acid, Croscarmellose Sodium, Crospovidone, Fumed Silica, Hydroxpropyl Cellulose, Magnesium Stearate, Microcrystalline Cellulose, Pink Coating (FD&C Red #40 Lake, Hydroxypropylmethyl Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Sucralose, Talc, Titanium Dioxide), Polyvinylpyrrolidone, Silicon Dioxide, Stearic Acid, TriPotassium Citrate.

Since colors, flavors of natural origin vary from batch to batch in consistency - it may be necessary to substitute excipients as needed to ensure the highest therapeutic target, safety and quality.

Daily Values not established for patients with unique nutritional needs who are in need of supplementation as directed by a licensed medical practitioner.

FOLATE REGULATION

The term "folate" are B vitamins that include folic acid and any forms of active pteroylglutamates regardless of the reduction state of the molecule. Folates, or vitamin B₉, are primarily hydrolyzed in the intestinal jejunum and the liver to the active circulating form of folate, l-methylfolate, with an intermediate stable form, 5,10-methylenetetrahydrofolate.

Individuals with genetic polymorphisms for the genes coding methylenetetrahydrofolate reductase (MTHFR) may not be capable of utilizing or metabolizing folic acid adequately for the vitamin B₁₂ dependent methylation cycle.

Folic acid, including reduced formsIt is not known whether or not l-methylfolate can obscure pernicious anemia above 0.1 mg doses, so caution is advised also with this form of folate.
 
Folic acid - including reduced forms, may be added to medical foods as defined in section 5(b)(3) of the Orphan Drug Act (21 USC 360ee(b)(3)), or to food (21 CFR 172.345). such as folinic acid, may obscure pernicious anemia above 0.1 mg doses, and must be administered under the supervision of a licensed medical practitioner.

The 1971, 1972, 1973, 1980, 1984, 2000, and 2010 Federal Register Notices addressed this concern while establishing that increased folate was proper therapy in megaloblastic anemias - specifically where homocysteine levels were elevated or risk of neural tube defects (NTDs) was at issue. The Federal Register Notice of August 2, 1973 (38 FR 20750) specifically states that:

Dietary supplement preparations are available without a prescription (21 CFR 121.1134). Levels higher than dietary supplement amounts are available only with a prescription.

V-NATAL INDICATIONS AND USAGE

V-Natal Tabs is indicated for the distinct nutritional requirements of patients in need of PRENATAL/POSTNATAL dietary supplementation as determined by a licensed medical practitioner. V-Natal Tabs is also indicated as supplementation therapy during pre/post pregnancy as well as while lactating / non-lactating.

V-Natal Tabs should be administered under the supervision of a licensed medical practitioner.

V-NATAL CONTRAINDICATIONS

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

WARNINGS

See product ingredients. Consult your licensed healthcare practitioner or pharmacist for more information.

PRECAUTIONS

General

Folate, when administered as a single agent in doses about 0.1 mg daily, may obscure the detection of vitamin B₁₂ deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B₁₂ deficiency, including pernicious anemia, while not addressing the neurological manifestations). Folate therapy alone is inadequate for treatment of a vitamin B₁₂ deficiency.

PATIENT INFORMATION

V-Natal Tabs is a PRENATAL / POSTNATAL prescription folate to be used only under licensed medical supervision.

DRUG INTERACTIONS

Drugs which may interact with folate Folate is a broad term that includes folic acid and all reduced forms including l-methylfolate and folinic acid. V-Natal Tabs does not contain l-methylfolate or folinic acid but these warnings are included as general folate information. 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 and 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 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 haematopoietic response to folate.
• Caution should be exercised with the concomitant use of folinic acid and trimethoprimsulfamethoxazole 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 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 which 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 levodopa.
• Isoniazid can produce a vitamin B₆ deficiency.

Drugs which 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 which may interact with zinc:

• Concomitant administration of zinc supplements and certain antibiotics, specifically tetracyclines and quinolones, may decrease absorption of the antibiotic and potentially reduce its efficacy.

PREGNANCY and NURSING MOTHERS

V-Natal Tabs is intended for use as a prescription PRENATAL folate before, during, and after pregnancy regardless of lactation status.

V-NATAL ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parental administration of folic acid, and may possibly occur with other forms of folate. Paresthesia, somnolence, nausea and headaches have been reported with 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.

V-NATAL DOSAGE AND ADMINISTRATION

One tablet daily or as directed by a licensed medical practitioner.

STORAGE

Store at Controlled Room Temperature 15°-30°C (59°-86°F). [See USP]. Protect from light and moisture. Dispense in a tight, light-resistant container.

HOW SUPPLIED

V-Natal Tabs is supplied as oval, pink film-coated tablets debossed on one side with "VTAB", dispensed in bottles of 90 tablets.

Product Code: 76439-226-90

*This product is a PRENATAL/POSTNATAL prescription folate that contains folate in an amount higher than 0.1 mg, and has an increased risk associated with masking of vitamin B₁₂ deficiency and must be administered under a physician's supervision (AUG 3 1973 FR 20750). This product requires licensed medical supervision and a Rx status as required by pedigree reporting requirements.

KEEP THIS OUT OF REACH OF CHILDREN.

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Call your medical practitioner about side effects. You may report side effects by calling (813) 283- 1344.

Rx

Manufactured for:
Virtus Pharmaceuticals, LLC
Tampa, Florida 33619

MADE IN CANADA

Rev. 6/2012

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

VIRTUS
PHARMACEUTICALS

Product Code: 76439-226-90
V-Natal Tabs
PRENATAL / POSTNATAL
Prescription Folate

Rx
90 Tablets