Virt-Bal DHA Plus (doconexent 262 mg icosapent 112 mg) Dailymed

Indications And Usage

Virt-BAL DHA Plus is indicated for the distinct nutritional requirements of patients in need of PRENATAL/POSTNATAL dietary supplementation as determined by a licensed medical practitioner.

Virt-BAL DHA Plus is also indicated as supplementation therapy during pre/post pregnancy as well as while lactating / non-lactating.

Virt-BAL DHA Plus should be administered under the supervision of a licensed medical practitioner.

Contraindications

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish or fish oil.

Warnings

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

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 INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.

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.

This product contains FD&C Yellow No. 5 Lake (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. This product also contains FD&C Yellow No. 6 Lake.

CAUTION

Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

PATIENT INFORMATION

Virt-BAL DHA Plus 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. Virt-BAL DHA Plus does not contain l-methylfolate 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 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 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, orulat, 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.
• Iron may reduce zinc absorption.

PREGNANCY and NURSING MOTHERS

Virt-BAL DHA Plus is intended for use as a prescription PRENATAL folate before, during, and after pregnancy regardless of lactation status.

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.

Dosage And Administration

Before, during, and after pregnancy, one tablet and one softgel capsule, taken by mouth daily, or as directed by a licensed medical practitioner. Tablets and softgel capsules may be taken together or at different times of the day. Caution should be exercised to ensure that the prescribed dose of DHA does not exceed 1 gram (1000 mg) per day.

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. NOTICE: Contact with moisture can discolor or erode the tablet.

How Supplied

Virt-BAL DHA Plus is supplied as oval, yellow tablets debossed on one side with "V225" and oblong, light-yellow / semi-transparent enteric-coated soft gelatin capsules, dispensed in child-resistant buler packs of 30 tablets and 30 softgel capsules.

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.

Product Code: 76439-225-60

*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.

Rx

Manufactured for:Virtus Pharmaceuticals, LLCTampa, Florida 33619

MADE IN CANADA

VIRTUS PHARMACEUTICALS

Rev. 6/2012