ADVERSE REACTIONS SECTION.


ADVERSE REACTIONS. Allergic sensitization has been reported following both oral and parenteral administration 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.

BOXED WARNING SECTION.


WARNING. Accidental overdose of iron-containing products is the leading cause of poisoning of children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call doctor or poison control center immediately.

CONTRAINDICATIONS SECTION.


CONTRAINDICATIONS. Viva(R) CT Prenatal Chewable is contraindicated in individuals with known hypersensitivity to any of the ingredients.

DESCRIPTION SECTION.


DESCRIPTION. Viva(R) CT Prenatal Chewable is an orally administered, chewable prescription PRENULLTAL/POSTNULLTAL vitamin specifically formulated for the dietary management of individuals with unique nutritional needs requiring increased folate levels. Viva(R) CT Prenatal Chewable should be administered under the supervision of licensed medical practitioner.Each ROUND, LIGHT TO PINK-colored, chewable tablet contains the following dietary ingredients:Folic Acid1 mgDaily Value not established for individuals with unique nutritional needs who are in need of nutritional supplementation as directed by licensed medical practitioner. Iron (ferrous fumarate)28 mg Vitamin (ascorbic acid)100 mg Vitamin D3 (cholecalciferol)400 IU Vitamin (acetate)30 IU Vitamin B1 (thiamine mononitrate)3 mg Vitamin B2 (riboflavin)3 mg Vitamin B6 (pyridoxine HCl)50 mg Vitamin B12 (cyanocobalamin)15 mcg Zinc (oxide)20 mg Copper (sulfate)1 mg L-(+)-SelenomethionineL-(+)-Selenomethionine as Selenium SeLECT(R) is registered trademark of Sabinsa Corporation, Piscataway, NJ. It has CAS 3211-76-5, and is chemically known as the diasterioisomerically pure (S)-(+)-2-Amino-4(methylseleno)-butanoic acid. 50 mcg Other Ingredients. Xylitol, Microcrystalline Cellulose, Povidone, Magnesium Stearate, Talc, Fruit Punch Flavor, Sucralose.

DOSAGE & ADMINISTRATION SECTION.


DOSAGE AND ADMINISTRATION. Chew and swallow one tablet daily, or as directed by licensed medical practitioner.

DRUG INTERACTIONS SECTION.


DRUG INTERACTIONS. Drugs which 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 individuals 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 noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine.Isotretinoin: Reduced folate levels have occurred in some individuals 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 individuals 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 individuals with type diabetes decreases serum folate.Warfarin can produce significant impairment in folate status after 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 placebo controlled study.Folate is broad term that includes folic acid and all reduced forms including I-methylfolate and folinic acid. Viva(R) CT Prenatal Chewable does not contain I-methylfolate or folinic acid but these warnings are included as general folate information.Drugs which interact with vitamin B6:Vitamin B6 should not be given to individuals receiving the drug levodopa because the action of levodopa is antagonized by vitamin B6. However, vitamin B6 may be used concurrently in individuals receiving preparation containing both carbidopa and levodopa.Drugs which may 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 functional vitamin B12 deficiency.. 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 individuals 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 noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine.. Isotretinoin: Reduced folate levels have occurred in some individuals 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 individuals 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 individuals with type diabetes decreases serum folate.. Warfarin can produce significant impairment in folate status after 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 placebo controlled study.. Vitamin B6 should not be given to individuals receiving the drug levodopa because the action of levodopa is antagonized by vitamin B6. However, vitamin B6 may be used concurrently in individuals receiving preparation containing both carbidopa and levodopa.. Antibiotics, cholestyramine, colchicines, colestipol, metformin, para-aminosalicylic acid, and potassium chloride may decrease the absorption of vitamin B12.. Nitrous oxide can produce functional vitamin B12 deficiency.

HOW SUPPLIED SECTION.


HOW SUPPLIED. Viva(R) CT Prenatal Chewable is supplied as round, light pink to pink-colored chewable tablets embossed VCT, and are dispensed in bottles of 30 tablets.NDC 64661-811-30.

INDICATIONS & USAGE SECTION.


INDICATIONS AND USAGE. Viva(R) CT Prenatal Chewable is indicated for the distinct nutritional requirements of individuals in need of PRENULLTAL/POSTNULLTAL dietary supplementation as determined by licensed medical practitioner. This product can be used fordietary management prior to conception. Viva(R) CT Prenatal Chewable should be administered under the supervision of licensed medical practitioner.

INFORMATION FOR PATIENTS SECTION.


PATIENT INFORMATION. Viva(R) CT Prenatal Chewable is prescription PRENULLTAL/POSTNULLTAL vitamin to be used only under licensed medical supervision.

NURSING MOTHERS SECTION.


Viva(R) CT Prenatal Chewable is intended for use as PRENULLTAL/POSTNULLTAL vitamin for lactating and non-lactating mothers. Talk with your medical practitioner to ensure adequate prenatal/postnatal supplementation. Consult with your licensed medical practitioner before using Viva(R) CT Prenatal Chewable if pregnant or nursing.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL 30 Chewable Tablet Label. RxPatent Protected30 ct. Fruit-flavored,Chewable TabletsViva(R)CTPrenatal ChewableManufactured for: JAYMAC Pharmaceuticals, LLC Sunset, LA 70584Prescription VitaminNDC++64661-811-30. PRINCIPAL DISPLAY PANEL 30 Chewable Tablet Label.

PRECAUTIONS SECTION.


PRECAUTIONS. Folate alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folate in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.. PATIENT INFORMATION. Viva(R) CT Prenatal Chewable is prescription PRENULLTAL/POSTNULLTAL vitamin to be used only under licensed medical supervision.. DRUG INTERACTIONS. Drugs which 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 individuals 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 noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine.Isotretinoin: Reduced folate levels have occurred in some individuals 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 individuals 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 individuals with type diabetes decreases serum folate.Warfarin can produce significant impairment in folate status after 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 placebo controlled study.Folate is broad term that includes folic acid and all reduced forms including I-methylfolate and folinic acid. Viva(R) CT Prenatal Chewable does not contain I-methylfolate or folinic acid but these warnings are included as general folate information.Drugs which interact with vitamin B6:Vitamin B6 should not be given to individuals receiving the drug levodopa because the action of levodopa is antagonized by vitamin B6. However, vitamin B6 may be used concurrently in individuals receiving preparation containing both carbidopa and levodopa.Drugs which may 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 functional vitamin B12 deficiency.. 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 individuals 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 noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine.. Isotretinoin: Reduced folate levels have occurred in some individuals 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 individuals 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 individuals with type diabetes decreases serum folate.. Warfarin can produce significant impairment in folate status after 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 placebo controlled study.. Vitamin B6 should not be given to individuals receiving the drug levodopa because the action of levodopa is antagonized by vitamin B6. However, vitamin B6 may be used concurrently in individuals receiving preparation containing both carbidopa and levodopa.. Antibiotics, cholestyramine, colchicines, colestipol, metformin, para-aminosalicylic acid, and potassium chloride may decrease the absorption of vitamin B12.. Nitrous oxide can produce functional vitamin B12 deficiency.

PREGNULLNCY SECTION.


PREGNULLNCY and NURSING MOTHERS. Viva(R) CT Prenatal Chewable is intended for use as PRENULLTAL/POSTNULLTAL vitamin for lactating and non-lactating mothers. Talk with your medical practitioner to ensure adequate prenatal/postnatal supplementation. Consult with your licensed medical practitioner before using Viva(R) CT Prenatal Chewable if pregnant or nursing.

SPL UNCLASSIFIED SECTION.


Rx Only30ct round, light pink to pink-colored, fruit-flavored chewable tablets, embossed VCTPrescription PRENULLTAL/POSTNULLTAL Vitamin.

STORAGE AND HANDLING SECTION.


STORAGE. Store at Controlled Room Temperature 15- 30C (59- 86F). [See USP]. Dispense in tight, light-resistant container.

WARNINGS SECTION.


WARNINGS. WARNING. Accidental overdose of iron-containing products is the leading cause of poisoning of children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call doctor or poison control center immediately.