Prenatal Multivitamin Tablet and Combination Omega-3 Softgel/Mineral

Accentrate® PNV (Folate/Omega-3/Iron) (6 mg-210 mg-10 mg) is a Prescription Prenatal Multivitamin Tablet and combination Omega-3 Softgel/Mineral Capsule indicated for preventing neural tube defects and use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.

This product is contraindicated in patients with a known hypersensitivity to any of the articles contained in this product. This product is contraindicated for individuals with conditions for which any of the ingredients are contraindicated. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver.

WARNINGS/PRECAUTIONS: Caution is recommended in patients with a family history of bipolar illness. Mood elevation is possible in this population. Caution is also recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold. Furthermore, it has been reported that anticonvulsant medications interfere with folate metabolism, but the exact action is unclear; therefore caution is recommended with patients in this therapeutic group. Patients undergoing cancer treatment should consult their licensed medical practitioner for advice. Folate alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient. Folate in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission may occur while neurological manifestations progress. Daily ingestion of more than 3 grams per day of omega-3 fatty acids (DHA, ALA, and EPA) may have potential antithrombotic activities, or effects, and may increase bleeding times. Administration of omega-3 fatty acids, including DHA, should be avoided in patients with inherited or acquired bleeding diathesis, including those taking anticoagulants. Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

Allergic reactions have been reported following the use of oral and parenteral folate. xxix Mild transient diarrhea, polycythemia vera, itching, transitory exanthema, and the feeling of swelling of the entire body have been associated with methylcobalamin. xxx Allergic reactions, acne, skin reactions, photosensitivity, nausea, vomiting, abdominal pain, loss of appetite, paresthesia, somnolence, nausea, and headaches have been associated with pyridoxal-5’-phosphate. xxxi Call your medical practitioner about side effects. You may report side effects to the FDA at 1-800- FDA-1088 or call Key Therapeutics, LLC. at 888-981-8337.

Talk to your licensed medical practitioner, healthcare practitioner, personal physician, and/or pharmacist before taking or using any prescription, over-the-counter medicines, or herbal/health supplements alongside this product. 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 patients who are receiving treatment with phenytoin and other anticonvulsants.
• 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.
• 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 serum 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. 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 may interact with vitamin B 12 (Methylcobalamin):
• Antibiotics, cholestyramine, colchicines, colestipol, metformin, para-aminosalicylic, and potassium chloride may decrease the absorption of vitamin B 12 .
• Nitrous oxide can produce a functional vitamin B 12 deficiency *These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

AND NURSING MOTHERS Accentrate® PNV is intended for women of childbearing age who are – or desire to become, pregnant regardless of lactation status. Accentrate® PNV may be preferred for women at risk of dysregulated dopamine or serotonin regulation, which may include depression as a result of folate or cobalamin deficiency as well as folate-induced postpartum depression, or are at risk of folate-induced birth defects such as may be found with spina bifida and other neural tube defects (NTDs). It has been shown that folate enhances the synthesis and/or regeneration of tetrahydrobiopterin (BH 4 ), which is an essential cofactor in the biosynthesis of monoamine neurotransmitters serotonin, dopamine and norepinephrine i, ii, iii . The conversion of tryptophan to serotonin also requires BH 4 . Accentrate® PNV may also be an appropriate source of folate for those at high risk of NTDs because of the amount and bioavailability of L-methylfolate contained therein. Accentrate® PNV is Pregnancy Category A; however, Accentrate® PNV is NOT a standard complete prenatal/postnatal supplement for the following reasons: Accentrate® PNV contains over 1,000% of DV of folate for pregnant and lactating women, which may or may not be important depending upon your genetic disposition and previous pregnancies; please consult with your licensed medical practitioner on advanced folate supplementation during pregnancy for women at risk of NTDs and/or suboptimal folate/depression/postpartum. Accentrate® PNV contains over 600% of DV for cobalamin for pregnant and lactating women. Accentrate® PNV contains less than have the DV–only 37%–of iron for pregnant and lactating women, and Accentrate® PNV does not contain other vitamins and minerals that might be more suitable to your specific metabolic needs or part of a standard prenatal/postnatal multivitamin/multimineral/dietary supplement. iv, v, vi, vii