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Prenatal Multivitamin Tablet And Combination Omega-3 Softgel/Mineral Capsule

FDA Drug Information • Also known as: Accentrate Pnv

Brand Names
Accentrate Pnv
Route
ORAL
Dosage Form
KIT
Product Type
HUMAN PRESCRIPTION DRUG

⚠ Boxed Warning (Black Box)

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 a Poison Control Center immediately .

Description

DESCRIPTION Accentrate® PNV (Folate/Omega-3/Iron) (6 mg-210 mg-10 mg) is an orally administered Prescription Prenatal Multivitamin Tablet and combination Omega-3 Softgel/Mineral Capsule. Accentrate® PNV contains a prenatal tablet, omega-3 softgels, and mineral capsules. Each one tablet contains 6 mg of L-methylfolate Calcium, each two softgel serving contains 210 mg of EPA and DHA, and each three capsule serving contain 10 mg of iron. Each prenatal tablet contains: L-methylfolate Calcium 6 mg Pyridoxal-5-phosphate (Vitamin B6) 10 mg Methylcobalamin (Vitamin B12) 1 mg Riboflavin-5-phosphate (Vitamin B2) 3 mg Niacinamide (Vitamin B3) 5 mg Pantothenate (Vitamin B5) 15 mg Thiamine (Vitamin B1) 1 mg Vitamin D3 1200 IU / 30 mcg Vitamin C 85 mg Tyrosine 150 mg Other Ingredients: L-Glutathione, Starch, Croscarmellose Sodium, Silicon Dioxide, USP, Magnesium Stearate, Microcrystalline Cellulose. Each two omega-3 softgel serving contains: LYSOVETA® LPC which contains 1000 mg Lysophosphatidylcholine (LPC) 260 mg Eicosapentaenoic Acid 140 mg Docosahexaenoic Acid 70 mg Other Ingredients: Lysophosphatidylcholine (LPC)-Rich Oil, Extract of Antarctic Krill (Euphausia superba), Gelatin (bovine), Glycerin, Sorbitol, Water. CONTAINS: Shellfish (Krill) Each three mineral capsule serving contains: Magnesium (magnesium glycinate chelate) 290 mg Zinc (zinc glycinate chelate) 35 mg Iron (ferrous bisglycinate chelate) 10 mg Other Ingredients: Potato starch, ascorbic acid, magnesium stearate, fumed silica, hypomellose, copper bisglycinate.

What Is Prenatal Multivitamin Tablet And Combination Omega-3 Softgel/Mineral Capsule Used For?

INDICATIONS AND USAGE 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.

Dosage and Administration

DOSAGE AND ADMINISTRATION The usual adult dose may be taken as one (1) white vitamin tablet (Neuro 110™), two (2) red omega-3 softgels (Omega 110™), and three (3) white mineral capsules (Minerals 110™) daily, before, during and after pregnancy, or as directed by a physician. FOLATE is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. About 70% of food folate and cellular folate is comprised of L-methylfolate. It is the primary form of folate in circulation, and is also the form transported across membranes – particularly across the blood brain barrier – into peripheral tissues. In the cell, L-methylfolate is used in the remethylation of homocysteine to form methionine and tetrahydrofolate (THF). L-methylfolate is converted into functional, metabolically active coenzyme forms for use in the body, and supplies the active folate substrate, THF (tetrahydrofolate) for use in transformylation and methylation biochemistry. Folates are best known for reducing the incidence of fetal neural tube defects (NTDs). viii, ix,x NTDs are congenital malformations produced by failure of the neural tube to form and close properly during embryonic development. xi,xii During the first four weeks of pregnancy – when many women do not even realize that they have conceived, adequate maternal folate intake is essential to reduce the risk of NTDs. Folate is also essential in the synthesis and maintenance of nucleoprotein in erythropoiesis. It also promotes white blood cell (WBC) and platelet production in folate-deficiency anemia. Folate is associated with methylation and transformylation biochemistry. Folate is involved in transformylation and methylation metabolism as well as, indirectly, succinylation metabolism (through the “methyl trap” hypothesis). Folate plays a central role in the formation of nucleic acid precursors, such as thymidylic acid and purine nucleotides, which are essential for nucleic acid synthesis and cell division. IOM/NAS (1998) noted that the evidence for a protective effect from folate supplements is much stronger than that for food folate. Other ingredients are added to folate as cofactors, coenzymes and co-metabolites; in studies by Czeizel and Dudas (1992) and Berry et al. (1999), factors other than folate intake may affect the magnitude of risk reduction or participate in a co-protective effect with folate. 4,5 L-methylfolate supplementation increases the formation of endothelian nitric oxide synthase resulting in increase nitric oxide. This causes vasodilation to the nerves, increasing blood supply to the nerves, and reducing vascular oxidative stress. xiv L-methylfolate supplementation also increases nitric oxide levels by increasing the amount of tetrahydrobioterin (BH4). BH4 is required for nitric oxide synthesis. xv FOLATE COENZYMES, COFACTORS, AND COMETABOLITES - The following ingredients are added to enhance the bioavailable potential of folate, and include: COBALAMIN -...

Side Effects (Adverse Reactions)

ADVERSE REACTIONS 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.

Drug Interactions

DRUG INTERACTIONS 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 .
  • ...

    • Contraindications

    CONTRAINDICATIONS 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.

    Pregnancy and Breastfeeding

    PREGNANCY 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

    How Supplied

    HOW SUPPLIED Accentrate® PNV (Folate/Omega/Iron) (6 mg-210 mg-10 mg) is available in a carton with NDC † 70868-510-30 containing: Neuro 110™ in a bottle with 30 (white) tablets with the imprint “110”, Omega 110™ in a bottle with 60 (red) softgels, and Minerals 110™ in a bottle with 90 (white) capsules. † This product is a prescription folate with or without other dietary ingredients, due to increased folate levels (AUG 2 1973 FR 20750). The “Rx” on the label is to ensure prescription dispensing and that the product is administered under the supervision of a licensed medical practitioner due to the increased risk associated with masking of B 12 deficiency (pernicious anemia). Based on the risk of obscuring pernicious anemia, this product requires supervision of a licensed medical practitioner. The “Rx Only” status and a National Drug Code (NDC), or similar Product Code, facilitate pedigree reporting requirements and supply-chain control as well as, in some cases, insurance-reimbursement applications.

    About This Information

    This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

    What are side effects?

    Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

    What are drug interactions?

    Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.