Accentrate PNV — FDA Approved Drug

Indications & Usage

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.

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.

Warnings & Precautions

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.

Indications & Usage

Contraindications

Warnings & Precautions

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 . • 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.

Accentrate PNV(PRENATAL MULTIVITAMIN TABLET AND COMBINATION OMEGA-3 SOFTGEL/MINERAL CAPSULE)

Indications & Usage

Contraindications

Warnings & Precautions

Accentrate PNV(PRENATAL MULTIVITAMIN TABLET AND COMBINATION OMEGA-3 SOFTGEL/MINERAL CAPSULE)

Indications & Usage

Contraindications

Warnings & Precautions

Adverse Reactions

Drug Interactions

Use in Pregnancy & Lactation