PreFol-DHA

Method Pharmaceuticals, Inc.

Capsules

FULL PRESCRIBING INFORMATION

PreFol-DHA™ is a prescription prenatal/postnatal multivitamin/mineral softgel capsule with fish oil-based DHA. PreFol-DHA™ are oblong, maroon softgel capsules with “M100” imprinted on one side.

Each capsule has the following active ingredient:
Folic Acid................................................................................1.2 mg

Each capsule also contains the following ingredients for nutritional supplementation:
Vitamin C (ascorbic acid) ...................................................... 28 mg
Calcium (tribasic calcium phosphate) ................................. 160 mg
Iron (ferrous fumarate) ......................................................... 26 mg
Vitamin D3 (cholecalciferol) ................................................. 400 IU
Vitamin E (d-alpha tocopherol).............................................. 30 IU
Vitamin B6 (pyridoxine hydrochloride) ................................ 25 mg
DHA (Docosahexaenoic Acid)............................................... 300 mg*
Docusate Sodium................................................................ 55 mg
*from approximately 350 mg of Omega-3s derived from approximately 380 mg

Capsules (Gelatin, Glycerin, Purified Water, FD&C Red #40, Titanium Dioxide, Ethyl Vanillin, FD&C Yellow #6, FD&C Blue #1), Lecithin, Soybean Oil, Yellow Bees Wax, Citric Acid, Natural Creamy Orange Flavor.

PreFol-DHA™ is indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of nutritional supplementation.

PreFol-DHA™ is contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish or fish oil. Do not take this product if you are presently taking mineral oil, unless directed by a doctor.

Daily ingestion of more than 3 grams per day of omega-3 fatty acids (ALA, EPA, and DHA) from fish oils 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 diatheses, including those taking anticoagulants.

THIS PRODUCT CONTAINS SOYBEAN OIL AND FISH OIL.

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

Folates (including folic acid and reduced folates), when administered as a single agent in doses above 0.1 mg daily, may obscure the detection of 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). Reduced folates may be less likely than folic acid to mask vitamin B12 deficiency. Folate therapy alone is inadequate for the treatment of B12 deficiency.

PreFol-DHA™ is a prescription vitamin for use only under the direction and supervision of a licensed physician.

Pyridoxine hydrochloride should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine hydrochloride. However, pyridoxine hydrochloride may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Drugs which may interact with folate include:

• Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, 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 levels of this AED in the blood and allowing breakthrough seizures to occur.
• 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.

• 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.

• Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine.

• 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.

Allergic sensitization has been reported following both oral and parenteral administration of folic acid, as well as possibly the use of other forms of folates, including reduced folates. Paresthesia, somnolence, nausea and headaches have been reported with pyridoxine hydrochloride.

Before, during, and or after pregnancy, one tablet daily or as prescribed by a physician.

PreFol-DHA™ is dispensed in bottles of 30 softgel capsules.
PRODUCT CODE 58657-100-30
KEEP OUT OF REACH OF CHILDREN.
Rx Only

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.

Manufactured for:
Method Pharmaceuticals, LLC
www.methodpharm.com
Rev. 08/13

Before, during and/or after pregnancy, one softgel capsule daily or as prescribed by a physician.

Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP controlled room temperature].

Call your doctor about side effects. You may report side effects by calling (877) 250-3427.
KEEP OUT OF THE REACH OF CHILDREN.

Manufactured for:
Method Pharmaceuticals, LLC, Arlington, TX 76006
www.methodpharm.com

58657-100-30
PreFol-DHA ^TM
CAPSULES
Rx ONLY
30 CAPSULES