Tablets/Softgels

Rx Only

DESCRIPTION

Cavan™-Folate DHA is a prescription prenatal/postnatal multivitamin/mineral tablet and a softgel with an essential fatty acid.

Inactive Ingredients:

PVP K30, Sodium Phosphate Dibasic, Potassium Chloride, Fumed Silica, Citric Acid, TriPotassium Citrate, Microcrystalline Cellulose, Croscarmellose Sodium, Magnesium Stearate, Stearic Acid, Gum Arabic, Carboxylmethyl Cellulose, Prosolv™, Maltodextrin, Silicon Dioxide, Pregelatinized Starch, Hypromellose, Polyethylene Glycol, Ethyl Cellulose, Titanium Dioxide, Talc, FD&C Blue #1, Vegetable Oil, Polysorbate 80, Vitamin E, Natural Creamy Orange Flavor, Gelatin, Glycerin and Purified Water.

INDICATIONS AND USAGE

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

CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish or fish oil.

WARNINGS

Daily ingestion of more than 3 g 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 fish oil.

CAUTION

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

PRECAUTIONS

General:

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.

PATIENT INFORMATION

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

INTERACTIONS

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 level 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.

Drugs which may interact with pyridoxine hydrochloride:

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

ADVERSE REACTIONS

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. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with cyanocobalamin.

DOSAGE AND ADMINISTRATION

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

HOW SUPPLIED

Cavan™-Folate DHA is supplied in child-resistant blister packs of 30 tablets and 30 softgels. The Cavan™-Folate DHA tablet is an oblong, blue coated tablet with "S124" debossed on one side. The DHA softgel is an oblong, clear softgel capsule.

NDC 13925-125-60

STORAGE

Store at controlled room temperature 15°C to 30°C (59°F to 86°F). Avoid excessive heat.

Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Rx Only

Reserved for Professional Recommendation

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.

Manufactured For:
Seton Pharmaceuticals
Manasquan, NJ 08736
1-800-510-3401
MADE IN CANADA

06/10

SETON
PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL:

NDC 13925-125-60

Cavan TM- Folate
DHA

Tablets/Softgels

Rx Only

30-Day Supply

30 Tablets / 30 Softgels

SETON
PHARMACEUTICALS