Cavan Alpha

Seton Pharmaceuticals

Cavan™- Alpha Kit

FULL PRESCRIBING INFORMATION: CONTENTS*

• CAVAN ALPHA DESCRIPTION
• CAVAN ALPHA INDICATIONS AND USAGE
• CAVAN ALPHA CONTRAINDICATIONS
• WARNING
• PRECAUTIONS
• PATIENT INFORMATION
• INTERACTIONS
• CAVAN ALPHA ADVERSE REACTIONS
• CAVAN ALPHA DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
  • STORAGE
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

Tablets/Softgels

R_x Only

CAVAN ALPHA DESCRIPTION

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

Each tablet has the following active Ingredient:

Each tablet also contains the following ingredients for nutritional supplementation:

Each softgel contains the following ingredients for nutritional supplementation:

Inactive Ingredients (tablet): Ascorbyl Palmitate, Citric Acid, Croscarmellose Sodium, Ethyl Cellulose, FD&C Blue #1, FD&C Yellow #5, Fumed Silica, Gum Arabic, Hydroxypropyl Cellulose, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, PVP K30, Stearic Acid, Talc, Titanium Dioxide, TriPotassium Citrate, Vegetable Oil.

Inactive Ingredients (softgel): Acetyl a ted Monoglycerides, Ethyl Vanillin, Gelatin, Glycerin, Polysorbate 80, Potassium Sorb ate, Purified Water, Shellac Ammonium Salt, Sodium Alginate, Specially Denatured Alcohol, Stearic Acid, Vitamin E.

CAVAN ALPHA INDICATIONS AND USAGE

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

CAVAN ALPHA CONTRAINDICATIONS

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

WARNING

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.

PRECAUTIONS

General: Folic acid, 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™- Alpha Kit is a prescription vitamin for use only under the direction and supervision of a licensed physician.

INTERACTIONS

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:

• Anti epileptic 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.
• Cholestyramlne: 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. DHFRls include aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim.
• Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine.
• lsotretinoin: 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.

CAVAN ALPHA 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.

CAVAN ALPHA DOSAGE AND ADMINISTRATION

One tablet and one softgel daily with or without food, or as prescribed by a licensed health care provider with prescribing authority.

HOW SUPPLIED

Cavan™- Alpha Kit is supplied in child-resistant blister packs of 30 tablets and 30 softgels. The Cavan™- Alpha Kit tablet is an oval, yellow tablet with "S127" debossed on one side. The Cavan™- Alpha Kit softgel is an enteric-coated oblong, clear softgel.

NDC 13925-127-10

STORAGE

Store at controlled room temperature 20-25°C (68-77°F). Protect from moisture and excessive heat. Note that contact with moisture may produce surface discoloration of the tablet.

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.

R_x 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

06/11

SETON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 13925-127-10

Cavan™- Alpha Kit

Tablets / Softgels

R _x Only

30-Day Supply
30 Tablets / 30 Softgels

SETON PHARMACEUTICALS