Cavan alpha kit

Spl unclassified section

Tablets/Softgels

R xOnly

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:

Folic Acid 1 mg

Each tablet also contains the following ingredients for nutritional supplementation:

Vitamin A(beta carotene) 3,000 IU
Vitamin C(ascorbic acid) 120 mg
Vitamin D(cholecalciferol) 800 IU
Vitamin E(dl-alpha tocopheryl acetate) 3 mg
Vitamin B 1 (thiamine mononitrate) 1.8 mg
Vitamin B 2 (riboflavin) 4 mg
Niacinamide 20 mg
Vitamin B 6 (pyridoxine hydrochloride) 50 mg
Vitamin B 12 (cyanocobalamin) 12 mcg
Calcium(calcium carbonate) 230 mg
Iron(polysaccharide iron complex and
sodium iron EDTA)
27 mg
Magnesium(magnesium oxide) 25 mg
Zinc(zinc oxide) 25 mg
Copper(cupric oxide) 2 mg
Iodine 220 mcg

Each softgel contains the following ingredients for nutritional supplementation:

Total omega-3 long chain fatty acids at least 300 mg*
As DHA 200 mg**
As other omega-3 long-chain fatty acids 100 mg**
* from at least 429 mg of purified fish oil.
** approximately.

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.

Indications and usage

Cavan™-Alpha Kit 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 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.

Boxed warning section

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 poison control center immediately.

Spl unclassified section

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 B 12deficiency {specifically, the administration of folic acid may reverse the hematological manifestations of B 12deficiency, including pernicious anemia, while not addressing the neurological manifestations). Reduced folates may be less likely than folic acid to mask vitamin B 12deficiency. Folate therapy alone is Inadequate for the treatment of B 12deficiency.

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 includeibuprofen, 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.

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

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

Spl unclassified section

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 xOnly

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

Ingredients and appearance - Product information

Cavan alpha kit- Beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide, iodine, omega-3 fatty acids

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 13925-127
Route of Administration Oral

Product Characteristics

Color yellow (clear) Shape CAPSULE (oblong)
Size 8 mm Score 1
Imprint Code S127

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
unapproved drug other USA 2010/07/01

Labeler - Seton Pharmaceuticals( 828898002)

Establishment

Name ID/FEI Business Operations
Seton Pharmaceuticals 828898002 MANUFACTURE( 13925-127)

Package label.principal display panel

NDC 13925-127-10

Cavan™- Alpha Kit

Tablets / Softgels

R xOnly

30-Day Supply
30 Tablets / 30 Softgels

SETON PHARMACEUTICALS