Nicomide Tablets (Sirius)

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DESCRIPTION

Nicomide® Tablets for oral administration are peach-colored; oval-shaped tablets imprinted "Sirius" in blue ink on one side.    792

Each oral tablet provides:

Nicomide® has been designed to provide biphasic delivery of each of the active ingredients in order to minimize the potential for competitive antagonism in absorption of its ingredients. The biphasic delivery system facilitates the immediate release of 750 mg Nicotinamide, 1.5 mg Cupric Oxide, and 500 mcg Folic Acid, as well as, the sustained release of 25 mg Zinc Oxide. The biphasic delivery system also minimizes the potential for drug interaction induced deficiency states and impaired absorptions of other therapeutic agents.

Inactive Ingredients:

Carnauba wax powder, ethyl cellulose, FD&C Blue # 1, FD&C Yellow # 6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propylene glycol, shellac, stearic acid, and titanium dioxide.

CLINICAL PHARMACOLOGY

Nicotinamide is a water-soluble component of the vitamin B complex group. In vivo, Nicotinamide is incorporated into nicotinamide adenine dinucleotide (NAD) and nicotinamide adenine dinucleotide phosphate (NADP). NAD and NADP function as coenzymes in a wide variety of enzymatic oxidation-reduction reactions essential for tissue respiration, lipid metabolism, and glycogenolysis.

Nicotinamide has demonstrated anti-inflammatory actions which may be of benefit in patients with inflammatory acne vulgaris, including but not limited to, suppression of antigen induced-lymphocytic transformation and inhibition of 3'-5' cyclic AMP phosphodiesterase. Nicotinamide has demonstrated the ability to block the inflammatory actions of iodides known to precipitate or exacerbate inflammatory acne.

Nicotinamide lacks the vasodilator, gastrointestinal, hepatic, and hypolipemic actions of nicotinic acid or niacin. As such nicotinamide has not been shown to produce the flushing, itching and burning sensations of the skin as is commonly seen when large doses of nicotinic acid or niacin are administered orally.

(See ADVERSE REACTIONS section)

Zinc has been shown to inhibit the inflammatory polymorphonuclear leukocyte chemotaxis in acne patients. Zinc has also demonstrated an inhibitory effect on the lipase of the three Propionibacterium species found in human pilosebaceous follicles.

Patients with inflammatory acne have been shown to have significantly lower serum zinc levels than matched healthy controls.

Copper is an essential trace mineral in human nutrition. Although rare, copper deficiency has been induced by supplemental zinc therapy. Chronic zinc supplementation has been shown to reduce the intestinal absorption and utilization of copper, which can induce signs of copper deficiency in some patients. Symptoms of copper deficiency include anemia and decreased activity of cytochrome c oxidase. Heartbeat irregularities have also been reported in some studies. The biphasic delivery system is designed to address this issue by delivering supplemental copper with zinc in a manner that minimizes the potential for competitive antagonism in absorption.

Folic acid serves as an essential cofactor for the biosynthesis of thymidine and purine nucleotides required for normal cellular DNA synthesis. Deficiencies of folic acid have been demonstrated to occur in some cutaneous inflammatory disorders.

INDICATIONS AND USAGE

Indicated for non-pregnant patients with acne vulgaris, rosacea or other inflammatory skin disorders who are deficient in, or at risk of deficiency in, one or more of the components of Nicomide®.

CONTRAINDICATIONS

Nicomide® is contraindicated in patients with hypersensitivity to any of its components.

Supplemental copper is contraindicated in those with Wilson's disease (hepatolenticular degeneration) a disease of abnormal copper accumulation.

WARNINGS

Folic Acid alone is improper treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

PRECAUTIONS

General:    Large doses of nicotinamide should be administered with caution in patients with a history of jaundice, liver disease, or diabetes mellitus.

Folic Acid above 0.1 mg daily may obscure pernicious anemia (hematologic remission may occur while neurological manifestations remain progressive).

Those with chronic liver failure and chronic renal failure should exercise extreme caution in the use of supplements containing copper.

Drug Interactions:   Nicotinamide: The clearance of primidone and carbamazepine may be reduced with the concomitant use of nicotinamide.

Zinc Oxide:   The absorption of quinolones or tetracycline may be decreased with the concomitant use of zinc.

Cupric Oxide:   Concomitant use of penicillamine and copper can cause decreased absorption of both substances.

Pregnancy:    Large doses of nicotinamide, zinc, or copper should be avoided in pregnancy.

Nursing Mothers:    Caution should be exercised when using Nicomide® in nursing mothers.

Pediatrics:    Safety and effectiveness of Nicomide® in pediatric patients have not been established.

Geriatrics:

Clinical studies of Nicomide® have not been performed to determine whether elderly subjects respond differently than younger subjects. In general dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS

Allergic sensitization has been reported rarely following oral and parenteral administration of Folic Acid.

At recommended doses, Nicomide® is expected to be well tolerated. Gastrointestinal distress such as nausea or vomiting have been associated with the administration of nicotinamide or zinc at doses greater than the recommended dose of Nicomide®.

Nicotinamide:   Dizziness, headache, hyperglycemia, nausea, vomiting, diarrhea, elevations in liver function tests, hepatotoxicity, blurred vision, flushing, rash.

DOSAGE and ADMINISTRATION

Usual adult dose is one tablet taken once or twice a day or as prescribed by a physician.

HOW SUPPLIED

Is supplied in bottles of 60's--NDC 65880-792-60. Store between 15°-30°C (59°-86°F).

Manufactured for:

Sirius Laboratories, Inc.

Vernon Hills, IL 60061

New formula adopted February 2003.    1204    8357-02

Patent Pending

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