Nicomide® Tablets for oral administration are peach-colored; oval-shaped tablets imprinted "Sirius" in blue ink on one Side.
Each oral tablet provides:
Nicotinamide, USP 750 mg
Zinc Oxide, USP 25 mg
Cupric Oxide, USP 1.5 mg
Folic Acid, USP 500 mcg
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.
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.
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 or other inflammatory skin disorders who are deficient in, or at risk of deficiency in, one or more of the components of Nicomide®.