Each tablet provides:
Nicotinamide, USP 750 mg
Carnauba wax powder, FD&C Blue # 1, FD&C Yellow # 6 Aluminum Lake, hydroxypropyl methyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, 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 (niacin). As such nicotinamide has not been shown to produce the flushing, itching and burning skin sensations commonly observed when large doses of nicotinic acid are administered orally. (See ADVERSE REACTIONS section
Zinc has been shown to inhibit inflammatory polymorphonuclear leukocyte chemotaxis in acne patients. Zinc has also been demonstrated to have 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.
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.
Indicated for nonpregnant patients with acne vulgaris, acne rosacea, or other inflammatory skin disorders who are deficient in, or at risk of deficiency in, one or more of the components of Nicomide™.
Nicomide™ is contraindicated in patients with hypersensitivity to any of its components.
Folic Acid alone is improper treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.
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).
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.
Large doses of nicotinamide or zinc should be avoided in pregnancy.
Caution should be exercised when using Nicomide™ in nursing mothers.
Safety and effectiveness of Nicomide™ in pediatric patients have not been established.
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.
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™. These effects usually resolved when nicotinamide or zinc was administered with food.
Although rare, transient elevations of liver functions tests have been reported when nicotinamide was administered in doses greater than the recommended dose of Nicomide™.
Usual adult dose is one tablet taken once or twice a day or as prescribed by a physician.
Is supplied in bottles of 60's--NDC 65880-726-60.
Store at controlled room temperature, 15°-30°C (59°-86°F).
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Manufactured for Sirius Laboratories, Inc. 100 Fairway Drive, Suite 130 Vernon Hills, IL 60061 |
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03/01 8186-00 |
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