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Appearex Tablets (Merz)
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DESCRIPTION AND MECHANISM OF ACTION
Appearex® is a biotin preparation (2.5 mg) available for oral administration as a small, easy-to-swallow tablet. Each Appearex® tablet contains as its active ingredient 2.5 mg of biotin, a dose clinically proven to improve nail strength and quality. 1-4 Inactive ingredients include lactose monohydrate, cornstarch, povidone (K25), and magnesium stearate.
Biotin is a water-soluble vitamin component of the vitamin B complex. As an essential nutrient, biotin acts as a coenzyme for the body's carboxylation reactions and is a factor in maintaining healthy muscle, hair, nails, and skin. Its molecular formula is C 10 H 16 N 2 O 3 S, and its molecular weight is 244.308. It has the following structural formula:
The presumed mechanism of action by which Appearex® affects brittle nails is via the pharmacologic effects of biotin on all keratin structures. Biotin stimulates the differentiation of epidermal cells and is involved in keratinization. It is also believed that biotin increases the quantity of keratin matrix proteins in the nail, thereby improving keratin structure. 3,5
ABSORPTION AND TRANSPORT:
Biotin is efficiently absorbed in the small intestine sodium-mediated carrier transport. 6,7 Once absorbed, 80% of biotin is free, and the remaining 20% is bound to plasma proteins. 8 Cellular entry of biotin occurs by both diffusion and sodium-dependent transport.
DEGRADATION AND EXCRETION:
About 43% of biotin is excreted unchanged in the urine. 9 The remainder is excreted as degradation products including bisnorbiotin (30%), biotin sulfoxide (11%), and other small amounts of biotin sulfone, bisnorbiotin methylketone, and tetranorbiotin sulfoxide. 10
Adverse reactions associated with biotin supplementation are rare in the medical literature; however, urticaria and gastrointestinal upset have been reported. As with any oral treatment, if patients experience any adverse reactions or side effects, they should inform their physicians immediately and discontinue use.
The anticonvulsants carbamazepine, phenytoin, phenobarbital, and primidone may accelerate biotin metabolism, leading to a reduction in available biotin. Chronic use of these drugs has been associated with decreased plasma concentrations of biotin. 11,12
The use of antibiotics may reduce the contribution of biotin made by bacteria within the large intestine.
PRECAUTIONS AND WARNINGS
Pregnant women and nursing mothers should consult their physicians before taking this product. Appearex® should not be used in patients with known allergy or hypersensitivity to any of its ingredients.
No toxic effects have been reported, even at higher doses. 13
INDICATION AND USAGE
Appearex® is recommended for first-line treatment of weak, brittle, splitting, or soft nails.
Appearex® therapy should be taken regularly as directed to maintain strong, healthy nails. Clinical improvement is generally realized within 3 to 6 months. 1-3 Cessation of therapy may result in deterioration of nail health within 6 to 9 months.
Appearex® is contraindicated in patients allergic or hypersensitive to any of its ingredients.
DOSAGE AND ADMINISTRATION
Recommended treatment for adults is 1 tablet taken daily with water. For use in children under 12 years of age, consult a physician for guidance regarding proper dosing and administration.
One Appearex® package contains 30 tablets (1 month's supply) enclosed in blister packs.
Appearex®, for the treatment of weak, brittle, splitting, or soft nails, is pharmaceutical grade oral biotin that restores nail quality by promoting keratinization. It has been clinically proven to increase nail plate thickness, smooth brittle nail ridges, and improve overall nail quality. As a water-soluble essential vitamin the biotin in Appearex® is safe and well tolerated. For patients with brittle nails, one Appearex® tablet taken daily provides the additional biotin needed to manage onychoschizia/onychorrhexis.
5010814 Rev 05/04