Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
Doxycycline Hyclate (UNII: 19XTS3T51U) (Doxycycline Anhydrous - UNII:334895S862)
Sun Pharmaceutical Industries, Inc.
Doxycycline Hyclate
Doxycycline Anhydrous 20 mg
ORAL
PRESCRIPTION DRUG
Doxycycline hyclate is indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis. This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines.
Doxycycline hyclate tablets USP equivalent to 20 mg of doxycycline, round, white, unscored, film coated tablet, debossed MP 573 on one side and blank on the other side. Bottles of 30 NDC 53489-647-07 Bottles of 60 NDC 53489-647-06 Bottles of 90 NDC 53489-647-90 Bottles of 100 NDC 53489-647-01 Bottles of 250 NDC 53489-647-03 Bottles of 500 NDC 53489-647-05 Bottles of 1000 NDC 53489-647-10 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
Abbreviated New Drug Application
DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET, FILM COATED SUN PHARMACEUTICAL INDUSTRIES, INC. ---------- DOXYCYCLINE HYCLATE TABLETS USP RX ONLY DESCRIPTION Doxycycline hyclate is available as a 20 mg tablet formulation of doxycycline for oral administration. The structural formula of doxycycline hyclate is: with an empirical formula of (C H N O •HCl) •C H O•H O and a molecular weight of 1025.89. The chemical designation for doxycycline is 4-(dimethylamino)-1, 4, 4a, 5, 5a, 6, 11, 12a-octahydro-3, 5, 10, 12, 12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow to light-yellow crystalline powder which is soluble in water. Each tablet for oral administration contains 23 mg doxycycline hyclate equivalent to 20 mg of doxycycline. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, titanium dioxide, and triacetin. CLINICAL PHARMACOLOGY After oral administration, doxycycline hyclate is rapidly and nearly completely absorbed from the gastrointestinal tract. Doxycycline is eliminated with a half-life of approximately 18 hours by renal and fecal excretion of unchanged drug. MECHANISM OF ACTION Doxycycline has been shown to inhibit collagenase activity _in vitro_. Additional studies have shown that doxycycline reduces the elevated collagenase activity in the gingival crevicular fluid of patients with adult periodontitis. The clinical significance of these findings is not known. MICROBIOLOGY Doxycycline is a member of the tetracycline class of antibiotics. The dosage of doxycycline achieved with this product during administration is well below the concentration required to inhibit microorganisms commonly associated with adult periodontitis. Clinical studies with this product 22 24 2 8 2 2 6 2 1 2,3 demonstrated no effect on total anaerobic a Citiți documentul complet