Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)
PD-Rx Pharmaceuticals, Inc.
DOXYCYCLINE HYCLATE
DOXYCYCLINE ANHYDROUS 100 mg
ORAL
PRESCRIPTION DRUG
To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline is indicated for the treatment of the following infections: - Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae . - Respiratory tract infections caused by Mycoplasma pneumoniae . - Lymphogranuloma venereum caused by Chlamydia trachomatis . - Psittacosis (ornithosis) caused by Chlamydophila psittaci . - Trachoma caused by Chlamydia trachomatis
Doxycycline Hyclate Tablets, USP equivalent to 100 mg doxycycline: Orange Coated, Round, Unscored Tablets, Debossed “WW 112”. NDC 55289-866-02 : Bottle of 2 Tablets NDC 55289-866-04 : Bottle of 4 Tablets NDC 55289-866-06 : Bottle of 6 Tablets NDC 55289-866-07 : Bottle of 7 Tablets NDC 55289-866-10 : Bottle of 10 Tablets NDC 55289-866-14 : Bottle of 14 Tablets NDC 55289-866-20 : Bottle of 20 Tablets NDC 55289-866-28 : Bottle of 28 Tablets NDC 55289-866-30 : Bottle of 30 Tablets NDC 55289-866-60 : Bottle of 60 Tablets NDC 55289-866-71 : Bottle of 210 Tablets NDC 55289-866-74 : Bottle of 400 Tablets NDC 55289-866-85 : Bottle of 330 Tablets NDC 55289-866-86 : Bottle of 360 Tablets NDC 55289-866-87 : Bottle of 300 Tablets NDC 55289-866-90 : Bottle of 90 Tablets NDC 55289-866-93 : Bottle of 180 Tablets NDC 55289-866-98 : Bottle of 120 Tablets NDC 55289-866-01 : Bottle of 100 Tablets Store at 20° to 25°C (68° to 77°F), [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Abbreviated New Drug Application
DOXYCYCLINE- DOXYCYCLINE HYCLATE TABLET, COATED PD-RX PHARMACEUTICALS, INC. ---------- DOXYCYCLINE HYCLATE TABLETS, USP RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Doxycycline Hyclate Tablets, USP are an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is: with a molecular formula of C H N O •HCL•1/2C N OH•1/2H O and a molecular weight of 512.93. The chemical designation for doxycycline is 2-Naphthacemecarboxamide, 4- (dimethylamino)-1, 4, 4a, 5, 5a, 6, -11, 12a-octahydro-3,5,10, 12, 12a-pentahydroxy-6- mothyl-1, 11-dioxo-monohydrochloride, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a light yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium Stearate, and Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and Titanium Dioxide. 22 24 2 8 2 5 2 CLINICAL PHARMACOLOGY Tetracyclines are readily absorbed and are bound to plasma proteins in varying degree. They are concentrated by the liver in the bile and excreted in the urine and feces at high concentrations and in a biologically active form. Doxycycline is virtually completely absorbed after oral administration. Following a 200 mg dose, normal adu Lees het volledige document