Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)
KAISER FOUNDATION HOSPITALS
DOXYCYCLINE
DOXYCYCLINE ANHYDROUS 100 mg
ORAL
PRESCRIPTION DRUG
To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline tablets and other antibacterial drugs, doxycycline 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 Chlamydia psittaci . Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always elimin
Doxycycline Tablets 100 mg are yellow, film coated, caplets, debossed LCI on one face and 1338 on the other face. Each tablet contains doxycycline monohydrate equivalent to 100 mg of doxycycline. They are supplied as follows: Bottles of 20-NDC 0179-0129-20 Bottles of 14-NDC 0179-0129-14 Dispense in a tight light-resistant container with a child-resistant closure. Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. PROTECT FROM LIGHT.
Abbreviated New Drug Application
DOXYCYCLINE- DOXYCYCLINE TABLET, FILM COATED KAISER FOUNDATION HOSPITALS ---------- DOXYCYCLINE TABLETS RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline tablets and other antibacterial drugs, doxycycline tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Doxycycline is a broad-spectrum antibiotic synthetically derived from oxytetracycline. Doxycycline 100 mg tablets contain doxycycline monohydrate equivalent to 100 mg of doxycycline for oral administration. Inactive ingredients include anhydrous lactose, microcrystalline cellulose, corn starch, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, D&C yellow #10 aluminum lake, and FD&C yellow #6 aluminum lake. The chemical designation of the light-yellow crystalline powder 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 monohydrate. Structural formula: Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. CLINICAL PHARMACOLOGY Tetracyclines are readily absorbed and are bound to plasma proteins in varying degrees. They are concentrated by the liver in the bile and excreted in the urine and feces at high concentrations in a biologically active form. Doxycycline is virtually completely absorbed after oral administration. Following a 200 mg dose of doxycycline monohydrate, 24 normal adult volunteers averaged the following serum concentration values: Time (hr): 0.5 1.0 1.5 2.0 3.0 4.0 8.0 12.0 24.0 48.0 72.0 Conc. (mcg/mL) 1.02 2.26 2.67 3.01 3.16 3.03 2.03 1.62 0.95 0.37 0.15 AVERAGE OBSERVED VALUES Maximum Concentration 3.61 mcg/mL (± 0.9 sd) Time of Maximum Concentration 2.60 hr (± 1.10 sd) Elimination Rate Constant 0.049 per hr (± 0.030 sd) Half-Life 16.33 hr Olvassa el a teljes dokumentumot