Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
DOXYCYCLINE
DOXYCYCLINE ANHYDROUS 50 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 Chlamydophila psittaci . Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminated
Doxycycline Tablets 50 mg are a peach colored, film coated round biconvex tablets, debossed with 'I61' on one side and plain on the other side. Each tablet contains doxycycline monohydrate equivalent to 50 mg of doxycycline. They are supplied as follows: Doxycycline Tablets 75 mg are a peach colored, film coated, capsule shaped, biconvex tablets, debossed with 'I62' on one side and plain on the other side. Each tablet contains doxycycline monohydrate equivalent to 75 mg of doxycycline. They are supplied as follows: Doxycycline Tablets 100 mg are a peach colored, film coated, round biconvex tablets, debossed with 'I63' on one side and plain on the other side. Each tablet contains doxycycline monohydrate equivalent to 100 mg of doxycycline. They are supplied as follows: Doxycycline Tablets 150 mg are a peach colored, film coated capsule shaped scored tablets, debossed with 'I' and '64' on either side of a breakline and plain on other side. Each tablet contains doxycycline monohydrate equivalent to 150 mg of doxycycline. They are supplied as follows: STORE AT 20°-25°C (68°-77°F). [SEE USP CONTROLLED ROOM TEMPERATURE.] PROTECT FROM LIGHT. DISPENSE IN A TIGHT LIGHT-RESISTANT CONTAINER AS DEFINED IN THE USP/NF.
Abbreviated New Drug Application
DOXYCYCLINE- DOXYCYCLINE TABLET HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC. ---------- DOXYCYCLINE TABLETS, USP 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 antibacterial synthetically derived from oxytetracycline. Doxycycline 150 mg, 100 mg, 75 mg, and 50 mg tablets contain doxycycline monohydrate equivalent to 150 mg, 100 mg, 75 mg, or 50 mg of doxycycline for oral administration. The chemical designation of the light- yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. Structural formula: C H N O •H O M.W. = 462.45 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. Inert ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, hypromellose 2910, magnesium stearate and opadry 04G84829 pink which contains: hypromellose 2910, talc, titanium dioxide, propylene glycol, polyethylene glycol 6000, iron oxide yellow and iron oxide red. 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. 1.02 2.26 2.67 3.01 3.16 3.03 2.03 1.62 0.95 0.37 0.15 (µg/mL) Average Observed Values Maximum Concentration 3.61 µg/mL (± 0.9 sd) Time of Maximum Concentration 2.60 hr (± 1.10 sd) Elimination Rate Constant 0.049 Прочитайте повний документ