Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)
Amneal Pharmaceuticals of New York LLC
DOXYCYCLINE
DOXYCYCLINE ANHYDROUS 150 mg
ORAL
PRESCRIPTION DRUG
To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline capsules, USP and other antibacterial drugs, doxycycline capsules, USP 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
Doxycycline Capsules USP, 150 mg have an orange opaque cap printed “M1” in black ink/orange opaque body. Each capsule contains doxycycline monohydrate equivalent to 150 mg of doxycycline. They are supplied as follows: Bottles of 30: NDC 0115-1327-08 Bottles of 60: NDC 0115-1327-13 Bottles of 90: NDC 0115-1327-10 Bottles of 100: NDC 0115-1327-01 Bottles of 1000: NDC 0115-1327-03 STORE AT 20° TO 25°C (68° TO 77°F) [SEE USP CONTROLLED ROOM TEMPERATURE]. DISPENSE IN A TIGHT LIGHT-RESISTANT CONTAINER AS DEFINED IN THE USP /NF.
Abbreviated New Drug Application
DOXYCYCLINE- DOXYCYCLINE CAPSULE AMNEAL PHARMACEUTICALS OF NEW YORK LLC ---------- DOXYCYCLINE CAPSULES, USP 150 MG RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline capsules and other antibacterial drugs, doxycycline capsules 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 capsules USP, 150 mg contain doxycycline monohydrate equivalent to 150 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. The inactive ingredients in doxycycline capsules, USP include colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The capsule shells contain gelatin, titanium dioxide, and FD&C Yellow No. 6. Additionally, the capsule imprint ink contains shellac, ferrosoferric oxide, propylene glycol, FD&C Blue No. 2, FD&C Red No. 40, D&C Yellow No. 10 Aluminum Lake, and FD&C Blue No. 1. 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. 1.022.26 2.673.013.16 3.032.031.620.950.37 0.15 22 24 2 8 2 (mcg/mL): 1.022.26 2.673.013.16 3.032.031.620.950.37 0.15 AVERAGE OBSERVED VALUES Ma Διαβάστε το πλήρες έγγραφο