Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)
Lupin Pharmaceuticals, Inc.
DOXYCYCLINE
DOXYCYCLINE ANHYDROUS 25 mg in 5 mL
ORAL
PRESCRIPTION DRUG
To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline for oral suspension and other antibacterial drugs, doxycycline for oral suspension 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 trachom
Doxycycline for Oral Suspension USP (doxycycline monohydrate) is available as a raspberry-flavored, dry powder for oral suspension. When reconstituted, each teaspoonful (5 mL) contains doxycycline monohydrate equivalent to 25 mg of doxycycline: 60 mL bottles (NDC 68180-657-01). Doxycycline for Oral Suspension USP is to be stored at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature] and dispensed in tight, light-resistant containers (USP).
Abbreviated New Drug Application
DOXYCYCLINE - DOXYCYCLINE FOR SUSPENSION LUPIN PHARMACEUTICALS, INC. ---------- DOXYCYCLINE FOR ORAL SUSPENSION USP RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline for oral suspension and other antibacterial drugs, doxycycline for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline for oral suspension USP (doxycycline monohydrate) for oral administration. The structural formula of doxycycline monohydrate is with a molecular formula of C H N O •H O and a molecular weight of 462.46. 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 monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline monohydrate is very slightly 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. Inert ingredients for the oral suspension formulation are: carboxymethylcellulose sodium, FD & C Blue No. 1, methylparaben, microcrystalline cellulose, propylparaben, raspberry flavor, D & C Red 28 and sucrose. 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. 22 24 2 8 2 Following a 200 mg dose, normal adult volunteers averaged peak serum levels of 2.6 mcg/mL of doxycycline at 2 hours, decreasing to 1.45 mcg/mL at 24 hours. Excretion of doxycycline by the kidney is about 40%/72 hours in individuals with normal function (creatinine clearance Olvassa el a teljes dokumentumot