国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)
Lupin Pharmaceuticals,Inc.
DOXYCYCLINE
DOXYCYCLINE ANHYDROUS 50 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 always eliminated as judged by immunofluorescence Inclusion conjunctivitis caused by Chlamydia trachomatis Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis Nongonococcal urethritis caused by Ureaplasma urealyticum Relapsing fever due to Borrelia recurrentis . Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: Chancroid caused by Haemophilus ducreyi Plague due to Yersinia pestis . Tularemia due to Francisella tularensis Cholera caused by Vibrio cholerae Campylobacter fetus infections caused by Campylobacter fetus Brucellosis due to Brucella species (in conjunction with streptomycin) Bartonellosis due to Bartonella bacilliformis Granuloma inguinale caused by Calymmatobacterium granulomatis . Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug: Escherichia coli Enterobacter aerogenes Shigella species Acinetobacter species Respiratory tract infections caused by Haemophilus influenzae Respiratory tract and urinary tract infections caused by Klebsiella species . Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: Upper respiratory infections caused by Streptococcus pneumoniae Anthrax due to Bacillus anthracis , including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis . When penicillin is contraindicated, doxycycline is an alternative in the treatment of the following infections: Uncomplicated gonorrhea caused by Neisseria gonorrhoeae Syphilis caused by Treponema pallidum Yaws caused by Treponema pertenue Listeriosis due to Listeria monocytogenes Vincent's infection caused by Fusobacterium fusiforme Actinomycosis caused by Actinomyces israelii Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy. This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
Doxycycline Capsules, USP 50 mg have a yellow opaque cap and a white opaque body. The capsules are imprinted "NL 790" with white ink on the cap and "50 mg" with brown ink on the body, filled with yellow to beige powder. Each capsule contains doxycycline monohydrate equivalent to 50 mg doxycycline. Doxycycline Capsules, USP 50 mg is available in: Bottles of 50 capsules ............................NDC 43386-790-11 Bottles of 100 capsules ...........................NDC 43386-790-01 Bottles of 1000 capsules ..........................NDC 43386-790-10 Doxycycline Capsules, USP 75 mg have a brown opaque cap and a white opaque body. The capsules are imprinted "NL 791" with white ink on the cap and "75 mg" with brown ink on the body, filled with yellow to beige powder. Each capsule contains doxycycline monohydrate equivalent to 75 mg doxycycline. Doxycycline Capsules, USP 75 mg is available in: Bottles of 50 capsules ..............................NDC 43386-791-11 Bottles of 100 capsules .............................NDC 43386-791-01 Bottles of 1000 capsules ...........................NDC 43386-791-10 Doxycycline Capsules, USP 100 mg have a brown opaque cap and a yellow opaque body. The capsules are imprinted "NL 792" with white ink on the cap and "100 mg" with brown ink on the body, filled with yellow to beige powder. Each capsule contains doxycycline monohydrate equivalent to 100 mg doxycycline. Doxycycline Capsules, USP 100 mg is available in: Bottles of 50 capsules .............................NDC 43386-792-11 Bottles of 250 capsules..............................NDC 43386-792-02 Bottles of 1000 capsules ............................NDC 43386-792-10 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. PROTECT FROM LIGHT.
Abbreviated New Drug Application
DOXYCYCLINE - DOXYCYCLINE CAPSULE LUPIN PHARMACEUTICALS,INC. ---------- DOXYCYCLINE CAPSULES, USP 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, 50 mg, 75 mg, and 100 mg contain doxycycline monohydrate equivalent to 50 mg, 75 mg, and 100 mg of doxycycline for oral administration. The chemical designation of the light yellow to pale yellow powder is 2- Naphthacenecarboxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro- 3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-,[4_S_-(4α,4aα,5α,5aα,6α,12aα)]- ,monohydrate. 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: colloidal silicon dioxide; magnesium stearate; microcrystalline cellulose; sodium starch glycolate; and a hard gelatin capsule which contains titanium dioxide, FD&C Red # 3, D&C Yellow # 10, gelatin, sodium lauryl sulfate, for the 50 mg strength; iron oxide black, iron oxide red, iron oxide yellow, titanium dioxide, gelatin, sodium lauryl sulfate for the 75 mg strength and iron oxide black, Iron Oxide Red, Iron Oxide Yellow, Titanium Dioxide, FD & C Red# 3, D&C Yellow # 10, gelatin, sodium lauryl sulfate for the 100 mg strength. The capsules are printed with edible ink containing shellac, titanium dioxide, black iron oxide, red iron oxide and potassium hydroxide for 50 mg, 75 mg and 100 mg strengths. 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 fece 完全なドキュメントを読む