DOXYCYCLINE tablet, film coated

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)

Inapatikana kutoka:

A-S Medication Solutions

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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 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 Klebsiella 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 drug in the treatment of the following infections: Uncomplicated gonorrhea caused by Neisseria gonorrhoeae . Syphilis caused by Treponema pallidum. Yaws caused by Treponema pallidum subspecies 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.

Bidhaa muhtasari:

Product: 50090-3809 NDC: 50090-3809-0 20 TABLET, FILM COATED in a BOTTLE

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

DOXYCYCLINE- DOXYCYCLINE TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
----------
DOXYCYCLINE TABLETS, USP
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 tablets USP, 50 mg, 75 mg, 100 mg and 150 mg contain
doxycycline
monohydrate equivalent to 50 mg, 75 mg, 100 mg or 150 mg of
doxycycline, USP for
oral administration.
Doxycycline, USP is light yellow to pale yellow powder, very slightly
soluble in alcohol and
water; practically insoluble in ether. It dissolves in dilute
solutions of mineral acids and in
solutions of alkali hydroxides and carbonates. Its molecular weight is
462.45. The
chemical designation of doxycycline is
alpha-6-deoxy-5-oxytetracycline.
Structural formula:
IMAGE
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.
Inactive ingredients are as follows: colloidal silicon dioxide,
crospovidone, hydroxyl
propyl methylcellulose, magnesium stearate and microcrystalline
cellulose, titanium
dioxide.
In addition,
50 mg tablets contain: D&C yellow#10 aluminum lake, FD&C blue#2, iron
oxide yellow,
polyethylene glycol and polysorbate 80.
75 mg tablets contain: iron oxide red, iron oxide yellow, lactose
monohydrate, triethyl
citrate.
100 mg tablets contain: D&C yellow#10 aluminum lake, FD&C red#40, iron
oxide yellow,
22
24
2
8
2
polyethylene glycol, polysorbate 80.
150 mg tablets contain: D&C yellow#10 aluminum lake, iron oxide red,
iron oxide yellow,
lactose monohydrate, triethyl citrate.
The Product meets USP dissolution test - 2
CLINICAL PHARMACOLOGY
Tetracyclines are readily absorbed and are bound to plasma pro