DOXYCYCLINE HYCLATE capsule

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

Doxycycline Hyclate (UNII: 19XTS3T51U) (Doxycycline Anhydrous - UNII:334895S862)

Dostupno od:

Quality Care Products, LLC

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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. Treatment: 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 Chlamydia 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 (formerly Pasteurella pestis ). - Tularemia due to Francisella tularensis (formerly Pasteurella tularensis ). - Cholera caused by Vibrio cholerae (formerly Vibrio comma ). - Campylobacter fetus infections caused by Campylobacter fetus (formerly Vibrio 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 (formerly Aerobacter aerogenes ). - Shigella species. - Acinetobacter species (formerly Mima species and Herellea 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 (formerly Diplococcus 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 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. Prophylaxis: Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains. (See DOSAGE AND ADMINISTRATION section and Information for Patients subsection of the PRECAUTIONS section.) This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

Proizvod sažetak:

HOW SUPPLIED: Doxycycline hyclate capsules and tablets are available as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER. Protect from Light.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE CAPSULE
QUALITY CARE PRODUCTS, LLC
----------
DOXYCYCLINE HYCLATE CAPSULES USP
50 MG AND 100 MG
DOXYCYCLINE HYCLATE TABLETS USP
100 MG
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
doxycycline hyclate and other antibacterial drugs, doxycycline hyclate
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 antibiotic synthetically derived from
oxytetracycline,
and is available as doxycycline hyclate (doxycycline hydrochloride
hemiethanolate
hemihydrate) capsules and tablets for oral administration. The
chemical designation of
this light-yellow crystalline powder is
alpha-6-deoxy-5-oxytetracycline. 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.
Doxycycline hyclate has the following structural formula:
(C
H
N O •HCL) •C H O•H O M.W. 1025.89
(C
H
N O •HCL) •C H O•H O M.W. 1025.89
Each capsule for oral administration contains 50 mg or 100 mg
doxycycline hyclate,
equivalent to 50 mg or 100 mg doxycycline (anhydrous). Inactive
ingredients for
capsules are: anhydrous lactose, croscarmellose sodium, D&C Red #28,
FD&C Blue #1,
gelatin, magnesium stearate, microcrystalline cellulose, and titanium
dioxide. Each tablet
for oral administration contains 100 mg doxycycline hyclate,
equivalent to 100 mg
doxycycline. Inactive ingredients for tablets are: anhydrous lactose,
carnauba wax,
croscarmellose sodium, D&C Yellow #10 aluminum lake, FD&C Red #40
aluminum lake,
22 24 2
8
2
2 6
2
22 24 2
8
2
2 6
2
hypromellose, magnesium stearate, microcrystalline cellulose,
polyethylene glycol,
polysorbate 80, and titanium dioxide.
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