DOXYCYCLINE HYCLATE tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)

Dostupné s:

McKesson Corporation dba SKY Packaging

INN (Mezinárodní Name):

DOXYCYCLINE HYCLATE

Složení:

DOXYCYCLINE ANHYDROUS 100 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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. 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 bacteria, 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 isr aelii . - 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. 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.

Přehled produktů:

Doxycycline Hyclate Tablets USP (equivalent to 100 mg doxycycline) are round, film-coated, light orange, unscored tablets imprinted “DAN” and “5553” supplied in Boxes of 3x10 UD 30, NDC 63739-168-33 Store below 30°C (86°F). Dispense in a tight, light-resistant container with child-resistant closure.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET
MCKESSON CORPORATION DBA SKY PACKAGING
----------
DOXYCYCLINE HYCLATE CAPS AND TABS A062031 A062421
DOXYCYCLINE HYCLATE CAPSULES USP
DOXYCYCLINE HYCLATE TABLETS USP
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 an antibacterial drug synthetically derived from
oxytetracycline, and is
available as doxycycline hyclate, USP (doxycycline hydrochloride
hemiethanolate
hemihydrate) for oral administration.
The structural formula of doxycycline hyclate is
with a molecular formula of (C
H
N
O
•HCl)
•C
H
O•H
O and a molecular
weight of 1025.89. 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 monohydrochloride, compound with ethyl alcohol
(2:1),
monohydrate. Doxycycline hyclate is a yellow crystalline powder which
is 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.
Each capsule, for oral administration, contains doxycycline hyclate,
USP equivalent to 50
mg or 100 mg of doxycycline.
Each tablet, for oral administration, contains doxycycline hyclate,
USP equivalent to 100
mg of doxycycline.
Doxycycline Hyclate Capsules USP 50 mg and 100 mg contain the
following inactive
ingredients: magnesium stearate and microcrystalline cellulose.
The capsule shells contain: FD&C Blue No. 1, gelatin and titanium
dioxide.
22
24
2
8
2
2
6
2
Doxycycline Hyclate Tablets USP 100 mg contain the following inactive
ingredients:
croscarmellose sodium, FD&C Red No. 40, FD&C Yellow No. 6,
hypromellose,
magnesium stearate, microcrystalline cellulose, polyethylene glycol,
p