DOXYCYCLINE HYCLATE capsule

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

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Активный ингредиент:

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

Доступна с:

Alembic Pharmaceuticals Limited

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate capsules, USP and other antibacterial drugs, doxycycline hyclate 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. 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 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 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.

Обзор продуктов:

Doxycycline hyclate capsules USP, 50 mg are light blue opaque cap/white opaque body, hard gelatin capsules of size “2” having imprinting “A248” on cap in black ink, filled with yellow powder. Each capsule contains doxycycline hyclate USP equivalent to 50 mg doxycycline. NDC 46708-362-50                Bottle of 50 capsules NDC 46708-362-71                Bottle of 500 capsules Doxycycline hyclate capsules USP, 100 mg are light blue opaque cap/light blue opaque body, hard gelatin capsules of size “0” having imprinting “A249” on cap in black ink, filled with yellow powder. Each capsule contains doxycycline hyclate USP equivalent to 100 mg doxycycline. NDC 46708-363-50                Bottle of 50 capsules NDC 46708-363-71                Bottle of 500 capsules  Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant containers (USP). 

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

                                DOXYCYCLINE HYCLATE - DOXYCYCLINE HYCLATE CAPSULE
ALEMBIC PHARMACEUTICALS LIMITED
----------
DOXYCYCLINE HYCLATE CAPSULES, USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
doxycycline hyclate capsules, USP and other antibacterial drugs,
doxycycline hyclate
capsules, USP should be used only to treat or prevent infections that
are proven or
strongly suspected to be caused by bacteria.
DESCRIPTION
Doxycycline hyclate, USP is an antibacterial drug synthetically
derived from
oxytetracycline. 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. The molecular formula for
doxycycline
hydrochloride hemiethanolate hemihydrate is (C
H
N O •HCl) •C H O•H O and the
molecular weight is 1025.89. Doxycycline hyclate is a yellow to
light-yellow powder which
is freely soluble in water and in methanol; sparingly soluble in
alcohol; practically insoluble
in chloroform and in ether. It dissolves in aqueous solutions of
alkali hydroxides and
carbonates.
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
equivalent to 50 mg or
100 mg of doxycycline (anhydrous). Inert ingredients are
microcrystalline cellulose,
colloidal silicon dioxide, magnesium stearate.
50 mg and 100 mg capsule shell contains FD&C Blue No. 1, gelatin, and
titanium dioxide.
The printing ink contains shellac, propylene glycol, potassium
hydroxide and iron oxide
black.
22
24
2
8
2
22
24
2
8
2
2
6
2
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 excret
                                
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