DOXYCYCLINE HYCLATE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

ST. MARY'S MEDICAL PARK PHARMACY

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline and other antibacterial drugs, doxycycline 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 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. 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 ADMINISTRATIONsection and Information for Patientssubsection of the PRECAUTIONS section.) This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

Proizvod sažetak:

Doxycycline hyclate tablets USP, are available in yellow colored, round, biconvex film-coated tablets containing doxycycline hyclate equivalent to: 100 m g dox y c y cline 60760-723-20 BOTTLES OF 20 60760-723-60 BOTTLES OF 60 The tablets are imprinted on one side with "CY" and "185" on the other side. All products are to be Stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] and dispensed in tight, light-resistant containers with a child-resistant closure (USP).

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET
ST. MARY'S MEDICAL PARK PHARMACY
----------
DOXYCYCLINE HYCLATE TABLETS, USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
doxycycline hyclate tablets, USP and other antibacterial drugs,
doxycycline hyclate
tablets, USP 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 tablets, USP.
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 is a light-yellow
crystalline powder.
Doxycycline hyclate is soluble in water, while doxycycline monohydrate
is very slightly
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.
Inert ingredients for the tablet formulation are: croscarmellose
sodium, ferric oxide red,
ferric oxide yellow, hypromellose, magnesium stearate,
microcrystalline cellulose PH112,
polyethylene glycol, silicon dioxide, titanium dioxide and water.
FDA approved dissolution test specifications differ from USP.
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 excreted in the
urine and feces at high
concentrations and in a biologically active form. Doxycycline is
virtually completely
absorbed after oral administration.
Following a