DOXYCYCLINE HYCLATE tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Amneal Pharmaceuticals NY LLC

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate 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. Treatment Doxycycline hyclate tablets are 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 hyclate tablets are 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 hyclate tablets are 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 hyclate tablets are 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 hyclate tablets are 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.

Produkt oversigt:

Doxycycline Hyclate Tablets USP, 100 mg are supplied as mossy-green colored, round shaped, biconvex, film-coated tablets, debossed with “J8” on one side and plain on the other side. They are available as follows: Bottles of 20 with child-resistant closure:                  NDC 60219-2132-3 Bottles of 100 with child-resistant closure:                NDC 60219-2132-1 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep this and all medications out of the reach of children.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET, FILM COATED
AMNEAL PHARMACEUTICALS NY LLC
----------
DOXYCYCLINE HYCLATE TABLETS, USP
(100 MG)
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
doxycycline hyclate tablets and other antibacterial drugs, doxycycline
hyclate tablets
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, for oral
administration.
The chemical designation for doxycycline hyclate, USP 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. The molecular formula for doxycycline hyclate, USP is
[C
H
N O •HCl] •C H O•H O and the molecular weight is 1025.87 g/mol.
The structural formula of doxycycline hyclate, USP is
Doxycycline hyclate, USP is a yellow color crystalline powder. It is
soluble in water and in
solutions of alkali hydroxides and carbonates; slightly soluble in
alcohol; practically
insoluble in chloroform and in ether.
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 film-coated tablet contains 115.41 mg doxycycline hyclate, USP
equivalent to 100
mg doxycycline, USP.
Inactive ingredients for the tablet formulation are: croscarmellose
sodium; FD&C blue
#2, iron oxide yellow; magnesium stearate; microcrystalline cellulose;
polyethylene
glycol; polyvinyl alcohol-part. hydrolyzed; sodium lauryl sulfate;
talc and titanium dioxide.
FDA approved dissolution specifications differ from the USP.
22
21
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 t