DOXYCYCLINE HYCLATE- doxycycline capsule

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Amneal Pharmaceuticals NY LLC

Designació comuna internacional (DCI):

DOXYCYCLINE HYCLATE

Composición:

DOXYCYCLINE ANHYDROUS 100 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

Doxycycline hyclate capsules, USP is equivalent to 100 mg doxycycline, USP and are supplied as hard gelatin capsules filled with yellow to light yellow powder having “AMNEAL” printed on light blue opaque cap and “1100” printed on light blue opaque body with black ink. They are available as follows: Bottles of 50:                          NDC 69238-1100-2 Bottles of 500:                        NDC 69238-1100-5 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]. Dispense in tight, light-resistant containers as defined in the USP.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

DOXYCYCLINE HYCLATE- DOXYCYCLINE CAPSULE
AMNEAL PHARMACEUTICALS NY LLC
----------
DOXYCYCLINE HYCLATE CAPSULES, 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 hyclate, USP is an antibacterial drug synthetically
derived from
oxytetracycline for oral administration.
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, USP is a light-yellow crystalline powder. Doxycycline
hyclate, USP is soluble
in water.
Doxycycline, USP has a high degree of lipoid solubility and a low
affinity for calcium
binding. It is highly stable in normal human serum. Doxycycline, USP
will not degrade
into an epianhydro form.
Inert ingredients in the capsule formulations are: magnesium stearate,
microcrystalline
22
24
2
8
2
22
24
2
8
2
2
6
2
Inert ingredients in the capsule formulations are: magnesium stearate,
microcrystalline
cellulose and sodium lauryl sulfate. The hard gelatin capsule shells
contains: FD&C Blue
1, gelatin, sodium lauryl sulfate and titanium dioxide. The printing
ink contains: black iron
oxide, potassium hydroxide, propylene glycol, shellac and strong
ammonia solution.
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 compl