DOXYCYCLINE capsule

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)

Disponibil de la:

PD-Rx Pharmaceuticals, Inc.

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline capsules, USP and other antibacterial drugs, doxycycline 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. 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 C hlamydia 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 microorganisms, 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.  This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

Rezumat produs:

Doxycycline Capsules, USP 100 mg have a brown opaque cap and a yellow opaque body. The capsules are imprinted “CP 572” with white ink on the cap and “100 mg” with brown ink on the body, filled with yellow to beige powder. Each capsule contains doxycycline monohydrate equivalent to 100 mg doxycycline. Doxycycline Capsules, USP 100 mg is available in: Bottles of 20 capsules ........................................................ NDC 72789-199-20 Bottles of 60 capsules ....................................................... NDC 72789-199-60 Bottles of 250 capsules ..................................................... NDC 72789-199-37 STORE AT 20° to 25°C (68° to 77°F). [SEE USP CONTROLLED ROOM TEMPERATURE.] DISPENSE IN A TIGHT, LIGHT-RESISTANT CONTAINER AS DEFINED IN THE USP/NF. PROTECT FROM LIGHT.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

DOXYCYCLINE- DOXYCYCLINE CAPSULE
PD-RX PHARMACEUTICALS, INC.
----------
DOXYCYCLINE CAPSULES, USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
doxycycline capsules and other antibacterial drugs, doxycycline
capsules should be
used only to treat or prevent infections that are proven or strongly
suspected to be
caused by bacteria.
DESCRIPTION
Doxycycline is a broad-spectrum antibacterial synthetically derived
from oxytetracycline.
Doxycycline capsules USP, 50 mg, 75 mg, and 100 mg contain doxycycline
monohydrate equivalent to 50 mg, 75 mg, and 100 mg of doxycycline for
oral
administration. The chemical designation of the light yellow to pale
yellow powder is 2-
Naphthacenecarboxamide,
4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-
3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-,[4
_S_-(4α,4aα,5a,5aα,6a,12aα)]-,
monohydrate.
Structural formula:
C
H
N
O
• H
O
M.W. = 462.45
Doxycycline has a high degree of lipid 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: colloidal silicon dioxide; magnesium stearate;
microcrystalline cellulose;
sodium starch glycolate; and a hard gelatin capsule which contains FD
& C Red # 3, D&C
Yellow # 10, titanium dioxide, gelatin, sodium lauryl sulfate for the
50 mg strength; iron
oxide black, iron oxide red, iron oxide yellow, titanium dioxide,
gelatin, sodium lauryl
sulfate for the 75 mg strength and iron oxide black, iron oxide red,
iron oxide yellow,
titanium dioxide, FD & C Red # 3, D&C Yellow # 10, gelatin, sodium
lauryl sulfate for the
100 mg strength. The capsules are printed with edible ink containing
shellac, titanium
22
24
2
8
2
dioxide, black iron oxide, brown iron oxide and potassium hydroxide
for 50 mg, 75 mg
and 100 mg strengths.
CLINICAL PHARMACOLOGY
Tetracyclines are readily absorbed and are bound to plasma proteins in
varying degrees.
They are concentrated by the liver in the bile and excreted in th