DOXYCYCLINE capsule

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

REMEDYREPACK INC.

INN (Међународно име):

DOXYCYCLINE

Састав:

DOXYCYCLINE ANHYDROUS 100 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

To reduce the development of drug-resistant bacteria and maintain the 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 Capsules USP 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 Capsules USP 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 Capsules USP 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 Capsules USP 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.

Резиме производа:

Doxycycline Capsules USP 100 mg have a brown opaque cap printed “par 727” in white ink/white opaque body printed “par 727” in brown ink. Each capsule contains doxycycline monohydrate equivalent to 100 mg of doxycycline. They are supplied as follows: NDC: 70518-0187-00 NDC: 70518-0187-01 NDC: 70518-0187-02 PACKAGING: 20 in 1 BOTTLE PLASTIC PACKAGING: 14 in 1 BOTTLE PLASTIC PACKAGING: 2 in 1 BOTTLE PLASTIC Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light. DISPENSE IN A TIGHT LIGHT RESISTANT CONTAINER AS DEFINED IN THE USP/NF. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

DOXYCYCLINE- DOXYCYCLINE CAPSULE
REMEDYREPACK INC.
----------
DOXYCYCLINE CAPSULES USP
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 Capsules USP is a broad-spectrum antibacterial
synthetically derived from
oxytetracycline. Doxycycline 150 mg, 100 mg and 50 mg capsules contain
doxycycline
monohydrate equivalent to 150 mg, 100 mg or 50 mg of doxycycline for
oral
administration. The chemical designation of the light-yellow
crystalline powder is alpha-6-
deoxy-5-oxytetracycline.
Structural formula:
C
H
N
O
•H
0
M.W. = 462.45
Doxycycline Capsules USP 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.
Inactive ingredients include colloidal silicon dioxide, gelatin,
magnesium stearate,
microcrystalline cellulose, sodium starch glycolate and titanium
dioxide. In addition, the
50 mg strength contains FD&C Yellow #6 and D&C Yellow #10. The 100 mg
strength
also contains black iron oxide, red iron oxide and yellow iron oxide.
The 150 mg strength
includes FD&C Red #40 and FD&C Yellow #6.
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 the
urine and feces at high
concentrations in a biologically active form. Doxycycline is virtually
completely absorbed
22
24
2
8
2
after oral administration.
Following a 200 mg dose of doxycycline monohydrate, 24 normal adult
volunteers
averaged the following serum concentration values:
Time (hr):
0.5
1.0
1.5
2.0
3.0
4.0
8.0
12.0
24.0
48.0
72.0
Conc.
(mcg/mL):
1.02
2.26
2.67
3.01
3.16
3.03
2.03
1.62
0.95
0.37
0.15
Average Observed Values
Maximum
Concentration
3.61 mcg/mL (± 0.9 sd)
Time of
Maximum
C