DOXYCYCLINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

DOXYCYCLINE

Composition:

DOXYCYCLINE ANHYDROUS 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline tablets and other antibacterial drugs, doxycycline 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. 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 Calymmatobacterium 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.

Product summary:

Doxycycline Tablets 100 mg are a peach colored, film coated, round biconvex tablets, debossed with 'I63' on one side and plain on the other side. Each tablet contains doxycycline monohydrate equivalent to 100 mg of doxycycline. They are supplied as follows: NDC: 70518-0038-00 NDC: 70518-0038-01 PACKAGING: 40 in 1 BOTTLE PLASTIC PACKAGING: 14 in 1 BOTTLE PLASTIC STORE AT 20°-25°C (68°-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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXYCYCLINE- DOXYCYCLINE TABLET
REMEDYREPACK INC.
----------
DOXYCYCLINE TABLETS, USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
doxycycline tablets and other antibacterial drugs, doxycycline tablets
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 150 mg, 100 mg, 75 mg, and 50 mg tablets contain
doxycycline
monohydrate equivalent to 150 mg, 100 mg, 75 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
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: lactose monohydrate, microcrystalline cellulose,
sodium starch
glycolate, hypromellose 2910, magnesium stearate and opadry 04G84829
pink which
contains: hypromellose 2910, talc, titanium dioxide, propylene glycol,
polyethylene glycol
6000, iron oxide yellow and iron oxide red.
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
after oral administration.
22
24
2
8
2
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. 1.02
2.26 2.67
3.01
3.16
3.03
2.03
1.62
0.95
0.37 0.15 (µg/mL)
Average Observed Values
Maximum Concentration
3.61 µg/mL (± 0.9 sd)
Time of Maximum Concentration
2.60 hr (± 1.10 sd)
Elimination Rate Constant
0.049 per hr (± 0.030 sd)
Half-Life