DOXYCYCLINE tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Par Pharmaceutical, Inc.

INN (Международно Name):

DOXYCYCLINE

Композиция:

DOXYCYCLINE ANHYDROUS 100 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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 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 eliminat

Каталог на резюме:

Doxycycline Tablets, USP 50 mg are a yellow, film coated, round, biconvex tablet, debossed “par” on one side and “091” on the other side. Each tablet contains doxycycline monohydrate equivalent to 50 mg of doxycycline. They are supplied as follows: Bottles of 100 NDC 49884-091-01 Doxycycline Tablets, USP  75 mg are a light orange, film coated, round, biconvex tablet, debossed “par” on one side and “092” on the other side. Each tablet contains doxycycline monohydrate equivalent to 75 mg of doxycycline. They are supplied as follows: Bottles of 100 NDC 49884-092-01 Doxycycline Tablets, USP  100 mg are a yellow, film coated, round, biconvex tablet, debossed “par” on one side and “093” on the other side. Each tablet contains doxycycline monohydrate equivalent to 100 mg of doxycycline. They are supplied as follows: Bottles of 50 NDC 49884-093-03 Bottles of 250 NDC 49884-093-04 Doxycycline Tablets, USP 150 mg are a peach colored, film coated, round, scored, biconvex tablet, debossed “par” on one side and “236” on the other side. Each tablet contains doxycycline monohydrate equivalent to 150 mg of doxycycline. They are supplied as follows: Bottles of 30 NDC 49884-236-11 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.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

DOXYCYCLINE- DOXYCYCLINE TABLET
PAR PHARMACEUTICAL, 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, USP 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.
Inactive ingredients include colloidal silicon dioxide, FD&C yellow
#6, magnesium stearate,
microcrystalline cellulose, sodium starch glycolate, and titanium
dioxide. In addition, Doxycycline 100
mg and 50 mg tablets contain hypromellose 3cP, hypromellose 6cP, D&C
yellow #10 lake,
polyethylene glycol 400, polysorbate 80; Doxycycline 75 mg and 150 mg
tablets contain hypromellose
15cP, lactose monohydrate, yellow iron oxide and triethyl citrate.
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.
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
22
24
2
8
2
AVERAGE OBSERVED VALUES
M