DOXYCYCLINE tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Sun Pharmaceutical Industries Inc.

INN (International Name):

DOXYCYCLINE

Sammensætning:

DOXYCYCLINE ANHYDROUS 50 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 tablets are 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 elim

Produkt oversigt:

Doxycycline tablets 50 mg are light blue colored, round, convex faced, film-coated, debossed with “RX130 ” on one side and plain on the other side. Each tablet contains doxycycline monohydrate, USP equivalent to 50 mg of doxycycline. They are supplied as follows: NDC 63304-130-10 Bottles of 1000 Doxycycline tablets 75 mg are green colored, round, convex faced, film-coated, debossed with “RX131 ” on one side and plain on the other side. Each tablet contains doxycycline monohydrate, USP equivalent to 75 mg of doxycycline. They are supplied as follows: NDC 63304-131-01 Bottles of 100 NDC 63304-131-10 Bottles of 1000 Doxycycline tablets 100 mg are dark blue colored, round, convex faced, film-coated, debossed with “RX132 ” on one side and plain on the other side. Each tablet contains doxycycline monohydrate, USP equivalent to 100 mg of doxycycline. They are supplied as follows: NDC 63304-132-50 Bottles of 50 NDC 63304-132-04 Bottles of 250 NDC 63304-132-10 Bottles of 1000 Doxycycline tablets 150 mg are white colored, convex faced, film-coated, debossed with “RX ” above the bisect and “173 ” below the bisect on one side and plain on the other side. Each tablet contains doxycycline monohydrate, USP equivalent to 150 mg of doxycycline. They are supplied as follows: NDC 63304-173-03 Bottles of 10 NDC 63304-173-30 Bottles of 30 NDC 63304-173-10 Bottles of 1000 NDC 63304-173-69 Blister pack of 10 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. Storage of Blister Pack PROTECT FROM LIGHT. RETAIN IN CARTON UNTIL TIME OF USE. You may report side effects to FDA at 1-800-FDA-1088.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

DOXYCYCLINE- DOXYCYCLINE TABLET, FILM COATED
SUN PHARMACEUTICAL INDUSTRIES INC.
----------
DOXYCYCLINE TABLETS
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, USP equivalent to 150 mg,
100 mg, 75 mg, or 50 mg of doxycycline for oral administration.
Inactive ingredients include colloidal
silicon dioxide, hypromellose, magnesium stearate, microcrystalline
cellulose, polysorbate 80, sodium
starch glycolate, and titanium dioxide. In addition, doxycycline 50 mg
tablets contain: FD&C Blue #1
Aluminum lake and polyethylene glycol, 75 mg tablets contain: D&C
Yellow #10 Aluminum lake, FD&C
Blue #1 Aluminum lake, FD&C Yellow #6 Aluminum lake and triacetin, 100
mg tablets contain:
polyethylene glycol and FD&C Blue #1 Aluminum lake and 150 mg tablets
contain: polyethylene glycol.
Its molecular weight is 462.46. The chemical designation of the
light-yellow crystalline powder is
alpha-6-deoxy-5-oxytetracycline.
Structural formula:
C
H N O •H O
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
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
1.5
2
3
4
8
12
24
48
72
Conc: