DOXYCYCLINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

INN (International Name):

DOXYCYCLINE

Composition:

DOXYCYCLINE ANHYDROUS 50 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

Product summary:

Doxycycline Tablets 50 mg are a peach colored, film coated round biconvex tablets, debossed with 'I61' on one side and plain on the other side. Each tablet contains doxycycline monohydrate equivalent to 50 mg of doxycycline. They are supplied as follows: Doxycycline Tablets 75 mg are a peach colored, film coated, capsule shaped, biconvex tablets, debossed with 'I62' on one side and plain on the other side. Each tablet contains doxycycline monohydrate equivalent to 75 mg of doxycycline. They are supplied as follows: 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: Doxycycline Tablets 150 mg are a peach colored, film coated capsule shaped scored tablets, debossed with 'I' and '64' on either side of a breakline and plain on other side. Each tablet contains doxycycline monohydrate equivalent to 150 mg of doxycycline. They are supplied as follows: 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXYCYCLINE- DOXYCYCLINE TABLET
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS 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.
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