DOXYCYCLINE MONOHYDRATE- doxycycline capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PD-Rx Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline monohydrate capsules and other antibacterial drugs, doxycycline monohydrate capsules 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

Product summary:

Doxycycline monohydrate capsules 100 mg have an ivory opaque body with a brown opaque cap. The capsule bears the inscription WATSON 411 in white and 100 mg in brown. Each capsule contains doxycycline monohydrate equivalent to 100 mg of doxycycline, supplied in bottles of 2, 6, 14, 20 and 28.. STORE AT 20° - 25°C (68° -77°F) WITH EXCURSIONS PERMITTED TO 15°C TO 30°C (59° TO 86°F). [SEE USP CONTROLLED ROOM TEMPERATURE.] DISPENSE IN A TIGHT LIGHT-RESISTANT CONTAINER AS DEFINED IN THE USP/NF.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

DOXYCYCLINE MONOHYDRATE- DOXYCYCLINE CAPSULE
PD-RX PHARMACEUTICALS, INC.
----------
DOXYCYCLINE MONOHYDRATE CAPSULES
REVISED: MAY 2017
RX ONLY
236306
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of doxycycline
monohydrate capsules and other antibacterial drugs, doxycycline
monohydrate capsules 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
monohydrate capsules 100 mg, 75 mg, and 50 mg capsules contain
doxycycline monohydrate equivalent
to 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: colloidal silicon dioxide; magnesium stearate;
microcrystalline cellulose; sodium
starch glycolate; and a hard gelatin capsule which contains black iron
oxide, red iron oxide, titanium
dioxide, and yellow iron oxide for the 100 mg and 75 mg strengths,
titanium dioxide and yellow iron
oxide for the 50 mg strength. The capsules are printed with edible ink
containing black iron oxide, red
iron oxide, and yellow iron oxide for the 50 mg and 100 mg strengths
and black iron oxide, FD&C Blue
No. 2, FD&C Red No. 40, FD&C Blue No. 1, and D&C Yellow No. 10 for the
75 mg strength.
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 n