DOXYCYCLINE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aidarex Pharmaceuticals LLC

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 and other antibacterial drugs, doxycycline 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:

Each capsule contains doxycycline monohydrate USP equivalent to 100 mg doxycycline. Doxycycline capsules USP, 100 mg is available in: 20 CAPSULE in a BOTTLE (53217-224-20) Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP controlled room temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP/NF. Repackaged by: Aidarex Pharmaceuticals, LLC Corona, CA 92880

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXYCYCLINE- DOXYCYCLINE CAPSULE
AIDAREX PHARMACEUTICALS LLC
----------
DOXYCYCLINE CAPSULES USP, 50 MG, 75 MG AND 100 MG
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of doxycycline and
other antibacterial drugs, doxycycline 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
Capsules USP, 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:
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 and sodium
starch glycolate. Hard gelatin capsule contains black iron oxide,
gelatin, red iron oxide, titanium
dioxide and yellow iron oxide. The capsules are printed with edible
ink containing black iron oxide,
potassium hydroxide, propylene glycol, shellac and titanium dioxide.
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 (mcg/mL)
AVERAGE OBSERVED VALUES
Maximum Concentration
3.61 mcg/mL (± 0.9 sd)
Time of Maximum Concentration 2.60 hr (± 1.10 sd)
Eliminat