DOXYCYCLINE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Elorac, Inc.

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 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 alw

Product summary:

Doxycycline Tablets, USP 100 mg are yellow, film coated, caplets, debossed LCI on one face and 1338 on the other face. Each tablet contains doxycycline monohydrate equivalent to 100 mg of doxycycline. They are supplied as follows: Bottles of 30 NDC 42783-601-30 Bottles of 60 NDC 42783-601-60 Dispense in a tight light-resistant container with a child-resistant closure. Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. PROTECT FROM LIGHT.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXYCYCLINE- DOXYCYCLINE TABLET, FILM COATED
ELORAC, 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 tablets, USP is a broad-spectrum antibacterial
synthetically derived from oxytetracycline.
Doxycycline 100 mg tablets contain doxycycline monohydrate equivalent
to 100 mg of doxycycline for
oral administration. Inactive ingredients include anhydrous lactose,
microcrystalline cellulose, corn
starch, colloidal silicon dioxide, magnesium stearate, polyvinyl
alcohol, titanium dioxide, polyethylene
glycol, talc, D&C yellow #10 aluminum lake, and FD&C yellow #6
aluminum lake. The chemical
designation of the light-yellow crystalline powder is
4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-
octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide
monohydrate.
Structural formula:
Doxycycline tablets, USP 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 1.0
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
Average Observed Values
Maximum Concentration
3.61 mcg/mL (± 0.9 sd)
Time of Maximum Concentration2.60 hr (± 1.10 sd)
Elimination Rate Constant
0.049 per hr (± 0.030 sd)
H