DOXYCYCLINE tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

American Health Packaging

INN (Nome Internazionale):

DOXYCYCLINE

Composizione:

DOXYCYCLINE ANHYDROUS 100 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline tablets, USP and other antibacterial drugs, doxycycline tablets, USP 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, USP 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 b

Dettagli prodotto:

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: Unit dose packages of 30 (5 x 6) NDC 60687-344-25 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

DOXYCYCLINE- DOXYCYCLINE TABLET, FILM COATED
AMERICAN HEALTH PACKAGING
----------
DOXYCYCLINE TABLETS, USP
RX ONLY
8434425/0520F
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 Tablets USP, 150 mg, 100 mg, 75 mg and 50 mg, contain
doxycycline
monohydrate equivalent to 150 mg, 100 mg, 75 mg, or 50 mg of
doxycycline for oral
administration. Inactive ingredients include microcrystalline
cellulose, anhydrous lactose,
corn starch, magnesium stearate, colloidal silicon dioxide, polyvinyl
alcohol, polyethylene
glycol, talc, titanium dioxide, 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 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 Concentration
2.60 hr (± 1.1