DOXYCYCLINE- doxycycline tablet, film coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

KAISER FOUNDATION HOSPITALS

INN (Nama Internasional):

DOXYCYCLINE

Komposisi:

DOXYCYCLINE ANHYDROUS 100 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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 Chlamydia psittaci . Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always elimin

Ringkasan produk:

Doxycycline Tablets 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 20-NDC 0179-0129-20 Bottles of 14-NDC 0179-0129-14 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.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

DOXYCYCLINE- DOXYCYCLINE TABLET, FILM COATED
KAISER FOUNDATION HOSPITALS
----------
DOXYCYCLINE TABLETS
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 antibiotic 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 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 (± 1.10 sd)
Elimination Rate
Constant
0.049 per hr (± 0.030
sd)
Half-Life
16.33 hr