DOXYCYCLINE tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Lannett Company, Inc.

INN (שם בינלאומי):

DOXYCYCLINE

הרכב:

DOXYCYCLINE ANHYDROUS 50 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 by Chlamydia trachomatis

leaflet_short:

Doxycycline Tablets USP, 50 mg are yellow, round, film coated, tablets, debossed "LCI" on one face and "1335" on the other face. Each tablet contains doxycycline monohydrate equivalent to 50 mg of doxycycline. They are supplied as follows: Bottles of 100                            NDC 0527-1335-01 Doxycycline Tablets USP, 75 mg are yellow, round, film coated, tablets, debossed "LCI" on one face and "1535" on the other face. Each tablet contains doxycycline monohydrate equivalent to 75 mg of doxycycline. They are supplied as follows: Bottles of 100                            NDC 0527-1535-01 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 50                             NDC 0527-1338-50 Bottles of 250                           NDC 0527-1338-25 Doxycycline Tablets USP, 150 mg are yellow, round, film coated, tablets, debossed "LCI" on one face and "1537" on the other face. Each tablet contains doxycycline monohydrate equivalent to 150 mg of doxycycline. They are supplied as follows: Bottles of 30                             NDC 0527-1537-30 Bottles of 100                           NDC 0527-1537-01 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.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

DOXYCYCLINE- DOXYCYCLINE TABLET, FILM COATED
LANNETT COMPANY, 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 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.
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)
Elimination Ra