DOXYCYCLINE capsule

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

RedPharm Drug, Inc.

INN (שם בינלאומי):

DOXYCYCLINE

הרכב:

DOXYCYCLINE ANHYDROUS 100 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 as judged by immunof

leaflet_short:

Doxycycline capsules USP, 50 mg are brown opaque cap and yellow opaque body imprinted with "LU" on cap in white ink and "M71" on the body in black ink filled with light yellow to grey colored blend. Each capsule contains doxycycline monohydrate USP equivalent to 50 mg doxycycline. Doxycycline capsules USP, 50 mg is available in: Bottle of 100 capsules NDC 68180-650-01 Doxycycline capsules USP, 75 mg are brown opaque cap and light yellow opaque body imprinted with "LU" on cap in white ink and "M72" on the body in black ink filled with light yellow to grey colored blend. Each capsule contains doxycycline monohydrate USP equivalent to 75 mg doxycycline. Doxycycline capsules USP, 75 mg is available in: Bottle of 100 capsules NDC 68180-651-01 Doxycycline capsules USP, 100 mg are brown opaque cap and yellow opaque body imprinted with "LU" on cap in white ink and "M73" on the body in black ink filled with light yellow to grey colored blend. Each capsule contains doxycycline monohydrate USP equivalent to 100 mg doxycycline. Doxycycline capsules USP, 100 mg is available in: Bottle of 50 capsules NDC 68180-652-08 Bottle of 250 capsules NDC 68180-652-29 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.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

DOXYCYCLINE- DOXYCYCLINE CAPSULE
REDPHARM DRUG, INC.
----------
DOXYCYCLINE MONOHYDRATE 100MG
SPL UNCLASSIFIED SECTION
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 Monohydrate]
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 Type A Potato. 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 Concen