DOXYCYCLINE capsule

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Bryant Ranch Prepack

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline capsules, USP and other antibacterial drugs, doxycycline capsules, 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 capsules, 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, although the infectious agent i

ملخص المنتج:

NDC: 71335-1479-1: 30 Capsules in a BOTTLE NDC: 71335-1479-2: 60 Capsules in a BOTTLE

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

DOXYCYCLINE- DOXYCYCLINE CAPSULE
BRYANT RANCH PREPACK
----------
DOXYCYCLINE CAPSULES, USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
doxycycline capsules and other antibacterial drugs, doxycycline
capsules 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 100 mg, 75 mg, and 50 mg capsules contain
doxycycline
monohydrate, USP equivalent to 100 mg, 75 mg, or 50 mg of doxycycline
for oral
administration. The chemical designation of the light-yellow to pale
yellow powder is
alpha-6-deoxy-5-oxytetracycline.
Structural formula:
C
H
N O • H O M.W. = 462.45
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.
Each doxycycline capsule, USP intended for oral administration
contains 50 mg or 75
mg or 100 mg of doxycycline. In addition, each capsule contains the
following inactive
ingredients: colloidal silicon dioxide, gelatin, magnesium stearate,
microcrystalline
cellulose, sodium lauryl sulfate, sodium starch glycolate and titanium
dioxide.
Additionally, each 50 and 100 mg capsule shell contains iron oxide
yellow, each 75 mg
22
24
2
8
2
and 100 mg capsule shell contains: D & C yellow # 10, FD & C blue # 1,
FD & C red # 3
and FD & C yellow # 6 and each 100 mg capsule shell contains iron
oxide red. The
capsule is printed with black pharmaceutical ink which contains
following ingredients:
black iron oxide, potassium hydroxide, propylene glycol, shellac and
strong ammonia
solution.
The Product meets USP Dissolution Test 2.
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