DOXYCYCLINE HYCLATE tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)

זמין מ:

RPK Pharmaceuticals, Inc.

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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 eli

leaflet_short:

Product: 53002-2711 NDC: 53002-2711-1 6 TABLET, FILM COATED in a BOTTLE NDC: 53002-2711-2 10 TABLET, FILM COATED in a BOTTLE NDC: 53002-2711-3 14 TABLET, FILM COATED in a BOTTLE NDC: 53002-2711-4 20 TABLET, FILM COATED in a BOTTLE NDC: 53002-2711-6 30 TABLET, FILM COATED in a BOTTLE NDC: 53002-2711-7 40 TABLET, FILM COATED in a BOTTLE NDC: 53002-2711-9 60 TABLET, FILM COATED in a BOTTLE NDC: 53002-2711-0 100 TABLET, FILM COATED in a BOTTLE

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET, FILM COATED
RPK PHARMACEUTICALS, INC.
----------
DOXYCYCLINE HYCLATE TABLETS, USP
100 MG
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
doxycycline hyclate tablets and other antibacterial drugs, doxycycline
hyclate tablets
should be used only to treat or prevent infections that are proven or
strongly suspected
to be caused by bacteria.
DESCRIPTION
Doxycycline is an antibacterial drug synthetically derived from
oxytetracycline, and is
available as doxycycline hyclate tablets for oral administration. The
chemical designation
of doxycycline is
4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-
pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide
monohydrochloride,
compound with ethyl alcohol (2:1), monohydrate.
The structural formula of doxycycline hyclate is:
with a molecular formula of (C
H
N O •HCl) •C H O•H O and the molecular weight is
1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline
hyclate is soluble
in water.
Doxycycline has a high degree of lipoid solubility and a low affinity
for calcium binding. It
is highly stable in normal human serum. Doxycycline will not degrade
into an epianhydro
form.
Active Ingredient: Doxycycline hyclate USP equivalent to 100 mg of
doxycycline.
Inactive Ingredient: Microcrystalline cellulose and magnesium
stearate.
Tablet coating contains hypromellose, titanium dioxide, polyethylene
glycol, FD&C yellow
#6, polysorbate 80 and FD&C blue #2.
CLINICAL PHARMACOLOGY
Tetracyclines are readily absorbed and are bound to plasma proteins in
varying degree.
They are concentrated by the liver in the bile and excreted in the
urine and feces at high
concentrations and in a biologically active form. Doxycycline is
virtually completely
absorbed after oral administration.
22
24
2
8
2
2
6
2
Following a 200 mg dose, normal adult volunteers averaged peak serum
levels of 2.6
mcg/mL of doxycycline at 2 hours, decreasing to 1.45 mcg/mL at 24
hours. Excretion of
doxycycli