DOXYCYCLINE tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

KAISER FOUNDATION HOSPITALS

INN (שם בינלאומי):

DOXYCYCLINE

הרכב:

DOXYCYCLINE ANHYDROUS 100 mg

סוג מרשם:

PRESCRIPTION DRUG

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

DOXYCYCLINE - DOXYCYCLINE TABLET
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
150 mg, 100 mg, 75 mg and 50 mg tablets contain doxycycline
monohydrate equivalent to 150 mg, 100
mg, 75 mg or 50 mg of doxycycline for oral administration. Inactive
ingredients include colloidal
silicon dioxide, FD&C yellow #6, magnesium stearate, microcrystalline
cellulose, sodium starch
glycolate, and titanium dioxide. In addition, Doxycycline 100 mg and
50 mg tablets contain
hypromellose 3cP, hypromellose 6cP, D&C yellow #10 lake, polyethylene
glycol 400, polysorbate
80; Doxycycline 75 mg and 150 mg tablets contain hypromellose 15cP,
lactose monohydrate, yellow
iron oxide and triethyl citrate. Its molecular weight is 462.46. The
chemical designation of the light-
yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline.
Structural formula:
C
H N O •H O
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
Max