DOXYCYCLINE capsule

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Cardinal Health

Designación común internacional (DCI):

DOXYCYCLINE

Composición:

DOXYCYCLINE ANHYDROUS 100 mg

tipo de receta:

PRESCRIPTION DRUG

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

DOXYCYCLINE- DOXYCYCLINE CAPSULE
CARDINAL HEALTH
----------
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 Capsules USP is a broad-spectrum antibiotic synthetically
derived from oxytetracycline.
Doxycycline 150 mg, 100 mg and 50 mg capsules contain Doxycycline
monohydrate equivalent to 150
mg, 100 mg or 50 mg of doxycycline for oral administration. Inactive
ingredients include colloidal
silicon dioxide, gelatin, magnesium stearate, microcrystalline
cellulose, sodium starch glycolate and
titanium dioxide. In addition, the 50 mg strength contains FD&C Yellow
#6 and D&C Yellow #10. The
100 mg strength also contains black iron oxide, red iron oxide and
yellow iron oxide. The 150 mg
strength includes FD&C Red #40 and FD&C Yellow #6. 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 0
Doxycycline Capsules USP 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
Maximum Concentration
3.61 mcg/mL (± 0.9 sd)
Time of Maximum C