DOXYCYCLINE- doxycycline capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Mylan Pharmaceuticals Inc.

INN (Διεθνής Όνομα):

DOXYCYCLINE

Σύνθεση:

DOXYCYCLINE ANHYDROUS 150 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline capsules, USP 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 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 alway

Περίληψη προϊόντος:

Doxycycline Capsules, USP contain doxycycline monohydrate equivalent to 150 mg of doxycycline, USP. The 150 mg capsules are hard shell gelatin capsules with an orange opaque cap and orange opaque body filled with yellow powder. The capsules are axially printed with MYLAN over DX 150 in black ink on the cap and body. They are available as follows: NDC 0378-5475-91 bottles of 60 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

DOXYCYCLINE- DOXYCYCLINE CAPSULE
MYLAN PHARMACEUTICALS INC.
----------
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, USP is a broad-spectrum antibacterial synthetically
derived from oxytetracycline.
Doxycycline 150 mg capsules, USP contain doxycycline monohydrate
equivalent to 150 mg of
doxycycline for oral administration. Its molecular weight is 462.46.
The chemical designation of the
light-yellow crystalline powder is
4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-
pentahydroxy-6-methyl-1,11-de monohydrate.
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.
Inactive ingredients include colloidal silicon dioxide, crospovidone,
gelatin, lactose anhydrous,
magnesium stearate, red iron oxide, sodium lauryl sulfate, titanium
dioxide and yellow iron oxide. The
imprinting ink contains ammonium hydroxide, black iron oxide,
propylene glycol and shellac glaze.
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 Concentration
2.60 hr (± 1.10 sd)
22
24
2
8
2
Elimination Rate Constant
0.049