DOXYCYCLINE capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Amneal Pharmaceuticals of New York LLC

INN (International Name):

DOXYCYCLINE

Sammensætning:

DOXYCYCLINE ANHYDROUS 150 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 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

Produkt oversigt:

Doxycycline Capsules USP, 150 mg have an orange opaque cap printed “M1” in black ink/orange opaque body. Each capsule contains doxycycline monohydrate equivalent to 150 mg of doxycycline. They are supplied as follows: Bottles of 30:              NDC 0115-1327-08 Bottles of 60:              NDC 0115-1327-13 Bottles of 90:              NDC 0115-1327-10 Bottles of 100:            NDC 0115-1327-01 Bottles of 1000:          NDC 0115-1327-03 STORE AT 20° TO 25°C (68° TO 77°F) [SEE USP CONTROLLED ROOM TEMPERATURE]. DISPENSE IN A TIGHT LIGHT-RESISTANT CONTAINER AS DEFINED IN THE USP /NF.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

DOXYCYCLINE- DOXYCYCLINE CAPSULE
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
----------
DOXYCYCLINE CAPSULES, USP
150 MG
RX ONLY
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 USP, 150 mg contain doxycycline monohydrate equivalent to 150
mg of doxycycline for oral
administration. The chemical designation of the light-yellow
crystalline 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.
The inactive ingredients in doxycycline capsules, USP include
colloidal silicon dioxide, magnesium
stearate, microcrystalline cellulose, and sodium starch glycolate. The
capsule shells contain gelatin,
titanium dioxide, and FD&C Yellow No. 6. Additionally, the capsule
imprint ink contains shellac,
ferrosoferric oxide, propylene glycol, FD&C Blue No. 2, FD&C Red No.
40, D&C Yellow No. 10
Aluminum Lake, and FD&C Blue No. 1.
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.
1.022.26 2.673.013.16 3.032.031.620.950.37 0.15
22
24
2
8
2
(mcg/mL):
1.022.26 2.673.013.16 3.032.031.620.950.37 0.15
AVERAGE OBSERVED VALUES
Ma