DOXYCYCLINE HYCLATE tablet, film coated

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

Doxycycline Hyclate (UNII: 19XTS3T51U) (Doxycycline Anhydrous - UNII:334895S862)

Disponible desde:

Aphena Pharma Solutions - Tennessee, LLC

Designación común internacional (DCI):

Doxycycline Hyclate

Composición:

Doxycycline Anhydrous 100 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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. Treatment: 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 i

Resumen del producto:

HOW SUPPLIED: Doxycycline hyclate capsules and tablets are available as follows: Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER. Protect from Light.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
REFERENCE LABEL SET ID: FA4170F8-E846-4083-A948-6FBC04D9E919
----------
DOXYCYCLINE HYCLATE CAPSULES USP
50 MG AND 100 MG
DOXYCYCLINE HYCLATE TABLETS USP
100 MG
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
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
bacteria.
DESCRIPTION
Doxycycline hyclate is an antibacterial drug synthetically derived
from oxytetracycline, and is available
as doxycycline hyclate (doxycycline hydrochloride hemiethanolate
hemihydrate) capsules and tablets
for oral administration. The chemical designation of this light-yellow
crystalline powder is alpha-6-
deoxy-5-oxytetracycline. 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. Doxycycline hyclate has the following structural
formula:
(C
H
N O •HCL)
•C H O•H O M.W. 1025.89
Each capsule for oral administration contains doxycycline hyclate
equivalent to 50 mg or 100 mg
doxycycline (anhydrous). Inactive ingredients for capsules are:
anhydrous lactose, croscarmellose
sodium, D&C Red #28, FD&C Blue #1, gelatin, magnesium stearate,
microcrystalline cellulose, and
titanium dioxide. Each tablet for oral administration contains
doxycycline hyclate equivalent to 100 mg
doxycycline. Inactive ingredients for tablets are: anhydrous lactose,
carnauba wax, croscarmellose
sodium, D&C Yellow #10 aluminum lake, FD&C Red #40 aluminum lake,
hypromellose, magnesium
stearate, microcrystalline cellulose, polyethylene glycol, polysorbate
80, and titanium dioxide.
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
fe