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:

A-S Medication Solutions

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: Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic

Resumen del producto:

Product: 50090-0023 NDC: 50090-0023-0 10 TABLET, FILM COATED in a BOTTLE, PLASTIC NDC: 50090-0023-1 14 TABLET, FILM COATED in a BOTTLE, PLASTIC NDC: 50090-0023-3 20 TABLET, FILM COATED in a BOTTLE, PLASTIC NDC: 50090-0023-5 28 TABLET, FILM COATED in a BOTTLE, PLASTIC NDC: 50090-0023-6 30 TABLET, FILM COATED in a BOTTLE, PLASTIC NDC: 50090-0023-8 60 TABLET, FILM COATED in a BOTTLE, PLASTIC

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
----------
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:
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, 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 feces at high
concentrations and in a biologically active form. Doxycycline is
virtually completely
absorbed after oral administration.
Fol