DOXYCYCLINE- doxycycline powder, for suspension

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Harris Pharmaceutical, Inc

INN (Nama Internasional):

DOXYCYCLINE

Komposisi:

DOXYCYCLINE ANHYDROUS 25 mg in 5 mL

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline for Oral Suspension, USP and other antibacterial drugs 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 always elimi

Ringkasan produk:

Doxycycline for Oral Suspension, USP is available as a raspberry-flavored, pink dry powder for oral suspension. When reconstituted, each teaspoonful (5 mL) contains doxycycline monohydrate equivalent to 25 mg of doxycycline in a 2 oz. (60 mL) bottle. Dispense in a tight, light-resistant container as defined in the USP. Use child-resistant closure (as required). NDC 67405-475-62   60 mL bottle Store dry powder at 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature].

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

DOXYCYCLINE- DOXYCYCLINE POWDER, FOR SUSPENSION
HARRIS PHARMACEUTICAL, INC
----------
DOXYCYCLINE FOR ORAL SUSPENSION, USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Doxycycline and
other antibacterial drugs, Doxycycline should be used only to treat or
prevent infections that are proven
or strongly suspected to be caused by bacteria.
DESCRIPTION
Doxycycline is an antibacterial drug synthetically derived from
oxytetracycline, and is available as
Doxycycline for Oral Suspension, USP (doxycycline monohydrate); for
oral administration.
The structural formula of doxycycline monohydrate is
with a molecular formula of C
H N O ·H O and a molecular weight of 462.46. The chemical
designation for doxycycline is
4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,
12,12apentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide
monohydrate. Doxycycline is a
light yellow crystalline powder. Doxycycline monohydrate is very
slightly soluble in water.
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 for Oral Suspension, USP contains the following inactive
ingredients: confectioner's
sugar, D&C red #27 aluminum lake, ethyl acetate, maltodextrin,
methylparaben, microcrystalline
cellulose/ sodium carboxymethylcellulose, modified cornstarch, natural
flavoring; propylparaben,
simethicone and sucrose.
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.
Following a 200 mg dose, normal adult volunteers averaged peak serum
levels of 2.6 mcg/mL of
doxycycline at 2 hours, decreasing to 1.45 mcg/mL at 24 hours.
Excretion of doxycycline by the kidney
is about 40%/72 hours