DOXYCYCLINE HYCLATE tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)

Boleh didapati daripada:

Heritage Pharmaceuticals Inc.

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate tablets, USP and other antibacterial drugs, doxycycline hyclate tablets, 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. 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

Ringkasan produk:

Doxycycline hyclate tablets, USP equivalent to 100 mg doxycycline are orange, film-coated, round shaped tablets debossed with "HP" on one side and "376" on other side. They are available as follows: Bottles of 50 tablets (NDC 23155-376-25) Bottles of 100 tablets (NDC 23155-376-01) Bottles of 500 tablets (NDC 23155-376-05) Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant containers (USP).

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET, FILM COATED
HERITAGE PHARMACEUTICALS INC.
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DOXYCYCLINE HYCLATE TABLETS, USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of doxycycline
hyclate tablets, USP and other antibacterial drugs, doxycycline
hyclate tablets, USP 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 hyclate tablets, USP for oral administration.
The structural formula of doxycycline hyclate is
with a molecular formula for doxycycline hydrochloride hemiethanolate
hemihydrate
(C
H N O ·HCl) C H OH·H O and a molecular weight of 1025.87. The
chemical designation for
doxycycline hyclate is 2-Naphthacenecarboxamide,
4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octohydro-
3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-,monohydrochloride,
compound with ethanol (2:1),
monohydrate, [4S-(4 ,4a ,5 , 5a , 6 ,12 , 12a ]. Doxycycline hyclate
USP is yellow to light yellow
powder. Doxycycline hyclate USP is freely soluble in water and
methanol; sparingly soluble in ethanol;
practically insoluble in chloroform and ether.
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.
Inert ingredients for the tablet formulation are: colloidal silicon
dioxide USP/NF, corn starch USP/NF,
croscarmellose sodium USP/NF, magnesium stearate USP/NF, and
microcrystalline cellulose USP/NF,
hypromellose USP. Film coating contains: FD&C Blue No. 2, FD&C Yellow
No. 6, hypromellose
USP, polyethylene glycol NF, and titanium dioxide USP.
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
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