DOXYCYCLINE HYCLATE tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Novel Laboratories, Inc.

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 t

Povzetek izdelek:

Doxycycline Hyclate Tablets, USP 100 mg are orange color coated, round, biconvex tablets, debossed with "n" above and "794" below on one side and plain on other side. Bottles of 20 tablets NDC 40032-794-02 Bottles of 50 tablets NDC 40032-794-50 Bottles of 100 tablets NDC 40032-794-01 Bottles of 500 tablets NDC 40032-794-05 Bottles of 1000 tablets NDC 40032-794-10 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 using a child-resistant closure.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET
NOVEL LABORATORIES, INC.
----------
DOXYCYCLINE HYCLATE TABLETS, USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Doxycycline
Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate
Tablets 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 (doxycycline hydrochloride hemiethanolate
hemihydrate) for oral
administration.
The structural formula of doxycycline hyclate is:
The chemical designation for doxycycline is
4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-
3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide
monohydrate. The
molecular formula for doxycycline hydrochloride hemiethanolate
hemihydrate is
(C
H N O •HCl) •C H O•H O and the molecular weight is 1025.89.
Doxycycline is a light-yellow
crystalline powder. Doxycycline hyclate is 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.
Inert ingredients are: colloidal silicon dioxide, corn starch,
croscarmellose sodium, docusate sodium,
magnesium stearate, microcrystalline cellulose, ethyl alcohol and a
coating containing hypromellose,
polyethylene glycol, titanium dioxide, FD&C Blue No. 2 and FD&C Yellow
No. 6.
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