DOXYCYCLINE HYCLATE capsule

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Zhejiang Yongtai Pharmaceutical Co., Ltd

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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. 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 el

Sommarju tal-prodott:

bottles of 500 (NDC:69434-016-03) bottles of 500 (NDC:69434-017-03) Store at 20oC to 25 oC (68oF to 77 oF); excursions permitted from 15 oC to 30 oC (59 oF to 86 oF)[see USP Controlled Room Temperature].

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE CAPSULE
ZHEJIANG YONGTAI PHARMACEUTICAL CO., LTD
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DOXYCYCLINE HYCLATE CAPSULES USP
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 Hyclate (doxycycline hydrochloride
hemiethanolate
hemihydrate)for oral administration.
The structural formula of doxycycline hyclate is
with a molecular formula of C22H24N2O8•HCl)2•C2H6O•H2Oand a
molecular weight of
1025.87. The chemical designation for doxycycline hyclate is
4-(Dimethylamino)-1,4,4a,
5,5a,6,11,12a-octahydro - 3,5,10,
12,12apentahydroxy-6-methyl-1,11-dioxo-2-
naphthacen ecarboxamide monohydrochloride, compound with ethyl alcohol
(2:1),
monohydrate. Doxycycline hyclate is a yellowish crystalline powder.
Doxycycline hyclate
is soluble in water, while 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.
Inert ingredients in the capsule formulations are: hard gelatin
capsules (which contain
FD&C Ble 1, gelatin, purified water and titanium dioxide );
microcrystalline cellulose ;
magnesium stearate.
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