DOXYCYCLINE- doxycycline hyclate tablet, coated

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

St Marys Medical Park Pharmacy

INN:

DOXYCYCLINE HYCLATE

composition:

DOXYCYCLINE ANHYDROUS 100 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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 Chlamydia psittaci. -  Trachoma caused by

leaflet_short:

Doxycycline Hyclate Tablets USP, equivalent to 100 mg doxycycline: Orange Coated, Round, Unscored Tablets; Debossed "WW 112". NDC: 60760-0215-60 bottle of 60 60760-0215-20 bottle of 20 Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

authorization_status:

Abbreviated New Drug Application

SPC

DOXYCYCLINE- DOXYCYCLINE HYCLATE TABLET, COATED
ST MARYS MEDICAL PARK PHARMACY
----------
DOXYCYCLINE HYCLATE
TABLETS, USP
REV. 06/11
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 hyclate is a broad-spectrum antibiotic synthetically
derived from
oxytetracycline. The chemical designation is
4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-
octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-
carboxamide monohydrochloride, compound with ethyl alcohol (2:1),
monohydrate.
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.
The structural formula is as follows:
Each tablet for oral administration contains doxycycline hyclate
equivalent to 100 mg of
doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon
Dioxide, Corn Starch,
Croscarmellose Sodium, Docusate Sodium, Magnesium Stearate, and
Microcrystalline
Cellulose. Film Coating and Polishing contains: FD&C Blue No. 2, FD&C
Yellow No. 6, and
Titanium Dioxide.
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.
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 in individuals with
normal function
(creatinine clearance about 75 mL/min). This p