DOXYCYCLINE- doxycycline hyclate tablet, coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

Doxycycline hyclate (UNII: 19XTS3T51U) (Doxycycline anhydrous - UNII:334895S862)

Disponible depuis:

Rebel Distributors Corp.

DCI (Dénomination commune internationale):

Doxycycline hyclate

Composition:

Doxycycline anhydrous 100 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

To reduce the development of drug-resistant bacteria and maintain 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 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: Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates app

Descriptif du produit:

Doxycycline Hyclate Tablets USP, equivalent to 100 mg doxycycline: Film coated orange, round, unscored tablets imprinted "WW 112". 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.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

DOXYCYCLINE - DOXYCYCLINE HYCLATE TABLET, COATED
REBEL DISTRIBUTORS CORP.
----------
DOXYCYCLINE HYCLATE, USP
REV. 06/04
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, Hydroxypropyl
Methylcellulose, Polyethylene
Glycol, and 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 abou