DOXYCYCLINE- doxycycline hyclate tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Legacy Pharmaceutical Packaging

INN (International Name):

DOXYCYCLINE HYCLATE

Composition:

DOXYCYCLINE HYCLATE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: -  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 Chlamydia trachomatis, although the infectious agent is not always eliminated as judg

Product summary:

Doxycycline Hyclate Tablets USP, equivalent to 100 mg doxycycline: Film coated orange, round, unscored tablets imprinted "WW 112". Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXYCYCLINE- DOXYCYCLINE HYCLATE TABLET, COATED
LEGACY PHARMACEUTICAL PACKAGING
----------
DOXYCYCLINE HYCLATE
TABLETS, USP
REV. 04/10
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