DOXYCYCLINE HYCLATE- doxycycline hyclate tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Doxycycline Hyclate (UNII: 19XTS3T51U) (Doxycycline Anhydrous - UNII:334895S862)

Available from:

Preferred Pharmaceuticals Inc.

INN (International Name):

Doxycycline Hyclate

Composition:

Doxycycline Anhydrous 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain 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 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 bacteria, when bacterio

Product summary:

Doxycycline Hyclate Tablets, USP equivalent to 100 mg doxycycline: Round, orange film-coated tablet engraved with "3626" on one side, and plain on the other side NDC 68788-9767-1 Bottles of 14 tablets NDC 68788-9767-2 Bottles of 20 tablets NDC 68788-9767-3 Bottles of 30 tablets NDC 68788-9767-6 Bottles of 60 tablets Dispense in a tight, light resistant container as defined in the USP, with a child resistant closure (as required). Store at 20° to 25° C (68° to 77° F) (see USP controlled room temperature)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET, FILM COATED
PREFERRED PHARMACEUTICALS INC.
----------
DOXYCYCLINE HYCLATE TABLETS, 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 Tablets and Capsules for oral administration.
The structural formula of doxycycline monohydrate is
with a molecular formula of C
H N O ·H O and a molecular weight of 462.46. 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, 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.
Each tablet, for oral administration, contains doxycycline hyclate
equivalent to 100 mg doxycycline. In
addition, each tablet contains the following inactive ingredients;
anhydrous lactose, colloidal silicon
dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium
stearate, methylcellulose,
microcrystalline cellulose, polyethylene glycol, sodium starch
glycolate, stearic acid, 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