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:

Major Pharmaceuticals

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: Orange Coated, Round, Unscored Tablets, Debossed “WW 112”. Bottle of 20 tablets, NDC 0904-0430-95 Cartons of 30 tablets (10 tablets each blister pack x 3) NDC 0904-0430-04 Cartons of 50 tablets (10 tablets each blister pack x 5) NDC 0904-0430-06 Store at 20° to 25°C (68° to 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

Summary of Product characteristics

DOXYCYCLINE- DOXYCYCLINE HYCLATE TABLET, COATED
MAJOR PHARMACEUTICALS
----------
DOXYCYCLINE HYCLATE TABLETS, USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
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 bacteria.
DESCRIPTION
Doxycycline Hyclate Tablets, USP are an antibacterial drug
synthetically derived from
oxytetracycline. The structural formula of doxycycline hyclate is:
with a molecular formula of C
H
N O •HCL•1/2C N OH•1/2H O and a molecular
weight of 512.93.
The chemical designation for doxycycline is 2-Naphthacemecarboxamide,
4-
(dimethylamino)-1, 4, 4a, 5, 5a, 6, -11, 12a-octahydro-3,5,10, 12,
12a-pentahydroxy-6-
mothyl-1, 11-dioxo-monohydrochloride, compound with ethanol(2:1),
monohydrate,
[4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)].
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.
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, Sodium Benzoate, 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.
22
24
2
8
2
5
2
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 vol