DOXYCYCLINE HYCLATE tablet, film coated

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

NuCare Pharmaceuticals, Inc.

INN (Alþjóðlegt nafn):

DOXYCYCLINE HYCLATE

Samsetning:

DOXYCYCLINE ANHYDROUS 100 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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: - 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 Chlamydophila psittaci . - Trachoma caused by

Vörulýsing:

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 66267-146-10 Bottles of 10 NDC 66267-146-14 Bottles of 14 NDC 66267-146-20 Bottles of 20 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)

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET, FILM COATED
NUCARE 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 i