DOXYCYCLINE HYCLATE- doxycycline hyclate tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Par Pharmaceutical

INN (International Name):

DOXYCYCLINE HYCLATE

Sammensetning:

DOXYCYCLINE ANHYDROUS 100 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets, USP and other antibacterial drugs, Doxycycline Hyclate Tablets, USP 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 Chlamydia trachomatis , although the infec

Produkt oppsummering:

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 67253-391-15                    Bottles of 50 tablets NDC 67253-391-50                    Bottles of 500 tablets 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.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET
PAR PHARMACEUTICAL
----------
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 is an antibacterial drug synthetically derived
from oxytetracycline.
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
(anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide,
Lactose Anhydrous, FD&C Red No.
40, 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 is virtually completely absorbed
after oral administration.
Following a 200 mg dose, normal adult