DOXYCYCLINE HYCLATE tablet film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

CHARTWELL GOVERNMENTAL & SPECIALTY RX LLC

INN (International Name):

Doxycycline Hyclate

Sammensetning:

Doxycycline Anhydrous 100 mg

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET, FILM COATED
CHARTWELL GOVERNMENTAL & SPECIALTY RX LLC
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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.