DOXYCYCLINE HYCLATE capsule, gelatin coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Proficient Rx LP

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 Capsules, USP and other antibacterial drugs, Doxycycline Hyclate Capsules, 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: 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, w

Produkt oppsummering:

Doxycycline Hyclate Capsules, USP equivalent to 100 mg doxycycline: No. 0 Blue/Blue Opaque Hard Gelatin Capsule Printed “West-ward 3142” in Black Ink. 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 CAPSULE, GELATIN COATED
PROFICIENT RX LP
----------
DOXYCYCLINE HYCLATE CAPSULES
DOXYCYCLINE HYCLATE CAPSULES, USP
Rev. 06/16
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of doxycycline
hyclate capsules and other antibacterial drugs, doxycycline hyclate
capsules should be used only to
treat or prevent infections that are proven or strongly suspected to
be caused by bacteria.
DESCRIPTION
Doxycycline Hyclate Capsules, USP, are 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 capsule for oral administration contains doxycycline hyclate
equivalent to 50 mg or 100 mg of
doxycycline (anhydrous). Inactive ingredients: lactose monohydrate,
microcrystalline cellulose,
magnesium stearate.
The 50 mg and 100 mg capsule shells contain: gelatin, diacetylated
monoglycerides, sucrose fatty acid
esters, glacial acetic acid, sodium lauryl sulfate, colloidal silicon
dioxide, FD&C Blue #1 and titanium
dioxide. The printing ink may contain: Shellac Glaze, Iron Oxide
Black, N-Butyl Alcohol, Propylene
Glycol, SDA 3A Alcohol, FD&C Blue #2, FD&C Red #40, FD&C Blue #1, D&C
Yellow #10.
CLINICAL PHARMACOLOGY
Tetracyclines are readily absorbed a