DOXYCYCLINE HYCLATE capsule, gelatin coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

VersaPharm Incorporated

Designació comuna internacional (DCI):

DOXYCYCLINE HYCLATE

Composición:

DOXYCYCLINE ANHYDROUS 100 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

Doxycycline Hyclate Capsules, USP equivalent to 50 mg doxycycline: No. 2 Blue/White Opaque Hard Gelatin Capsule Printed “West-ward 3141” in Black Ink. Bottles of 50 capsules. Bottles of 500 capsules. Doxycycline Hyclate Capsules, USP equivalent to 100 mg doxycycline: No. 0 Blue/Blue Opaque Hard Gelatin Capsule Printed “West-ward 3142” in Black Ink. Bottles of 14 capsules. Bottles of 20 capsules. Bottles of 50 capsules. Bottles of 500 capsules. 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.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED
VERSAPHARM INCORPORATED
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DOXYCYCLINE HYCLATE CAPSULES, USP
Rev. 11/14
R 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 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 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.
50 mg gelatin capsule shell contains: FD&C Blue #1, silicon dioxide,
sodium lauryl sulfate and titanium
dioxide. 100 mg gelatin capsule shell contains: FD&C Blue #1, silicon
dioxide, sodium lauryl sulfate
and titanium dioxide. The printing ink contains: D&C Yellow #10, FD&C
Blue #1, FD&C Blue #2,
FD&C Red #40, n-Butyl Alcohol, Pharmaceutical Glaze, Propylene Glycol,
SDA-3A Alcohol and
Synthetic Black Iron Oxide.
CLINICAL PHARMACOLOGY
Tetracyclines are readily absorbed and are boun