DOXYCYCLINE HYCLATE capsule

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

C.O. Truxton, Inc.

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 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 (omithosis) caused by Chlamydia trachomatis . - Trachoma caused by Chlamydia trachomatis , although the infectious

Resumen del producto:

Doxycycline Hyclate Capsule USP, equivalent to 100 mg doxycycline: No. 0 Blue/Blue Opaque Hard Gelatin Capsule Printed "West-ward 3142" in Black Ink.                     50 capsules (NDC 0463-2013-05)                     500 capsules (NDC 0463-2013-50) Store at 20-25°C (68-77°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
C.O. TRUXTON, INC.
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DOXYCYCLINE HYCLATE CAPSULES, USP
Rev. 12/13
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 is a broad-spectrum antibiotic synthetically
derived from oxytetracycline. The
structural formula is as follows:
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.
Doxycycline is a light
yellow crystalline powder. Doxycycline hyclate is 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.
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 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 volunteers averaged peak serum
levels of 2.6 mcg/mL of
22
24
2
8
2