DOXYCYCLINE HYCLATE capsule

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

NuCare Pharmaceuticals, Inc.

Designación común 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 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 (ornithosis) caused by Chlamydophila psittaci . - Trachoma caused b

Resumen del producto:

Doxycycline; 100 mg are available as a light blue capsule filled with yellow powder imprinted with "2985" containing Doxycycline Hyclate, equivalent to 100 mg of doxycycline. NDC 68071-3252-1 Bottles of 10 NDC 68071-3252-2 Bottles of 20 NDC 68071-3252-4 Bottles of 14 NDC 68071-3252-3 Bottles of 30 Dispense in a tight, light resistant container as defined in the USP, with a child resistant closure (as required). Store at 20° to 25° C (68° to 77° F) (see USP controlled room temperature)

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE CAPSULE
NUCARE PHARMACEUTICALS, INC.
----------
DOXYCYCLINE HYCLATE CAPSULES, 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 Capsules and Tablets 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 capsule for oral administration contains doxycycline hyclate
equivalent to 50 mg or
100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal
Silicon Dioxide,
Lactose Anhydrous, Magnesium Stearate, Methylcellulose,
Microcrystalline Cellulose,
Polyethylene Glycol, Sodium Starch Glycolate, and Stearic Acid. 50 mg
gelatin capsule
shell contains: FD&C Blue #1, D&C Yellow #10, and other inert
ingredients. 100 mg
gelatin capsule shell contains: FD&C Blue #1 and other inert
ingredients.
CLINICAL PHARMACOLOGY
22
24
2
8
2
22
24
2
8
2
2
6
2
Tetracyclines are readily absorbed and are bound to plasma proteins in
varying degree.
They are concentrated by the liver in th