DOXYCYCLINE HYCLATE capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

NuCare Pharmaceuticals, Inc.

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

Doxycycline Hyclate Capsules, USP 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 66267-085-10 100 mg capsules - Bottles of 10 capsules NDC 66267-085-14 100 mg capsules - Bottles of 14 capsules NDC 66267-085-20 100 mg capsules - Bottles of 20 capsules NDC 66267-085-30 100 mg capsules - Bottles of 30 capsules 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)

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

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
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 an