OCUDOX - 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:

OCuSOFT INC.

Designació comuna internacional (DCI):

Doxycycline Hyclate

Composición:

Doxycycline Hyclate 50 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 and other antibacterial drugs, doxycycline hyclate 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. Treatment: 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 Chlamydia psittaci. - Trachoma caused by Chlamydia trachomatis, although the infectious agent is not

Resumen del producto:

Doxycycline hyclate capsules USP equivalent to 50 mg doxycycline (No. 2 opaque white and light blue capsule) in: Bottles of 60 capsules NDC 54799-536-30 imprinted Mutual 100 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

OCUDOX - DOXYCYCLINE HYCLATE CAPSULE
OCUSOFT INC.
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OCUDOX CONVENIENCE KIT
DES CRIPTION
Doxycycline is a broad-spectrum antibiotic synthetically derived from
oxytetracycline, and is available
as doxycycline hyclate (doxycycline hydrochloride hemiethanolate
hemihydrate) capsules and tablets
for oral administration. The chemical designation of this light-yellow
crystalline powder is alpha-6-
deoxy-5-oxytetracycline. 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. Doxycycline hyclate has the following structural
formula:
(C
H N O •HCl) •C H O•H O M.W. 1025.89
Each capsule for oral administration contains 50 mg or 100 mg
doxycycline hyclate, equivalent to 50
mg or 100 mg doxycycline (anhydrous). Inactive ingredients for
capsules are: anhydrous lactose,
croscarmellose sodium, D and C Red #28, FD and C Blue #1, gelatin,
magnesium stearate,
microcrystalline cellulose, titanium dioxide. Each tablet for oral
administration contains 100 mg
doxycycline hyclate, equivalent to 100 mg doxycycline. Inactive
ingredients for tablets are: anhydrous
lactose, carnauba wax, croscarmellose sodium, D and C Yellow #10
aluminum lake, FD and C Red #40
aluminum lake, hypromellose, magnesium stearate, microcrystalline
cellulose, polyethylene glycol,
polysorbate 80, titanium dioxide.
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
doxycycline at 2 hours decreasing to 1.45 mcg/mL at 24 hours.
Excretion of doxycycline by the kidney
is about 40%/72 hours in individuals with normal function (creatinine
clearance about 75 mL/min.). T