DOXYCYCLINE HYCLATE tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

JG Pharma Inc.

INN (שם בינלאומי):

DOXYCYCLINE HYCLATE

הרכב:

DOXYCYCLINE ANHYDROUS 50 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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. 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 by Chlamydia trachomatis, although the infectious agent is not always elim

leaflet_short:

Doxycycline hyclate tablets, USP equivalent to 50 mg of doxycycline: Light beige color, round convex, film-coated tablets debossed “311” below, “B” on one side and plain on the other. Bottles of 60 tablets NDC 72143-211-60 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.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET, FILM COATED
JG PHARMA INC.
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DOXYCYCLINE HYCLATE TABLETS, USP
50 MG
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of doxycycline
hyclate tablets and other antibacterial drugs, doxycycline hyclate
tablets 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 tablets, USP for oral administration. The chemical
designation of 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-
naphthacene-carboxamide monohydrochloride, compound with ethyl alcohol
(2:1), monohydrate.
The structural formula of doxycycline hyclate is:
with a molecular formula of (C
H N O •HCl) •C H •H O and the molecular weight is 1025.89.
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.
Active Ingredient: Doxycycline hyclate, USP equivalent to 50 mg of
doxycycline.
Inactive Ingredient: Microcrystalline cellulose and magnesium
stearate.
Tablet coating contains hypromellose, titanium dioxide, polyethylene
glycol, FD&C yellow #6,
polysorbate 80 and FD&C Blue #2.
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 kidne