DOXYCYCLINE HYCLATE tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Legacy Pharmaceutical Packaging

INN (Kansainvälinen yleisnimi):

DOXYCYCLINE HYCLATE

Koostumus:

DOXYCYCLINE HYCLATE 100 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 Chlamydia psittaci . • Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always elimi

Tuoteyhteenveto:

Doxycycline Hyclate Tablets USP, 100 mg are available as an orange film-coated tablet, debossed with company logo and "3626", containing doxycycline hyclate, equivalent to 100 mg doxycycline, packaged in bottles of 20 and 100 tablets.  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]. Manufactured by Ivax Pharmaceuticals Miami, FL 33137 Packaged by Legacy Pharmaceutical Packaging Earth City, MO 63045 Rev. B 1/2010

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET, FILM COATED
LEGACY PHARMACEUTICAL PACKAGING
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DOXYCYCLINE HYCLATE TABLETS USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
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
bacteria.
DESCRIPTION
Doxycycline is a broad-spectrum antibiotic synthetically derived from
oxytetracycline. The chemical
designation of this light-yellow crystalline powder 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
monohydrochloride, compound with ethyl alcohol (2:1), monohydrate.
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 tablet, for oral administration, contains doxycycline hyclate
equivalent to 100 mg doxycycline.
In addition, each tablet contains the following inactive ingredients:
anhydrous lactose, colloidal silicon
dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium
stearate, methylcellulose,
microcrystalline cellulose, polyethylene glycol, sodium starch
glycolate, stearic acid and 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 fu