DOXYCYCLINE HYCLATE capsule

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Blenheim Pharmacal, Inc.

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 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 (omithosis) caused by Chlamydia trachomatis . - Trachoma caused by Chlamydia trachomatis , although the infectious agent

Tuoteyhteenveto:

Doxycycline Hyclate Capsules USP, equivalent to 50 mg doxycycline: Opaque Blue/White, No. 2 hard gelatin capsule printed “West-ward 3141.”       Bottles of 50 capsules.       Bottles of 500 capsules.       Unit Doxe Boxes of 100 capsules. Doxycycline Hyclate Capsule USP, equivalent to 100 mg doxycycline: Opaque Blue, No. 0 hard gelatin capsules printed “West-ward 3142.”      Bottles of 14 capsules.      Bottles of 20 capsules.      Bottles of 50 capsules.      Bottles of 500 capsules.      Unit Dose Boxes of 100 capsules. Store at 20-25°C (68-77°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.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

DOXYCYCLINE HYCLATE - DOXYCYCLINE HYCLATE CAPSULE
BLENHEIM PHARMACAL, INC.
----------
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE CAPSULES, USP
Rev. 01/09
Rx ONLY
To reduce the development of drug-resistant bacteria and maintain the
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 bacteria.
DESCRIPTION
Doxycycline hyclate is a broad-spectrum antibiotic synthetically
derived from oxytetracycline. The
structural formula is as follows:
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.
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.
Each capsule for oral administration contains doxycycline hyclate
equivalent to 50 mg or 100 mg of
doxycycline (anhydrous). Inactive ingredients: lactose monohydrate,
microcrystalline cellulose,
magnesium stearate.
50 mg gelatin capsule shell contains: FD&C Blue #1, silicon dioxide,
sodium lauryl sulfate and titanium
dioxide. 100 mg gelatin capsule shell contains: FD&C Blue #1, silicon
dioxide, sodium lauryl sulfate
and titanium dioxide. The printing ink contains: D&C Yellow #10, FD&C
Blue #1, FD&C Blue #2,
FD&C Red #40, n-Butyl Alcohol, Pharmaceutical Glaze, Propylene Glycol,
SDA-3A Alcohol and
Synthetic Black Iron Oxide.
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