DOXYCYCLINE capsule

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)

Beszerezhető a:

Sun Pharmaceutical Industries, Inc.

INN (nemzetközi neve):

DOXYCYCLINE

Összetétel:

DOXYCYCLINE ANHYDROUS 50 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline capsules, USP and other antibacterial drugs, doxycycline capsules, USP 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 capsules, USP are 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 agen

Termék összefoglaló:

Doxycycline capsules, USP 50 mg have light greenish yellow powder filled in size ‘4’ blue opaque cap/blue opaque body, hard gelatin capsules, imprinted with “RX614” on cap and body in black ink. Each capsule contains doxycycline monohydrate, USP equivalent to 50 mg of doxycycline. Doxycycline capsules, USP 50 mg are available in: Bottles of 20 capsules NDC 63304-614-20 Bottles of 100 capsules NDC 63304-614-01 Bottles of 120 capsules NDC 63304-614-13 Bottles of 500 capsules NDC 63304-614-05 Doxycycline capsules, USP 75 mg have light greenish yellow powder filled in size ‘3’ reflex blue opaque cap/blue opaque body, hard gelatin capsules, imprinted with “RX615” on cap and body in black ink. Each capsule contains doxycycline monohydrate, USP equivalent to 75 mg of doxycycline. Doxycycline capsules, USP 75 mg are available in: Bottles of 100 capsules NDC 63304-615-01 Bottles of 500 capsules NDC 63304-615-05 Unit-dose blister pack of 1 capsule NDC 63304-615-11 Doxycycline capsules, USP 100 mg have light greenish yellow powder filled in size ‘2’ reflex blue opaque cap/blue opaque body, hard gelatin capsules, imprinted with “RX616” on cap and body in black ink. Each capsule contains doxycycline monohydrate, USP equivalent to 100 mg of doxycycline. Doxycycline capsules, USP 100 mg are available in: Bottles of 20 capsules NDC 63304-616-20 Bottles of 100 capsules NDC 63304-616-01 Bottles of 120 capsules NDC 63304-616-13 Bottles of 500 capsules NDC 63304-616-05 Dispense in a tight, light-resistant container as defined in the USP/NF. Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature]. Protect from light. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

DOXYCYCLINE- DOXYCYCLINE CAPSULE
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
PACKAGE/LABEL DISPLAY PANEL
DOXYCYCLINE CAPSULES, USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of doxycycline
capsules, USP and other antibacterial drugs, doxycycline capsules, USP
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 antibacterial synthetically derived
from oxytetracycline. Doxycycline
capsules, USP 100 mg, 75 mg, and 50 mg contain doxycycline
monohydrate, USP equivalent to 100 mg,
75 mg, or 50 mg of doxycycline for oral administration. The chemical
designation of the 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-naphthacene-carboxamide monohydrate.
Structural formula:
Doxycycline has a high degree of lipid 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 monohydrate,
USP equivalent to 50 mg, 75
mg or 100 mg of doxycycline. In addition, each capsule contains the
following inactive ingredients:
colloidal silicon dioxide, magnesium stearate, microcrystalline
cellulose, and sodium starch glycolate.
The capsule shell contains D&C Red No. 28, FD&C Blue No. 1, gelatin,
and titanium dioxide. The
edible printing ink contains black iron oxide, potassium hydroxide,
propylene glycol, and shellac.
CLINICAL PHARMACOLOGY
Tetracyclines are readily absorbed and are bound to plasma proteins in
varying degrees. They are
concentrated by the liver in the bile and excreted in the urine and
feces at high concentrations in a
biologically active form. Doxycycline is virtually completely absorbed
after oral administration.
Following a 200 mg dose of doxycycline monohydrate, 24 normal adult
volunteers averaged the
following serum concentration values:
T