DOXYCYCLINE capsule

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

PharmPak, Inc.

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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 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

Toote kokkuvõte:

Doxycycline Capsules, USP 100 mg have a brown opaque cap and a yellow opaque body. The capsules are imprinted “G&W 0555” with white ink on the cap and “100 mg” with brown ink on the body, filled with yellow to beige powder. Each capsule contains doxycycline monohydrate equivalent to 100 mg doxycycline. Doxycycline Capsules, USP 100 mg is available in: Bottles of 1 capsules ....................................................... NDC 54348-573-00  Bottles of 2 capsules ........................................................NDC 54348-573-02 Bottles of 14 capsules .......................................................NDC 54348-573-14 Bottles of 28 capsules .......................................................NDC 54348-573-28 STORE AT 20° to 25°C (68° to 77°F). [SEE USP CONTROLLED ROOM TEMPERATURE.] DISPENSE IN A TIGHT, LIGHT-RESISTANT CONTAINER AS DEFINED IN THE USP/NF. PROTECT FROM LIGHT.

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

DOXYCYCLINE- DOXYCYCLINE CAPSULE
PHARMPAK, INC.
----------
DOXYCYCLINE CAPSULES, USP
RX ONLY
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF
DOXYCYCLINE CAPSULES AND OTHER ANTIBACTERIAL DRUGS, DOXYCYCLINE
CAPSULES 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, 75 mg, and 100 mg contain doxycycline monohydrate
equivalent to 75 mg, and 100 mg of
doxycycline for oral administration. The chemical designation of the
light yellow to pale yellow
powder is 2-Naphthacenecarboxamide,
4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-
3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-,[4 _S_-(4a,4a ,5 ,5a
,6 ,12a ,)]-, monohydrate.
Structural formula:
C
H
N
O
• H
O M.W. = 462.45
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.
Inert ingredients: colloidal silicon dioxide; magnesium stearate;
microcrystalline cellulose; sodium
starch glycolate; and a hard gelatin capsule which contains iron oxide
black, iron oxide red, iron oxide
yellow, titanium dioxide, gelatin, sodium lauryl sulfate for the 75 mg
strength and iron oxide black, iron
oxide red, iron oxide yellow, titanium dioxide, FD & C Red # 3, D&C
Yellow # 10, gelatin, sodium
lauryl sulfate for the 100 mg strength. The capsules are printed with
edible ink containing shellac,
titanium dioxide, black iron oxide, brown iron oxide and potassium
hydroxide for 75 mg and 100 mg
strengths.
CLINICAL PHARMACOLOGY
22
24
2
8
2
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.