DOXYCYCLINE for suspension

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Lupin Pharmaceuticals, Inc.

INN (mednarodno ime):

DOXYCYCLINE

Sestava:

DOXYCYCLINE ANHYDROUS 25 mg in 5 mL

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline for oral suspension and other antibacterial drugs, doxycycline for oral suspension 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 trachom

Povzetek izdelek:

Doxycycline for Oral Suspension USP (doxycycline monohydrate) is available as a raspberry-flavored, dry powder for oral suspension. When reconstituted, each teaspoonful (5 mL) contains doxycycline monohydrate equivalent to 25 mg of doxycycline: 60 mL bottles                         (NDC 68180-657-01). Doxycycline for Oral Suspension USP is to be stored at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature] and dispensed in tight, light-resistant containers (USP).

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

DOXYCYCLINE - DOXYCYCLINE FOR SUSPENSION
LUPIN PHARMACEUTICALS, INC.
----------
DOXYCYCLINE FOR ORAL SUSPENSION USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
doxycycline for oral suspension and other antibacterial drugs,
doxycycline for oral
suspension 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 for oral suspension USP (doxycycline
monohydrate) for oral
administration.
The structural formula of doxycycline monohydrate is
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 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.
Inert ingredients for the oral suspension formulation are:
carboxymethylcellulose
sodium, FD & C Blue No. 1, methylparaben, microcrystalline cellulose,
propylparaben,
raspberry flavor, D & C Red 28 and sucrose.
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.
22
24
2
8
2
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 function
(creatinine clearance