DOXYCYCLINE powder, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

CIPLA USA, Inc

INN (International Name):

DOXYCYCLINE

Composition:

DOXYCYCLINE ANHYDROUS 25 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline for Oral Suspension, USP and other antibacterial drugs 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 trachomatis , although the infectious agent is not always elimin

Product summary:

Doxycycline for Oral Suspension USP is available as a raspberry-flavored, pink dry powder for oral suspension. When reconstituted, each teaspoonful (5 mL) contains doxycycline monohydrate equivalent to 25 mg of doxycycline in a 2 oz (60 mL) bottle. Dispense in a tight, light-resistant container as defined in the USP. Use child-resistant closure (as required). NDC 69097-228-43 60 mL bottle Store dry powder at 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXYCYCLINE- DOXYCYCLINE POWDER, FOR SUSPENSION
CIPLA USA, INC
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DOXYCYCLINE FOR ORAL SUSPENSION, USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Doxycycline and
other antibacterial drugs, Doxycycline 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 ·H2O and a molecular weight of 462.46. The chemical
designation for doxycycline is
4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-
3,5,10,12,12apentahydroxy-6-
methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate.
Doxycycline is a light-yellow crystalline powder. The molecular
formula for DOXYCYCLINE
HYDROCHLORIDE HEMIETHANOLATE HEMIHYDRATE (C
H N O ·HCl) ·C H O·H O and the molecular
weight is 1025.89.
Doxycycline is a light yellow crystalline powder. 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.
Doxycycline for Oral Suspension, USP contains the following inactive
ingredients: confectioner's
sugar, D&C red #27 aluminum lake, ethyl acetate, maltodextrin,
methylparaben, microcrystalline
cellulose/ sodium carboxymethylcellulose, modified cornstarch, natural
flavoring; propylparaben,
simethicone 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 administra