DOXYCYCLINE HYCLATE capsule DOXYCYCLINE HYCLATE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sun Pharmaceutical Industries, Inc.

INN (International Name):

DOXYCYCLINE HYCLATE

Composition:

DOXYCYCLINE ANHYDROUS 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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. Treatment: 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 eliminated, as judged by immunofluorescence. - Inclusion conjunctivitis caused by Chlamydia trachomatis . - Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis . - Nongonococcal urethritis caused by Ureaplasma urealyticum . - Relapsing fever due to Borrelia recurrentis . Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: - Chancroid caused by Haemophilus ducreyi . - Plague due to Yersinia pestis . - Tularemia due to Francisella tularensis . - Cholera caused by Vibrio cholerae . - Campylobacter fetus infections caused by Campylobacter fetus . - Brucellosis due to Brucella species (in conjunction with streptomycin). - Bartonellosis due to Bartonella bacilliformis . - Granuloma inguinale caused by Klebsiella granulomatis . Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug: - Escherichia coli. - Enterobacter aerogenes . - Shigella species. - Acinetobacter species. - Respiratory tract infections caused by Haemophilus influenzae . - Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: - Upper respiratory infections caused by Streptococcus pneumoniae . - Anthrax due to Bacillus anthracis , including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis . When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections: - Uncomplicated gonorrhea caused by Neisseria gonorrhoeae . - Syphilis caused by Treponema pallidum . - Yaws caused by Treponema pallidum subspecies pertenue . - Listeriosis due to Listeria monocytogenes . - Vincent's infection caused by Fusobacterium fusiforme . - Actinomycosis caused by Actinomyces israelii . - Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy. Prophylaxis: Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains. (See DOSAGE AND ADMINISTRATIONsection and Information for Patientssubsection of the PRECAUTIONSsection.) This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

Product summary:

HOW SUPPLIED: Doxycycline hyclate capsules and tablets are available as follows: a. Capsule-equivalent to 50 mg doxycycline (No. 2 opaque white and light blue capsule) in: Bottles of 50 capsules NDC 53489-118-02 imprinted Mutual 100 Bottles of 500 capsules NDC 53489-118-05 imprinted Mutual 100 b. Capsule-equivalent to 100 mg doxycycline (No. 0 opaque light blue capsule) in: Bottles of 50 capsules NDC 53489-119-02 imprinted Mutual 105 Bottles of 500 capsules NDC 53489-119-05 imprinted Mutual 105 c. Tablet-equivalent to 100 mg doxycycline (light orange film coated tablet) in: Bottles of 50 tablets NDC 53489-120-02 debossed MP 37 Bottles of 500 tablets NDC 53489-120-05 debossed MP 37 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER. Protect from Light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE CAPSULE
DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET, FILM COATED
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
DOXYCYCLINE HYCLATE CAPSULES USP 50 MG AND 100 MG DOXYCYCLINE
HYCLATE TABLETS USP 100 MG
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
doxycycline hyclate and other antibacterial drugs, doxycycline hyclate
should be used
only to treat or prevent infections that are proven or strongly
suspected to be caused
by bacteria.
DESCRIPTION
Doxycycline hyclate is an antibacterial drug synthetically derived
from oxytetracycline,
and is available as doxycycline hyclate (doxycycline hydrochloride
hemiethanolate
hemihydrate) capsules and tablets for oral administration. The
chemical designation of
this light-yellow crystalline powder is
alpha-6-deoxy-5-oxytetracycline. 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 hyclate has the following structural formula:
Each capsule for oral administration contains doxycycline hyclate
equivalent to 50 mg or
100 mg doxycycline (anhydrous). Inactive ingredients for capsules are:
anhydrous
lactose, croscarmellose sodium, FD&C Blue #1, gelatin, magnesium
stearate,
microcrystalline cellulose, and titanium dioxide. Each tablet for oral
administration
contains doxycycline hyclate equivalent to 100 mg doxycycline.
Inactive ingredients for
tablets are: lactose monohydrate, carnauba wax, croscarmellose sodium,
D&C Yellow
#10 aluminum lake, FD&C Red #40 aluminum lake, hypromellose, magnesium
stearate,
microcrystalline cellulose, polyethylene glycol, polysorbate 80, and
titanium dioxide.
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 i