DOXYCYCLINE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lupin Pharmaceuticals,Inc.

INN (International Name):

DOXYCYCLINE

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 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 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 Calymmatobacterium  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 microorganisms, 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  in the treatment of the following infections:      Uncomplicated gonorrhea caused by Neisseria  gonorrhoeae      Syphilis caused by Treponema  pallidum      Yaws caused by Treponema  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. This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

Product summary:

Doxycycline Capsules, USP 50 mg have a yellow opaque cap and a white opaque body. The capsules are imprinted  "NL 790"  with white ink on the cap and "50 mg"  with brown ink on the body, filled with yellow to beige powder. Each capsule contains doxycycline monohydrate equivalent to 50 mg doxycycline. Doxycycline Capsules, USP 50 mg is available in:     Bottles of 50 capsules ............................NDC 43386-790-11     Bottles of 100 capsules ...........................NDC 43386-790-01    Bottles of 1000 capsules ..........................NDC 43386-790-10 Doxycycline Capsules, USP 75 mg have a brown opaque cap and a white opaque body. The capsules are imprinted  "NL 791"  with white ink on the cap and "75 mg"  with brown ink on the body, filled with yellow to beige powder. Each capsule contains doxycycline monohydrate equivalent to 75 mg doxycycline. Doxycycline Capsules, USP 75 mg is available in:      Bottles of 50 capsules ..............................NDC 43386-791-11     Bottles of 100 capsules .............................NDC 43386-791-01    Bottles of 1000 capsules ...........................NDC 43386-791-10 Doxycycline Capsules, USP 100 mg have a brown opaque cap and a yellow opaque body. The capsules are imprinted  "NL 792"  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 50 capsules .............................NDC 43386-792-11     Bottles of 250 capsules..............................NDC 43386-792-02    Bottles of 1000 capsules ............................NDC 43386-792-10 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXYCYCLINE - DOXYCYCLINE CAPSULE
LUPIN PHARMACEUTICALS,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, 50 mg, 75 mg, and 100 mg contain doxycycline
monohydrate equivalent to 50 mg, 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_-(4α,4aα,5α,5aα,6α,12aα)]-
,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
titanium dioxide,
FD&C Red # 3, D&C Yellow # 10, gelatin, sodium lauryl sulfate, for the
50 mg strength;
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, red iron oxide and potassium hydroxide for
50 mg, 75 mg and
100 mg strengths.
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 fece