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:

Department of State Health Services, Pharmacy Branch

INN (International Name):

DOXYCYCLINE HYCLATE

Composition:

DOXYCYCLINE ANHYDROUS 100 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

Product summary:

HOW SUPPLIED: Doxycycline hyclate capsules and tablets are available as follows: 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 TABLET, FILM COATED
DEPARTMENT OF STATE HEALTH SERVICES, PHARMACY BRANCH
REFERENCE LABEL SET ID: FA4170F8-E846-4083-A948-6FBC04D9E919
----------
DOXYCYCLINE HYCLATE CAPSULES USP
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.
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.
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 about 75 mL/min.). This
percentage excretion may fall as low as 1 to 5%/72 hours in
individuals with severe renal insufficiency
(creatinine clearance below 10 mL/min.). Studies have shown no
significant difference in serum half-
life of doxycycline (range 18 to 22 hours) in individuals with normal
and severely impaired renal
function.
Hemodialysis does not alter serum half-life.
Results of animal studies indicate that tetracyclines cross the
placenta and are found in fetal tissues.
MICROBIOLOGY
Doxycycline inhibits bacterial protein synthesis by binding to the 30S
ribosomal subunit. Doxycycline
has bacteriostatic activity against a broad range of Gram-positive and
Gram-negative bacteria. Cross
resistance with other tetracyclines is common.
Doxycycline has been shown to be active against most isolates of the
following microorganisms, both
_in vitro_ and in clinical infections as described in