DOXYCYCLINE- doxycycline hyclate tablet, coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Blenheim Pharmacal, Inc.

INN (International Name):

DOXYCYCLINE HYCLATE

구성:

DOXYCYCLINE ANHYDROUS 100 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets, USP and other antibacterial drugs, Doxycycline Hyclate Tablets, 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 psi

제품 요약:

Doxycycline Hyclate Tablets, USP equivalent to 100 mg doxycycline: Orange Coated, Round, Unscored Tablets; Debossed “WW 112”.                 Bottles of 20 tablets                 Bottles of 50 tablets                 Bottles of 500 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

DOXYCYCLINE- DOXYCYCLINE HYCLATE TABLET, COATED
BLENHEIM PHARMACAL, INC.
----------
DOXYCYCLINE HYCLATE
TABLETS, USP
REV. 11/14
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of doxycycline
hyclate tablets and other antibacterial drugs, doxycycline hyclate
tablets 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% per 72 hours in individuals with normal function
(creatinine clearance about 75 mL/min).
This percentage excretion may fall as low as 1 to 5% per 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 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 the INDICATIONS
AND USAGE section of the
package insert for doxycycline hyclate tablets.
_GRAM-NEGATIVE BACTERIA _
_Acin