DOXYCYCLINE HYCLATE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

C.O. Truxton, 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 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 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 i

제품 요약:

Doxycycline hyclate tablets, USP equivalent to 100 mg of doxycycline: Beige color, round convex, film coated tablets debossed “312” below, “B” on one side and plain on the other. Bottles of 500 tablets                NDC 0463-6000-50 Store at 20 to 25O C (68 to 77 O 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 HYCLATE- DOXYCYCLINE HYCLATE TABLET
C.O. TRUXTON, INC.
----------
DOXYCYCLINE HYCLATE TABLETS, USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of doxycycline
tablets and other antibacterial drugs, doxycycline tablets 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 hyclate tablets for oral administration.
The chemical designation of doxycycline is
4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-
3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide
monohydrochloride,
compound with ethyl alcohol (2:1), monohydrate.
The structural formula of doxycycline hyclate is
with a molecular formula of (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.
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.
Active Ingredient: Doxycycline hyclate USP equivalent to 100 mg of
doxycycline USP.
Inactive Ingredient: Microcrystalline cellulose and magnesium
stearate.
Tablet coating contains hypromellose, titanium dioxide, polyethylene
glycol, FD&C yellow #6,
polysorbate 80 and FD&C blue #2.
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 individ