DOXYCYCLINE powder for suspension

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

CHARTWELL GOVERNMENTAL & SPECIALTY RX LLC

INN (국제 이름):

DOXYCYCLINE

구성:

DOXYCYCLINE ANHYDROUS 25 mg in 5 mL

처방전 유형:

PRESCRIPTION DRUG

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

DOXYCYCLINE- DOXYCYCLINE POWDER, FOR SUSPENSION
CHARTWELL GOVERNMENTAL & SPECIALTY RX LLC
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DOXYCYCLINE FOR ORAL SUSPENSION, USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Doxycycline and
other antibacterial drugs, Doxycycline 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 antibiotic synthetically derived from
oxytetracycline. The chemical
designation is
4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-
methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate.
Doxycycline monohydrate has the following structural formula:
C
H
N O ·H O M.W. 4 62.4 6
Doxycycline is a light-yellow crystalline powder. Doxycycline
monohydrate is very slightly 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. Doxycycline for
Oral Suspension USP contains the following inactive ingredients:
confectioner's sugar, D&C red #27
aluminum lake, ethyl acetate, maltodextrin, methylparaben,
microcrystalline cellulose/ sodium
carboxymethylcellulose, modified cornstarch, natural flavoring;
propylparaben, simethicone and
sucrose.
When reconstituted as directed each teaspoonful (5 mL) contains
doxycycline monohydrate equivalent to
25 mg of doxycycline.
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