DOXYCYCLINE- doxycycline hyclate capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Greenstone LLC

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 and other antibacterial drugs, doxycycline 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 jud

Product summary:

Doxycycline Hyclate Capsules, USP is available in capsules containing doxycycline hyclate equivalent to: 100 m g dox y c y cline bottles of 50 (NDC 59762-3690-1) bottles of 500 (NDC 59762-3690-2) The capsules are light blue and are imprinted with "VIBRA" on one half and "PFIZER 095" on the other half. All products are to be stored below 86°F (30°C) and dispensed in tight, light-resistant containers (USP).

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

DOXYCYCLINE- DOXYCYCLINE HYCLATE CAPSULE
GREENSTONE LLC
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DOXYCYCLINE HYCLATE CAPSULES, 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 an antibacterial drug synthetically derived from
oxytetracycline, and is available as
capsules of doxycycline hyclate for oral administration.
The structural formula of doxycycline monohydrate is
with a molecular formula of C
H N O ·H O and a molecular weight of 462.46. The chemical
designation for 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-naphthacenecarboxamide monohydrate.
The molecular formula
for doxycycline hydrochloride hemiethanolate hemihydrate is (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, while 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.
Inert ingredients in the capsule formulations are: hard gelatin
capsules (which may contain Blue 1 and
other inert ingredients); magnesium stearate; microcrystalline
cellulose; sodium lauryl sulfate.
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