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:

Lake Erie Medical DBA Quality Care Products LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Capsules & Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Capsules & 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. - 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 a

Product summary:

Doxycycline Hyclate Capsules, USP 50 mg are available as a blue and white capsule filled with yellow powder, imprinted with "2984", containing Doxycycline Hyclate, equivalent to 50 mg Doxycycline; 100 mg are available as a light blue capsule filled with yellow powder imprinted with "2985" containing Doxycycline Hyclate, equivalent to 100 mg of doxycycline. Doxycycline Hyclate Tablets, USP equivalent to 100 mg doxycycline: Round, orange film-coated tablet engraved with "3626" on one side, and plain on the other side. Dispense in a tight, light resistant container as defined in the USP, with a child resistant closure (as required). Store at 20° to 25° C (68° to 77° F) (see USP controlled room temperature)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE CAPSULE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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DOXYCYCLINE HYCLATE CAPSULES, USP
DOXYCYCLINE HYCLATE TABLETS, 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 Doxycycline Hyclate Capsules and Tablets for oral
administration.
The structural formula of doxycycline monohydrate is
with a molecular formula of C22H24N2O8∙H2O 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.
Each capsule for oral administration contains doxycycline hyclate
equivalent to 50 mg or
100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal
Silicon Dioxide,
Lactose Anhydrous, Magnesium Stearate, Methylcellulose,
Microcrystalline Cellulose,
Polyethylene Glycol, Sodium Starch Glycolate, and Stearic Acid. 50 mg
gelatin capsule
shell contains: FD&C Blue #1, D&C Yellow #10, and other inert
ingredients. 100 mg
gelatin capsule shell contains: FD&C Blue #1 and other inert
ingredients.
Each tablet, for oral administration, contains doxycycline hyclate
equivalent to 100 mg
doxycycline. In addition, each tablet