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:

Denton Pharma, Inc. DBA Northwind Pharmaceuticals

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 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. - 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 Chlamydi

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
DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS
----------
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 cont