DOXYCYCLINE- doxycycline hyclate tablet, coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Hikma Pharmaceuticals USA Inc.

DCI (Dénomination commune internationale):

DOXYCYCLINE HYCLATE

Composition:

DOXYCYCLINE ANHYDROUS 100 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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. Doxycycline is indicated for the treatment of the following infections: Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug: Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections: In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy. Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains (See DOSAGE AND ADMINISTRATION  section and Information for Patients  subsection of the PRECAUTIONS section). This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

Descriptif du produit:

Doxycycline Hyclate Tablets, USP equivalent to 100 mg doxycycline: Orange Coated, Round, Unscored Tablets, Debossed “WW 112”. NDC 0143-2112-50: Bottle of 50 Tablets NDC 0143-2112-05: Bottle of 500 Tablets Store at 20° to 25°C (68° to 77°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.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

DOXYCYCLINE- DOXYCYCLINE HYCLATE TABLET, COATED
HIKMA PHARMACEUTICALS USA INC.
----------
DOXYCYCLINE HYCLATE
TABLETS, USP
REV. 04/19
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
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 bacteria.
DESCRIPTION
Doxycycline Hyclate Tablets, USP, are an antibacterial drug
synthetically derived from
oxytetracycline. 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.
Each tablet for oral administration contains doxycycline hyclate
equivalent to 100 mg of
doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon
Dioxide, Corn Starch,
Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium
Stearate, and
Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C
Blue No. 2, FD&C
Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and
Titanium Dioxide.
CLINICAL PHARMACOLOGY
Tetracyclines are readily absorbed and are bound to plasma proteins in
varying degree.
22
24
2
8
2
22
24
2
8
2
2
6
2
Tetracyclines are readily absorbed and are bound to plasma proteins in
varying degree.
They are concentrated by the liver