DOXYCYCLINE HYCLATE tablet

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Preferred Pharmaceuticals Inc

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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 hyclate tablets are indicated for  the treatment of following infections: Doxycycline hyclate tablets are 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 hyclate tablets are indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug: Doxycycline hyclate tablets are 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 hyclate tablets are 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 hyclate tablets are 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.

leaflet_short:

Each film-coated tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Doxycycline Hyclate Tablets USP, equivalent to 100 mg doxycycline: Light yellow to beige colored, round, beveled edge, biconvex tablets debossed with "D77" on one side and plain on other side.   NDC 68788-8217-1 in bottle of 14 tablets NDC 68788-8217-2 in bottle of 20 tablets NDC 68788-8217-3 in bottle of 30 tablets Storage: Store at 20°C to 25°C (68°F 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.

authorization_status:

Abbreviated New Drug Application

SPC

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET
PREFERRED PHARMACEUTICALS INC
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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 hyclate is an antibacterial drug synthetically derived
from oxytetracycline.
The chemical designation for doxycyclin is
4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-
octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-
carboxamide monohydrate.
Doxycycline hyclate is yellow to light yellow powder. It is freely
soluble in water and
methanol, sparingly soluble in alcohol; practically insoluble in
chloroform and in ether. It
dissolves in aqueous solution of alkali hydroxides and carbonates.
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. The structural formula is as follows:
Each film-coated tablet for oral administration contains doxycycline
hyclate equivalent to
100 mg of doxycycline (anhydrous). Inactive ingredients are: anhydrous
lactose,
croscarmellose sodium, colloidal silicon dioxide, hypromellose, iron
oxide yellow , iron
oxide red, microcrystalline cellulose, magnesium stearate,
polyethylene glycol,
pregelatinised starch and titanium dioxide.
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%/