DOXYCYCLINE HYCLATE- doxycycline hyclate tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Zydus Pharmaceuticals (USA) Inc.

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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:    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 , al

Prehľad produktov:

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 68382-211-18 in bottle of 50 tablets NDC 68382-211-01 in bottle of 100 tablets NDC 68382-211-05 in bottle of 500 tablets               NDC 68382-211-10 in bottle of 1000 tablets NDC 68382-211-77 in cartons of 100 tablets (10 x 10 unit-dose) Storage: 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.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET
ZYDUS PHARMACEUTICALS (USA) INC.
----------
DOXYCYCLINE HYCLATE TABLETS
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 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%/72 hours in indiv