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:

Aphena Pharma Solutions (Formerly TestPak)

INN (Medzinárodný Name):

Doxycycline Hyclate

Zloženie:

Doxycycline Hyclate 100 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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 Chlamydia trachomatis . - Psittacosis (ornithosis) caused by Chlamydia psittaci . - Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always elimi

Prehľad produktov:

Available as a blue and white capsule with yellow powder, imprinted with company logo and 2984, containing doxycycline hyclate, equivalent to 50 mg doxycycline, packaged in bottles of 50 capsules; as a light blue capsule with yellow powder, imprinted with company logo and 2985, containing doxycycline hyclate, equivalent to 100 mg doxycycline, packaged in bottles of 50 and 500 capsules and unit dose boxes of 100 capsules; and as an orange film-coated tablet, debossed with company logo and 3626, containing doxycycline hyclate, equivalent to 100 mg doxycycline, packaged in bottles of 20, 50, 100, 200 and 500 tablets, and unit dose boxes of 100 tablets. PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP. Use child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET
APHENA PHARMA SOLUTIONS (FORMERLY TESTPAK)
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DOXYCYCLINE
DESCRIPTION
Doxycycline is a broad-spectrum antibiotic synthetically derived from
oxytetracycline. The chemical
designation of this light-yellow crystalline powder 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
monohydrochloride, compound with ethyl alcohol (2:1), monohydrate.
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 doxycycline.
Each capsule for oral administration contains doxycycline hyclate
equivalent to 50 mg or 100 mg
doxycycline. In addition, each tablet and capsule contains the
following inactive ingredients: anhydrous
lactose, colloidal silicon dioxide, magnesium stearate,
methylcellulose, microcrystalline cellulose,
polyethylene glycol, sodium starch glycolate, stearic acid, and
titanium dioxide. In addition, the 100 mg
tablet contains FD&C Yellow No. 6, FD&C Red No. 40, and hypromellose;
the 50 mg capsule contains
FD&C Blue No. 1, and D&C Yellow No. 10; the 100 mg capsule contains
FD&C Blue No. 1. The
structural formula is as follows:
(C22H24N2O8 • HCl)2 • C2H6O • H2O M.W. 1025.89
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