DOXYCYCLINE capsule

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)

Dostopno od:

Alembic Pharmaceuticals Limited

INN (mednarodno ime):

DOXYCYCLINE

Sestava:

DOXYCYCLINE ANHYDROUS 75 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline capsules, USP and other antibacterial drugs, doxycycline capsules, USP 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 Chlamydophila psittaci .   Trachoma caused by Chlamydia trachomatis , although the infectio

Povzetek izdelek:

Doxycycline capsules USP, 75  mg  are opaque brown cap/opaque white body hard gelatin capsules size “2” having imprinting “A” on cap with black ink and “241” on body with black ink filled with yellow to brown granular powder. Each  capsule  contains  doxycycline  monohydrate   equivalent  to  75   mg   doxycycline. NDC  46708-249-30    bottle  of   30  capsules NDC  46708-249-31    bottle  of   100  capsules Doxycycline  capsules USP, 100  mg  are opaque brown cap/opaque yellow body hard gelatin capsules size “1” having imprinting “A” on cap with white ink and “242” on body with brown ink filled with yellow to brown granular powder. Each  capsule  contains  doxycycline  monohydrate  equivalent  to  100  mg  doxycycline. NDC  46708-250-30    bottle  of   30  capsules NDC  46708-250-50    bottles  of   50  capsules NDC  46708-250-60    bottle  of    60  capsules NDC  46708-250-61    bottle  of   250  capsules Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a  tight  light- resistant  container  as  defined  in  the  USP/NF. 

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

DOXYCYCLINE - DOXYCYCLINE CAPSULE
ALEMBIC PHARMACEUTICALS LIMITED
----------
DOXYCYCLINE CAPSULES, USP
RX ONLY
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF DOXYCYCLINE CAPSULES, USP AND OTHER ANTIBACTERIAL
DRUGS,
DOXYCYCLINE CAPSULES, USP SHOULD BE USED ONLY TO TREAT OR PREVENT
INFECTIONS
THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE CAUSED BY BACTERIA.
DESCRIPTION
Doxycycline, USP is a broad - spectrum antibacterial synthetically
derived from
oxytetracycline. Doxycycline monohydrate capsules USP, 100 mg and 75
mg
contain doxycycline monohydrate equivalent to 100 mg and 75 mg of
doxycycline for oral administration. The chemical designation of the
light yellow
to pale yellow powder is alpha- 6- deoxy- 5- oxytetracycline.
Structural formula:
C
H
N O • H O M.W. = 462.45
Doxycycline has a high degree of lipid solubility and a low affinity
for calcium
binding. It is highly stable in normal human serum. Doxycycline will
not degrade
into an epianhydro form.
Inert ingredients: microcrystalline cellulose; sodium starch
glycolate; povidone;
colloidal silicon dioxide; magnesium stearate; and a hard gelatin
capsule which
contains iron oxide black, iron oxide red, iron oxide yellow, titanium
dioxide,
gelatin and sodium lauryl sulphate. The capsule shells of 75 mg are
printed with
edible black ink containing shellac, propylene glycol, iron oxide
black and
potassium hydroxide. The cap of 100 mg capsule shells is printed with
edible
white ink containing shellac, propylene glycol, potassium hydroxide
and titanium
dioxide. The body of 100 mg capsule shells is printed with edible and
brown
ink containing shellac, propylene glycol, potassium hydroxide, iron
oxide brown
and iron oxide black.
CLINICAL PHARMACOLOGY
Tetracyclines are readily absorbed and are bound to plasma proteins in
varying degrees. They are concentrated by the liver in the bile and
excreted in the urine and feces at high concentrations in a
biologically active form. Doxycycline is virtually completely absorbed
after oral adm