DOXYCYCLINE capsule

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Novel Laboratories, Inc.

INN (इंटरनेशनल नाम):

DOXYCYCLINE

रचना:

DOXYCYCLINE ANHYDROUS 50 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 infectious agent is

उत्पाद समीक्षा:

Doxycycline Capsules, USP 50 mg have a yellow opaque cap and a white opaque body. The capsules are imprinted  "NL 790"  with white ink on the cap and "50 mg"  with brown ink on the body, filled with yellow to beige powder. Each capsule contains doxycycline monohydrate equivalent to 50 mg doxycycline. Doxycycline Capsules, USP 50 mg is available in:     Bottles  of  50  capsules  ............................NDC  40032-790-11     Bottles  of  100  capsules  ...........................NDC  40032-790-01    Bottles  of  1000  capsules  ..........................NDC  40032-790-10 Doxycycline Capsules, USP 75 mg have a brown opaque cap and a white opaque body. The capsules are imprinted  "NL 791"  with white ink on the cap and "75 mg"  with brown ink on the body, filled with yellow to beige powder. Each capsule contains doxycycline monohydrate equivalent to 75 mg doxycycline. Doxycycline Capsules, USP 75 mg is available in:      Bottles  of  50  capsules  ..............................NDC  40032-791-11     Bottles  of  100  capsules  .............................NDC  40032-791-01    Bottles  of  1000  capsules  ...........................NDC  40032-791-10 Doxycycline Capsules, USP 100 mg have a brown opaque cap and a yellow opaque body. The capsules are imprinted  "NL 792"  with white ink on the cap and "100 mg"  with brown ink on the body, filled with yellow to beige powder. Each capsule contains doxycycline monohydrate equivalent to 100 mg doxycycline. Doxycycline Capsules, USP 100 mg is available in:      Bottles  of  50  capsules  .............................NDC  40032-792-11     Bottles  of  250  capsules..............................NDC  40032-792-02    Bottles  of  1000  capsules  ............................NDC  40032-792-10 STORE  AT  20°  to  25°C  (68°  to  77°F).  [SEE  USP  CONTROLLED  ROOM  TEMPERATURE.] DISPENSE  IN  A  TIGHT , LIGHT-RESISTANT  CONTAINER  AS  DEFINEDIN  THE  USP/NF. PROTECT FROM LIGHT.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

DOXYCYCLINE- DOXYCYCLINE CAPSULE
NOVEL LABORATORIES, INC.
----------
DOXYCYCLINE CAPSULES, USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of doxycycline
capsules and other antibacterial drugs, doxycycline capsules should be
used only to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Doxycycline is a broad-spectrum antibacterial synthetically derived
from oxytetracycline. Doxycycline
capsules USP, 50 mg, 75 mg, and 100 mg contain doxycycline monohydrate
equivalent to 50 mg, 75 mg,
and 100 mg of doxycycline for oral administration. The chemical
designation of the light yellow to pale
yellow powder is
2-Naphthacenecarboxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-
3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-,[4_S_-(4α,4aα,5α,5aα,6α,12aα)]-,monohydrate.
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: colloidal silicon dioxide; magnesium stearate;
microcrystalline cellulose; sodium
starch glycolate; and a hard gelatin capsule which contains titanium
dioxide, FD&C Red # 3, D&C
Yellow # 10, gelatin, sodium lauryl sulfate, for the 50 mg strength;
iron oxide black, iron oxide red,
iron oxide yellow, titanium dioxide, gelatin, sodium lauryl sulfate
for the 75 mg strength and iron oxide
black, Iron Oxide Red, Iron Oxide Yellow, Titanium Dioxide, FD & C
Red# 3, D&C Yellow # 10,
gelatin, sodium lauryl sulfate for the 100 mg strength. The capsules
are printed with edible ink
containing shellac, titanium dioxide, black iron oxide, brown iron
oxide and potassium hydroxide for 50
mg, 75 mg and 100 mg strengths.
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 a