DOXYCYCLINE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Pharmaceuticals USA Inc.

INN (International Name):

DOXYCYCLINE

Composition:

DOXYCYCLINE ANHYDROUS 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline tablets and other antibacterial drugs, doxycycline 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 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 not always eliminat

Product summary:

Doxycycline Tablets USP, 50 mg contains doxycycline monohydrate equivalent to 50 mg of doxycycline. Doxycycline Tablets USP, 50 mg are off-white to pale yellow colored, round, biconvex, beveled edged film coated tablets debossed with "1121" on one side and plain on other side and are supplied as follows: NDC 70710-1121-1 in bottle of 100 tablets with child-resistant closure Doxycycline Tablets USP, 75 mg contains doxycycline monohydrate equivalent to 75 mg of doxycycline. Doxycycline Tablets USP, 75 mg are light orange to creamish orange colored, round, biconvex, beveled edged film coated tablets debossed with "1122" on one side and plain on other side and are supplied as follows: NDC 70710-1122-1 in bottle of 100 tablets with child-resistant closure Doxycycline Tablets USP, 100 mg contains doxycycline monohydrate equivalent to 100 mg of doxycycline. Doxycycline Tablets USP, 100 mg are lemon yellow to buff colored, round, biconvex, beveled edged film coated tablets debossed with "1123" on one side and plain on other side and are supplied as follows: NDC 70710-1123-7 in bottle of 50 tablets with child-resistant closure NDC 70710-1123-8 in bottle of 250 tablets Doxycycline Tablets USP, 150 mg contains doxycycline monohydrate equivalent to 150 mg of doxycycline. Doxycycline Tablets USP, 150 mg are dark orange to creamish orange colored, round, biconvex, beveled edged film coated tablets debossed with scoreline on one side and debossed "1124" on other side and are supplied as follows: NDC 70710-1124-3 in bottle of 30 tablets with child-resistant closure NDC 70710-1124-1 in bottle of 100 tablets Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. DISPENSE IN A TIGHT LIGHT RESISTANT CONTAINER AS DEFINED IN THE USP/NF.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXYCYCLINE- DOXYCYCLINE TABLET, FILM COATED
ZYDUS PHARMACEUTICALS USA INC.
----------
DOXYCYCLINE TABLETS, USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
doxycycline tablets and other antibacterial drugs, doxycycline tablets
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 tablets USP, 50 mg, 75 mg, 100 mg and 150 mg contain
doxycycline
monohydrate equivalent to 50 mg, 75 mg, 100 mg or 150 mg of
doxycycline, USP for
oral administration.
Doxycycline, USP is light yellow to pale yellow powder, very slightly
soluble in alcohol and
water; practically insoluble in ether. It dissolves in dilute
solutions of mineral acids and in
solutions of alkali hydroxides and carbonates. Its molecular weight is
462.45. The
chemical designation of doxycycline is
alpha-6-deoxy-5-oxytetracycline.
Structural formula:
IMAGE
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.
Inactive ingredients are as follows: colloidal silicon dioxide,
crospovidone, hydroxyl
propyl methylcellulose, magnesium stearate and microcrystalline
cellulose, titanium
dioxide.
In addition,
50 mg tablets contain: D&C yellow#10 aluminum lake, FD&C blue#2, iron
oxide yellow,
polyethylene glycol and polysorbate 80.
75 mg tablets contain: iron oxide red, iron oxide yellow, lactose
monohydrate, triethyl
citrate.
100 mg tablets contain: D&C yellow#10 aluminum lake, FD&C red#40, iron
oxide yellow,
22
24
2
8
2
polyethylene glycol, polysorbate 80.
150 mg tablets contain: D&C yellow#10 aluminum lake, iron oxide red,
iron oxide yellow,
lactose monohydrate, triethyl citrate.
The Product meets USP dissolution test - 2
CLINICAL PHARMACOLOGY
Tetracyclines are readily absorbed and are bound to plas