DOXYCYCLINE HYCLATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Viona Pharmaceuticals Inc

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 trachomati

Product summary:

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 72578-001-18 in bottle of 50 tablets with child-resistant closure NDC 72578-001-01 in bottle of 100 tablets NDC 72578-001-05 in bottle of 500 tablets NDC 72578-001-10 in bottle of 1000 tablets NDC 72578-001-77 in cartons of 100 tablets (10 x 10 unit-dose) Storage: Store at 20°C to 25°C (68°F 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET
VIONA PHARMACEUTICALS INC
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DOXYCYCLINE HYCLATE TABLETS, USP
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 for doxycyclin 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 h