DOXYCYCLINE HYCLATE- doxycycline tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

DOXYCYCLINE HYCLATE

Composition:

DOXYCYCLINE ANHYDROUS 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain 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 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: Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropri

Product summary:

Doxycycline Hyclate Tablets, USP are available containing doxycycline hyclate, USP equivalent to 100 mg of doxycycline. The 100 mg tablets are beige, film-coated, round, unscored tablets debossed with MYLAN over 167 on one side of the tablet and 100 on the other side. They are available as follows: NDC 0378-0167-89 bottles of 50 tablets NDC 0378-0167-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] 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 TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
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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 is an antibacterial drug synthetically derived from
oxytetracycline, and is available as
doxycycline hyclate tablets, USP (doxycycline hydrochloride
hemiethanolate hemihydrate) for oral
administration.
The structural formula of doxycycline hyclate is:
The chemical designation for doxycycline hyclate 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. The
molecular formula for
doxycycline hydrochloride hemiethanolate hemihydrate is (C
H N O •HCl) •C H O•H O and the
molecular weight is 1025.87. Doxycycline is a light-yellow crystalline
powder. Doxycycline hyclate is
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.
Inert ingredients for the tablet formulation are: colloidal silicon
dioxide, croscarmellose sodium,
FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake,
hypromellose, magnesium
stearate, microcrystalline cellulose, polydextrose, polyethylene
glycol, sodium lauryl sulfate, titanium
dioxide and triacetin.
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