DOXYCYCLINE HYCLATE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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. Treatment: 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

Product summary:

HOW SUPPLIED: Doxycycline hyclate capsules and tablets are available as follows: a. Capsule-equivalent to 50 mg doxycycline (No. 2 opaque white and light blue capsule) in: Bottles of 10 capsules NDC 71205-653-10 imprinted Mutual 100 Bottles of 14 capsules Bottles of 20 capsules Bottles of 30 capsules Bottles of 60 capsules Bottles of 90 capsules NDC 71205-653-14 NDC 71205-653-20 NDC 71205-653-30 NDC 71205-653-60 NDC 71205-653-90 imprinted Mutual 100 imprinted Mutual 100 imprinted Mutual 100 imprinted Mutual 100 imprinted Mutual 100 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER. Protect from Light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE CAPSULE
PROFICIENT RX LP
----------
DOXYCYCLINE HYCLATE CAPSULES USP 50 MG AND 100 MG DOXYCYCLINE
HYCLATE TABLETS USP 100 MG
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
doxycycline hyclate and other antibacterial drugs, doxycycline hyclate
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,
and is available as doxycycline hyclate (doxycycline hydrochloride
hemiethanolate
hemihydrate) capsules and tablets for oral administration. The
chemical designation of
this light-yellow crystalline powder is
alpha-6-deoxy-5-oxytetracycline. 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.
Doxycycline hyclate has the following structural formula:
Each capsule for oral administration contains doxycycline hyclate
equivalent to 50 mg or
100 mg doxycycline (anhydrous). Inactive ingredients for capsules are:
anhydrous
lactose, croscarmellose sodium, FD&C Blue #1, gelatin, magnesium
stearate,
microcrystalline cellulose, and titanium dioxide. Each tablet for oral
administration
contains doxycycline hyclate equivalent to 100 mg doxycycline.
Inactive ingredients for
tablets are: anhydrous lactose, carnauba wax, croscarmellose sodium,
D&C Yellow #10
aluminum lake, FD&C Red #40 aluminum lake, hypromellose, magnesium
stearate,
microcrystalline cellulose, polyethylene glycol, polysorbate 80, 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