DOXYCYCLINE HYCLATE capsule

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

DIRECT RX

INN (Algemene Internationale Benaming):

DOXYCYCLINE HYCLATE

Samenstelling:

DOXYCYCLINE ANHYDROUS 100 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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: - 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 a

Product samenvatting:

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 50 capsules NDC 53489-118-02 imprinted Mutual 100 Bottles of 500 capsules NDC 53489-118-05 imprinted Mutual 100 b. Capsule-equivalent to 100 mg doxycycline (No. 0 opaque light blue capsule) in: Bottles of 50 capsules NDC 53489-119-02 imprinted Mutual 105 Bottles of 500 capsules NDC 53489-119-05 imprinted Mutual 105 c. Tablet-equivalent to 100 mg doxycycline (light orange film coated tablet) in: Bottles of 50 tablets NDC 53489-120-02 debossed MP 37 Bottles of 500 tablets NDC 53489-120-05 debossed MP 37 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER. Protect from Light.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE CAPSULE
DIRECT RX
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DOXYCYCLINE HYCLATE
DESCRIPTION SECTION
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, D&C Red #28, 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 SECTION
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 hours in individuals with
normal function
(creatinine clearance about 75 mL/min.). This percentage excretion may
fall as low as 1
to 5%/72