DOXYCYCLINE HYCLATE capsule, gelatin coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Golden State Medical Supply

INN (International Name):

DOXYCYCLINE HYCLATE

Sammensætning:

DOXYCYCLINE ANHYDROUS 100 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Capsules and other antibacterial drugs, Doxycycline Hyclate Capsules 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

Produkt oversigt:

Doxycycline Hyclate Capsules, USP equivalent to 100 mg doxycycline: No. 0 Blue/Blue Opaque Hard Gelatin Capsule Printed “West-ward 3142” in Black Ink. NDC 60429-263-50: Bottle of 50 Capsules Store at 20° to 25°C (68° 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.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED
GOLDEN STATE MEDICAL SUPPLY
----------
DOXYCYCLINE HYCLATE CAPSULES, USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Doxycycline
Hyclate Capsules and other antibacterial drugs, Doxycycline Hyclate
Capsules should be used only to
treat or prevent infections that are proven or strongly suspected to
be caused by bacteria.
DESCRIPTION
Doxycycline Hyclate Capsules, USP are an antibacterial drug
synthetically derived from
oxytetracycline. The structural formula of doxycycline hyclate is:
with a molecular formula of C
H
N
O
•HCL•1/2C
N
OH•1/2H
O and a molecular weight of
512.93.
The chemical designation for doxycycline is 2-Naphthacemecarboxamide,
4-(dimethylamino)-1, 4, 4a,
5, 5a, 6, -11, 12a-octahydro-3,5,10, 12, 12a-pentahydroxy-6-mothyl-1,
11-dioxo-monohydrochloride,
compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα,
6α, 12aα)].
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.
Each capsule for oral administration contains doxycycline hyclate
equivalent to 50 mg or 100 mg of
doxycycline (anhydrous). Inactive ingredients: lactose monohydrate,
microcrystalline cellulose,
magnesium stearate.
The 50 mg and 100 mg capsule shells contain: gelatin, FD&C Blue #1 and
titanium dioxide. The printing
ink may contain: Shellac Glaze, Iron Oxide Black, N-Butyl Alcohol,
Propylene Glycol, SD-45 Alcohol,
FD&C Blue #2, FD&C Red #40, FD&C Blue #1, D&C Yellow #10.
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
22
24
2
8
2
5
2
biologically active form. Doxycycline is virtually completely absorbed
afte