DOXYCYCLINE HYCLATE capsule, gelatin coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Hikma Pharmaceuticals USA Inc.

INN (Mezinárodní Name):

DOXYCYCLINE HYCLATE

Složení:

DOXYCYCLINE ANHYDROUS 100 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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: 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 appropriate susceptibility to the drug: Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections: In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy. Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains (See DOSAGE AND ADMINISTRATION section and Information for Patients subsection of the PRECAUTIONS section). This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

Přehled produktů:

Doxycycline Hyclate Capsules, USP equivalent to 50 mg doxycycline: No. 2 Blue/White Opaque Hard Gelatin Capsule Printed “West-ward 3141” in Black Ink. NDC 0143-3141-50: Bottle of 50 Capsules NDC 0143-3141-05: Bottle of 500 Capsules 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 0143-3142-50: Bottle of 50 Capsules NDC 0143-3142-05: Bottle of 500 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.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED
HIKMA PHARMACEUTICALS USA INC.
----------
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
22
24
2
8
2
5
2
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 biologically active form. Doxycycline is
virtually completely
absorbed