DOXYCYCLINE HYCLATE capsule, gelatin coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Northwind Pharmaceuticals

INN (International Nazwa):

DOXYCYCLINE HYCLATE

Skład:

DOXYCYCLINE ANHYDROUS 100 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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

Podsumowanie produktu:

Doxycycline Hyclate Capsules, USP equivalent to 50 mg doxycycline: No. 2 Blue/White Opaque Hard Gelatin Capsule Printed “West-ward 3141” in Black Ink. Bottles of 50 capsules. NDC 0143-3141-50 Bottles of 500 capsules. NDC 0143-3141-05 Doxycycline Hyclate Capsules, USP equivalent to 100 mg doxycycline: No. 0 Blue/Blue Opaque Hard Gelatin Capsule Printed “West-ward 3142” in Black Ink. Bottles of 50 capsules. NDC 0143-3142-50 Bottles of 500 capsules. NDC 0143-3142-05 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. Please review the manufacturer's complete drug information available from the FDA at www.fda.gov Permanent Link: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d9aa97a-665a-44d4-990f-3d1a54c04174

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED
NORTHWIND PHARMACEUTICALS
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DOXYCYCLINE HYCLATE
SPL UNCLASSIFIED SECTION
DOXYCYCLINE HYCLATE CAPSULES, USP
Rev. 01/17
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.
Please review the manufacturer's complete drug information available
from the FDA at www.fda.gov
Permanent Link:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d9aa97a-665a-44d4-990f-
3d1a54c04174
DESCRIPTION SECTION
Doxycycline Hyclate Capsules, USP, are an antibacterial drug
synthetically derived from
oxytetracycline. The structural formula of doxycycline monohydrate is
viewable at the permanent link
below and with a molecular formula of C22H24N2O8•H2O and a molecular
weight of 462.46. The
chemical designation for doxycycline 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
monohydrate. The
molecular formula for doxycycline hydrochloride hemiethanolate
hemihydrate is
(C22H24N2O8•HCl)2•C2H6O•H2O and the molecular weight is 1025.89.
Doxycycline is a light
yellow crystalline powder. Doxycycline hyclate is soluble in water,
while doxycycline monohydrate is
very slightly 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, diacetylated
monoglycerides, sucrose fatty acid
esters, glacial acetic acid, sodium lauryl sulfate, colloi