DOXYCYCLINE HYCLATE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

EPIC PHARMA, LLC

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Doxycycline hyclate tablets, USP are indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis. To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture susceptibility information is 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. This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines.

Ürün özeti:

Doxycycline hyclate tablets USP, 20 mg are round, white unscored tablet, debossed “Є” above “362” on one side and plain on the other side. They are supplied as follows: NDC 42806-362-01 Bottles of 100 tablets NDC 42806-362-10 Bottles of 1000 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant containers as defined in the USP. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET
EPIC PHARMA, LLC
----------
DOXYCYCLINE HYCLATE TABLETS, USP
DESCRIPTION
Doxycycline hyclate tablets, USP are available as a 20 mg formulation
of doxycycline for
oral administration.
The structural formula of doxycycline hyclate is:
with a structural formula of (C
H
N O •HCl) •C H O•H O and a molecular weight of
1025.89. 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 monohydrochloride, compound with ethyl alcohol
(2:1),
monohydrate.
Doxycycline hyclate is a yellow to light-yellow crystalline powder
which is soluble in water.
Each tablet contains the following inactive ingredients: hypromellose,
lactose anhydrous,
magnesium stearate, microcrystalline cellulose, polyethylene glycol,
polysorbate 80 and
titanium dioxide.
Meets USP Dissolution Test 4.
CLINICAL PHARMACOLOGY
After oral administration, doxycycline hyclate is rapidly and nearly
completely absorbed
from the gastrointestinal tract. Doxycycline is eliminated with a
half-life of approximately
18 hours by renal and fecal excretion of unchanged drug.
INDICATIONS AND USAGE
22
24
2
8
2
2
6
2
Doxycycline hyclate tablets, USP are indicated for use as an adjunct
to scaling and root
planing to promote attachment level gain and to reduce pocket depth in
patients with
adult periodontitis.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
doxycycline hyclate tablets and other antibacterial drugs, doxycycline
hyclate tablets
should be used only to treat or prevent infections that are proven or
strongly suspected
to be caused by susceptible bacteria. When culture susceptibility
information is 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.
CONTRAINDICATIONS
This drug is contraindicated in persons who h