KETEK- telithromycin tablet, film coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

telithromycin (UNII: KI8H7H19WL) (telithromycin - UNII:KI8H7H19WL)

Tersedia dari:

Physicians Total Care, Inc.

INN (Nama Internasional):

telithromycin

Komposisi:

telithromycin 400 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

KETEK is contraindicated in patients with myasthenia gravis. Exacerbations of myasthenia gravis have been reported in patients and sometimes occurred within a few hours of the first dose of telithromycin. Reports have included fatal and life-threatening acute respiratory failure with a rapid onset and progression. KETEK is contraindicated in patients with previous history of hepatitis and/or jaundice associated with the use of KETEK tablets, or any macrolide antibiotic. KETEK is contraindicated in patients with a history of hypersensitivity to telithromycin and/or any components of KETEK tablets, or any macrolide antibiotic. Concomitant administration of KETEK with cisapride or pimozide is contraindicated. (See CLINICAL PHARMACOLOGY, Drug-drug Interactions and PRECAUTIONS .) Concomitant administration of KETEK and colchicine is contraindicated in patients with renal or hepatic impairment. (See WARNINGS, Drug Interactions and PRECAUTIONS, Drug interactions .)

Ringkasan produk:

KETEK® 400 mg tablets are supplied as light-orange, oval, film-coated tablets, imprinted "H3647" on one side and "400" on the other side. These are packaged in bottles or blister cards (Ketek Pak™ and unit dose) as follows: Ketek Pak™, 10-tablet cards (2 tablets per blister cavity)     (NDC 54868-5171-0) Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].

Status otorisasi:

New Drug Application

Selebaran informasi

Physicians Total Care, Inc.
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MEDICATION GUIDE
KETEK® (KEE tek)
(telithromycin)
Tablets
Read the Medication Guide that comes with KETEK before you start
taking it and each time you get a
new prescription. There may be new information. Talk to your doctor if
you have any questions about
KETEK. This Medication Guide does not take the place of talking with
your doctor about your medical
condition or treatment.
What is the most important information I should know about KETEK?
Do not take KETEK if you have myasthenia gravis (a rare disease which
causes muscle weakness).
Worsening of myasthenia gravis symptoms including life-threatening
breathing problems have happened
in people with myasthenia gravis after taking KETEK, in some cases
leading to death.
KETEK can cause other serious side effects, including:
1.
Severe liver damage (hepatotoxicity). Severe liver damage, in some
cases leading to a liver
transplant or death has happened in people treated with KETEK. Severe
liver damage has happened
during treatment, even after a few doses, or right after treatment
with KETEK has ended.
Stop taking KETEK and call your doctor right away if you have signs of
liver problems. Do not take
another dose of KETEK unless your doctor tells you to.
Signs of liver problems include:
•
increased tiredness
•
loss of appetite
•
nausea
•
yellowing of your skin or whites of your eyes
•
dark colored urine (tea colored)
•
light colored stools
•
right upper belly pain
•
itchy skin
Do not take KETEK if you have ever had liver problems while taking
KETEK or macrolide antibiotics.
Macrolide antibiotics include:
•
erythromycin
•
azithromycin (Zithromax®, Zmax®)
•
clarithromycin (Biaxin®)
•
dirithromycin (Dynabac®)
2.
Vision problems. KETEK may cause you to have blurred vision, trouble
focusing your eyes, and
double vision. You may especially notice vision problems if you look
quickly between objects close
to you and objects far away from you.
3.
Fainting. KETEK may cause you to faint, especially if you also have

Karakteristik produk

KETEK - TELITHROMYCIN TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
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KETEK
(TELITHROMYCIN) TABLETS
KETEK IS CONTRAINDICATED IN PATIENTS WITH MYASTHENIA GRAVIS. There
have been reports of fatal
and life-threatening respiratory failure in patients with myasthenia
gravis associated with the use
of Ketek. (See CONTRAINDICATIONS.)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of KETEK and
other antibacterial drugs, KETEK should be used only to treat
infections that are proven or strongly
suspected to be caused by bacteria.
DESCRIPTION
KETEK tablets contain telithromycin, a semisynthetic antibacterial in
the ketolide class for oral
administration. Chemically, telithromycin is designated as
Erythromycin, 3-de[(2,6-dideoxy-3-C-methyl-
3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-11,12-dideoxy-6-O-methyl-3-oxo-12,11-[oxycarbonyl[[4-[4-
(3-pyridinyl)-1H-imidazol-1-yl]butyl]imino]]-.
Telithromycin, a ketolide, differs chemically from the macrolide group
of antibacterials by the lack of
α-L-cladinose at position 3 of the erythronolide A ring, resulting in
a 3-keto function. It is further
characterized by a C11-12 carbamate substituted by an imidazolyl and
pyridyl ring through a butyl chain.
Its empirical formula is C
H N O
and its molecular weight is 812.03. Telithromycin is a white to
off-white crystalline powder. The following represents the chemical
structure of telithromycin.
KETEK tablets are available as light-orange, oval, film-coated
tablets, each containing 400 mg or 300
mg of telithromycin, and the following inactive ingredients:
croscarmellose sodium, hypromellose,
magnesium stearate, microcrystalline cellulose, polyethylene glycol,
povidone, red ferric oxide, talc,
titanium dioxide, and yellow ferric oxide.
CLINICAL PHARMACOLOGY
®
®
43
65
5
10
PHARMACOKINETICS
Absorption
Following oral administration, telithromycin reached maximal
concentration at about 1 hour (0.5 – 4
hours).
It has an absolute bioavailability of 57% in both young and elderly
subjects.
The rate a