LEVOFLOXACIN tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14)

Boleh didapati daripada:

DIRECT RX

INN (Nama Antarabangsa):

LEVOFLOXACIN

Komposisi:

LEVOFLOXACIN ANHYDROUS 250 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets 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. Levofloxacin tablets are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Levofloxacin injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form). Culture and susceptibility testing Appropriate culture and sus

Ringkasan produk:

16.1 Levofloxacin Tablets Levofloxacin Tablets, 250 mg are terra pink colored capsule shaped, biconvex film-coated tablets, debossed with ‘13’ on one side and ‘T’ on the other side.          Bottles of 50                             NDC 65862-536-50          Bottles of 1000                         NDC 65862-536-99          10 x 10 Unit-dose Tablets         NDC 65862-536-10 Levofloxacin Tablets, 500 mg are peach colored capsule shaped, biconvex film-coated tablets, debossed with ‘12’ on one side and ‘T’ on the other side.          Bottles of 50                             NDC 65862-537-50          Bottles of 1000                         NDC 65862-537-99          10 x 10 Unit-dose Tablets         NDC 65862-537-10 Levofloxacin Tablets, 750 mg are white capsule shaped, biconvex film-coated tablets, debossed with ‘11’ on one side and ‘T’ on the other side.           Bottles of 20                             NDC 65862-538-20           Bottles of 500                           NDC 65862-538-05           10 x 10 Unit-dose Tablets         NDC 65862-538-10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] in well-closed containers.

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
DIRECT RX
----------
SPL MEDGUIDE SECTION
Levofloxacin Tablets
Read this Medication Guide before you start taking levofloxacin
tablets and each time you get a refill.
There may be new information. This Medication Guide does not take the
place of talking to your
healthcare provider about your medical condition or your treatment.
What is the most important information I should know about
levofloxacin tablets?
Levofloxacin tablets, a fluoroquinolone antibiotic, can cause serious
side effects. Some of these serious
side effects could result in death.
If you have any of the following serious side effects while you take
levofloxacin tablets, get medical help
right away. Talk with your healthcare provider about whether you
should continue to take levofloxacin
tablets.
1. Tendon rupture or swelling of the tendon (tendinitis).
•
Tendon problems can happen in people of all ages who take levofloxacin
tablets. Tendons are
tough cords of tissue that connect muscles to bones.
Some tendon problems include pain, swelling, tears, and inflammation
of tendons including the back of
the ankle (Achilles), shoulder, hand, or other tendon sites.
•
The risk of getting tendon problems while you take levofloxacin
tablets are higher if you:
•
are over 60 years of age
•
are taking steroids (corticosteroids)
•
have had a kidney, heart or lung transplant.
•
Tendon problems can happen in people who do not have the above risk
factors when they take
levofloxacin tablets.
•
Other reasons that can increase your risk of tendon problems can
include:
•
physical activity or exercise
•
kidney failure
•
tendon problems in the past, such as in people with rheumatoid
arthritis (RA)
•
Call your healthcare provider right away at the first sign of tendon
pain, swelling or inflammation.
Stop taking levofloxacin tablets until tendinitis or tendon rupture
has been ruled out by your
healthcare provider. Avoid exercise and using the affected area.
The most common area of pain and swelling is the

Ciri produk

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
DIRECT RX
----------
LEVOFLOXACIN
BOXED WARNING SECTION
FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN, ARE ASSOCIATED WITH AN
INCREASED RISK OF TENDINITIS
AND TENDON RUPTURE IN ALL AGES. THIS RISK IS FURTHER INCREASED IN
OLDER PATIENTS USUALLY OVER
60 YEARS OF AGE, IN PATIENTS TAKING CORTICOSTEROID DRUGS, AND IN
PATIENTS WITH KIDNEY, HEART OR
LUNG TRANSPLANTS [SEE WARNINGS AND PRECAUTIONS (5.1)].
FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN, MAY EXACERBATE MUSCLE
WEAKNESS IN PERSONS WITH
MYASTHENIA GRAVIS. AVOID LEVOFLOXACIN IN PATIENTS WITH A KNOWN HISTORY
OF MYASTHENIA GRAVIS
[SEE WARNINGS AND PRECAUTIONS (5.2)].
INDICATIONS & USAGE SECTION
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of levofloxacin
tablets and other antibacterial drugs, levofloxacin tablets 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.
Levofloxacin tablets are indicated for the treatment of adults (≥18
years of age) with mild, moderate,
and severe infections caused by susceptible isolates of the designated
microorganisms in the conditions
listed in this section. Levofloxacin injection is indicated when
intravenous administration offers a route
of administration advantageous to the patient (e.g., patient cannot
tolerate an oral dosage form).
Culture and susceptibility testing
Appropriate culture and susceptibility tests should be performed
before treatment in order to isolate and
identify organisms causing the infection and to determine their
susceptibility to levofloxacin [see
Microbiology (12.4)]. Therapy with levofloxacin tablets may be
initiated before results of these tests
are known; once results become available, appropria