OFLOXACIN tablet, film coated

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

OFLOXACIN (UNII: A4P49JAZ9H) (OFLOXACIN - UNII:A4P49JAZ9H)

Disponible desde:

Larken Laboratories, Inc.

Designación común internacional (DCI):

OFLOXACIN

Composición:

OFLOXACIN 400 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ofloxacin tablets and other antibacterial drugs, ofloxacin 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. Ofloxacin tablets are indicated for the treatment of adults with mild to moderate infections (unless otherwise indicated) caused by susceptible strains of the designated microorganisms in the infections listed below. Please see DOSAGE AND ADMINISTRATION for specific recommendations. Acute Bacterial Exacerbations of Chronic Bronchitis (ABECB) due to Haemophilus influenzae or Streptococcus pneumoniae . Because fluoroquinolones, including

Resumen del producto:

Ofloxacin Tablets, USP 400 mg are white, modified capsule shaped, biconvex film coated tablets. Each tablet is distinguished by an imprint of “LL713” on one side and blank on the other side. They are available in bottles of 100 tablets (NDC 68047-713-01). Ofloxacin Tablets, USP should be stored in well-closed containers. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

OFLOXACIN- OFLOXACIN TABLET, FILM COATED
Larken Laboratories, Inc.
----------
MEDICATION GUIDE
OFLOXACIN TABLETS (oh floks' a sin)
Rx only
Read the Medication Guide that comes with ofloxacin before you start
taking it 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 ofloxacin
tablets?
Ofloxacin belongs to a class of antibiotics called fluoroquinolones.
Ofloxacin tablets can cause serious
side effects. Some of these serious side effects can happen at the
same time and could result in death. If
you get any of the following serious side effects, get medical help
right away. Talk with your healthcare
provider about whether you should continue to take ofloxacin tablets.
1. Tendon rupture or swelling of the tendon (tendinitis).
•
Tendon problems can happen in people of all ages who take ofloxacin
tablets. Tendons are tough
cords of tissue that connect muscles to bones.
•
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 ofloxacin tablets
is 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
ofloxacin 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).
•
Stop taking ofloxacin immediately and get medical help right away at
the first sign of tendon pain,
swelling or inflammation. Stop taking ofloxacin tablets until
tendinitis or tendon rupture has been
ruled out by your healthcare provider. Avoid exercise and using the
affected area. The m

Ficha técnica

OFLOXACIN- OFLOXACIN TABLET, FILM COATED
LARKEN LABORATORIES, INC.
----------
OFLOXACIN TABLETS 400 MG
RX ONLY
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON
RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS
AND EXACERBATION OF MYASTHENIA GRAVIS
FLUOROQUINOLONES, INCLUDING OFLOXACIN, HAVE BEEN ASSOCIATED WITH
DISABLING AND POTENTIALLY
IRREVERSIBLE SERIOUS ADVERSE REACTIONS THAT HAVE OCCURRED TOGETHER,
INCLUDING:
TENDINITIS AND TENDON RUPTURE
PERIPHERAL NEUROPATHY
CENTRAL NERVOUS SYSTEM EFFECTS (SEE WARNINGS)
DISCONTINUE OFLOXACIN IMMEDIATELY AND AVOID THE USE OF
FLUOROQUINOLONES, INCLUDING
OFLOXACIN, IN PATIENTS WHO EXPERIENCE ANY OF THESE SERIOUS ADVERSE
REACTIONS (SEE
WARNINGS).
FLUOROQUINOLONES, INCLUDING OFLOXACIN, MAY EXACERBATE MUSCLE WEAKNESS
IN PERSONS
WITH MYASTHENIA GRAVIS. AVOID OFLOXACIN IN PATIENTS WITH KNOWN HISTORY
OF MYASTHENIA
GRAVIS (SEE WARNINGS).
BECAUSE FLUOROQUINOLONES, INCLUDING OFLOXACIN, HAVE BEEN ASSOCIATED
WITH SERIOUS
ADVERSE REACTIONS (SEE WARNINGS), RESERVE OFLOXACIN FOR USE IN
PATIENTS WHO HAVE NO
ALTERNATIVE TREATMENT OPTIONS FOR THE FOLLOWING INDICATIONS:
ACUTE EXACERBATION OF CHRONIC BRONCHITIS
UNCOMPLICATED CYSTITIS (SEE INDICATIONS AND USAGE)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of ofloxacin tablets
and other antibacterial drugs, ofloxacin tablets should be used only
to treat or prevent infections that are
proven or strongly suspected to be caused by bacteria.
DESCRIPTION
Ofloxacin tablets are a synthetic broad-spectrum antimicrobial agent
for oral administration. Chemically,
ofloxacin,USP, a fluorinated carboxyquinolone, is the racemate,
(±)-9-fluoro-2,3-dihydro-3-methyl-10-
(4-methyl-1-piperazinyl)-7-oxo-7 _H-_pyrido[1,2,3-
_de_]-1,4-benzoxazine-6-carboxylic acid. The
chemical structure is:
C
H
FN
O
MW= 361.4
18
20
3
4
Ofloxacin, USP is an off-white to pale yellow crystalline powder. The
molecule exists as a zwitterion
at the pH conditions in the small intestine. The relative solubility
characterist