OFLOXACIN tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cadila Pharmaceuticals Limited

INN (International Name):

OFLOXACIN

Composition:

OFLOXACIN 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ofloxacin tablets, USP and other antibacterial drugs, ofloxacin tablets, 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. Ofloxacin tablets, USP 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 pneumonia . Because fluoroquinolones, including ofloxacin, ha

Product summary:

Ofloxacin tablets USP, 200 mg are available as light yellow to yellow, oval, biconvex, film coated tablets, imprinted with “C213” in blue ink on one side and plain on the other side. They are available in bottles of 50, 100 and 500 tablets.. Bottles of 50 (NDC 71209-097-02) Bottles of 100 (NDC 71209-097-05) Bottles of 500 (NDC 71209-097-10)    Ofloxacin tablets USP, 300 mg are available as white to off white, oval, biconvex, film coated tablets, imprinted with “C212” in blue ink on one side and plain on the other side.. They are available in bottles of 50, 100 and 500 tablets. Bottles of 50 (NDC 71209-098-02) Bottles of 100 (NDC 71209-098-05) Bottles of 500 (NDC 71209-098-10) Ofloxacin tablets USP, 400 mg are available as yellow to dark yellow, oval, biconvex, film coated tablets, imprinted with ‘C211’ in blue ink on one side and plain on other side. They are available in bottles of 50, 100 and 500 tablets. Bottles of 50 (NDC 71209-099-02) Bottles of 100 (NDC 71209-099-05) Bottles of 500 (NDC 71209-099-10) Store at 20° to 25°C (68° to 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

OFLOXACIN - OFLOXACIN TABLET, FILM COATED
Cadila Pharmaceuticals Limited
----------
MEDICATION GUIDE
MEDICATION GUIDE
Ofloxacin Tablets, USP
(oh-FLOX-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 usin

Summary of Product characteristics

OFLOXACIN - OFLOXACIN TABLET, FILM COATED
CADILA PHARMACEUTICALS LIMITED
----------
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 A 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: O ACUTE EXACERBATION OF CHRONIC BRONCHITIS O 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
M.W. 361.4
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 characteristics