CIPROFLOXACIN- ciprofloxacin hydrochloride tablet, film coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

CIPROFLOXACIN HYDROCHLORIDE (UNII: 4BA73M5E37) (CIPROFLOXACIN - UNII:5E8K9I0O4U)

متاح من:

PD-Rx Pharmaceuticals, Inc.

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Ciprofloxacin is indicated in adult patients for treatment of skin and skin structure infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes. Ciprofloxacin is indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa. Ciprofloxacin is indicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or

ملخص المنتج:

Ciprofloxacin Tablets USP (white to off-white round tablets) containing 250 mg of Ciprofloxacin and engraved with Bottle of 6..........(NDC 72789-006-06) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

CIPROFLOXACIN- ciprofloxacin hydrochloride tablet, film coated
PD-Rx Pharmaceuticals, Inc.
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Medication Guide
CIPROFLOXACIN TABLETS
(Sip roe flox a sin)
for oral use
Read this Medication Guide before you start taking Ciprofloxacin and
each time you get a refill. There may
be new information. This information 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
Ciprofloxacin?
Ciprofloxacin, a fluoroquinolone antibacterial medicine, can cause
serious side effects. Some of these serious
side effects could result in death.
If you get any of the following serious side effects while you take
Ciprofloxacin, you should stop taking
Ciprofloxacin immediately and get medical help right away.
1.
Tendon rupture or swelling of the tendon (tendinitis).
•
Tendon problems can happen in people of all ages who take
Ciprofloxacin. Tendons are tough cords
of tissue that connect muscles to bones. Symptoms of tendon problems
may 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 Ciprofloxacin 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
Ciprofloxacin.
•
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 Ciprofloxacin immediately and get medical help right away
at the first sign of
tendon pain, swelling, or inflammation.
The most common area of pain and swelling is the Achilles tendon at
the back of your ankle. This can also
happen with other tendons.
•
Tendon rupture can happen while you are taking

خصائص المنتج

CIPROFLOXACIN- CIPROFLOXACIN HYDROCHLORIDE TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CIPROFLOXACIN TABLETS,
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CIPROFLOXACIN TABLETS,
USP.
CIPROFLOXACIN TABLETS, USP (CIPROFLOXACIN HYDROCHLORIDE) TABLET FOR
ORAL USE
INITIAL U.S. APPROVAL: 1987
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON
RUPTURE,
PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION
OF MYASTHENIA GRAVIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, HAVE BEEN ASSOCIATED WITH
DISABLING AND
POTENTIALLY IRREVERSIBLE SERIOUS ADVERSE REACTIONS THAT HAVE OCCURRED
TOGETHER (5.1),
INCLUDING:
TENDINITIS AND TENDON RUPTURE(5.2)
PERIPHERAL NEUROPATHY (5.3)
CENTRAL NERVOUS SYSTEM EFFECTS(5.4)
DISCONTINUE CIPROFLOXACIN IMMEDIATELY AND AVOID THE USE OF
FLUOROQUINOLONES,
INCLUDING CIPROFLOXACIN, IN PATIENTS WHO EXPERIENCE ANY OF THESE
SERIOUS ADVERSE
REACTIONS (5.1)
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, MAY EXACERBATE MUSCLE
WEAKNESS IN
PATIENTS WITH MYASTHENIA GRAVIS. AVOID CIPROFLOXACIN IN PATIENTS WITH
KNOWN HISTORY
OF MYASTHENIA GRAVIS. (5.5)
BECAUSE FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, HAVE BEEN
ASSOCIATED WITH
SERIOUS ADVERSE REACTIONS (5.1- 5.15), RESERVE CIPROFLOXACIN FOR USE
IN PATIENTS WHO
HAVE NO ALTERNATIVE TREATMENT OPTIONS FOR THE FOLLOWING INDICATIONS:
ACUTE EXACERBATION OF CHRONIC BRONCHITIS (1.10)
ACUTE UNCOMPLICATED CYSTITIS (1.11)
ACUTE SINUSITIS (1.12)
RECENT MAJOR CHANGES
Boxed Warning
07/2016
Indications and Usage ( 1.10, 1.11, 1.12)
07/2016
Dosage and Administration, Dosage in Adults ( 2.1)
07/2016
Warnings and Precautions ( 5.1)
07/2016
INDICATIONS AND USAGE
Ciprofloxacin Tablets 250 mg, 500 mg, and 750 mg are a fluoroquinolone
antibacterial indicated in adults
(≥18 years of age) with the following infections caused by
designated, susceptible bacteria