HIGHLIGHTS OF PRESCRIBING INFORMATION

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

CIPROFLOXACIN HYDROCHLORIDE

Sammensætning:

CIPROFLOXACIN 250 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Ciprofloxacin tablets are 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 tablets are indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa. Ciprofloxacin tablets are 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 Bacteroides fragilis. Ciprofloxacin tablets are indicated in adult patients for treatment of infectious diarrhea caused by Escherichia coli (enterotoxigenic isola

Produkt oversigt:

Ciprofloxacin Tablets USP, 250 mg are available as white to off-white, oval, biconvex, unscored, film-coated tablets, debossed “TEVA” on one side and “5311” on the other side containing ciprofloxacin hydrochloride, USP equivalent to 250 mg ciprofloxacin, packaged in bottles of 100 tablets (NDC 0172-5311-60). Ciprofloxacin Tablets USP, 500 mg are available as white to off-white, oval, biconvex, unscored, film-coated tablets, debossed “TEVA” on one side and “5312” on the other side containing ciprofloxacin hydrochloride, USP equivalent to 500 mg ciprofloxacin, packaged in bottles of 100 (NDC 0172-5312-60) and 500 (NDC 0172-5312-70) tablets. Ciprofloxacin Tablets USP, 750 mg are available as white to off-white, oval, biconvex, unscored, film-coated tablets, debossed “TEVA” on one side and “5313” on the other side containing ciprofloxacin hydrochloride, USP equivalent to 750 mg ciprofloxacin, packaged in bottles of 100 tablets (NDC 0172-5313-60). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
Teva Pharmaceuticals USA, Inc.
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MEDICATION GUIDE
CIPROFLOXACIN (SIP-roe-FLOX-a-sin)
TABLETS
for oral use
Read this Medication Guide before you start taking ciprofloxacin
tablets 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 tablets?
Ciprofloxacin tablets, a fluoroquinolone antibacterial medicine, 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 while you take
ciprofloxacin tablets, you should stop
taking ciprofloxacin tablets 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 tablets. Tendons are
tough cords of tissue that connect muscles to bones. Symptoms of
tendon problems may include:
•
Pain, swelling, tears and swelling of the tendons including the back
of the ankle (Achilles),
shoulder, hand, or other tendon sites.
•
The risk of getting tendon problems while you take ciprofloxacin
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
ciprofloxacin 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 ciprofloxacin tablets 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 c

Produktets egenskaber

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CIPROFLOXACIN TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CIPROFLOXACIN
TABLETS.
CIPROFLOXACIN TABLETS, 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 TO 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
Warnings and Precautions (5.15) 7/2017
INDICATIONS AND USAGE
Ciprofloxacin tablets are a fluoroquinolone antibacterial indicated in
adults (18 years of age and older) with the following
infections caused by designated, susceptible bacteria and in pediatric
patients where indicated:
Skin and Skin Structure Infections (1.1)
Bone and Joint Infections (1.2)
Complicated Intra-Abdominal Infections (1.3)
Infectious Diarrhea (1.4)
Typhoid Fever (Enteric