CIPROFLOXACIN tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Major Pharmaceuticals

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 isol

Product summary:

Ciprofloxacin Tablets, USP are available as white medium capsule shape film-coated tablet containing 500 mg ciprofloxacin. The 500 mg tablet is engraved with “WW928” from one side and plain from the other side. Available: Bottle of 20 tablets, NDC 0904-7083-95 Cartons of 100 tablets (10 tablets per blister pack x 10), NDC 0904-7083-61 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 using a child-resistant closure.                                                                                                                       

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
Major Pharmaceuticals
----------
Medication Guide
Ciprofloxacin Tablets USP
(sip-roh-flok-suh-sin)
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, thumb, 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 can

Summary of Product characteristics

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
MAJOR PHARMACEUTICALS
----------
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._
•
O TENDINITIS AND TENDON RUPTURE (5.2)
O PERIPHERAL NEUROPATHY (5.3)
O CENTRAL NERVOUS SYSTEM EFFECTS (5.4)
DISCONTINUE CIPROFLOXACIN TABLETS IMMEDIATELY AND AVOID THE USE OF
FLUOROQUINOLONES,
INCLUDING CIPROFLOXACIN TABLETS, IN PATIENTS WHO EXPERIENCE ANY OF
THESE SERIOUS
ADVERSE REACTIONS (5.1)
•
•
O ACUTE EXACERBATION OF CHRONIC BRONCHITIS (1.10)
O ACUTE UNCOMPLICATED CYSTITIS (1.11)
O ACUTE SINUSITIS (1.12)
RECENT MAJOR CHANGES
Dosage and Administration (2.4) 5/2020
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 Fever) (1.5)
• Uncomplicated Cervical and Urethral Gonorrhea (1.6)
• Inhalational Anthrax post-exposure in adult and pediatric patients
(1.7)
• Plague in adult and pediatric patients (1.8)
• Chronic Bacterial Prostatitis (1.9)
• Lower Respiratory Tract Infections (1.10)
o Acute Exacerbation of Chronic Bronchitis
• Urinary Tract Infections (1.11)
o Urinary Tract Infections (UTI)
o Acute Uncomplicated Cystitis
o Complicated UTI and Pyelonephritis in Pediatric Patients
• Acute Sinusitis (1.12)
USAGE
To reduce the development of drug-