CIPROFLOXACIN- ciprofloxacin tablets tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

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,

Product summary:

Ciprofloxacin tablets, USP 500 mg are available as oval shaped, white film-coated tablets, debossed with “Y102” on one side. NDC: 70518-2286-00 NDC: 70518-2286-01 NDC: 70518-2286-02 NDC: 70518-2286-03 PACKAGING: 20 in 1 BOTTLE PLASTIC PACKAGING: 14 in 1 BLISTER PACK PACKAGING: 20 in 1 BLISTER PACK PACKAGING: 30 in 1 BLISTER PACK Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Preserve in well-closed container. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CIPROFLOXACIN- ciprofloxacin tablets tablet, coated
REMEDYREPACK INC.
----------
Medication Guide
Ciprofloxacin (sip
＂
roe flox
＇
a sin) Tablets, USP
for oral use
Read this Medication Guide before you start taking ciprofloxacin
tabletsand 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 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. Th

Summary of Product characteristics

CIPROFLOXACIN- CIPROFLOXACIN TABLETS TABLET, COATED
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
CIPROFLOXACIN TABLETS
---------------
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 (5.1-5.16), 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
Dosage and Administration (2.4) 05/2020
INDICATIONS AND USAGE
Ciprofloxacin is 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-Abd