CIPROFLOXACIN- ciprofloxacin hydrochloride 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:

RedPharm Drug Inc.

INN (International Name):

ciprofloxacin hydrochloride

Composition:

ciprofloxacin 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ciprofloxacin tablets, USP are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions and patient populations listed below. Please see DOSAGE AND ADMINISTRATION for specific recommendations. Urinary Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter diversus, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or Enterococcus faecalis. Acute Uncomplicated Cystitis in females caused by Escherichia coli or Staphylococcus saprophyticus. Chronic Bacterial Prostatitis caused by Escherichia coli or Proteus mirabilis. Lower Respiratory Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or penicillin-sus

Product summary:

Ciprofloxacin tablets, USP are available as round, white to off-white film-coated tablets containing 250 mg ciprofloxacin. The 250 mg tablet is coded with “CR" over "250” on one side and “>” on the other side.  Store at 20°- 25°C (68°- 77°F); excursions permitted to 15°- 30°C (59°- 86°F) [see USP Controlled Room Temperature].                 

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CIPROFLOXACIN - CIPROFLOXACIN HYDROCHLORIDE TABLET, FILM COATED
RedPharm Drug Inc.
----------
MEDICATION GUIDE: CIPROFLOXACIN
TABLETS, USP
Read the Medication Guide that comes with ciprofloxacin hydrochloride
tablets 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
ciprofloxacin hydrochloride tablets?
Ciprofloxacin hydrochloride tablets belong to a class of antibiotics
called fluoroquinolones. Ciprofloxacin
hydrochloride tablets can cause side effects that may be serious or
even cause 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 ciprofloxacin hydrochloride
tablets.
Tendon rupture or swelling of the tendon (tendinitis)
•
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 can happen in people of all ages
who take fluoroquinolone
antibiotics, including ciprofloxacin hydrochloride tablets. The risk
of getting tendon problems is
higher if you:
•
are over 60 years of age
•
are taking steroids (corticosteroids)
•
have had a kidney, heart or lung transplant.
•
Swelling of the tendon (tendinitis) and tendon rupture (breakage) have
also happened in patients
who take fluoroquinolones who do not have the above risk factors.
•
Other reasons for tendon ruptures can include:
•
physical activity or exercise
•
kidney failure
•
tendon problems in the past, such as in people with rheumatoid
arthritis (RA)
•
Call your healthcare provider right away at the first sign of tendon
pain, swelling or inflammation.
Stop taking ciprofloxacin hydrochloride tablets until tendinitis or
tendon rupture has been ruled
out by your hea

Summary of Product characteristics

CIPROFLOXACIN - CIPROFLOXACIN HYDROCHLORIDE TABLET, FILM COATED
REDPHARM DRUG INC.
----------
CIPROFLOXACIN TABLETS, USP
WARNING
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN HYDROCHLORIDE, ARE
ASSOCIATED WITH AN INCREASED
RISK OF TENDINITIS AND TENDON RUPTURE IN ALL AGES. THIS RISK IS
FURTHER INCREASED IN OLDER
PATIENTS USUALLY OVER 60 YEARS OF AGE, IN PATIENTS TAKING
CORTICOSTEROID DRUGS, AND IN PATIENTS
WITH KIDNEY, HEART OR LUNG TRANSPLANTS (SEE WARNINGS).
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN HYDROCHLORIDE, MAY
EXACERBATE MUSCLE WEAKNESS
IN PERSONS WITH MYASTHENIA GRAVIS. AVOID CIPROFLOXACIN HYDROCHLORIDE
IN PATIENTS WITH
KNOWN HISTORY OF MYASTHENIA GRAVIS (SEE WARNINGS).
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of ciprofloxacin
hydrochloride tablets and other antibacterial drugs, ciprofloxacin
hydrochloride tablets should be used
only to treat or prevent infections that are proven or strongly
suspected to be caused by bacteria.
DESCRIPTION
Ciprofloxacin tablets, USP is a synthetic broad spectrum antimicrobial
agent for oral administration.
Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the
monohydrochloride monohydrate salt of
1-cyclopropyl-6-fluoro-1,
4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a
faintly
yellowish to light yellow crystalline substance with a molecular
weight of 385.8. Its empirical formula
is C
H FN O •HCl•H O and its chemical structure is as follows:
Ciprofloxacin is
1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic
acid. Its empirical formula is C
H FN O and its molecular weight is 331.4. It is a faintly yellowish
to light yellow crystalline substance and its chemical structure is as
follows:
Ciprofloxacin film-coated tablets are available in 100 mg, 250 mg, 500
mg and 750 mg (ciprofloxacin
equivalent) strengths. Ciprofloxacin tablets are white to off-white.
The inactive ingredients are
17
18
3
3
2
17
18
3
3
cornstarch, microcrystalline cellulose, silicon dioxide, crospovidone,