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:

HHS/Program Support Center/Supply Service Center

INN (International Name):

CIPROFLOXACIN HYDROCHLORIDE

Composition:

CIPROFLOXACIN 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ciprofloxacin tablets 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 penicil

Product summary:

Ciprofloxacin Tablets, USP are available containing 500 mg of ciprofloxacin as the hydrochloride salt. The 500 mg tablets are white film-coated, modified capsule-shaped, unscored tablets debossed with G on one side of the tablet and CF 500 on the other side. They are available as follows: NDC 11819-363-00 bottles of 100 tablets 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. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
HHS/Program Support Center/Supply Service Center
----------
MEDICATION GUIDE
CIPROFLOXACIN TABLETS, USP
(SIP" ROE FLOX' A SIN)
Read the Medication Guide that comes with ciprofloxacin 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 tablets?
Ciprofloxacin tablets belong to a class of antibiotics called
fluoroquinolones. Ciprofloxacin 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 tablets.
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 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
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)
•
Call your healthcare provider right away at the first sign of tendon
pain, swelling or inflammation.
Stop taking ciprofloxacin tablets until tendinitis or tendon rupture
has been ruled out by your
healthcare provider. Avoid e

Summary of Product characteristics

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER
----------
WARNING
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, 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, MAY EXACERBATE MUSCLE
WEAKNESS IN PERSONS
WITH MYASTHENIA GRAVIS. AVOID CIPROFLOXACIN IN PATIENTS WITH KNOWN
HISTORY OF MYASTHENIA
GRAVIS. (SEE WARNINGS.)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of ciprofloxacin
tablets and other antibacterial drugs, ciprofloxacin 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 are 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 molecular formula
is C
H FN O ·HCl ·H O and its chemical structure is as follows:
Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg or
750 mg (ciprofloxacin equivalent)
strengths. Ciprofloxacin tablets are white. The inactive ingredients
are: colloidal silicon dioxide, corn
starch, crospovidone, hypromellose, magnesium stearate,
microcrystalline cellulose, polydextrose,
polyethylene glycol, pregelatinized starch, titanium dioxide and
triacetin.
CLINICAL PHARMACOLOGY
ABS ORPTION
Ciprofloxacin given as an oral tablet is rapidly and well absorbed
from the gastrointestinal tract after
oral administration. The absolute bioavailability is approximately 70%
with no substantial loss by first
pass metabolism. Ciprofl