CIPROFLOXACIN tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Ranbaxy Pharmaceuticals Inc.

INN (Διεθνής Όνομα):

CIPROFLOXACIN HYDROCHLORIDE

Σύνθεση:

CIPROFLOXACIN 250 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Ciprofloxacin tablets, USP are indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below. Please see DOSAGE AND ADMINISTRATION for specific recommendations. Adult Patients Urinary Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter koseri (diversus), Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or vancomycin-susceptible 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 influe

Περίληψη προϊόντος:

Ciprofloxacin tablets, USP 250 mg containing ciprofloxacin hydrochloride, USP equivalent to 250 mg ciprofloxacin, are available as white to off-white, round, film-coated tablets debossed with ‘RX709 ’ on one side and plain on the other side. They are supplied as: Bottles of 14s                             NDC 63304-709-14 Bottles of 100s                           NDC 63304-709-01 Bottles of 500s                           NDC 63304-709-05 (Strips of 100)                            NDC 63304-709-80 Ciprofloxacin tablets, USP 500 mg containing ciprofloxacin hydrochloride, USP equivalent to 500 mg ciprofloxacin, are available as white to off-white, caplet shaped, film-coated tablets debossed with ‘RX710’ on one side and plain on the other side. They are supplied as: Bottles of 14s                          NDC 63304-710-14 Bottles of 100s                        NDC 63304-710-01 Bottles of 500s                        NDC 63304-710-05 (Strips of 100)                         NDC 63304-710-80 Ciprofloxacin tablets, USP 750 mg containing ciprofloxacin hydrochloride, USP equivalent to 750 mg ciprofloxacin, are available as white to off-white, caplet shaped, film-coated tablets debossed with ‘RX711’ on one side and plain on the other side. They are supplied as: Bottles of 14s                          NDC 63304-711-14 Bottles of 50s                          NDC 63304-711-50 Bottles of 100s                        NDC 63304-711-01 Bottles of 500s                        NDC 63304-711-05 (Strips of 100)                         NDC 63304-711-80 Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature]. Protect from moisture.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
Ranbaxy Pharmaceuticals Inc.
----------
MEDICATION GUIDE
CIPROFLOXACIN TABLETS, USP
Rx only
Read the Medication Guide that comes with ciprofloxacin tablets, USP
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, USP?
Ciprofloxacin tablets, USP belongs to a class of antibiotics called
fluoroquinolones. Ciprofloxacin tablets,
USP 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, USP.
1.Tendon rupture or swelling of the tendon (tendinitis)
•
Tendon problems can happen in people of all ages who take
ciprofloxacin tablets, USP. 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, USP 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, USP. 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, USP until tendinitis or tendon
rupture has been ruled out by your
healthcare provide

Αρχείο Π.Χ.Π.

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
RANBAXY PHARMACEUTICALS INC.
----------
CIPROFLOXACIN TABLETS, USP
RX ONLY
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 synthetic broad spectrum antimicrobial
agents 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 molecular structure is as follows:
Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and
750 mg (ciprofloxacin
equivalent) strengths. Ciprofloxacin tablets, USP are white to
off-white. The inactive ingredients are
colloidal silicon dioxide, corn starch, hypromellose, magnesium
stearate, microcrystalline cellulose,
polyethylene glycol, sodium starch glycolate, talc and titanium
dioxide.
CLINICAL PHARMACOLOGY
ABSORPTION: 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. Cipr