CIPROFLOXACIN tablet, coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

Ciprofloxacin (UNII: 5E8K9I0O4U) (Ciprofloxacin - UNII:5E8K9I0O4U)

Dostupné z:

Testpak Holding Company

INN (Medzinárodný Name):

Ciprofloxacin

Zloženie:

Ciprofloxacin 500 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 peni

Prehľad produktov:

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 0378-7098-01 bottles of 100 tablets NDC 0378-7098-05 bottles of 500 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.

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

Testpak Holding Company
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MEDICATION GUIDE
CIPROFLOXACIN TABLETS, USP
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?
Ciprofloxacin belongs to a class of antibiotics called
fluoroquinolones. Ciprofloxacin 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.
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. 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 until tendinitis or tendon rupture has been
ruled out by your healthcare
provider. Avoid exercise and using the affected area. The most common
area of pain and swelling
is the Achilles tendon at the back of your ankle. This can also happen
with other tendons. Talk to

Súhrn charakteristických

CIPROFLOXACIN- CIPROFLOXACIN TABLET, COATED
TESTPAK HOLDING COMPANY
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CIPROFLOXACIN 500 MG
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).
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 tablet, 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 molecular formula
is C
H FN O •HCl •H O and its chemical structure is as follows:
Ciprofloxacin film-coated tablets are available in 500 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. Ciprofloxacin maximum serum concentrations and area
under the curve are shown in
the chart for the 250 mg to 1000 mg dose range.
DOS E
(MG)
MAXIMUM
SERUM CONCENTRATION
(MCG/ML)
AREA
UNDER CURVE (AUC)
(MCG·HR/ML)
250
1.2
4.8
500
2.4