CIPROFLOXACIN tablet, film coated

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Aphena Pharma Solutions - New Jersey, LLC

INN (Tarptautinis Pavadinimas):

CIPROFLOXACIN HYDROCHLORIDE

Sudėtis:

CIPROFLOXACIN 500 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 penicillin-suscept

Produkto santrauka:

Repackaged by Aphena Pharma Solutions - NJ. See Repackaging Information for available configurations. Ciprofloxacin Tablets USP, 250 mg are available as white to off-white, round shaped film coated tablets debossed with ‘C’ on one side and ‘95’ on the other side.                        Bottles of 30                             NDC 13107-076-30                      Bottles of 100                           NDC 13107-076-01                      Bottles of 1000                         NDC 13107-076-99   Ciprofloxacin Tablets USP, 500 mg are available as white to off-white, capsule shaped film coated tablets debossed with ‘C’ on one side and ‘94’ on the other side.                        Bottles of 30                             NDC 13107-077-30                      Bottles of 100                           NDC 13107-077-01                      Bottles of 1000                         NDC 13107-077-99 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

CIPROFLOXACIN - CIPROFLOXACIN TABLET, FILM COATED
Aphena Pharma Solutions - New Jersey, LLC
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MEDICATION GUIDE
Ciprofloxacin Tablets, USP
Read the Medication Guide that comes with ciprofloxacin tablets before
you start taking them 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
fluoroquinalones. 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 heathcare
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
tabletsare 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 exercise and using the affec

Prekės savybės

CIPROFLOXACIN - CIPROFLOXACIN TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC
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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 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 chemical structure is as follows:
Ciprofloxacin is
1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-
quinolinecarboxylic acid. Its molecular 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 250 mg and 500 mg
(ciprofloxacin equivalent)
strengths. Ciprofloxacin tablets are white to off-white. The inactive
ingredients are microcrystalline
cellulose, sodium starch glycolate, povidone, colloidal silicon
dioxide, magnesium stearate,
17
18
3
3
2
17
18
3
3
hypromellose, polyethylene glycol, and titanium dioxide.
CLINICAL PHAR