CIPRO- ciprofloxacin hydrochloride tablet, film coated CIPRO- ciprofloxacin kit

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Bayer HealthCare Pharmaceuticals Inc.

INN (International Nazwa):

CIPROFLOXACIN HYDROCHLORIDE

Skład:

CIPROFLOXACIN 250 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

CIPRO is indicated in adult patients for treatment of skin and skin structure infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes. CIPRO is indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa. CIPRO is indicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis. CIPRO is indicated in adult patients for treatment of infectious diarrhea caused by Escherichia coli (enterotoxigenic isolates), Campylobacter jejuni, Shigella boydii † , Shigella dysenteri

Podsumowanie produktu:

CIPRO (ciprofloxacin hydrochloride) Tablets are available as round, slightly yellowish film-coated tablets containing 250 mg ciprofloxacin. The 250 mg tablet is coded with the word “BAYER” on one side and functionally scored and engraved with “CIP 250” on the reverse side. CIPRO is also available as capsule shaped, slightly yellowish film-coated tablets containing 500 mg ciprofloxacin. The 500 mg tablet is coded with the word “BAYER” on one side and functionally scored and engraved with “CIP 500” on the reverse side. CIPRO 250 mg and 500 mg are available in bottles of 100. Strength NDC Code Tablet Identification Bottles of 100: 250 mg NDC 50419-758-01 CIPRO 250 500 mg NDC 50419-754-01 CIPRO 500 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]. CIPRO Oral Suspension is supplied in 5% and 10% strengths. The drug product is composed of two components (microcapsules containing the active ingredient and diluent) which must be mixed by the pharmacist [see Dosage and Administration (2.5)]. Strengths Total volume after reconstitution Ciprofloxacin Concentration Ciprofloxacin contents per bottle NDC Code 5% 100 mL 250 mg/5 mL 5,000 mg 50419-777-01 10% 100 mL 500 mg/5 mL 10,000 mg 50419-773-01 Store microcapsules and diluent below 25°C (77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from freezing. The reconstituted product may be stored at 25°C (77°F) for 14 days; excursions are permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from freezing. A graduated teaspoon (5mL) with markings 1/2 (2.5 mL) and 1/1 (5 mL) is provided for the patient.

Status autoryzacji:

New Drug Application

Ulotka dla pacjenta

CIPRO- CIPROFLOXACIN
Bayer HealthCare Pharmaceuticals Inc.
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MEDICATION GUIDE
Medication Guide
CIPRO® (Sip-row)
(ciprofloxacin hydrochloride)
tablets, for oral use
CIPRO® (Sip-row)
(ciprofloxacin)
for oral suspension
Read this Medication Guide before you start taking CIPRO and each time
you get a refill. There may be
new information. This information 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 CIPRO?
CIPRO, a fluoroquinolone antibacterial medicine, can cause serious
side effects. Some of these serious side
effects can happen at the same time and could result in death.
If you get any of the following serious side effects while you take
CIPRO, you should stop taking CIPRO
immediately and get medical help right away.
1.
Tendon rupture or swelling of the tendon (tendinitis).
•
Tendon problems can happen in people of all ages who take CIPRO.
Tendons are tough cords of
tissue that connect muscles to bones. Symptoms of tendon problems may
include:
o
pain
o
swelling
o
tears and swelling of the tendons including the back of the ankle
(Achilles), shoulder, hand, thumb, or
other tendon sites.
•
The risk of getting tendon problems while you take CIPRO is higher if
you:
o
are over 60 years of age
o
are taking steroids (corticosteroids)
o
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
CIPRO.
•
Other reasons that can increase your risk of tendon problems can
include:
o
physical activity or exercise
o
kidney failure
o
tendon problems in the past, such as in people with rheumatoid
arthritis (RA).
•
Stop taking CIPRO immediately and get medical help right away at the
first sign of tendon pain,
swelling or inflammation. 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.
•
Tendon rupture can happen while you are taki

Charakterystyka produktu

CIPRO- CIPROFLOXACIN HYDROCHLORIDE TABLET, FILM COATED
CIPRO- CIPROFLOXACIN
BAYER HEALTHCARE PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CIPRO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CIPRO.
CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FOR ORAL USE
CIPRO (CIPROFLOXACIN), FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1987
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON
RUPTURE,
PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION
OF MYASTHENIA GRAVIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
ACUTE SINUSITIS (1.12)
INDICATIONS AND USAGE
CIPRO is a fluoroquinolone antibacterial indicated in adults (18 years
of age and older) with the following
infections caused by designated, susceptible bacteria and in pediatric
patients where indicated:
•
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®
®
FLUOROQUINOLONES, INCLUDING CIPRO , HAVE BEEN ASSOCIATED WITH
DISABLING AND
POTENTIALLY IRREVERSIBLE SERIOUS ADVERSE REACTIONS THAT HAVE OCCURRED
TOGETHER
(5.1), INCLUDING:
•
•
•
®
TENDINITIS AND TENDON RUPTURE (5.2)
PERIPHERAL NEUROPATHY (5.3)
CENTRAL NERVOUS SYSTEM EFFECTS (5.4)
DISCONTINUE CIPRO IMMEDIATELY AND AVOID THE USE OF FLUOROQUINOLONES,
INCLUDING
CIPRO, IN PATIENTS WHO EXPERIENCE ANY OF THESE SERIOUS ADVERSE
REACTIONS (5.1)
FLUOROQUINOLONES, INCLUDING CIPRO, MAY EXACERBATE MUSCLE WEAKNESS IN
PATIENTS
WITH MYASTHENIA GRAVIS. AVOID CIPRO IN PATIENTS WITH KNOWN HISTORY OF
MYASTHENIA
GRAVIS. (5.5)
BECAUSE FLUOROQUINOLONES, INCLUDING CIPRO, HAVE BEEN ASSOCIATED WITH
SERIOUS
ADVERSE REACTIONS (5.1-5.16), RESERVE CIPRO FOR USE IN PATIENTS WHO
HAVE NO
ALTERNATIVE TREATMENT OPTIONS FOR THE FOLLOWING INDICATIONS:
•
•
ACUTE EXACERBATION OF CHRONIC BRONCHITIS (1.10)
ACUTE UNCOMPLICATED CYSTITIS (1.11)
Skin and Skin Structure Infections (1.1)
Bone and Joint Infections (1.2)
Complicated Intra-Abdominal Infections (1.3)
Infectious Diarrhea (1.4)
Typhoid