CIPROFLOXACIN - ciprofloxacin

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

CIPROFLOXACIN (UNII: 5E8K9I0O4U) (CIPROFLOXACIN - UNII:5E8K9I0O4U)

Pieejams no:

Lupin Pharmaceuticals, Inc.

SNN (starptautisko nepatentēto nosaukumu):

CIPROFLOXACIN

Kompozīcija:

CIPROFLOXACIN 250 mg in 5 mL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Ciprofloxacin for oral suspension 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. Ciprofloxacin for oral suspension is indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa. Ciprofloxacin for oral suspension 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. Ciprofloxacin for oral suspension is indicated in adult patients for treatment of infectious diarrhea caused

Produktu pārskats:

Ciprofloxacin for oral suspension is supplied in 5% and 10% strengths. The drug product is composed of two components (granular blend containing the active ingredient and diluent) which must be mixed by the pharmacist [see DOSAGE AND ADMINISTRATION (2.5)]. Store granular blend and diluent below 25°C (77°F); excursions are permitted from 15° to 30°C (59° 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° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from freezing. A twin spoon (one side 5 mL and other side 2.5 mL) is provided for the patient.

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

CIPROFLOXACIN - CIPROFLOXACIN
Lupin Pharmaceuticals, Inc.
----------
Medication Guide
CIPROFLOXACIN (SIP-roe-FLOX-a-sin)
FOR ORAL SUSPENSION
Rx only
Read this Medication Guide before you start taking ciprofloxacin for
oral suspension 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
ciprofloxacin for oral suspension?
Ciprofloxacin, 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
ciprofloxacin for oral suspension, you
should stop taking ciprofloxacin for oral suspension 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
ciprofloxacin. Tendons are tough
cords of tissue that connect muscles to bones. Symptoms of tendon
problems may include:
•
Pain, swelling, tears and swelling of the tendons including the back
of the ankle (Achilles),
shoulder, hand, or other tendon sites.
•
The risk of getting tendon problems while you take ciprofloxacin 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.
•
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)
•
Stop taking ciprofloxacin 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

Produkta apraksts

CIPROFLOXACIN - CIPROFLOXACIN
LUPIN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CIPROFLOXACIN FOR ORAL SUSPENSION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CIPROFLOXACIN FOR ORAL SUSPENSION.
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._
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, 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 CIPROFLOXACIN IMMEDIATELY AND AVOID THE USE OF
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, IN
PATIENTS WHO EXPERIENCE ANY OF THESE SERIOUS ADVERSE REACTIONS (5.1)
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, MAY EXACERBATE MUSCLE
WEAKNESS IN PATIENTS WITH
MYASTHENIA GRAVIS. AVOID CIPROFLOXACIN IN PATIENTS WITH KNOWN HISTORY
OF MYASTHENIA GRAVIS. (5.5)
BECAUSE FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, HAVE BEEN
ASSOCIATED WITH SERIOUS ADVERSE
REACTIONS (5.1 TO 5.15), RESERVE CIPROFLOXACIN 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) ° ACUTE SINUSITIS (1.12)
RECENT MAJOR CHANGES
Dosage and Administration (2.6, 2.7) 7/2017
Warnings and Precautions (5.15) 7/2017
INDICATIONS AND USAGE
Ciprofloxacin 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:
Skin and Skin Structure Infections (1.1)
Bone and Joint Infections (1.2)
Complicated Intra-Abdominal Infections (1