CIPROFLOXACIN- ciprofloxacin hydrochloride tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

RedPharm Drug, Inc.

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

Ciprofloxacin Tablets USP (white to off-white round tablets) containing 250 mg of Ciprofloxacin and engraved with Bottle of 100.............................................................................(NDC 61442-222-01) Bottle of 1,000..........................................................................(NDC 61442-222-10) Ciprofloxacin Tablets USP (white to off-white capsule-shaped tablets) containing 500 mg of ciprofloxacin and engraved with Bottle of 100.............................................................................(NDC 61442-223-01) Bottle of 500.............................................................................(NDC 61442-223-05) Ciprofloxacin Tablets USP (white to off-white capsule-shaped tablets) containing 750 mg of ciprofloxacin and engraved with Bottle of 50...............................................................................(NDC 61442-224-50) Bottle of 100.............................................................................(NDC 61442-224-01) Bottle of 400.............................................................................(NDC 61442-224-04) 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].

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

CIPROFLOXACIN- CIPROFLOXACIN HYDROCHLORIDE TABLET, FILM COATED
RedPharm Drug, Inc.
----------
Medication Guide
CIPROFLOXACIN TABLETS
(Sip roe flox a sin)
for oral use
Read this Medication Guide before you start taking Ciprofloxacin 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?
Ciprofloxacin, a fluoroquinolone antibacterial medicine, can cause
serious side effects. Some of these
serious side effects could result in death.
If you get any of the following serious side effects while you take
Ciprofloxacin, you should stop taking
Ciprofloxacin 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 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 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 happen with other tendons.
•
Tendon rupture can happen while you are taking or afte

Lastnosti izdelka

CIPROFLOXACIN- CIPROFLOXACIN HYDROCHLORIDE TABLET, FILM COATED
REDPHARM DRUG, INC.
----------
CIPROFLOXACIN 250MG
BOXED WARNING SECTION
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON
RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND
EXACERBATION OF MYASTHENIA GRAVIS
Fluoroquinolones, including Ciprofloxacin, have been associated with
disabling and potentially
irreversible serious adverse reactions that have occurred together
[see Warnings and Precautions
(5.1)] including:
Tendinitis and tendon rupture [see Warnings and Precautions (5.2)]
Peripheral neuropathy [see Warnings and Precautions (5.3)]
Central nervous system effects [see Warnings and Precautions (5.4)]
Discontinue Ciprofloxacin immediately and avoid the use of
fluoroquinolones, including
Ciprofloxacin, in patients who experience any of these serious adverse
reactions [see Warnings
and Precautions (5.1)].Fluoroquinolones, including Ciprofloxacin, may
exacerbate muscle
weakness in patients with myasthenia gravis. Avoid Ciprofloxacin in
patients with known history
of myasthenia gravis [see Warnings and Precautions (5.5)].
Because fluoroquinolones, including Ciprofloxacin, have been
associated with serious adverse
reactions [see Warnings and Precautions (5.1– 5.15)], reserve
Ciprofloxacin for use in patients
who have no alternative treatment options for the following
indications:
Acute exacerbation of chronic bronchitis [see Indications and Usage
(1.10)]
Acute uncomplicated cystitis [see Indications and Usage (1.11)]
Acute sinusitis [see Indications and Usage (1.12)]
1 INDICATIONS AND USAGE
1.1 SKIN AND SKIN STRUCTURE INFECTIONS
Ciprofloxacin 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 epidermidi