CIPROFLOXACIN tablet, film coated

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

RedPharm Drug, Inc.

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Ciprofloxacin tablets are indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below. 1.1 Skin and Skin Structure Infections Ciprofloxacin tablets are 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. 1.2 Bone and Joint Infections Ciprofloxacin tablets are indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa. 1.3 Complicated Intra-Abdominal Infections Ciprofloxacin tablets are indicated in adult patients for treatment of complicated intra-abdominal infections (used

Резиме производа:

Ciprofloxacin Tablets USP, 100 mg are white, oval shaped film-coated tablets debossed with“R” on one side and “125” on other side and supplied in a cystitis pack containing 6 tablets foruse only in female patients with acute uncomplicated cystitis. Cystitis package of 6 NDC 55111-125-06 Ciprofloxacin Tablets USP, 250 mg are white, oval shaped film-coated tablets debossed with “R” on one side and “126” on other side and are supplied in bottles of 50, 100, 500 and unit dose packages of 10 x 10. Bottles of 50 NDC 55111-126-50 Bottles of 100 NDC 55111-126-01 Bottles of 500 NDC 55111-126-05 Unit dose package of 10 x 10 NDC 55111-126-78 Ciprofloxacin Tablets USP, 500 mg are white, oval shaped, beveled edge film-coated tablets debossed with “R” on one side and “127” on other side and are supplied in bottles of 50, 100, 500 and unit dose packages of 10 x 10. Bottles of 50 NDC 55111-127-50 Bottles of 100 NDC 55111-127-01 Bottles of 500 NDC 55111-127-05 Unit dose package of 10 x 10 NDC 55111-127-78 Ciprofloxacin Tablets USP, 750 mg are white, modified capsule shaped film-coated tabletsdebossed with “R” on one side and “128” on other side and are supplied in bottles of 50, 100,500 and unit dose packages of 10 x 10. Bottles of 50 NDC 55111-128-50 Bottles of 100 NDC 55111-128-01 Bottles of 500 NDC 55111-128-05 Unit dose package of 10 x 10 NDC 55111-128-78 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

RedPharm Drug, Inc.
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MEDICATION GUIDE
Medication Guide
Ciprofloxacin Tablets, USP for oral use
(sip'' roe flox' a sin)
Read this Medication Guide before you start taking ciprofloxacin
tablets 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 tablets?
Ciprofloxacin tablet is 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 tablets, you should stop
taking ciprofloxacin tablets 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 tablets. 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
tablets 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
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)
Stop taking ciprofloxacin tablets 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

Карактеристике производа

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
REDPHARM DRUG, INC.
----------
CIPRO 250
BOXED WARNING
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)]
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
CIPROFLOXACIN
TABLETS safely and effectively. See full prescribing information for
CIPROFLOXACIN
TABLETS.
CIPROFLOXACIN tablets, for oral use
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 IN