CIPROFLOXACIN tablet, film coated

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

RedPharm Drug, Inc.

INN (Alþjóðlegt nafn):

CIPROFLOXACIN HYDROCHLORIDE

Samsetning:

CIPROFLOXACIN 250 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

1.1 Skin and Skin Structure Infections Ciprofloxacin tablets, USP 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, USP 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, USP are 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.

Vörulýsing:

Ciprofloxacin tablets, USP are available as white, round, film-coated tablets containing 250 mg ciprofloxacin. The 250 mg tablet is coded with "WW927" on one side. Ciprofloxacin tablets, USP are also available as white, capsule shaped, film-coated tablets containing 500 mg or 750 mg ciprofloxacin. The 500 mg tablet is coded with "WW928" on one side. The 750 mg tablet is coded with "WW929" on one side. Ciprofloxacin tablets, USP 250 mg and 500 mg are available in bottles of 30’s, 100’s and 500’s and unit dose boxes of 100 tablets. Ciprofloxacin tablets, USP 750 mg are available in bottles of 50’s and 100’s and unit dose boxes of 100 tablets. Strength Tablet Identification NDC CODE Bottles of 30’s 250 mg 500 mg WW927 WW928 0143-9927-30 0143-9928-30 Bottles of 50’s 750 mg WW929 0143-9929-50 Bottles of 100’s 250 mg 500 mg 750 mg WW927 WW928 WW929 0143-9927-01 0143-9928-01 0143-9929-01 Bottles of 500’s 250 mg 500 mg WW927 WW928 0143-9927-05 0143-9928-05 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
RedPharm Drug, Inc.
----------
MEDICATION GUIDE
Medication Guide
Ciprofloxacin Tablets USP
(sip-roh-flok-suh-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 tablets a fluoroquinolone antibacterial medicine, can
cause serious side effects. Some of these
serious side effects could result in death.
If you should 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 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 tendo

Vara einkenni

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