CIPROFLOXACIN tablet, film coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

RedPharm Drug, Inc.

INN (International Name):

CIPROFLOXACIN HYDROCHLORIDE

구성:

CIPROFLOXACIN 250 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis. 1.4 Infectious Diarrhea Ciproflox

제품 요약:

Ciprofloxacin Tablets USP, 250 mg are available as white to off-white, round shaped film coated tablets debossed with ‘C’ on one side and ‘95’ on the other side. Bottles of 20 NDC 65862-076-20 Bottles of 30 NDC 65862-076-30 Bottles of 100 NDC 65862-076-01 Bottles of 1,000 NDC 65862-076-99 Ciprofloxacin Tablets USP, 500 mg are available as white to off-white, capsule shaped film coated tablets debossed with ‘C’ on one side and ‘94’ on the other side. Bottles of 20 NDC 65862-077-20 Bottles of 30 NDC 65862-077-30 Bottles of 100 NDC 65862-077-01 Bottles of 500 NDC 65862-077-05 Bottles of 1,000 NDC 65862-077-99 Ciprofloxacin Tablets USP, 750 mg are available as white to off-white, capsule shaped film coated tablets debossed with ‘C’ on one side and ‘93’ on the other side. Bottles of 20 NDC 65862-078-20 Bottles of 50 NDC 65862-078-50 Bottles of 100 NDC 65862-078-01 Bottles of 500 NDC 65862-078-05 Bottles of 1,000 NDC 65862-078-98 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].

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

CIPROFLOXACIN- ciprofloxacin tablet, film coated
RedPharm Drug, Inc.
----------
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 tablets, 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

제품 특성 요약

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
REDPHARM DRUG, INC.
----------
CIPROFLOX 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 to
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)]
CLOSE
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 tablet, 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 INFORMATION FOR COMPLETE