CIPROFLOXACIN- ciprofloxacin hydrochloride tablet, film coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

H. J. Harkins Company Inc.

INN (International Name):

CIPROFLOXACIN HYDROCHLORIDE

구성:

CIPROFLOXACIN 750 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Ciprofloxacin is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below. 1.1 Urinary Tract Infections Ciprofloxacin is indicated in adult patients for treatment of urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter koseri, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or Enterococcus faecalis. 1.2 Acute Uncomplicated Cystitis Ciprofloxacin is indicated in adult female patients for treatment of acute uncomplicated cystitis caused by Escherichia coli or Staphylococcus saprophyticus. 1.3 Chronic Bacterial Prostatitis Ciprofloxacin is indicated in adult patients for treatment of chronic bacterial prostatitis caused by Escherichia coli or Proteus mirabilis. 1.4 Lower Respiratory Tract Infec

제품 요약:

iprofloxacin (ciprofloxacin hydrochloride) Tablets USP are available as round, biconvex white to slightly yellowish film coated tablets containing 250 mg of ciprofloxacin. The 250 mg tablet is embossed with the word “P” on one side and “250” on reverse side. Ciprofloxacin (ciprofloxacin hydrochloride) Tablets USP is also available as capsule shaped, white to slightly yellowish film coated tablets containing 500mg of ciprofloxacin. The 500 mg tablet is embossed with the word “P” on one side and “500” on reverse side. Ciprofloxacin (ciprofloxacin hydrochloride) Tablets USP is also available as capsule shaped, white to slightly yellowish film coated tablets containing 750 mg of ciprofloxacin. The 750 mg tablet is embossed with the word “P” on one side and “750” on reverse side. Strength

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

CIPROFLOXACIN- CIPROFLOXACIN HYDROCHLORIDE TABLET, FILM COATED
H. J. Harkins Company Inc.
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MEDICATION GUIDE
Medication Guide for
Ciprofloxacin Tablets USP, 250 mg, 500 mg and 750 mg
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, get medical help right
away. Talk with your healthcare provider about whether you should
continue to take ciprofloxacin.
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)
Call your healthcare provider right away at the first sign of tendon
pain, swelling or inflammation. Stop
taking ciprofloxacin until tendinitis or tendon rupture has been ruled
out by your healthcare provider.
Avoid exercise and using the affected area.
The most common area of pain and swelling is the Achilles tendon

제품 특성 요약

CIPROFLOXACIN- CIPROFLOXACIN HYDROCHLORIDE TABLET, FILM COATED
H. J. HARKINS COMPANY INC.
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BOXED WARNING
ARNING: TENDON EFFECTS AND MYASTHENIA GRAVIS
Fluoroquinolones, including ciprofloxacin, are associated with an
increased risk of tendinitis and
tendon rupture in all ages. This risk is further increased in older
patients usually over 60 years of
age, in patients taking corticosteroid drugs, and in patients with
kidney, heart, or lung transplants
[see WARNINGS AND PRECAUTIONS (5.1)].
Fluoroquinolones, including ciprofloxacin, may exacerbate muscle
weakness in persons with
myasthenia gravis. Avoid ciprofloxacin in patients with known history
of myasthenia gravis [see
WARNINGS AND PRECAUTIONS (5.2)].
INDICATIONS AND USAGE
Ciprofloxacin is indicated for the treatment of infections caused by
susceptible isolates of the
designated microorganisms in the conditions and patient populations
listed below.
1.1 Urinary Tract Infections
Ciprofloxacin is indicated in adult patients for treatment of urinary
tract infections caused by
Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae,
Serratia marcescens, Proteus mirabilis,
Providencia rettgeri, Morganella morganii, Citrobacter koseri,
Citrobacter freundii, Pseudomonas
aeruginosa, methicillin-susceptible Staphylococcus epidermidis,
Staphylococcus saprophyticus, or
Enterococcus faecalis.
1.2 Acute Uncomplicated Cystitis
Ciprofloxacin is indicated in adult female patients for treatment of
acute uncomplicated cystitis caused
by Escherichia coli or Staphylococcus saprophyticus.
1.3 Chronic Bacterial Prostatitis
Ciprofloxacin is indicated in adult patients for treatment of chronic
bacterial prostatitis caused by
Escherichia coli or Proteus mirabilis.
1.4 Lower Respiratory Tract Infections
Ciprofloxacin is indicated in adult patients for treatment of lower
respiratory tract infections caused by
Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus
mirabilis, Pseudomonas
aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or
Streptoc