CIPROFLOXACIN tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

RedPharm Drug, Inc.

INN (International Nazwa):

CIPROFLOXACIN HYDROCHLORIDE

Skład:

CIPROFLOXACIN 500 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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

Podsumowanie produktu:

Ciprofloxacin (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 NDC Code Tablet Identification Bottles of 50 250 mg 500 mg 750 mg NDC 16571-411-05 NDC 16571-412-05 NDC 16571-413-05 P 250 P 500 P 750 Bottles of 100 250 mg 500 mg 750 mg NDC 16571-411-10 NDC 16571-412-10 NDC 16571-413-10 P 250 P 500 P 750 Bottles of 500 250 mg 500 mg 750 mg NDC 16571-411-50 NDC 16571-412-50 NDC 16571-413-50 P 250 P 500 P 750 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 autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

CIPROFLOXACIN- ciprofloxacin tablet
RedPharm Drug, 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 at
the back of your ankle. This ca

Charakterystyka produktu

CIPROFLOXACIN- CIPROFLOXACIN TABLET
REDPHARM DRUG, INC.
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BOXED WARNING
WARNING: 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)].
1 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 Streptococcus pneumoniae. Also, ciprofl