CIPROFLOXACIN tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Apotheca Inc.

INN (International Nazwa):

CIPROFLOXACIN HYDROCHLORIDE

Skład:

CIPROFLOXACIN 500 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Ciprofloxacin Tablets, USP are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions and people population listed below. Please see DOSAGE AND ADMINISTRATION for specific recommendations. Urinary Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter diversus, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or Enterococcus faecalis. Acute Uncomplicated Cystitis in females caused by Escherichia coli or Staphylococcus saprophyticus . Chronic Bacterial Prostatitis caused by Escherichia coli or Proteus mirabilis . Lower Respiratory Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, E

Podsumowanie produktu:

Ciprofloxacin Tablets, USP are available as white, capsule shaped, film-coated tablets containing 500 mg ciprofloxacin. The 500 mg tablet is coded with "WW928" on one side.  Bottles of 6 tablets  Bottles of 10 tablets  500 mg  500 mg  WW928  WW928 24658-250-06 24658-250-11 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.

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
Apotheca Inc.
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MEDICATION GUIDE
Ciprofloxacin Tablets, USP
Read the Medication Guide that comes with ciprofloxacin before you
start taking it and each time you get
a refill. There may be new information. This Medication Guide 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 Tablets belong to a class of antibiotics called
fluoroquinolones. Ciprofloxacin Tablets can
cause side effects that may be serious or even cause death. If you get
any of the following serious side
effects, get medical help right away. Talk with your healthcare
provider about whether you should
continue to take Ciprofloxacin Tablets.
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 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
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)
• Call your healthcare provider right away at the first sign of
tendon pain, swelling or
inflammation. Stop taking Ciprofloxacin Tablets 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

Charakterystyka produktu

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
APOTHECA INC.
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CIPROFLOXACIN TABLETS, USP
REV. 09/13
RX ONLY
WARNING
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).
Fluoroquinolones, including ciprofloxacin, may exacerbate muscle
weakness in persons with
myasthenia gravis. Avoid ciprofloxacin in patients with known history
of myasthenia gravis (see
WARNINGS ).
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of ciprofloxacin
tablets and other antibacterial drugs, ciprofloxacin tablets should be
used only to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Ciprofloxacin Tablets, USP is a synthetic broad spectrum antimicrobial
agent for oral administration.
Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the
monohydrochloride monohydrate salt of
1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic
acid. It is a faintly
yellowish to light yellow crystalline substance with a molecular
weight of 385.8. Its empirical formula
is C
H
FN
O
•HCl•H
O and its chemical structure is as follows:
Ciprofloxacin film-coated tablets are available in 500 mg
(ciprofloxacin equivalent) strengths.
Ciprofloxacin Tablets, USP are white to slightly yellowish. The
inactive ingredients are colloidal
silicon dioxide, corn starch, hydrogenated vegetable oil,
hypromellose, magnesium stearate,
microcrystalline cellulose, polyacrylate dispersion (methylacrylate
and ethylacrylate copolymer),
polyethylene glycol, purified water, simethicone emulsion, sodium
starch glycolate, talc, and titanium
dioxide.
CLINICAL PHARMACOLOGY
17
18
3
3
2
ABS ORPTION
Ciprofloxacin given as an oral tablet is rapidly and well absorbed
from the gastrointestinal tract