CIPROFLOXACIN tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Clinical Solutions Wholesale

INN (Nama Antarabangsa):

CIPROFLOXACIN HYDROCHLORIDE

Komposisi:

CIPROFLOXACIN 500 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Ciprofloxacin tablets are indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations 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 koseri (diversus), Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or vancomycin-susceptible Enterococcus faecalis. Acute Uncomplicated Cystitis

Ringkasan produk:

Ciprofloxacin Tablets USP 100 mg are white, oval shaped film-coated tablets debossed with "R" on one side and "125" on other side and supplied in a cystitis pack containing 6 tablets for use only in female patients with acute uncomplicated cystitis. Cystitis package of 6                            NDC   55111-125-06 Ciprofloxacin Tablets USP 250 mg are white, oval shaped film-coated tablets debossed with "R" on one side and "126" on other side and are supplied in bottles of 50, 100, 500 and unit dose packages of 10 × 10. Bottles of 50                                         NDC   55111-126-50 Bottles of 100                                       NDC   55111-126-01 Bottles of 500                                       NDC   55111-126-05 Unit dose package of 10 × 10            NDC   55111-126-78 Ciprofloxacin Tablets USP 500 mg are white, oval shaped film-coated tablets debossed with "R" on one side and "127" on other side and are supplied in bottles of 50, 100, 500 and unit dose packages of 10 × 10. Bottles of 50                                         NDC   55111-127-50 Bottles of 100                                       NDC   55111-127-01 Bottles of 500                                       NDC   55111-127-05 Unit dose package of 10 × 10            NDC   55111-127-78 Ciprofloxacin Tablets USP 750 mg are white, modified capsule shaped film-coated tablets debossed with "R" on one side and "128" on other side and are supplied in bottles of 50, 100, 500 and unit dose packages of 10 × 10. Bottles of 50                                         NDC   55111-128-50 Bottles of 100                                       NDC   55111-128-01 Bottles of 500                                       NDC   55111-128-05 Unit dose package of 10 × 10            NDC   55111-128-78 Store below 86°F (30°C).

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
Clinical Solutions Wholesale
----------
MEDICATION GUIDE
CIPROFLOXACIN TABLETS, USP
CIPROFLOXACIN EXTENDED-RELEASE TABLETS
Read the medication guide that comes with ciprofloxacin tablets 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 tablets?
Ciprofloxacin belongs 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)
1.
Tendon problems can happen in people of all ages who take
ciprofloxacin tablets.
1.
Tendons are tough cords of tissue that connect muscles to bones.
Symptoms of tendon
problems may include:
2.
Pain, swelling, tears, and inflammation of tendons including the back
of the ankle
(Achilles), shoulder, hand, or other tendon sites.
2.
The risk of getting tendon problems while you take ciprofloxacin
tablets is higher if you:
1.
Are over 60 years of age
2.
Are taking steroids (corticosteroids)
3.
Have had a kidney, heart, or lung transplant.
3.
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:
1.
Physical activity or exercise
2.
Kidney failure
3.
Tendon problems in the past, such as in people with rheumatoid
arthritis (RA)
4.
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 usin

Ciri produk

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
CLINICAL SOLUTIONS WHOLESALE
----------
CIPROFLOXACIN TABLETS, USP
BOXED WARNING
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).
DRUG RESISTANT BACTERIA
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 hydrochloride tablets are synthetic broad spectrum
antimicrobial agents 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 tablets are film-coated and white in color. Each tablet,
for oral administration, contains
ciprofloxacin hydrochloride equivalent to 100 mg, 250 mg, 500 mg or
750 mg ciprofloxacin. In
addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide,
hypromellose, magnesium stearate, microcrystalline cellulose,
polyethylene glycol 400, sodium starch
glycolate, corn starch and titanium dioxide.
CLINICAL PHARMACOLOGY
ABS ORPTION
Ciprofloxacin given as an oral tablet is rapidly and well absorbed
from the gastrointestinal tract after
oral administration