CIPROFLOXACIN tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

ciprofloxacin hydrochloride (UNII: 4BA73M5E37) (ciprofloxacin - UNII:5E8K9I0O4U)

Tilgjengelig fra:

Proficient Rx LP

INN (International Name):

ciprofloxacin hydrochloride

Sammensetning:

ciprofloxacin 250 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Ciprofloxacin Tablets USP, 250 mg and 500 mg is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions and patient populations listed below. Please see Error! Hyperlink reference not valid. 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, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influen

Produkt oppsummering:

Ciprofloxacin tablets USP 250 mg are available as white colored, biconvex, circular, film coated tablets, debossed ‘P’ on one side and ‘250’ on the other side containing ciprofloxacin hydrochloride, USP equivalent to 250 mg of ciprofloxacin. Ciprofloxacin tablets USP 500 mg tablet are available as white colored, biconvex, capsule shaped, film coated tablets, debossed ‘P’ on one side and ‘500’ on the other side containing ciprofloxacin hydrochloride, USP equivalent to 500 mg ciprofloxacin. Bottles of 6: Bottles of 10: Bottles of 14: Bottles of 20: Bottles of 28: Bottles of 30: Bottles of 60: Bottles of 90: Bottles of 06: Bottles of 10: Bottles of 14: Bottles of 20: Bottles of 28: Bottles of 30: Bottles of 60: Bottles of 90: 250 mg 250 mg 250 mg 250 mg 250 mg 250 mg 250 mg 250 mg 500 mg 500 mg 500 mg 500 mg 500 mg 500 mg 500 mg 500 mg NDC 63187-142-06 NDC 63187-142-10 NDC 63187-142-14 NDC 63187-142-20 NDC 63187-142-28 NDC 63187-142-30 NDC 63187-142-60 NDC 63187-142-90 NDC 63187-017-06 NDC 63187-017-10 NDC 63187-017-14 NDC 63187-017-20 NDC 63187-017-28 NDC 63187-017-30 NDC 63187-017-60 NDC 63187-017-90 P 250 P 250 P 250 P 250 P 250 P 250 P 250 P 250 P 500 P 500 P 500 P 500 P 500 P 500 P 500 P 500 Store at 20° to 25°C (68° to 77°F) Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

CIPROFLOXACIN- CIPROFLOXACIN TABLET
Proficient Rx LP
----------
CIPROFLOXACIN TABLETS USP, 250 MG AND
500 MG
Read the Medication Guide that comes with Ciprofloxacin Tablets USP
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 USP ?
Ciprofloxacin Tablets USP belongs to a class of antibiotics called
fluoroquinolones. Ciprofloxacin Tablets
USP 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 USP.
Tendon rupture or swelling of the tendon (tendinitis)
•
Tendons are tough cords of tissue that connect muscles to bones.
•
Pain, swelling, tears and inflammation of tendons including the back
of the ankle (Achilles), shoulder,
hand, or other tendon sites can happen in people of all ages who take
fluoroquinolone antibiotics,
including Ciprofloxacin Tablets USP. The risk of getting tendon
problems is higher if you:
•
are over 60 years of age
•
are taking steroids (corticosteroids)
•
have had a kidney, heart or lung transplant
•
Swelling of the tendon (tendinitis) and tendon rupture (breakage) have
also happened in patients who
take fluoroquinolones who do not have the above risk factors.
•
Other reasons for tendon ruptures 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 USP 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
swel

Preparatomtale

CIPROFLOXACIN- CIPROFLOXACIN TABLET
PROFICIENT RX LP
----------
CIPROFLOXACIN TABLETS 250 MG AND 500 MG
WARNING:
Fluoroquinolones, including CIPROFLOXACIN TABLETS USP, 250 mg and 500
mg
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).
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Ciprofloxacin Tablets USP, 250 mg and 500 mg and other antibacterial
drugs
Ciprofloxacin Tablets USP, 250 mg and 500 mg should be used only to
treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Ciprofloxacin Hydrochloride Tablets USP, 250 mg and 500 mg 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 is
1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-
quinolinecarboxylic acid. Its empirical formula is C
H
FN O and its molecular weight is
331.4. It is a faintly yellowish to light yellow crystalline substance
and its chemical
structure is as follows:
17
18
3
3
2
17
18
3
3
Ciprofloxacin Tablets USP are film-coated tablets and are available in
250 mg and 500 mg
(ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets are white
to slightly yellowish.
The inactive ingredients are pregelatinized starch, microcrystalline
cellulose, colloidal
silicon dioxide, crospovidone, magnesium stearate, hypromellose,
titanium dioxide,
polyethylene glycol and purified water.
CLINICAL PHARMACOLOGY
ABSORPTION:
Ciprofloxacin