CIPROFLOXACIN tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

CIPROFLOXACIN (UNII: 5E8K9I0O4U) (CIPROFLOXACIN - UNII:5E8K9I0O4U)

Disponível em:

STAT RX USA LLC

DCI (Denominação Comum Internacional):

CIPROFLOXACIN

Composição:

CIPROFLOXACIN 750 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Resumo do produto:

Ciprofloxacin Tablets USP,  are available as white, round, film-coated tablets containing 250 mg ciprofloxacin. The 250 mg tablet is coded with "WW927" on one side. Ciprofloxacin Tablets, USP area also available as white, capsule shaped, film-coated tablets containing 500 mg or 750 mg ciprofloxacin. The 500 mg tablet is coded with "WW928" on one side. The 750 mg tablet is coded with "WW929" on one side. Ciprofloxacin Tablets, USP 250 mg and 500 mg are available in bottles of 30's, 100's and 500's. Ciprofloxacin Tablets, USP 750 mg are available in bottles of 50's and 100's and Unit Dose Boxes of 100 tablets.                                                         Strength                Tablet Identification Bottles of 30's:                                    250 mg                        WW927                                                             500 mg                        WW928 Bottles of 50's:                                    750 mg                        WW929 Bottles of 100's:                                  250 mg                        WW927                                                             500 mg                        WW928                                                             750 mg                        WW929 Bottles of 500's:                                  250 mg                        WW927                                                             500 mg                        WW928 Unit Dose Boxes of 100                      250 mg                        WW927                                                             500 mg                        WW928                                                             750 mg                        WW929     Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP using a child-resistant closure.

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

CIPROFLOXACIN - CIPROFLOXACIN TABLET, FILM COATED
STAT RX USA LLC
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MEDICATION GUIDE
Ciprofloxacin Tablets, USP
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 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.
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. 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 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 Achille

Características técnicas

CIPROFLOXACIN - CIPROFLOXACIN TABLET, FILM COATED
STAT RX USA LLC
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WARNING
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN TABLETS, 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 TABLETS, MAY EXACERBATE
MUSCLE WEAKNESS IN
PERSONS WITH MYASTHENIA GRAVIS. AVOID CIPROFLOXACIN TABLETS 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 empirical
weight of 385.8. Its molecular formula
is C
H FN O •HCl•H O and its chemical structure is as follows:
Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg, and
750 mg (ciprofloxacin
equivalent) strengths. Ciprofloxacin tablets 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
ABS ORPTION
Ciprofloxacin given as an oral tablet is rapidly and well absorbed
from the gastrointestinal tract after
oral admi