CIPROFLOXACIN HYDROCHLORIDE- ciprofloxacin hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

CIPROFLOXACIN HYDROCHLORIDE

Composition:

CIPROFLOXACIN HYDROCHLORIDE 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CIPROFLOXACIN HYDROCHLORIDE - CIPROFLOXACIN HYDROCHLORIDE TABLET, FILM
COATED
REMEDYREPACK INC.
----------
SPL MEDGUIDE
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.
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

Summary of Product characteristics

CIPROFLOXACIN HYDROCHLORIDE - CIPROFLOXACIN HYDROCHLORIDE TABLET, FILM
COATED
REMEDYREPACK INC.
----------
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
(SeeWARNINGS).
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 C17H18FN3O3HClH2O 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. The absolute bioavailability is approximately 70%
with no substantial loss by first
pass metabolism. Ciprofloxacin maximum serum concentrations and area
under the curve are shown in
the chart for the 250 mg to 1000 mg dose range.
DOSEMAXIMUM SERUMAREA UNDER CURVE(MG)CONCENTRATION ((AUC)
(2501.24.85002.411.67504.320.210005.430.8Maximum serum concentrations
are attained 1 to 2 hours
after oral dosing. Mean concentrations 12 hours after dosing with 250,
500, or 750 mg are 0.1, 0.2, and
0.4respectively. The se