CIPROFLOXACIN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

STAT RX USA LLC

INN (International Name):

CIPROFLOXACIN HYDROCHLORIDE

Composition:

CIPROFLOXACIN HYDROCHLORIDE 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Product summary:

Ciprofloxacin Tablets are available as round biconvex white to slightly yellowish film coated tablets containing 250 mg of ciprofloxacin. The 250 mg tablet is embossed with the word "P" on one side and "250" on reverse side. The 500 mg and 750 mg tablet are available as capsule shaped, white to slightly yellowish film coated tablets with the word "P" embossed on one side and "500" or "750" on reverse side, respectively. Store below 30°C (86°F). Manufactured by: Unique Pharmaceutical Laboratories Neelam Centre, Hind Cycle Road Worli, Mumbai 400 025, India Distributed by: PACK Pharmaceuticals, LLC, Buffalo Grove, IL 60089 USA

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CIPROFLOXACIN - CIPROFLOXACIN TABLET
STAT RX USA LLC
----------
CIPROFLOXACIN TABLETS USP, 250 MG,
500 MG AND 750 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

Summary of Product characteristics

CIPROFLOXACIN - CIPROFLOXACIN TABLET
STAT RX USA LLC
----------
CIPROFLOXACIN TABLETS 250 MG, 500 MG AND 750 MG
WARNING:
Fluoroquinolones, including CIPROFLOXACIN TABLETS USP, 250 mg, 500 mg
and 750 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, 500 mg and 750 mg and other antibacterial drugs
Ciprofloxacin Tablets USP, 250
mg, 500 mg and 750 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, 500 mg and 750 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, 500 mg and 750 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.