CIPROFLOXACIN 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:

Blenheim Pharmacal, Inc.

INN (International Name):

CIPROFLOXACIN HYDROCHLORIDE

Composition:

CIPROFLOXACIN 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ciprofloxacin tablets, USP 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.  Adult Patients 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 E nterococcus faecalis. Acute Uncomplicated Cystitis in F emales 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

Product summary:

Ciprofloxacin tablets, USP are available as round, white to off-white film-coated tablets containing 250 mg ciprofloxacin. The 250 mg tablet is coded with on one side and “  ” on the other side. Ciprofloxacin tablets, USP are also available as capsule shaped, white to off-white film-coated tablets containing 500 mg or 750 mg ciprofloxacin. The 500 mg tablet is coded with “CR 500 ” on one side and “  ” on the reverse side. The 750 mg tablet is coded with “CR 750” on one side and “  ” on the reverse side. Ciprofloxacin tablets, USP 250 mg, 500 mg, and 750 mg are available in the following pack types. Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
Blenheim Pharmacal, Inc.
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MEDICATION GUIDE
CIPROFLOXACIN (SIP-roe-FLOX-a-sin) 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.
1. Tendon rupture or swelling of the tendon (tendinitis)
•
Tendon problems can happen in people of all ages who take
ciprofloxacin tablets. Tendons are
tough cords of tissue that connect muscles to bones. Symptoms of
tendon problems may include:
● Pain, swelling, tears and inflammation of tendons including the
back of the ankle (Achilles),
shoulder, hand, or other tendon sites.
•
The risk of getting tendon problems while you take ciprofloxacin
tablets is higher if you:
● Are over 60 years of age
● Are taking steroids (corticosteroids)
● Have had a kidney, heart or lung transplant
•
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:
● 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 affec

Summary of Product characteristics

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
BLENHEIM PHARMACAL, INC.
----------
CIPROFLOXACIN TABLETS, USP
CIPROFLOXACIN TABLETS, USP
RX ONLY
WARNING:
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN HYDROCHLORIDE, 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 HYDROCHLORIDE, MAY
EXACERBATE MUSCLE WEAKNESS
IN PERSONS WITH MYASTHENIA GRAVIS. AVOID CIPROFLOXACIN HYDROCHLORIDE
IN PATIENTS WITH
KNOWN HISTORY OF MYASTHENIA GRAVIS (SEE WARNINGS).
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of ciprofloxacin
hydrochloride tablets and other antibacterial drugs, ciprofloxacin
hydrochloride 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 molecular
weight of 385.8. Its molecular formula
is C
H FN O ●ŸŸHClŸ●H O and its chemical structure is as follows:
Ciprofloxacin, USP is
1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-
quinolinecarboxylic acid. Its molecular 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 film-coated tablets are available in 250 mg, 500 mg and
750 mg (ciprofloxacin
equivalent) strengths. Ciprofloxacin tablets, USP are white to
off-white. The inactive ingredients are
cornstarch, microcrystalline cellulo