CIPROFLOXACIN HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

MedVantx, Inc.

INN (International Name):

CIPROFLOXACIN HYDROCHLORIDE

Composition:

CIPROFLOXACIN 500 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. Urinary Tract Infections caused by Escherichia coli , Klebsiella pneumoniae , Enterobactercloacae , Serratia marcescens , Proteus mirabilis , Providencia rettgeri, Morganella morganii , Citrobacter koseri(diversus) , Citrobacter freundii , Pseudomonas aeruginosa , methicillin-susceptible Staphylococcusepidermidis , Staphylococcus saprophyticus , or vancomycin-susceptible 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 influenzae, Haemo

Product summary:

Ciprofloxacin Tablets USP, 250 mg are available as white to off-white, oval, biconvex, unscored, film-coated tablets, debossed “TEVA” on one side and “5311” on the other side containing ciprofloxacin hydrochloride USP equivalent to 250 mg ciprofloxacin, packaged in bottles of 100 tablets. Ciprofloxacin Tablets USP, 500 mg are available as white to off-white, oval, biconvex, unscored, film-coated tablets, debossed “TEVA” on one side and “5312” on the other side containing ciprofloxacin hydrochloride USP equivalent to 500 mg ciprofloxacin, packaged in bottles of 100 and 500 tablets. Ciprofloxacin Tablets USP, 750 mg are available as white to off-white, oval, biconvex, unscored, film-coated tablets, debossed “TEVA” on one side and “5313” on the other side containing ciprofloxacin hydrochloride USP equivalent to 750 mg ciprofloxacin, packaged in bottles of 100 tablets. Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CIPROFLOXACIN HYDROCHLORIDE- CIPROFLOXACIN HYDROCHLORIDE TABLET
MedVantx, Inc.
----------
MEDICATION GUIDE
CIPROFLOXACIN (SIP-ROE-FLOX-A-SIN) TABLETS USP
Read the Medication Guide that comes with ciprofloxacin 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?
Ciprofloxacin belongs to a class of antibiotics called
fluoroquinolones. Ciprofloxacin 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.
1. Tendon rupture or swelling of the tendon (tendinitis)
• Tendon problems can happen in people of all ages who take
ciprofloxacin. 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
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. 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 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 Achilles
tendon at

Summary of Product characteristics

CIPROFLOXACIN HYDROCHLORIDE- CIPROFLOXACIN HYDROCHLORIDE TABLET
MEDVANTX, INC.
----------
CIPROFLOXACIN TABLETS USP
RX ONLY
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 (SEE WARNINGS).
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, MAY EXACERBATE MUSCLE
WEAKNESS IN PERSONS
WITH MYASTHENIA GRAVIS. AVOID CIPROFLOXACIN 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 USP and other antibacterial drugs, ciprofloxacin tablets USP
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 are 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 that has the
following chemical structure:
C
H FN O •HCl•H O M.W. 385.8
Each Ciprofloxacin Tablet USP, for oral administration, is available
in 250 mg, 500 mg or 750 mg
strengths. In addition, each tablet also contains the following
inactive ingredients: colloidal silicon
dioxide, hypromellose, magnesium stearate, microcrystalline cellulose,
polydextrose, polyethylene
glycol, pregelatinized starch, sodium starch glycolate, talc, titanium
dioxide and triacetin.
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
17
18
3
3
2
pass metabolis