Ciprofloxacin
(250mg , 500mg )
COMPOSITION
Cipro 250mg Tablet:
Each film-coated tablet contains: Ciprofloxacin (as hydrochloride) 250mg
Cipro 500mg Tablet:
Each film-coated tablet contains Ciprofloxacin (as hydrochloride) 500mg
DESCRIPTION
Cipro (ciprofloxacin
hydrochloride) is fluorinated 4-quinolone or fluoroquinolone antibacterial with
a wider spectrum of activity than nalidixic acid and more favourable
pharmacokinetics, allowing its use in systemic infections.
MECHANISM OF ACTION
Ciprofloxacin is a
member of the fluoroquinolone class of antibacterial agents. Ciprofloxacin is
a broad-spectrum antibiotic that is active against both Gram- positive and
Gram-negative bacteria. The bactericidal action of ciprofloxacin results from
inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV
(both Type II topoisomerases), which are required for bacterial DNA
replication, transcription, repair, and recombination.
PHARMACOKINETICS
Ciprofloxacin is
readily and well absorbed from the gastrointestinal tract. Oral bioavailability
is about 70% to 80% and a peak plasma concentration of about 2.4 micrograms/mL,
occurs 1 to 2 hours after a 500 mg oral dose. Absorption of the ciprofloxacin
may be delayed by the presence of food, but is not substantially affected
overall.
The binding of
ciprofloxacin to serum proteins is 20% to 40%, which is not likely to be high
enough to cause significant protein binding interactions with other drugs.
After oral administration, ciprofloxacin is widely distributed throughout the
body. Tissue concentrations often exceed serum concentrations in both men and
women, particularly in genital tissue, including the prostate. Ciprofloxacin is
present in active form in the saliva, nasal and bronchial secretions, mucosa of
the sinuses, sputum, skin blister fluid, lymph, peritoneal fluid, bile, and
prostatic secretions. Ciprofloxacin has also been detected in the lung, skin, fat,
muscle, cartilage, and bone. The drug diffuses into the cerebrospinal fluid
(CSF); however, CSF concentrations are generally less than 10% of peak serum
concentrations. Low levels of the drug have been detected in the aqueous and
vitreous humor of the eye. Ciprofloxacin is an inhibitor of human cytochrome
P450 1A2 (CYP1A2) mediated metabolism. Co-administration of ciprofloxacin with
other drugs primarily metabolized by CYP1A2 results in increased plasma
concentrations of these drugs and could lead to clinically significant adverse
events of the co-administered drug.
The elimination
half-life is about 3 hours to 5 hours and there is evidence of modest
accumulation. Half-life may be prolonged in renal impairment (a value of 8
hours has been reported in end-stage renal disease) and to some extent in the
elderly. There is limited information on effect of hepatic impairment; the
half-life of ciprofloxacin has been reported to be slightly prolonged in
patients with severe cirrhosis of liver.
Ciprofloxacin is
eliminated principally by urinary excretion, but non renal clearance may
account for about one-third of elimination and includes hepatic metabolism,
biliary excretion, and possibly Trans-luminal secretion across the intestinal
mucosa. At least 4 active metabolites have been identified; oxociprofloxacin
appears to be the major urinary metabolites. Urinary excretion is by active
tubular secretion as well as glomerular filtration and is reduced by
probenecid: it is virtually complete within 24 hours. About 40 to 50% of an
oral dose is excreted unchanged in the urine and about 15% as of metabolites.
Up to 70% of parenteral dose may be excreted unchanged within 24 hours and 10%
as metabolites. Faecal excretion over 5 days have accounted for 20 to 35% of an
oral dose and 15% of an intravenous dose. Only small amounts of ciprofloxacin
are removed by haemodialysis or peritoneal dialysis.
MICROBIOLOGY
Ciprofloxacin has been
shown to be active against most isolates of the following bacteria, both in
vitro and in clinical infections:
Gram-positive Bacteria
Bacillus anthracis,
Enterococcus faecalis, Staphylococcus aureus (methicillin-susceptible isolates
only), Staphylococcus epidermidis (methicillin-susceptible isolates only),
Staphylococcus saprophyti-cus, Streptococcus pneumoniae, Streptococcus pyogenes
Gram-negative Bacteria
Campylobacter jejuni,
Citrobacter koseri, Citrobacter freundii, Enterobacter cloacae, Escherichia
coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella
pneumoniae, Moraxella catarrhalis, Morganella morganii, Neisseria gonorrhoeae,
Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia
stuartii, Pseudomonas aeruginosa, Salmonella typhi, Serratia marcescens,
Shigella boydii, Shigella dysenteriae, Shigella flexneri, Shigella sonnei,
Yersinia pestis.
Learn about : Common Drug Interactions and Contraindications Every Doctor Should Know.
INDICATIONS AND USAGE
It is indicated for
treatment of infections caused by susceptible isolates of the designated
microorganisms in the conditions and patient populations listed below.
Urinary Tract Infections
It is indicated in
adult patients for treatment of urinary tract infections caused by Escherichia
coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus
mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter koseri,
Citrobacter freundii, Pseudomonas aeruginosa, methicillin-sus- meth ceptible
Staphylococcus epidermidis, Staphylococcus saprophyti-cus, or Enterococcus
faecalis.
Acute Uncomplicated Cystitis
It is indicated in
adult female patients for treatment of acute uncomplicated cystitis caused by
Escherichia coli or Staphylococ-cus saprophyticus.
Chronic Bacterial Prostatitis
It is indicated in
adult patients to treat chronic bacterial prostatitis caused by
Escherichia coli or Proteus mirabilis.
Lower Respiratory Tract Infections
It is indicated in
adult patients for the treatment of lower respiratory tract infections caused by
Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus
mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus
parainfluenzae, or Streptococcus pneumoniae. It is also indicated for the
treatment of acute exacerbations of chronic bronchitis caused by Moraxella
catarrhalis.
Acute Sinusitis
It is indicated in
adult patients for treatment of acute sinusitis caused by Haemophilus
influenzae, Streptococcus pneumoniae, or Moraxella catarrhalis.
Skin and Skin Structure Infections
It is indicated in
adult patients for treatment of skin and skin structure infections caused by
Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus
mirabilis, Proteus vulgaris, Providencia stuartii, Morganella freundii,
Pseudomonas aeruginosa, methicillin-susceptibl Staphylococcus Staphylococcus
aureus, methicillin-susceptible epidermidis, or Streptococcus pyogenes.
Bone and Joint Infections
It is indicated in
adult patients for treatment of bone and joint infections caused by
Enterobacter cloacae, Serratia marcescens. or Pseudomonas aeruginosa.
Complicated Intra-abdominal Infections
It is indicated in
adult patients for treatment of complicated Intra-abdominal infections (used in
combination with metronidazole) caused by Escherichia coll. Pseudomonas
aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.
Infectious Diarrhea
It is indicated in
adult patients for treatment of infectious diarrhea caused by Escherichia coli
(enterotoxigenic isolates), Campylobacter jejuni, Shigella boydii, Shigella
dysenteriae, Shigella flexneri or Shigella sonnel when antibacterial therapy is
indicated.
Typhoid Fever (Enteric Fever)
It is indicated in
adult patients for treatment of typhoid fever (enteric fever) caused by
Salmonella typhi. The efficacy of ciprofloxacin in the eradication of the
chronic typhoid carrier state has not been demonstrated.
Uncomplicated Cervical and Urethral Gonorrhoea
It is indicated in
adult patients for treatment of uncomplicated cervical and urethral gonorrhoea
due to Neisseria gonorrhoeae.
Complicated Urinary Tract Infections and
Pyelonephritis
It is indicated in
paediatric patients 1 year to 17 years of age for treatment of complicated
urinary tract infections (CUTI) and pyelonephritis due to Escherichia coli.
Inhalational Anthrax (Post-exposure)
It is indicated in
adults and paediatric patients from birth to 17 years of age for inhalational
anthrax (post-exposure) to reduce the incidence or progression of disease
following exposure to aerosolized Bacillus anthracis.
Plague
It is indicated for
treatment of plague, including pneumonic and septicaemic plague, due to
Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and paediatric
patients from birth to 17 years of age. Ciprofloxacin should be used only to
treat or prevent infections that are proven or strongly suspected to be caused
by susceptible bacteria. If anaerobic organisms are suspected of contributing
to the infection, appropriate therapy should be administered. Appropriate
culture and susceptibility tests should be performed before treatment in order
to isolate and identify organisms causing infection and to determine their
susceptibility to ciprofloxacin. Therapy with ciprofloxacin may be initiated
before results of these tests are known; once results become available
appropriate therapy should be continued. As with other drugs, some isolates of
Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment
with ciprofloxacin. Culture and susceptibility testing performed periodically
during therapy will provide information not only on the therapeutic effect of
the antimicrobial agent but also on the possible emergence of bacterial
resistance.
Ciprofloxacin is not a
drug of first choice in the treatment of presumed or confirmed pneumonia
secondary to Streptococcus pneumoniae.
DOSAGE AND ADMINISTRATION
The determination of
dosage and duration for any particular patient must take into consideration the
severity and nature of the infection, the susceptibility of the causative
microorganism, the integrity of the patient's host-defence mechanisms, and the
status of renal and hepatic function. If a dose is missed, it should be taken
anytime but not later than 6 hours before the next scheduled dose. If less
than 6 hours remain before the next dose, the missed dose should not be taken, and treatment should be continued as prescribed with the next scheduled dose.
Double doses should not be taken to compensate for a missed dose.
Learn about: Why Ringer lactate solution should be avoided in liver disease.
Adult Dosage:
![]() |
Adult dosage of ciprofloxacin |
Dosage in Paediatric Patients:
Infection |
Dose |
Frequency |
Total Duration |
Complicated
Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age) |
10mg/kg
to 20mg/kg (maximum 750 mg per dose; not to be exceeded even in patients
weighing more than 51 kg ) |
Every
12 hours |
10
days to 21 days |
Inhalational
Anthrax (post
Exposure) |
15
mg/kg (maximum 500 mg per dose) |
Every
12 hours |
60
days |
Plague
|
15
mg/kg (maximum 500 mg per dose ) |
Every
8 to 12 hours |
14
days |
Dosage Modifications in Patients with Renal Impairment
Ciprofloxacin is
eliminated primarily by renal excretion; however, the drug is also metabolized
and partially cleared through the biliary System of the liver and through the
intestine. These alternative pathways of drug elimination appear to compensate
for the reduced renal excretion in patients with renal impairment. Nonetheless,
some modification of dosage is recommended, particularly for patients with
severe renal dysfunction. Dosage for use in patients with renal impairment are:
Find creatinine clearance using an online creatinine clearance calculator.
Recommended Starting
and Maintenance Doses for Adult Patients with Impaired Renal Function:
Creatinine
Clearance (ml/min) |
Dose |
Great
than 50 |
See usual dose |
30- 50 |
250-500mg every 12 hours |
5-29 |
250-500 mg every 18 hours |
Patients on haemodialysis or
peritoneal dialysis |
250- 500mg every 24 hours (after
dialysis) |
ADVERSE EFFECTS
The reported adverse
events of ciprofloxacin are: tendinopathy and tendon rupture, exacerbation of
Myasthenia Gravis, hepatotoxicity, QT prolongation, hypersensitivity reactions
including serious and fatal reactions, serious adverse reactions with
concomitant theophylline, clostridium difficile-associated diarrhoea, peripheral
neuropathy, musculoskeletal disorders in paediatric patients,
photosensitivity/phototoxicity, development of drug resistant bacteria,
gastrointestinal disturbances include nausea, diarrhoea, vomiting,
constipation, abdominal pain, dyspepsia, pseudomembranous colitis,
pancreatitis, abdominal distention, gastrointestinal bleeding, intestinal
perforation, dysphagia, headache, dizziness, confusion, insomnia, tremors,
drowsiness, restlessness, nightmares, lethargy, abnormal gait, agitation,
anxiety, hallucination, psychotic reactions, depressions, convulsions,
intracranial hypertension, paraesthesia, paranoia, irritability, ataxia,
anorexia, phobia, migraine, hypertonia, twitching, polyneuropathy, rash,
pruritus, skin reactions included vasculitis, erythema multiforme,
Stevens-Johsons syndrome, urticaria, fever, exfoliative dermatitis, flushing,
angioedema, erythema nodosum, exfoliative dermatitis, fixed eruption, serum
sickness like reactions, acute generalized exanthematous pustulosis, petechia,
toxic epidermal necrolysis, reversible arthralgia, joint stiffness, myoclonus,
myalgia, muscle weakness in patient with myasthenia gravis, severe exacerbation
leading to respiratory failure or death, elevated liver enzyme values jaundice,
hepatitis, tachycardia, hypotension, oedema, syncope, hot flushes, sweating,
angina pectoris, myocardial infarction, cardiopulmonary arrest, Torssade de
Points and ventricular arrhythmia. Special senses adverse effects include
blurred vision, disturbed vision, decreased visual acuity, diplopia, tinnitus,
hearing loss, bad taste, anosmia, hyperesthesia and taste loss. Renal effects
include acute renal failure, dysuria, interstitial nephritis, acute tubular
necrosis, transient increase in serum creatinine, or blood urea nitrogen, crystalluria,
dyspnoea, laryngeal oedema, haemoptysis, bronchospasm, hypoglycaemia,
hyperglycaemia, haematological disturbances including eosinophilia,
thrombocytopenia, leukopenia and very rarely pancytopenia, haemolytic anaemia,
agranulocytosis, neutropenia, prothrombin time prolongation or decrease,
cholesterol elevation and potassium elevation.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category C.
Because no adequate or well-controlled studies have been conducted in pregnant
women, ciprofloxacin should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus.
Nursing Mothers
Ciprofloxacin is
excreted in the breast milk. Because of the potential risk of serious adverse
reactions (including articular damage) in infants nursing from mothers taking
ciprofloxacin, a decision should be made whether to discontinue nursing or to
discontinue the drug, taking into account the importance of the drug to the
mother.
Paediatric Use
Ciprofloxacin is not a
drug of first choice in the paediatric population due to an increased incidence
of adverse reactions compared to the controls, including events related to
joints and/or surrounding tissues.
Geriatric Use
Geriatric patients are
at increased risk for developing severe tendon disorders including tendon
rupture when being treated with a fluoroquinolone such as ciprofloxacin. This
risk is further increased in patients receiving concomitant corticosteroid
therapy.
Tendinitis or tendon
rupture can involve the Achilles, hand, shoulder, or other tendon sites and can
occur during or after completion of therapy; cases occurring up to several
months after fluoroquinolone treatment have been reported. Caution should be
used when prescribing ciprofloxacin to elderly patients especially those on
corticosteroids. Patients should be informed of this potential side effect and
advised to discontinue ciprofloxacin and contact their healthcare provider if
any symptoms of tendinitis or tendon rupture occur.
Read about : Ketorolac Tromethamine (Toradol) for Pain Relief: How It Works & What You Need to Know.
Renal Impairment
Ciprofloxacin is eliminated
primarily by renal excretion; however, the drug is also metabolized and
partially cleared through the biliary system of the liver and through the
intestine. These alternative pathways of drug elimination appear to compensate
for the reduced renal excretion in patients with renal impairment.
Nonetheless, some
modification of dosage is recommended, particularly for patients with severe
renal dysfunction.
Hepatic Impairment
In patients with stable
chronic liver cirrhosis, no significant changes in ciprofloxacin
pharmacokinetics have been observed. The pharmacokinetics of ciprofloxacin in
patients with acute hepatic insufficiency have not been studied.
DRUG INTERACTIONS
Fluoroquinolones,
including ciprofloxacin, are known to inhibit the cytochrome P450 isoenzyme
CYP1A2 and may increase plasma concentrations of drugs, such as clozapine,
ropinirole, theophylline and tizanidine that are metabolized by this isoenzyme.
Use of fluoroquinolones with tizanidine is contraindicated (due to potentiation
of hypotensive and sedative effects of tizanidine), although theophylline may
be used provided its dose is reduced and concentrations monitored. Clozapine
or ropinirole may also be used, provided appropriate clinical surveillance
occurs with subsequent dose adjustment where necessary.
The ciprofloxacin
should be taken at least two hours before or six hours after multivitamin
cation-containing products administration. Antacids, sucralfate, multivitamins
and other products containing multivalent cations (magnesium/aluminum antacids;
polymeric phosphate binders (for example, sevelamer, lanthanum carbonate);
sucralfate; didanosine chewable/buffered tablets or paediatric powder; other
highly buffered drugs; or products containing calcium, iron, or zinc and dairy
products) decrease ciprofloxacin absorption, resulting in lower serum and urine
levels.
Quinolones, including
ciprofloxacin, have been reported to enhance the anticoagulant effects of
warfarin or its derivatives in the patient population. In addition, infectious
disease and its accompanying inflammatory process, age, and general status of
the patient are risk factors for increased anticoagulant activity. Therefore
the prothrombin time, International Normalized Ratio (INR), or other suitable
anticoagulation tests should be closely monitored if a quinolone is
administered concomitantly with warfarin or its derivatives.
Disturbances of blood glucose,
including hypoglycaemia have been reported in patients treated concomitantly
with ciprofloxacin and an antidiabetic agents mainly sulfonylurea (for example
glyburide, glimepiride). Therefore, careful monitoring of blood glucose is
recommended when these agents are co-administered. If a hypoglycaemic reaction
occurs, ciprofloxacin should be discontinued and appropriate therapy should be
initiated immediately.
Altered serum levels of
phenytoin (increased and decreased) to avoid the loss of seizure control
associated with decreased phenytoin levels and to prevent phenytoin
overdose-related adverse reactions upon ciprofloxacin discontinuation in
patients receiving both agents, monitor phenytoin therapy, including phenytoin
serum concentration during and shortly after coadministration of ciprofloxacin
with phenytoin.
Concomitant
administration of a nonsteroidal anti-inflammatory drugs (but not acetyle
salicyclic acid) with a quinolone may increase the risks of CNS stimulation and
convulsions. Fluoroquinolones also interact with opioid analgesics.
Caution should be
exercised when used with sildenafil (two-fold increase in exposure). Carefully
monitor for sildenafil toxicity.
Avoid use with
duloxetine (five-fold increase in duloxetine exposure) if unavoidable, monitor
for duloxetine toxicity.
Ciprofloxacin inhibits
the formation of paraxanthine after caffeine administration (or pentoxifylline
containing products). Carefully, monitor for xanthine toxicity and adjust dose
as necessary.
Learn about : Pentavalent Combination Vaccine: A Detailed Overview of DTwP-HepB-Hib.
WARNINGS AND PRECAUTIONS
The following
precaution and warning should be measured during ciprofloxacin treatment:
Fluoroquinolones,
including ciprofloxacin, are associated with an increased risk of tendinitis
and tendon rupture in all ages. The reported events includes the rotator cuff
(the shoulder), the hand, the biceps, the thumb, and other tendon sites. The
most frequently involves the Achilles tendon, rupture of the Achilles tendon.
The risk of developing fluoroquinolone-associated tendinitis and tendon rupture
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. Factors, in addition to age and corticosteroid use, that may
independently increase the risk of tendon rupture include strenuous physical
activity, renal failure, and previous tendon disorders such as rheumatoid
arthritis. Tendinitis and tendon rupture have also occurred in patients taking
fluoroquinolones who do not have the above risk factors. Inflammation and
tendon rupture can occur, sometimes bilaterally, even within the first 48
hours, during or after completion of therapy; cases occurring up to several
months after completion of therapy have been reported. Ciprofloxacin should be
used with caution in patients with a history of tendon disorders. Ciprofloxacin
should be discontinued if the patient experiences pain, swelling, inflammation
or rupture of a tendon.
Fluoroquinolones,
including ciprofloxacin, have neuromuscular blocking activity and may exacerbate
muscle weakness in persons with myasthenia gravis. Avoid ciprofloxacin in
patients with known history of myasthenia gravis.
Serious and
occasionally fatal hypersensitivity (anaphylactic) reactions, some following
the first dose, have been reported in patients receiving quinolone therapy,
including ciprofloxacin. Some reactions were accompanied by cardiovascular
collapse, loss of consciousness, tingling, pharyngeal or facial oedema,
dysongen urticaria, and itching. Only a few patients had a history of hypersensitivity
reaction. Ciprofloxacin should be discontinued immediately at the first
appearance of a skin rash or any other sign of hypersensitivity. Serious
anaphylactic reactions require immediate emergency treatment with epinephrine
and other resuscitation measures, including oxygen, intravenous fluids,
intravenous antihistamines, corticosteroids, pressor amines, and airway
management, including intubation, as indicated.
Other serious and
sometimes fatal events, some due to hypersensitivity, and some due to uncertain
aetiology, have been reported rarely in patients receiving therapy with
quinolones, including ciprofloxacin. These events may be severe and generally
occur following the administration of multiple doses. Clinical manifestations
may include one or more of the following:
Ø Fever,
rash, or severe dermatologic reactions (e.g., toxic apidermal necrolysis,
Stevens-Johnson Syndrome):
Ø Vasculitis;
arthralgia; myalgia; serum sickness.
Ø Allergic
pneumonitis;
Ø Interstitial
nephritis; acute renal insufficiency or failure.
Ø Hepatitis;
jaundice; acute hepatic necrosis or failure;
Ø Anaemia,
including haemolytic and aplastic;
Ø thrombocytopenia,
including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis;
pancytopenia; and/or other hematologic abnormalities.
The drug should be
discontinued immediately at the first appearance of skin rash, jaundice, or any
other sign of hypersensitivity and supportive measures instituted
Cases of severe
hepatotoxicity, including hepatic necrosis, life-threatening hepatic failure,
and fatal events, have been reported with ciprofloxacin. In the event of any
signs and symptoms of hepatitis (such as anorexia, jaundice, dark urine,
pruritus, or tender abdomen), discontinue treatment immediately. There can be a
temporary increase in transaminases, alkaline phosphatase, or cholestatic
jaundice, especially in patients with previous liver damage, who are treated
with ciprofloxacin.
Serious and fatal
reactions have been reported in patients receiving concurrent administration of
ciprofloxacin and theophylline. These reactions have included cardiac arrest,
seizure, status epilepticus, and respiratory failure. Instances of nausea,
vomiting, tremor, irritability, or palpitation have also occurred. Although
similar serious adverse reactions have been reported in patients receiving
theophylline alone, the possibility that these reactions may be potentiated by
ciprofloxacin cannot be eliminated. If concomitant use cannot be avoided,
monitor serum levels of theophylline and adjust dosage as appropriate.
Convulsions, increased
intracranial pressure (including pseudotumor cerebri), and toxic psychosis have
been reported in patients receiving fluoroquinolones, including ciprofloxacin.
Ciprofloxacin may also cause central nervous system (CNS) events. These
reactions may occur following the first dose. Advise patients receiving
ciprofloxacin to inform their healthcare provider immediately if these
reactions occur, discontinue the drug, and institute appropriate care. Ciprofloxacin,
like other fluoroquinolones, is known to trigger seizures or lower the seizure
threshold. As with all fluoroquinolones, use ciprofloxacin with caution in
epileptic patients and patients with known or suspected CNS disorders that may
predispose to seizures or lower the seizure threshold (for example, severe
cerebral arteriosclerosis, previous history of convulsion, reduced cerebral
blood flow, altered brain structure, or stroke), or in the presence of other
risk factors that may predispose to seizures or lower the seizure threshold
(for example, certain drug therapy, renal dysfunction). Use ciprofloxacin when
the benefits of treatment exceed the risks, since these patients are endangered
because of possible undesirable CNS side effects. Cases of status epilepticus
have been reported. If seizures occur, discontinue ciprofloxacin.
Clostridium difficile
(C. difficile) - associated diarrhea (CDAD) has been reported with use of
nearly all antibacterial agents, including ciprofloxacin, and may range in
severity from mild diarrhoea to fatal colitis. CDAD must be considered in all
patients who present with diarrhoea following antibacterial use. Careful
medical history is necessary since CDAD has been reported to occur over two
months after the administration of antibacterial agents. If CDAD is suspected
or confirmed, ongoing antibacterial use not directed against C. difficile may
need to be discontinued. Appropriate fluid and electrolyte management, protein
supplementation, antibacterial treatment of C. difficile, and institute
surgical evaluation as clinically indicated.
Cases of sensory or
sensorimotor axonal polyneuropathy affecting small and/or large axons resulting
in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in
patients receiving fluoroquinolones, including ciprofloxacin Symptoms may occur
soon after initiation of ciprofloxacin and may be irreversible. Discontinue
ciprofloxacin immediately if the patient experiences symptoms of peripheral
neuropathy including pain, burning, tingling, numbness, and/or weakness, or
other alterations in sensations including light touch, pain, temperature,
position sense and vibratory sensation, and/or motor strength in order to
minimize the development of an irreversible condition.
Some fluoroquinolones,
including ciprofloxacin, have been associated with prolongation of the QT
interval on the electrocardiogram and cases of arrhythmia. Avoid ciprofloxacin
in patients with known prolongation of the QT interval, risk factors for QT
prolongation or torsade de pointes (for example, congenital long QT syndrome,
uncorrected electrolyte imbalance, such as hypokalaemia or hypomagnesemia and
cardiac disease, such as heart failure, myocardial infarction, or bradycardia),
and patients receiving Class IA antiarrhythmic agents (quinidine,
procainamide), or Class III antiarrhythmic agents (amiodarone, sotalol),
tricyclic antidepressants, macrolides, and antipsychotics. Elderly patients may
also be more susceptible to drug-associated effects on the QT interval.
Does Cipro (Ciprofloxacin) make you sensitive to sunlight?
Quinolone antibiotics
may make your skin become more sensitive to sunlight or UV light. You should
avoid prolonged exposure to sunlight or strong sunlight and should not use a
sunbed or any other UV lamp while taking ciprofloxacin. Drug therapy should be
discontinued if photosensitivity/phototoxicity occurs.
Prescribing
ciprofloxacin in the absence of a proven or strongly suspected bacterial
infection or a prophylactic indication is unlikely to provide benefit to the
patient and increases the risk of the development of drug-resistant bacteria.
Crystalluria related to
ciprofloxacin has been reported only rarely in humans because human urine is
usually acidic. Avoid alkalinity of the urine in patients receiving
ciprofloxacin. Hydrate patients well to prevent the formation of highly
concentrated urine.
Ciprofloxacin has not
been shown to be effective in the treatment of syphilis. Antimicrobial agents
used in high dose for short periods of time to treat gonorrhoea may mask or
delay the symptoms of incubating syphilis. Perform a serologic test for
syphilis in all patients with gonorrhoea at the time of diagnosis. Perform
follow-up serologic test for syphilis three months after ciprofloxacin
treatment.
Concomitant
administration of ciprofloxacin with dairy products (like milk or yogurt) or
calcium-fortified juices alone should be avoided since decreased absorption is
possible; however, ciprofloxacin may be taken with a meal that contains these
products
OVERDOSAGE
In the event of acute
overdosage, reversible renal toxicity has been reported in some cases. Empty
the stomach by inducing vomiting or by gastric lavage. Observe the patient
carefully and give supportive treatment, including monitoring of renal
function, urinary pH and acidify, if required, to prevent crystalluria and
administration of magnesium, aluminium, or calcium containing antacids which
can reduce the absorption of ciprofloxacin. Adequate hydration must be
maintained. Only a small amount of ciprofloxacin (less than 10%) is removed
from the body after haemodialysis or peritoneal dialysis.
DOSAGE AND INSTRUCTIONS
To be sold and used on
the prescription of a registered medical practitioner only. Keep out of reach
of children. Do not store above 30°C. Keep in dry place. Protect from light.
F&Q
1. What is
Ciprofloxacin used for?
Ciprofloxacin is an antibiotic used to
treat bacterial infections, including:
- Urinary tract infections (UTIs)
- Respiratory infections (e.g., pneumonia)
- Skin infections
- Sinus infections
- Bone and joint infections
- Typhoid fever
- Some sexually transmitted infections
(STIs) like gonorrhea
- Not effective for viral infections
(e.g., cold, flu).
2. What
are the side effects of Ciprofloxacin?
-
Common side effects:
- Nausea, diarrhea
- Headache, dizziness
- Insomnia
- Rash
-
Serious side effects (seek medical help):
- Tendon rupture (especially in older
adults or those on steroids)
- Nerve damage (tingling, numbness,
pain)
- Mood changes (anxiety, depression,
confusion)
- Irregular heartbeat (QT
prolongation)
- Severe allergic reactions (swelling,
difficulty breathing)
3. Can Ciprofloxacin cause tendon
problems?
Yes, Ciprofloxacin (and other
fluoroquinolones) can increase the risk of tendonitis and tendon rupture,
especially in the Achilles tendon. Risk is higher in:
- People over 60
-
Those taking corticosteroids
- Kidney transplant patients
- Athletes or physically active
individuals
4. Can
I drink alcohol while taking Ciprofloxacin?
It’s not recommended because alcohol
may:
- Increase side effects (dizziness,
nausea)
- Reduce the drug’s effectiveness
- Dehydrate you, worsening side
effects
5. Does Ciprofloxacin interact with other
medications?
Yes, Ciprofloxacin can interact with:
- Antacids (Tums, Maalox), iron, calcium,
zinc → Take Ciprofloxacin 2 hours before or 6 hours after these.
- Blood thinners (warfarin) → Increased
bleeding risk.
- NSAIDs (ibuprofen, aspirin) → Higher
seizure risk.
- Steroids (prednisone) → Increased tendon
rupture risk.
- Certain heart medications (amiodarone,
sotalol) → Risk of irregular heartbeat.
6. How long does it take for Ciprofloxacin to
work?
Symptoms may improve in 1-3 days, but it’s
important to finish the full course (usually 7-14 days) to prevent antibiotic
resistance.
7. Is Ciprofloxacin safe during pregnancy or
breastfeeding?
- Pregnancy: Generally avoided (Category C
– risk to fetus).
- Breastfeeding: Small amounts pass into
breast milk; consult a doctor before use.
8. Can Ciprofloxacin cause yeast
infections?
Yes, like other antibiotics, Ciprofloxacin
can kill "good" bacteria, leading to yeast infections (vaginal or
oral thrush).
9. Does
Ciprofloxacin make you sensitive to sunlight?
Yes, it can cause photosensitivity
(increased sunburn risk). Use sunscreen and avoid excessive sun exposure.
10. Why is Ciprofloxacin a "black
box" warning drug?
The FDA warns that fluoroquinolones
(including Ciprofloxacin) can cause:
- Tendon rupture
-
Nerve damage (peripheral neuropathy)
- Mental health effects (anxiety,
depression, hallucinations)
- Worsening of myasthenia gravis (muscle
weakness disease)
11. Can Ciprofloxacin treat STDs like
gonorrhea or chlamydia?
- Gonorrhea: Sometimes used (but
resistance is increasing).
- Chlamydia: Not recommended
(azithromycin/doxycycline are preferred).
12. Can
Ciprofloxacin cause diarrhea or C. diff infection?
Yes, like other antibiotics, Ciprofloxacin can disrupt gut bacteria, leading to diarrhea or C. difficile infection (severe, watery diarrhea).
Final Advice:
- Always take Cipro as prescribed (even if you feel
better).
- Avoid dairy, calcium-fortified juices, or antacids
close to dosing time.
- Stop and call your doctor if you have tendon pain, numbness, or severe diarrhea.
0 Comments