Alkem laboratories Ltd. Dev Asish Bldg,Near Mautulya Centre Senapati Bapat Marg, Lower Parel Mumbai 400013
Ciprofloxacin hcl monohydr 250mg,
List of Related Indications:
- Respiratory tract infection
- G.I.tract infections
- Skin & soft tissue infection
- Bone and joint infection
- Urinary tract infections- UTI
List Of Drugs:
- Ciprofloxacin ( *** ) - @ Fluoroquinolones- (FDC-List) (1997)
Indication Type Description:
Dosages/ Overdosage Etc
Interaction with Food
Pregnancy and lactation
Fluoroquinolones include the following :
Ciprofloxacin, Norfloxacin, Lomefloxacin, Ofloxacin, Pefloxacin, Enoxacin
Interacting drugs- Fluroquinolones -summary
Sucralfate + Quinolones
bioavailability of quinolones decreased . Administering the
quinolones > 2 hours before sucralfate may eliminate the interaction.
bioavailability of betablockers metabolised by cytochrome P-450
+ Fluoroquinolones +Antacids /Didanosine/Iron salts/Sucralfate / Zinc salts/ or + Fluoroquinolones
interference with GI absorption of the fluoroquinolones resulting in
decreased serum levels. Avoid simulataneous use. Administer
antacids 2 to 4 hours before or after the fluoroquinolones
Antineoplastic agents + Fluoroquinolones
fluoroquinolnes serum levels decreased
Azlocillin + Ciprofloxacin
clearance of ciprofloxacin is decreased possibly increasing its pharmacologic
effects. This combination beneficial for some serious gram-negative
infections, although it is not known if toxicity also increases.
Bismuth sub salicylate + Enoxacin
enoxacin bioavailability is decreased when bismuth sub salicylate is given
before or 60 minutes after enoxacin. Avoid concurrent use.
Cimetide + Fluroquinolones
cimetidine interfere with the elimination of the fluoroquinolones
Nitrofurantoin + Norfloxacin
antibacterial effect of norfloxacin inthe urinary tract antagonised
Probenecid + Fluoroquinolones
ciprofloxacin renal clearance is reduced 50% and its serum concentration
is increased 50% , diminished norfloxacin and lomefloxacin urinary excretion
Ciprofloxacin/ Enoxacin / Norfloxacin + Caffeine
total body clearance is reduced, possibly resulting in increased pharmacologic
effects. Ofloxacin and lomefloxacin do not appear to affect caffeine. Enoxacin
plasm levels were also 20% higher.
Ciprofloxacin / Norfloxacin + Cyclosporine
the nephrotoxic effect of cyclosporine increased
Enoxacin + Digoxin
digoxin serum levels increased . Monitor digoxin levels.
Ciprofloxacin + Hydantoin
phenytoin serum levels reduced , producing a decrease in therapeutic effects
Fluroquinolones + Anticoagulants
the effects of the anticoagulant may be increased. Monitor prothrombin
Fluroquinolones + Cyclosporine
nephrotoxic effects increased,. Closely monitor renal function.
Conflicting data exist
GU- Acidosis, interstital nephritis, nephritis, renal failure, polyuria, urinary retention, urethral bleeding, vaginal candidiasis, renal calculi.
Cardiovascular- angina pectoris, atrial flutter, cardiopulmonary arrest, cerebral thrombosis, myocardial infarction,ventricular ectopy, postural hypotensuion,
Respiratory- bronchodpasm, dyspnea, epitaxis, hemoptysis, hiccoughs, larryngeal/pulmonary edema, pulmonary embolism
Special senses- bad taste in mouth, eye pain, tinnitus, nystagmus
Miscellaneous- restlessness, oral/cutaneous candidiasis, intestinal perforation, GI bleeding, nightmares irritability, tremor, ataxia, anorexia, urticaria, flushing, hyperpigmentation, erythema nodosum, hepatic necrosis, exacerbation of myasthenia gravis, agranulocytosis, cholestastic jaundice
Miscellaneous- erythema, myoclonus (rare) erythema multiforme, hepatitis, pancreatitis, stomatitis, arthalgia
GU- vaginal discharge, genital pruritus, burning/irritation/pain of female genitalia, dysmenorrhea, metrorrhagia, urinary frequency/pain.
Cardiovascular- chest pain, vasodilation Respiratory- cough, rhinorrhea
Special senses- Dysgeusia, photophobia
CNS- sleep disorders, nervousness, anxiety, cognitive change, dream abnormality, euphoria, vertigo.
Miscellaneous- decreased appetite, arthalgia, asthenia, diaphoresis, myalgia, thirst, vasculitis, weight loss.
GU- dysuria, hematuria, strangury, micturation, anuria, leukorrkhea, intermenstrual bleeding, perineal pasin, vaginal moniliasis, orchitis, epididymitis
Cardiovascular- hypotension, tachycardia, bradycardia, arrhythmias, extrasystoles, cyanosis, cardiac failure, angina pectoris, myocardial infarction, pulmonary embolism, cerbrovascular disorder, cardiomyopathy, phlebitis
Respiratory- dyspnea, respiratory infection, epistaxis, respiratory disorder, bronchospasm, cough, increased sputum, stridor
CNS- coma, hyperkinesia, tremor, vertigo, nervousness, anorexia, anxiety, agitation, increased appetite, depersonalization, paroniria.
GI- GI inflammation,/bleeding, dysphagia, tongue discoloration, bad taste Special senses- earache, tinnitus, conjuntivitis, eye pain.
Dermatologic- urticaria, eczema, skin exfoliation, skin disorder
Miscellaneous- flushing, increased sweating, back/chest pain, asthenia, facial edema,influenza-like symptoms,decreased heat tolerance, purpura, lymphadenopathy, increased fibronysis, thirst, gout, hypoglycemia, leg cramps, artharlgia, myalgia, abnormalities of urine specific gravity or serum electrolytes
GI- anorexia, bloody stools, gastritis, stomatitis
CNS- nervousness, anxiety, tremor, agitation, myoclonus, depersonalization, hypertonia.
Dermatologic- urticaria, hyperhidrosis, mycotic infectoion, erythema multiforme,
Special senses- verigo, unusual taste, tinnitus, conjuntivitis.
Respiratory- dyspnea, cough, epistaxis
GU- vaginal monoliasis, urinary incontinence, renalfailure
Miscellaneous- asthena, back/chest pain, myalgia, arthralgia, tacchycardia, vasodilation, purpura
Children below 12years and growing adolescencts,except where benefits exceed risks. Pregnancy, lactation, hypersens.
Epilepsy, severe renal dysfunction, history of convulsive disorders.
Patients should be well hydrated. G6PD defects.
Monitoring- periodic assesment of organ functions, including renal, hepatic and hematopoetic is advisable during prolonged therapy
Opthalmologic abnormalities- including cataracts and multiple punctate lenticular opacities, hav occurred during therapy with some quinolones
Crystalluria- needleshaped crystals were found in the urine of some volunteers who received either placebo or 800 or 160 mg norfloxacin. While crystalluria is not expected to occur under usual conditions with 400mg twice daily, do not exceed the dose. Patientshould drinl sufficient fluids to ensure proper hydration and adequate urinary output.
Photoxicity- reactions moderate to severe have occured in patients who are exposed to direct sunlight while receiving some drugs in this class.
Superinfection: Use of antibiotics especially over a prolonged or repeated therapy may result in bacterial or fungal overgrowth of susecptible organisms. such overgrowth may lead to secondary infection. Take appropiate measures if this occurs.
Drug/Food interations- Food may decrease the absorption of norfloxacin. Food delays absorption of ciprofloxacin, resulting in peak concentrations that are closer to 2 hours after dosing rather than 1 hour. Food delays the rate of absorption of lomefloxacin( time to reach maximum plasma concentration delayed by 41%, and minimum concentration decreased by 18%.)
Photosensitivity- moderate to severe phototoxic reactions have ocurred in patients exposed to direct sunlight or indirect sunlight or to artificial ultraviolet light during or following treatment with lomefloxacin
Convulsion- increased intracranial pressure and toxic psychosis have occured
. CNS stimulation may also occur which may lead to tremor, restlessness, lightheadness, confusion and hallucinations. Use with caution in patients with known CNS disorders.
Syphillis- Ofloxacin and enoxacin are not effective for syphilis. High doses of antimicrobial agents for short periods of time to treat gonorrhea may mask or delay symptoms of incubating syphilis Patients treated with ofloxacin and enoxacin should have a follow- up serological test after 3 months.
Chronic bronchitis due to Staph pneumoniae- lomefloxacin is not indicated for the empiric treatment of acute bacterial exacerbation of chronic bronchitis when it is probable that S pneumoniae is the causative organism since it exhibits in vitro resistence to lo there is a predominance of gram negative and gram positive organisms.
Hypersensitivity- reactions serious and occasionally fatal have occured in patients receiving quinolone therapy, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness,tingling,pharyngeal or facial edema, dyspnea, urticaria and itching
Pseudonomembranous colitis- has been reported when nearly all antibacterial agents including fluoroquinolone and may range from mild to life threatening in severitry. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to administration of antibacterial agents.
Renal function impairment- alteration in dosage regimen is necessary.
Fertility impairment- decreased spermatogenesis and subsequent decreased fertility occured in animals given doses that produced plasma levels 3 times higher than those in humans in recommended dosage.
Elderly- norfloxacin is eliminated slowly because of decreased renal funtion., absorption appears unaffected.
The apparent half life of ofloxacin is 6 to 8 hours.
Lomefloxacin plasma clearance was reduced by about 25% and AUC was increased by 33% in elderly, which may be due to reduced renal function.
Enoxacin plasma concentrations are 50% higher in the elderly than in younger adults.
Pregnancy- Use during pregnancy only if the potential benefits justifies the potential risk to the fetus.
Lactation- because of the potential serious adverse reactions in nursing infants, decide whether to discontinue nursing or discontinue the drug, taking into consideration the importance of the drug to the mother.
Children- Do not use in children. Safety and efficacy of lomefloxacin, enoxacin, ofloxacin in children < 18 years of age have not been established
Dosages/ Overdosage Etc:
Approved by FDA in 1987
Infections of urinary tract, respiratory tract,
infections of bone & joints,skin & skin structure,
Mild to moderate infections- 500mg- 400mg I.V. divided 12 hourly
Severe/complicated infections - 1000mg- 800mg I.V. divided 12 hourly
Recommended maximum- 1500mg- divided 12 hourly
Administer I.V.infusion over 60 minutes. Slow infusion of dilute solutions into a lage vein will minimise patient discomfort and reduce risk of venous irritation.
Stability: Stable upto 14 days at refrigerated or room temp(5C to 25C;41F to 77F).,when diluted with 0.9% Nacl inl.USP or 5% dextrose inj,USP.. Protect from freezing.
. Overdosage- Symptoms
One patient developed oliguric acute renal failure following ingestion of 21g of ciprofloxacin. The patient responded to prednisolone therapy
1. Empty the stomach by inducing vomiting or by gastric lavage
2. Observe patient carefully and give supportive treatment
3. Maintain adequate hydration.
4. Hemodialysis or peritoneal dialysis may aid in the removal of ciprofloxacin,particularly if renal function is compromised.
5. Ofloxacin, enoxacin, norfloxacin, and lomefloxacin are not efficiently removed by dialysis.
1. If you miss a dose of this medicine, take it as soon as possible
2. However, if it is almost time for next dose, skip the missed dose and go back to your regular dosing schedule.
3. Do not double doses.
1. Drink fliuds liberally
2. Do not take antacids containing magnesium or aluminium or products containing iron or zinc simultaneously or within 4 before or 2 hours after dosing.
3. May cause dizziness or lightheadedness. Observe caution while driving or performing other tasks requiring alertness,co-ordination or physical dexterity.
4. CNS stimulation may occur (eg tremor, restlessness, confusion. Use with caution in patients predisposed to seizures or with CNS disorders.
5. Allergies- Tell your doctor if you have ever had any unusual or allergic reactions to fluoroquinolones or any related medicines such as cinoxacin or nalidixic acid. Also tell your doctor if your are allergic to any other substances such as foods, preservatives or dyes
6. Pregnancy- use not recommended during pregnancy
7.Breast feeding- fluoroquinolones have been reported to cause bone development problems in young animals.
8.Children- use not recommended for infants or children since fluoroquinolones have been shown to cause bone development problems in young animals
9. Elderly- these medicines have been tested in effective and have not shown to cause different problems in elderly people than in younger adults.
10. Other medicines-Tell your doctor if you are taking other medicines- Aminophylline or Oxytriphylline or Theophylline - enoxacin ,ciprofloxacin and norfloxacin may increase the chance of side effects of aminophylline,
11. Other medical problems- presence of other medical problems may affect the use of this medicine- Brain or spinal cord disease including hardening of arteries in the brain or epilepsy or other seizures- fluroquinolones may cause nervous system side effects
12. Missed dose- If you miss a dose of this medicine take it as soon as possible. However if it is almost time for your next dose go back to your regular dosing schedule. Do not double dose
Interaction with Food:
Food may decrease the absorption of norfloxacin.
Food delays absorption of ciprofloxacin, resulting in peak concentrations that are closer to 2 hours after dosing rather than 1 hour.
Food delays the rate of absorption of lomefloxacin( time to reach maximum plasma concentration delayed by 41%, and minimum concentration decreased by 18%.)
Pregnancy and lactation:
Do not use in pregnant women. There are no adequate and well controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risks to the fetus.
Norfloxacin was not detected in breast milk following administration of 20mg to nursing mothers; however this was a low dose.
Ciprofloxacin is excreted in breast milk,however the amount ingested by the infant appears low.
It is known whether lomefloxacin or enoxacin are excreted in breast milk. Because of the potential for serious adverse reactions in nursing infants, decide whether to discontinue nursing or discontinue the drug, taking into consideration the importance of the drug to the mother.
Do not use in children. Safety and efficacy of lomefloxacin, enoxacin and ofloxacin in children below 18 years of age have not been established.