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Products > Human Product > Antibiotics > Ciprofloxacin

Ciprofloxacin(Tablet 250 , 500 mg)


 

Category:

Antibacterial, Fluoroquinolone

 

Composition:

Each tablet contains:

ciprofloxacin (as HCI)        250 or 500mg

 

Indication:

§  Urinary Tract Infections

§  Uncomplicated Cystitis

§  Chronic Bacterial Prostatitis

§  Lower Respiratory Tract Infections

§  Acute Bacterial Sinusitis

§  Skin and Skin Structure Infections

§  Bone/Joint Infections

§  Intra-Abdominal Infections

§  Diarrhea

§  Typhoid Fever

§  Gonococcal Infections

§  Inhalational Anthrax (Postexposure)

§  Plague

 

 

Contraindication:

§  Hypersensitivity to any of the components

§  Concomitant administration with tizanidine.

 

 

Precaution & warnings:

§  Not a drug of 1st choice in the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumoniae.

§  Not a drug of 1st choice in the pediatric population due to an increased incidence of adverse events.

§  Caution with history of tendon disorders; discontinue if patient experiences pain, swelling, inflammation, or rupture of tendon.

§  Serious and occasionally fatal hypersensitivity (anaphylactic) reactions reported; discontinue immediately at the 1st appearance of a skin rash, jaundice, or any sign of hypersensitivity, and institute supportive measures.

§  Severe hepatotoxicity, including hepatic necrosis, life-threatening hepatic failure, and fatal events, reported; discontinue immediately if signs and symptoms of hepatitis occur.

§  Convulsions, status epilepticus, increased intracranial pressure (including pseudotumor cerebri), toxic psychosis, and other CNS events reported; discontinue and institute appropriate measures if CNS events occur.

§  Caution with epilepsy and CNS disorders (eg, severe cerebral arteriosclerosis, history of convulsion, reduced cerebral blood flow), or other risk factors that may predispose to seizures or lower the seizure threshold; discontinue if seizures occur.

§  Clostridium difficile-associated diarrhea (CDAD) reported; may need to discontinue if CDAD is suspected or confirmed.

§  Cases of sensory or sensorimotor axonal polyneuropathy resulting in paresthesias,

§  hypoesthesias, dysesthesias, and weakness reported; discontinue immediately if symptoms of peripheral neuropathy occur.

§  May prolong the QT interval; avoid with known QT interval prolongation and risk factors for QT prolongation/torsades de pointes (eg, congenital long QT syndrome, uncorrected electrolyte imbalance, cardiac disease).

§  Increased incidence of adverse reactions related to joints and/or surrounding tissues observed in pediatric patients.

§  Crystalluria reported; maintain hydration and avoid alkalinity of urine.

§  May cause photosensitivity/phototoxicity reactions; discontinue if phototoxicity occurs. Avoid excessive exposure to sun/UV light.

§  May result in bacterial resistance if used in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication.

§  Has not been shown to be effective in the treatment of syphilis; antimicrobial agents used in high dose for short periods to treat gonorrhea may mask or delay symptoms of incubating syphilis.

§  Caution in elderly.

 

Pregnancy & Breastfeeding:

Pregnancy: Category C.
Lactation: Found in breast milk; not for use in nursing.

 

 

 

 

 

Dosage and administration:

§  Urinary Tract Infections

250-500mg q12h for 7-14 days

§  Uncomplicated Cystitis

Acute:
250mg q12h for 3 days

§  Chronic Bacterial Prostatitis

500mg q12h for 28 days

§  Lower Respiratory Tract Infections

500-750mg q12h for 7-14 days

§  Acute Bacterial Sinusitis

500mg q12h for 10 days

§  Skin and Skin Structure Infections

500-750mg q12h for 7-14 days

§  Bone/Joint Infections

500-750mg q12h for 4-8 weeks

§  Intra-Abdominal Infections

Complicated:
500mg q12h for 7-14 days, in conjunction with metronidazole

§  Diarrhea

Infectious:
500mg q12h for 5-7 days

§  Typhoid Fever

500mg q12h for 10 days

§  Gonococcal Infections

Uncomplicated Urethral and Cervical:
250mg single dose

§  Inhalational Anthrax (Postexposure)

500mg q12h for 60 days

Begin as soon as possible after suspected or confirmed exposure

 

§  Plague

500-750mg q12h for 14 days

Begin as soon as possible after suspected or confirmed exposure

§  Conversions

Switching from IV to Oral:
200mg IV q12h: 250mg tab q12h
400mg IV q12h: 500mg tab q12h
400mg IV q8h: 750mg tab q12h

 

Side effects:

Nausea, vomiting, diarrhea, abnormal LFTs, rash.

 

Drug interaction:

§  May increase levels of CYP1A2 substrates (eg, theophylline, methylxanthines, olanzapine), duloxetine, or sildenafil. Use with caution and monitor for sildenafil toxicity. Avoid use with duloxetine; if unavoidable, monitor for duloxetine toxicity. Increased theophylline levels may increase the risk of developing CNS or other adverse reactions; if coadministration cannot be avoided, monitor theophylline levels and adjust dose.

§  May inhibit the formation of paraxanthine after caffeine administration (or pentoxifylline containing products); monitor for xanthine toxicity and adjust dose as necessary.

§  Monitor for clozapine- or ropinirole-related adverse reactions and adjust dose of clozapine or ropinirole during and shortly after coadministration.

§  Avoid with Class IA (eg, quinidine, procainamide) and Class III (eg, amiodarone, sotalol) antiarrhythmics, TCAs, macrolides, antipsychotics, and any other drug known to prolong the QT interval; may further prolong the QT interval.

§  Hypoglycemia reported with oral antidiabetic agents, mainly sulfonylureas (eg, glyburide, glimepiride); monitor blood glucose.

§  May alter serum levels of phenytoin; monitor phenytoin therapy, including phenytoin levels during and shortly after coadministration.

§  Transient SrCr elevations with cyclosporine; monitor renal function. May increase effects of oral anticoagulants; monitor PT and INR frequently during and shortly after coadministration.

§  May increase levels and toxic reactions of methotrexate; carefully monitor with concomitant use.

§  High-dose quinolones in combination with NSAIDs (not acetyl salicylic acid) may provoke convulsions.

§  Antacids, sucralfate, multivitamins, and other multivalent cation-containing products (eg, Mg2+/aluminum antacids, products containing Ca2+, iron, or zinc; dairy product) may decrease absorption, resulting in lower serum and urine levels than desired; administer ≥2 hrs before or 6 hrs after multivalent cation-containing products administration.

§  Probenecid may increase levels; use with caution.

§  Caution with drugs that may lower seizure threshold.

 

Storage:

§  Store below 30°C.

§  Do not use after expiration date.

§  Keep out of reach of children.

 

 

References:

PDR 2015

USPDI 2009
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