CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER (CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER).
Ciprofloxacin inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, preventing DNA replication and transcription.
| Metabolism | Primarily hepatic; CYP1A2 is the major enzyme involved; also undergoes renal tubular secretion and glomerular filtration. |
| Excretion | Renal excretion of unchanged drug accounts for approximately 50% of elimination, with 15% as metabolites; biliary/fecal excretion contributes about 20-35%. |
| Half-life | Terminal elimination half-life is approximately 4 hours (range 3-7 hours) in patients with normal renal function; extends to 12-24 hours in severe renal impairment (CrCl <30 mL/min). |
| Protein binding | 20-40% bound to serum proteins (primarily albumin). |
| Volume of Distribution | Volume of distribution is 2.5-3.5 L/kg, indicating extensive tissue penetration (e.g., lung, kidney, bone, prostate). |
| Bioavailability | Not applicable for intravenous administration; oral bioavailability of ciprofloxacin is 60-80% (not relevant for this product). |
| Onset of Action | Intravenous: Clinical effect (e.g., reduction of fever, symptom improvement) typically observed within 24-48 hours; serum concentrations reach therapeutic levels immediately after infusion. |
| Duration of Action | Duration of antimicrobial activity correlates with serum levels above MIC; typically dosing every 8-12 hours, with sustained effect throughout the dosing interval. Post-antibiotic effect against gram-negative bacteria may extend for 2-4 hours. |
| Molecular Weight | 331.34 |
400 mg intravenously every 8-12 hours over 60 minutes.
| Dosage form | INJECTABLE |
| Renal impairment | CrCl 30-50 mL/min: 400 mg every 12 hours; CrCl 5-29 mL/min: 400 mg every 18-24 hours; Hemodialysis: 400 mg every 24 hours (administer after dialysis). |
| Liver impairment | No adjustment required for mild to moderate hepatic impairment. Insufficient data for severe impairment (Child-Pugh C); use with caution. |
| Pediatric use | 10 mg/kg/dose intravenously every 8 hours (maximum 400 mg/dose) for most infections. For Pseudomonas or severe infections: 10-15 mg/kg/dose every 8 hours (max 400 mg/dose). |
| Geriatric use | Initiate at lower dose based on renal function; consider 400 mg every 12 hours initially; monitor renal function and adjust accordingly. |
| 1st trimester | Use only if benefit outweighs risk. Avoid due to potential cartilage damage in immature animals; human data limited. May be associated with birth defects in some studies. |
| 2nd trimester | Use only if benefit outweighs risk. Theoretical risk of arthropathy; cautious use if no alternative. |
| 3rd trimester | Use only if benefit outweighs risk. Near term, consider risk of fetal cartilage damage and infantile arthropathy. |
Clinical note
Comprehensive clinical and safety monograph for CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER (CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER).
| Placental transfer | Ciprofloxacin crosses the placenta; fetal serum levels reach approximately 30-60% of maternal serum concentrations. |
| Breastfeeding | Ciprofloxacin is excreted into breast milk. The American Academy of Pediatrics considers it usually compatible with breastfeeding, but caution in infants with renal impairment or those sensitive to quinolones. Avoid if alternative antibiotics are available. |
■ FDA Black Box Warning
Fluoroquinolones, including ciprofloxacin, are associated with an increased risk of tendinitis and tendon rupture, especially in patients >60 years, those taking corticosteroids, and kidney, heart, or lung transplant recipients. Use should be reserved for conditions where no alternative exists.
| Serious Effects |
Hypersensitivity to ciprofloxacin or any quinoloneTendon pathology related to quinolone useConcurrent use with tizanidine
| Precautions | Tendon damage (including rupture), Exacerbation of myasthenia gravis, Peripheral neuropathy, Central nervous system effects (seizures, dizziness), QT prolongation, Hypersensitivity reactions (including anaphylaxis), Clostridioides difficile-associated diarrhea, Photosensitivity, Blood glucose disturbances, Renal impairment requires dose adjustment |
| Food/Dietary | Avoid dairy products, calcium-fortified juices, and antacids containing calcium, magnesium, or aluminum within 2 hours of oral administration. Caffeine intake may increase caffeine effects. No specific food interactions for IV formulation. |
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| Lactation Rating | L2 (Safer) |
| Teratogenic Risk | Ciprofloxacin is contraindicated in pregnancy. In animal studies, ciprofloxacin caused arthropathy in juvenile animals and is associated with fetal cartilage damage. Human data are limited but suggest an increased risk of musculoskeletal anomalies when used in the first trimester. FDA Pregnancy Category C. Avoid use during all trimesters unless no safer alternative exists for a life-threatening infection. |
| Fetal Monitoring | Monitor maternal renal function, hydration status, and for adverse effects such as tendonitis, QT prolongation, and C. difficile colitis. Fetal monitoring includes ultrasound for potential musculoskeletal effects if exposure occurs, and assessment of amniotic fluid volume. For neonatal exposure, observe for signs of gastrointestinal disturbance or arthropathy. |
| Fertility Effects | Animal studies with ciprofloxacin have shown no impairment of fertility at clinically relevant doses. Human data are lacking. No specific adverse effects on fertility have been reported, but caution is advised due to lack of robust evidence. |
| Clinical Pearls | Ciprofloxacin in D5W is compatible with most IV solutions but incompatible with saline if Y-site with certain drugs. Monitor for QT prolongation, especially with concurrent antiarrhythmics. Adjust dose in renal impairment (CrCl <30 mL/min: 200-400 mg q18-24h). Avoid in myasthenia gravis. Use with caution in elderly due to increased tendon rupture risk. |
| Patient Advice | Do not crush or chew the tablets; take with or without food. · Drink plenty of fluids to prevent crystalluria. · Avoid taking dairy products, calcium-fortified juices, or antacids within 2 hours of oral ciprofloxacin. · Report any tendon pain, swelling, or rupture immediately. · Complete the full course of antibiotics even if you feel better. |