Floxabid200 mg/100 ml

Floxabid is a fluoroquinolone antibiotic used to treat a range of bacterial infections caused by susceptible organisms. Indications vary in the strength of supporting evidence, and fluoroquinolones should generally be reserved for infections with no other treatment option due to safety concerns (see Precautions and Warnings).

FDA-Approved / Established Uses

• Uncomplicated and complicated urinary tract infections (UTIs), including acute pyelonephritis
• Acute uncomplicated cystitis in women
• Chronic bacterial prostatitis
• Lower respiratory tract infections, including acute exacerbations of chronic bronchitis and nosocomial pneumonia
• Acute sinusitis
• Skin and skin-structure infections
• Bone and joint infections
• Complicated intra-abdominal infections (used in combination with metronidazole)
• Infectious diarrhea (including traveler's diarrhea) caused by susceptible organisms
• Typhoid fever (enteric fever) caused by susceptible Salmonella typhi
• Inhalational anthrax (post-exposure prophylaxis and treatment, as part of a combination regimen)
• Plague (treatment and post-exposure prophylaxis)

Guideline-Supported / Adjunct Uses

• Complicated intra-abdominal infections — used together with an antianaerobic agent (e.g., metronidazole), not as monotherapy
• Certain sexually transmitted infections in regions with documented local susceptibility (increasingly limited by resistance; local guidelines should be followed)

Floxabid should be reserved for infections proven or strongly suspected to be caused by susceptible bacteria, and should not be used for infections that are typically self-limiting or non-bacterial (e.g., most acute bronchitis) unless no other treatment option is suitable.

Each film-coated tablet of Ciprofloxacin contains Ciprofloxacin Hydrochloride equivalent to 250 mg, 500 mg, or 750 mg of ciprofloxacin base. Extended-release tablets (500 mg and 1000 mg) are also available for once-daily dosing in specific indications. An oral suspension and an intravenous infusion (200 mg/100 mL and 400 mg/200 mL) formulation of Ciprofloxacin are available where parenteral or liquid dosing is required. Strengths and available forms may vary by manufacturer.

Floxabid is a second-generation synthetic fluoroquinolone antibiotic with broad-spectrum activity against many Gram-negative and some Gram-positive bacteria. It is available as immediate-release and extended-release oral tablets, an oral suspension, and an intravenous infusion for the treatment of a wide range of susceptible bacterial infections. Due to a class-wide risk of serious, potentially irreversible adverse effects, Floxabid should be used only when the benefits of therapy outweigh the risks, particularly when safer alternative antibiotics are not suitable.

Fluoroquinolone antibiotic

Ciprofloxacin exerts its bactericidal effect by inhibiting bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes required for bacterial DNA replication, transcription, repair, and recombination. Inhibition of these enzymes causes breakage of bacterial DNA strands, leading to rapid bacterial cell death.

Ciprofloxacin is well absorbed after oral administration, with bioavailability of approximately 70–80%. It is widely distributed into body tissues and fluids, including bone, prostate, and lung tissue, with relatively low plasma protein binding. It undergoes partial hepatic metabolism and is eliminated primarily via renal excretion (both glomerular filtration and tubular secretion), with a smaller portion eliminated in feces. The elimination half-life is approximately 4 hours in patients with normal renal function, necessitating twice-daily dosing for most indications (or once daily for extended-release formulations).

Floxabid tablets should be swallowed whole with a full glass of water; extended-release tablets must not be crushed, split, or chewed. Floxabid oral suspension should be shaken gently before use and measured with an accurate dosing device (avoid using with a straight-tipped feeding tube due to the microcapsule formulation). Floxabid may be taken with food to reduce stomach upset, but not with milk, yogurt, or calcium-fortified products alone. Antacids, iron or zinc supplements, sucralfate, and calcium-containing products should be separated from Floxabid dosing by at least 2 hours before or 6 hours after. Intravenous Floxabid is administered by slow infusion over 60 minutes into a large vein. If a dose is missed, it should be taken as soon as remembered unless it is almost time for the next dose, in which case the missed dose should be skipped; doses should never be doubled.

The following interactions with Floxabid are well-established and clinically significant:

• Tizanidine: Contraindicated. Floxabid markedly increases tizanidine plasma concentrations (via CYP1A2 inhibition), causing significant hypotension and sedation.
• Antacids, sucralfate, and divalent/trivalent cation products (calcium, iron, zinc, magnesium, dairy products, calcium-fortified juices): Form insoluble chelates with Floxabid, substantially reducing its absorption and effectiveness. Separate dosing by at least 2 hours before or 6 hours after these products.
• Theophylline: Floxabid can raise theophylline plasma concentrations, increasing the risk of theophylline toxicity, including seizures; monitor levels if co-administered.
• Warfarin and other oral anticoagulants: Floxabid may potentiate anticoagulant effect; monitor prothrombin time/INR closely.
• NSAIDs: Concomitant use with Floxabid may increase the risk of central nervous system stimulation and seizures.
• Oral hypoglycemic agents (e.g., glyburide) or insulin: Floxabid may alter blood glucose control, causing hypoglycemia or hyperglycemia; monitor blood glucose closely.
• QT-prolonging drugs (Class IA/III antiarrhythmics, certain antipsychotics and antidepressants): Additive risk of QT prolongation and torsades de pointes; avoid combination when possible.
• Corticosteroids: Concomitant systemic corticosteroid use with Floxabid increases the risk of tendinitis and tendon rupture (see Precautions and Warnings).
• Probenecid: Reduces renal clearance of Floxabid, increasing its plasma concentration.
• Cyclosporine: Co-administration with Floxabid may transiently increase serum creatinine and nephrotoxicity risk.

Always inform the physician or pharmacist of all other medicines, supplements, and antacids being used before starting Floxabid.

Most adverse effects associated with Floxabid are mild to moderate, but the drug carries a boxed warning for certain serious, potentially irreversible reactions (see Precautions and Warnings).

Common

• Nausea
• Diarrhea
• Headache
• Dizziness
• Abdominal pain/discomfort
• Rash
• Elevated liver enzymes (transient)

Less Common / Serious (see Precautions and Warnings for detail)

• Tendinitis and tendon rupture
• Peripheral neuropathy
• Central nervous system effects (seizures, confusion, hallucinations, increased intracranial pressure)
• QT prolongation and cardiac arrhythmia
• Aortic aneurysm and aortic dissection
• Clostridioides difficile-associated diarrhea/colitis
• Hypersensitivity reactions, including anaphylaxis and severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Photosensitivity/phototoxicity reactions
• Hemolytic anemia (particularly in patients with G6PD deficiency)
• Blood glucose disturbances (hypoglycemia or hyperglycemia)

Pregnancy: Floxabid crosses the placenta. Animal studies have shown effects on developing cartilage (arthropathy) in juvenile animals, and although human data have not conclusively confirmed this risk, Floxabid should generally be avoided during pregnancy and reserved for situations where no safer alternative antibiotic is suitable and the potential benefit justifies the potential risk to the fetus. A physician should always be consulted before use in pregnancy.

Lactation: Floxabid is excreted into breast milk in concentrations similar to plasma. Because of the potential risk of arthropathy and gastrointestinal disturbance in the nursing infant, Floxabid should be used during breastfeeding only if clearly needed and no safer alternative is appropriate; consult a physician before use while breastfeeding.

Boxed Warning — Serious Adverse Reactions: Floxabid is associated with disabling and potentially irreversible serious adverse reactions, including tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects, that can occur together. Fluoroquinolones such as Floxabid should be reserved for patients who have no alternative treatment options for the specific infection being treated.

Tendinitis and Tendon Rupture: The risk (particularly of the Achilles tendon) is increased in patients over 60 years of age, those taking corticosteroids, and organ transplant recipients. Floxabid should be discontinued immediately if pain, swelling, or inflammation of a tendon occurs.

Peripheral Neuropathy: Rapid onset of sensory or sensorimotor axonal polyneuropathy has been reported; discontinue Floxabid immediately if symptoms of neuropathy (pain, burning, tingling, numbness, weakness) occur.

Central Nervous System Effects: Floxabid may cause seizures, increased intracranial pressure, confusion, hallucinations, anxiety, depression, and (rarely) suicidal thoughts. Use with caution in patients with known or suspected CNS disorders.

QT Prolongation: Floxabid can prolong the QT interval; use with caution in patients with known QT prolongation, uncorrected electrolyte abnormalities, or concomitant use of other QT-prolonging drugs.

Aortic Aneurysm and Dissection: Fluoroquinolones including Floxabid may increase the risk of aortic aneurysm and dissection, particularly in elderly patients and those with pre-existing aortic disease or risk factors; avoid use in these patients unless no other treatment options are available.

Clostridioides difficile-Associated Diarrhea: May occur during or up to several weeks after therapy with Floxabid; evaluate if persistent or severe diarrhea develops.

Myasthenia Gravis: Floxabid is contraindicated in patients with myasthenia gravis due to risk of exacerbating muscle weakness (see Contraindications).

Photosensitivity: Moderate to severe phototoxicity reactions can occur with sun/UV exposure; patients should avoid excessive sunlight and use sun protection while taking Floxabid.

Blood Glucose Disturbances: Floxabid has been associated with disturbances of blood glucose, including symptomatic hypoglycemia and hyperglycemia, particularly in diabetic patients on oral hypoglycemic agents or insulin.

Chelation with Multivalent Cations: Concurrent use of antacids, dairy products, or calcium/iron/zinc-containing products reduces absorption of Floxabid (see Interactions); doses must be separated appropriately.

Antibiotic stewardship: Take Floxabid exactly as prescribed by your physician; do not stop, extend, skip doses, or share this medicine with others without medical advice.

Overdose of Floxabid may cause nausea, vomiting, abdominal pain, diarrhea, dizziness, confusion, tremor, and, rarely, seizures or acute renal failure. If an overdose of Floxabid is suspected, seek immediate medical attention or contact a poison control center/emergency services. Management is general and supportive, including maintenance of adequate hydration; there is no specific antidote. Hemodialysis removes only a small amount of the drug.

Store Floxabid tablets at room temperature (below 30°C), away from light and moisture. Keep out of reach of children. Reconstituted Floxabid oral suspension should be stored at room temperature as directed on the label and discarded after 14 days; do not refrigerate the suspension. Intravenous Floxabid infusion bags should be stored as per manufacturer's label and protected from light and freezing.

Renal impairment: Dose adjustment of Floxabid is required based on creatinine clearance (see Dosage and Administration); monitor renal function during therapy.

Hepatic impairment: No specific dose adjustment is generally required for mild-to-moderate hepatic impairment; use Floxabid with caution and monitor liver function in significant hepatic disease.

Elderly: Patients over 60 years of age are at increased risk of tendon rupture, aortic aneurysm/dissection, and QT prolongation with Floxabid; use with caution and consider age-related decline in renal function when dosing.

Diabetic patients: Closely monitor blood glucose in patients taking oral hypoglycemic agents or insulin together with Floxabid due to the risk of disturbed glucose control.

G6PD deficiency: Use Floxabid with caution; hemolytic reactions have been reported.

Duration of treatment with Floxabid is indication-specific, ranging from a single 3-day course for uncomplicated cystitis, 7–14 days for most complicated infections, 28 days for chronic bacterial prostatitis, 4–6 weeks for bone and joint infections, and up to 60 days for inhalational anthrax post-exposure prophylaxis. The exact duration of Floxabid therapy should always follow the prescribing physician's instructions and should not be shortened or extended without medical advice.

Where supplied as a dry powder for oral suspension, Floxabid should be reconstituted by adding the specified amount of water to the bottle as indicated on the label, then shaking to form a uniform suspension. The reconstituted suspension of Floxabid should be shaken gently (not vigorously, to avoid damaging the microcapsules) before each dose, stored at room temperature, and any unused portion discarded after 14 days. It should not be administered through a nasogastric or feeding tube due to the microencapsulated formulation.

Fluoroquinolone antibiotics

Ciprofloxacin is bactericidal, acting by inhibiting bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, two type II topoisomerase enzymes essential for bacterial DNA supercoiling, replication, transcription, and repair. By blocking these enzymes, Ciprofloxacin causes double-strand breaks in bacterial DNA, which are not efficiently repaired, resulting in rapid bacterial cell death. This mechanism gives Ciprofloxacin broad-spectrum activity against many Gram-negative organisms (including Pseudomonas aeruginosa) and certain Gram-positive organisms.

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Because of the risk of arthropathy (joint/cartilage damage) observed in juvenile animal studies, Floxabid is generally avoided in children and adolescents under 18 years of age and should be reserved for specific approved pediatric indications where the benefit clearly outweighs this risk: complicated urinary tract infections and pyelonephritis (children 1–17 years, weight-based dosing, typically 6–10 mg/kg every 8 hours, maximum 500 mg/dose), and inhalational anthrax or plague post-exposure prophylaxis/treatment (weight-based dosing, typically 15 mg/kg every 12 hours, maximum 500 mg/dose). Safety and efficacy of Floxabid for other pediatric indications have not been established. Pediatric dosing of Floxabid must always be calculated and supervised by a physician.