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Prulifloxacin
Allopathy
Prescription Required
DCGI (Drugs Controller General of India)
Schedule H
Prulifloxacin is a Flouroquionoles that inhibits a critical step in bacterial folate synthesis.
Prulifloxacin is used in the treatment of urinary tract infections (UTIs). It may also be used in infections of tonsils, sinus, nose, throat, female genital organ, skin & soft tissues and lungs (pneumonia).
It is extensively distributed throughout body tissues. Volume of distribution: 1,231 L. Plasma protein binding: Approx 45%. It is Metabolised mainly to ulifloxacin in intestinal tissue, portal vein and liver; undergoes extensive first-pass metabolism.
and get excreted Via urine (as unchanged drug) with elimination half-life of 10.6-12.1 hours.
Prulifloxacin shows common side effects like Nausea, vomiting, stomatitis; diarrhea, abdominal pain.
Prulifloxacin is available in the form of Tablets.
Prulifloxacin is available in India, Germany, Canada, Italy.
Prulifloxacin is the prodrug of ulifloxacin, a fluoroquinolone antibacterial with properties similar to those of ciprofloxacin. Upon conversion to ulifloxacin, it is transferred into bacterial cells in high concentration and exhibits antibacterial activity by inhibiting the activity of deoxyribonucleic acid (DNA) gyrase. It has a broad antibacterial spectrum against both gram-positive and gram-negative bacteria.
Prulifloxacin is available in the form of Tablets.
Prulifloxacin is used in the treatment of urinary tract infections (UTIs). It may also be used in infections of tonsils, sinus, nose, throat, female genital organ, skin & soft tissues and lungs (pneumonia).
Prulifloxacin is an intermediate-acting sulfonamide which interferes with the synthesis of nucleic acids in sensitive organisms by blocking the conversion of PABA to the coenzyme dihydrofolic acid. Its action is bacteriostatic, although it can be bactericidal where concentrations of thymine are low in the surrounding medium. It has broad spectrum of action though its usefulness has been greatly reduced by widespread resistance.
Prulifloxacin is approved for use in the following clinical indications
For the treatment of urinary tract infections (UTIs).
It may also be used in infections of tonsils, sinus, nose, throat, female genital organ, skin & soft tissues and lungs (pneumonia).
Oral
Acute uncomplicated urinary tract infections
Adult: 600 mg as a single dose. Treatment or dosage recommendations may vary among countries or individual products (refer to specific product or local treatment guidelines).
Oral
Acute exacerbations of chronic bronchitis
Adult: 600 mg once daily for up to a Max of 10 days, depending on the severity of the disease and clinical outcome. Treatment or dosage recommendations may vary among countries or individual products (refer to specific product or local treatment guidelines).
Oral
Complicated lower urinary tract infections
Adult: 600 mg once daily for up to a Max of 10 days, depending on the severity of the disease and clinical outcome. Treatment or dosage recommendations may vary among countries or individual products .
Prulifloxacin is available in various strengths as 250 mg, 450 mg, 600 mg
Severe renal or hepatic impairment, blood disorders, hypersensitivity to sulfonamides, porphyria, SLE, infants <2 mth, pregnancy (3rd trimester) and lactation.
General warnings
- Use in pediatrics
This medicine is not recommended for use in children and adolescents due to the increased risk of serious adverse effects.
- Tendinitis and tendon rupture
Prulifloxacin may cause tendinitis and tendon rupture in some patients. This risk is especially higher in elderly patients on concomitant corticosteroid treatment. Report any symptoms such as tendon inflammation, muscle pain, etc. to the doctor immediately. Therapy may need to be discontinued based on the clinical condition.
- Seizure
Prulifloxacin should be used with caution in patients with central nervous system disorders due to the increased risk of seizures. Replacement with a suitable alternative may be required in some cases based on the clinical condition.
- Pseudomembranous colitis
Patients undergoing treatment with this medicine should be monitored closely for any persistent diarrhea. Diarrhea may be a sign of pseudomembranous colitis. Appropriate corrective measures and therapy discontinuation may be required based on the clinical condition.
- Drug resistance
Usage of Prulifloxacin without sufficient proof or suspicion of a bacterial infection should be avoided. Irrational dosing might fail in providing the benefits and even cause toxicity. It may also increase the risk of development of bacteria that are drug resistant.
Food Warning
High-fat meal may decrease the rate but not the extent of absorption. Management: May administer with meals.
- Common Adverse effects:
Phototoxicity, shock or anaphylactoid reaction, crystalluria, hypoglycaemia, pseudomembranous colitis.
- Less Common Adverse effects:
Abdominal pain, altered taste, epigastralgia, nausea, diarrhoea, gastritis, vomiting, Fever.
- Rare Common Adverse effects:
Rhabdomyolysis and rapid deterioration of renal function. Ear and labyrinth disorders: Impaired hearing.
May enhance the effects of theophylline. May reduce absorption with antacids containing Al or Mg, Fe or Ca preparations, H2-receptor antagonists (e.g. cimetidine), PPIs (e.g. omeprazole).
Potentially Fatal: Convulsions may occur with concomitant use of fenbufen or flurbiprofen.
The common side effects of Prulifloxacin include the following Phototoxicity, shock or anaphylactoid reaction, crystalluria, hypoglycaemia, pseudomembranous colitis.
Pharmacodynamic
Prulifloxacin is the prodrug of ulifloxacin, a fluoroquinolone antibacterial with properties similar to those of ciprofloxacin. Upon conversion to ulifloxacin, it is transferred into bacterial cells in high concentration and exhibits antibacterial activity by inhibiting the activity of deoxyribonucleic acid (DNA) gyrase. It has a broad antibacterial spectrum against both gram-positive and gram-negative bacteria.
Pharmacokinetics
- Absorption: Time to peak plasma concentration: 1 hour.
- Distribution: Extensively distributed throughout body tissues. Volume of distribution: 1,231 L. Plasma protein binding: Approx 45%.
- Metabolism: Metabolised mainly to ulifloxacin in intestinal tissue, portal vein and liver; undergoes extensive first-pass metabolism.
- Excretion: Via urine (as unchanged drug). Elimination half-life: 10.6-12.1 hours.
- https://clinicaltrials.gov/ct2/show/NCT04430790
- https://clinicaltrials.gov/ct2/show/NCT02820025
- https://pubmed.ncbi.nlm.nih.gov/27612991/
- https://clinicaltrials.gov/ct2/show/NCT03894189
- https://www.rxlist.com/dopram-drug.htm
- https://www.mims.com/india/drug/info/Prulifloxacin?type=full&mtype=generic
- https://go.drugbank.com/drugs/DB00561
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7003846/