Prulifloxacin: Indication, Dosage, Side Effect, Precaution

This information is not country-specific. Please refer to the Myanmar prescribing information.

Generic Medicine Info

Indications and Dosage

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, 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 (refer to specific product or local treatment guidelines).

Contraindications

Hypersensitivity to prulifloxacin or other quinolone antibacterials. Coeliac disease, anamnesis of tendon diseases related to the administration of quinolones. Children or adolescents below 18 years with uncomplicated skeletal development. Pregnancy and lactation. Concomitant use with fenbufen or flurbiprofen.

Special Precautions

Patient with CNS disorders that may predispose to convulsion or lower the convulsion threshold; remarkably low stomach acid state (e.g. achlorhydria), hypokalaemia, hypocalcaemia, rhythm disorders, latent or known G6PD deficiency. Renal impairment.

Adverse Reactions

Significant: Phototoxicity, shock or anaphylactoid reaction, crystalluria, hypoglycaemia, pseudomembranous colitis. Rarely, rhabdomyolysis and rapid deterioration of renal function.
Ear and labyrinth disorders: Impaired hearing.
Eye disorders: Ocular hyperaemia.
Gastrointestinal disorders: Abdominal pain, altered taste, epigastralgia, nausea, diarrhoea, gastritis, vomiting.
General disorders and administration site conditions: Fever.
Investigations: Increased AST/ALT.
Metabolism and nutrition disorders: Anorexia.
Musculoskeletal and connective tissue disorders: Muscle spasms.
Nervous system disorders: Cephalalgia, dizziness, drowsiness, lightheadedness.
Psychiatric disorders: Sleep disorders.
Skin and subcutaneous tissue disorders: Pruritus, rash.

Patient Counseling Information

Avoid excessive exposure to sunlight or UV rays. Maintain adequate water balance.

Drug Interactions

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.

Action

Description: 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.

Chemical Structure

Storage

Store below 30°C.

MIMS Class

Quinolones

ATC Classification

J01MA17 - prulifloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.

References

Anon. Prulifloxacin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 16/11/2021.

Buckingham R (ed). Prulifloxacin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 16/11/2021.

Darflox (Meiji). MIMS Thailand. http://www.mims.com/thailand. Accessed 16/11/2021.

Prulibact 600 mg Film-Coated Tablet (Micro Labs Limited). MIMS Philippines. http://www.mims.com/philippines. Accessed 16/11/2021.

Disclaimer: This information is independently developed by MIMS based on Prulifloxacin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com