International reference: 3 US FDA recalls for this ingredient

Failed Impurities/Degradation Specifications:OOS for unknown impurity. (gatifloxacin)

Labeling: Missing label; Product complaints reported missing bottle label. (gatifloxacin)

Lack of sterility assurance. (gatifloxacin)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Rwanda.

Registered Rwanda · Rwanda FDA

GATISTAR

Gatifloxacin 3mg/ml

Rwanda FDA-HMP-MA-1161 Eye Drops 3 mg/ml antiinfectives for systemic use INN generic

What it does

Gatifloxacin is an antibiotic used to treat various bacterial infections.

Commonly used for: bacterial infections, eye infections (conjunctivitis), respiratory infections

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
Rwanda FDA-HMP-MA-1161
Registration date
20/04/2024
Expiry date
19/04/2029
Status
Registered
Active ingredient
Gatifloxacin 3mg/ml
Dosage form
Eye Drops
Strength
3 mg/ml
Pack size
5 ml Bottle
Therapeutic class
-
ATC class (WHO)
J01MA - Fluoroquinolones
RxNorm RxCUI
228476
Country of origin
EGYPT
Manufacturer location
Street 110, Obour, Dakahlia Governorate 35511, Egypt

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:19 · updated 2026-09-17 02:30:43

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About this medicine

Gatifloxacin is an antibiotic used to treat various bacterial infections.

What it treats

  • bacterial infections
  • eye infections (conjunctivitis)
  • respiratory infections

How it works

It works by stopping the growth of bacteria, helping to eliminate the infection.

Who it's for

Gatifloxacin is for people with specific bacterial infections, as advised by a healthcare professional.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: gatifloxacin

BNF-referenced

Gatifloxacin is a synthetic broad-spectrum 8-methoxyfluoroquinolone antibiotic that exhibits bactericidal properties. It is effective against a wide range of bacterial infections due to its ability to inhibit the enzymes necessary for bacterial DNA replication, transcription, repair, and recombination. Gatifloxacin is administered orally or intravenously and is indicated for use in infections caused by susceptible strains of bacteria.

Indications

  • Bacterial infections
  • Respiratory tract infections
  • Skin and soft tissue infections
  • Urinary tract infections
  • Intra-abdominal infections

Dosage

Children: Refer to the BNF for Children for appropriate paediatric dosing recommendations.

Adults: Refer to the BNF for specific dosing guidance based on the type and severity of the infection.

Mechanism of action

The bactericidal action of gatifloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination.

Pharmacodynamics

Gatifloxacin is a broad-spectrum antibacterial agent that works by blocking bacterial DNA replication through binding to DNA gyrase. It has a significantly higher affinity for bacterial DNA gyrase compared to mammalian enzymes, which contributes to its selective toxicity. This results in the prevention of bacterial cell division and ultimately leads to cell death.

Pharmacokinetics

Gatifloxacin is well-absorbed from the gastrointestinal tract, with peak plasma concentrations occurring within 1 to 3 hours after oral administration. It shows good tissue penetration and is primarily eliminated via renal excretion, with a half-life of approximately 7 to 8 hours. The drug is not significantly metabolized in the liver, making it suitable for patients with hepatic impairment.

Contra-indications

  • Hypersensitivity to gatifloxacin or any of its components
  • History of tendon disorders related to fluoroquinolone use
  • Concurrent use of tizanidine

Adverse effects

  • Nausea
  • Diarrhea
  • Headache
  • Dizziness
  • Tendon rupture or tendinopathy
  • QT prolongation
  • Photosensitivity
  • Rash

Interactions

  • Antacids containing magnesium or aluminum may reduce the absorption of gatifloxacin
  • Cation-containing products (such as sucralfate) can interfere with efficacy
  • Concurrent use of NSAIDs may increase the risk of CNS stimulation
  • Drugs that prolong the QT interval may increase the risk of arrhythmias

Precautions

  • Caution in patients with renal impairment
  • Monitor for signs of tendon damage, especially in older patients or those receiving corticosteroids
  • Assess for potential CNS effects such as seizures
  • Consider the risk of Clostridium difficile associated diarrhea

Pregnancy

Gatifloxacin should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus, as it may affect fetal development.

Breast-feeding

Gatifloxacin should be avoided during breastfeeding due to the potential for serious adverse effects in the nursing infant.

Storage

Store at room temperature, away from light and moisture. Keep out of reach of children.

Formulations

  • Oral tablets
  • Intravenous solution

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: gatifloxacin

PubChem CID 5379

Molecular formula: C19H22FN3O4

Mechanism of action

The bactericidal action of Gatifloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination.

Pharmacodynamics

Gatifloxacin is a synthetic broad-spectrum 8-methoxyfluoroquinolone antibacterial agent for oral or intravenous administration. is bactericidal and its mode of action depends on blocking of bacterial DNA replication by binding itself to an enzyme called DNA gyrase, which allows the untwisting required to replicate one DNA double helix into two. Notably the drug has 100 times higher affinity for bacterial DNA gyrase than for mammalian. Gatifloxacin is a broad-spectrum antibiotic that is active against both Gram-positive and Gram-negative bacteria. It should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.