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.
GATISTAR
Gatifloxacin 3mg/ml
What it does
Gatifloxacin is an antibiotic used to treat various bacterial infections.
Commonly used for: bacterial infections, eye infections (conjunctivitis), respiratory infections
Read more in plain English ↓Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.
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Sourcing - Kenya onlyRegistration & product details
Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:19 · updated 2026-09-17 02:30:43
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-referencedGatifloxacin 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 5379Molecular 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.
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