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INN monograph

Gemifloxacin

Therapeutic agent (verify pharmacological class) · POM

POM

Verified · Updated 01 Aug 2026 · Source: Local active-ingredient clinical extract; Professional class pharmacology (Therapeutic agent (verify pharmacological class))

Class
Therapeutic agent (verify pharmacolo...
Schedule
POM
Route
See product SmPC
Onset
Product-specific
Duration
Product-specific
Pregnancy
Use only if potential be...
Renal
Review renal impairment...
High-alert
No

Kenya market

Wholesale / list prices where loaded

From
Median
Brands
1

Risk first

Contraindications

  • Hypersensitivity to the active substance or excipients.
  • Additional absolute contraindications are indication- and product-specific — consult SmPC.

Precautions

  • Quinolones should be used with caution in children with a history of epilepsy or conditions that predispose to seizures, in G6PD deficiency, myasthenia gravis (risk of exacerbation).
  • Exposure to excessive sunlight should be avoided (discontinue if photosensitivity occurs).
  • Quinolones may induce convulsions in patients with or without a history of convulsions
  • taking NSAIDs at the same time may also induce them.
  • May cause arthropathy in the weight-bearing joints of immature animals and are therefore generally not recommended in children and growing adolescents.
  • However, the significance of this effect in humans is uncertain and in some specific circumstances short-term use of a quinolone in children is justified.
  • Should be avoid in pregnancy and lactation.

Point of care

Dosing

Adult

Dosing is indication-, age-, weight- and organ-function-specific for this INN. Do not use class averages for high-risk patients. Confirm the exact regimen in the current SmPC and Kenya Standard Treatment Guidelines. Typical professional workflow: (1) confirm indication, (2) check renal/hepatic function, (3) screen interactions/allergies, (4) select dose/route/duration, (5) define monitoring.

Paediatric

Paediatric dosing is weight- and age-based; use a paediatric formulary / SmPC. Do not extrapolate adult tablets without calculation.

Renal

Review renal impairment dosing; many agents need CrCl/eGFR adjustment.

  • CrCl 0–120: Confirm renal dosing in product SmPC / primary label.

Hepatic

Review hepatic impairment dosing; monitor LFTs if agent is hepatically cleared or hepatotoxic.

Safety

Drug interactions

Open checker →
  • It is more potent in vitro than ciprofloxacin or ofloxacin against Gram-positive aerobes [but it is more expensive!].
  • It is the most potent of the quinolones tested against streptococci and most ciprofloxacin-resistant pneumococci.
  • Moxifloxacin and gemifloxacin is more potent than ciprofloxacin or ofloxacin against all staphylococci and many ciprofloxacin-resistant isolates.

Safety

Adverse effects

  • Adverse reactions vary by agent.
  • Counsel on common predictable effects and serious warning symptoms (allergy, severe rash, jaundice, unusual bleeding, severe GI symptoms, neurological changes).
  • Report suspected ADRs via national pharmacovigilance channels.

Use

Indications

  • ENT, UTI, RTI, skin and soft tissues, bone, joint, GI, intra-abdominal, pelvic and severe infections, gonorrhoea.
  • Clinical selection for Gemifloxacin should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC.
  • Class context: Therapeutic agent (verify pharmacological class).
  • Confirm site-specific dose, duration and monitoring before prescribing.

Pharmacology

Mode of action

Interferes with bacterial DNA synthesis by inhibiting topoisomerase II (DNA gyrase) and topoisomerase IV.

Inhibit DNA gyrase / topo IV Block replication Bactericidal
Full mechanism text

Interferes with bacterial DNA synthesis by inhibiting topoisomerase II (DNA gyrase) and topoisomerase IV. Mechanism is agent-specific. At receptor, enzyme, ion channel, transporter or microbial target level, the drug alters a physiological or pathological pathway to produce its therapeutic effect. Confirm precise molecular mechanism in current SmPC / pharmacology reference for this INN before high-stakes decisions.

ADME

Pharmacokinetics & PD

Onset Product-specific
Duration Product-specific
Route See product SmPC
Elimination are product-specific. Consider food effects, protein binding, hepatic CYP/UGT
Half-life when adjusting for organ impairment, age and drug interactions. Verify parameters in the current SmPC.
Full PK/PD text

Absorption, distribution, metabolism and excretion are product-specific. Consider food effects, protein binding, hepatic CYP/UGT metabolism, renal clearance and half-life when adjusting for organ impairment, age and drug interactions. Verify parameters in the current SmPC.

Kenya

Brands & prices

1 listed
Brand Company Pack KES
Gemiflox Popular Pharmaceuticals Ltd Standard Commercial Pack

Special populations

Pregnancy & lactation

Pregnancy

Use only if potential benefit justifies potential risk; prefer agents with better reproductive data when alternatives exist.

Lactation

Assess infant risk vs benefit of maternal therapy; prefer agents with lactation data.

Diet

Food & alcohol

  • Food
  • Food

Trust

Sources & disclaimer

Source: Local active-ingredient clinical extract; Professional class pharmacology (Therapeutic agent (verify pharmacological class))

Last reviewed: 01 Aug 2026

Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.

Kenya Verified Health Registry