Gemifloxacin

Pronunciation: jem-i-FLOX-a-sin.

Generic name: gemifloxacin
Drug class: Fluoroquinolone antibiotic
Form: Tablet
Route: Oral
Legal status: Prescription-only medicine

Availability and supply rules vary by country

Trade names by country: India

What gemifloxacin is and how it works

Gemifloxacin is a fluoroquinolone antibiotic that was historically labelled in the United States for selected susceptible bacterial respiratory infections. All information is derived from a label that was last revised in 2013 and is not current treatment guidance. (1)

This content is historical. The current U.S. approval, supply status, and any brand availability are unverified. No treatment, product selection, or dosing decision should be based on this page; a clinician must use a current product and current local prescribing information.

Mechanism of action: how gemifloxacin works

Gemifloxacin is a synthetic broad-spectrum fluoroquinolone antibacterial agent. (1)

What gemifloxacin is used for

Acute exacerbation of chronic bronchitis (historical)

A historical U.S. label described use for susceptible-bacterial acute worsening of chronic bronchitis when no alternative treatment options were suitable. This is not evidence of current supply or present-day clinical role. (1)

Community-acquired pneumonia (historical)

A historical U.S. label described use for selected susceptible cases of community-acquired pneumonia. Current supply, susceptibility patterns, and product availability are unverified. (1)

Before taking gemifloxacin

Do not take / not appropriate for

Do not take gemifloxacin after a prior hypersensitivity reaction to gemifloxacin or another fluoroquinolone unless the responsible clinician determines otherwise under a current product's exact label. (all products) (1)
Do not assume this historical product is currently available, suitable, or the right strength for you. Only a clinician using a current product can make that decision. (all indications) (1)

Tell your clinician about

Any history of tendon pain, tendon injury, tendon rupture, or myasthenia gravis.
Any previous peripheral neuropathy, central-nervous-system effects, or seizure disorder.
Any history of QT-interval prolongation, heart-rhythm disturbance, electrolyte disorder, or use of medicines that can affect the QT interval.
Any history of diabetes or blood-glucose disturbance.
All current prescription and non-prescription medicines, supplements, and herbal products.
Pregnancy, plans for pregnancy, or breastfeeding.

(1)

How to take gemifloxacin

Gemifloxacin is taken by mouth according to a clinician-directed schedule based on a current product's full prescribing information.
Do not change the dose, number of tablets, timing, or duration yourself.
Fluoroquinolones carry serious class warnings; a clinician must confirm that any chosen current product is appropriate for you.

(1)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician.

Missed dose

Contact the prescribing clinician for rescheduling instructions. Do not give an extra dose or alter the next dose or interval without clinician advice.

Overdose

If the wrong strength or number of tablets may have been taken, contact the prescribing service or poison-information service urgently. Seek emergency care immediately for any serious or allergic-reaction symptoms. (1)

Side effects

Side-effect information is derived from a historical label and may not reflect current product-risk data. Fluoroquinolones as a class carry serious risks that require individual assessment.

Gastrointestinal symptoms

What to notice: Diarrhoea, nausea, or abdominal discomfort.

What to do: Tell the treatment team if severe, worsening, persistent, or accompanied by blood or signs of dehydration. (1)

Rash

What to notice: New skin rash, redness, itching, or other skin change.

What to do: Discuss any rash promptly with the prescribing team. (1)

Severe diarrhoea

What to notice: Watery or bloody stool, cramping, fever, or persistent diarrhoea during or after treatment.

What to do: Contact the prescribing team promptly for assessment; this may indicate C. difficile-associated diarrhoea. (1)

Serious warnings

Tendon injury or rupture — serious_urgent

Symptoms: Sudden tendon pain, swelling, weakness, or difficulty moving a joint, especially the shoulder, hand, or Achilles area.

Action: Seek medical attention promptly and let the clinician you see advise on whether to continue or stop the medicine. Tendon damage can be disabling or irreversible. (1)

Peripheral neuropathy — serious_urgent

Symptoms: Pain, burning, tingling, numbness, or weakness, especially in the hands or feet, or changes in sensation.

Action: Seek medical attention promptly and let the clinician you see advise on whether to continue or stop the medicine. Nerve damage can be permanent. (1)

Central-nervous-system effects — serious_urgent

Symptoms: Seizures, confusion, hallucinations, agitation, anxiety, depression, nightmares, or other mental-status changes.

Action: Seek medical attention promptly. Let the clinician you see advise on the medicine's role. (1)

Myasthenia gravis exacerbation — emergency

Symptoms: Muscle weakness, especially breathing difficulty, trouble swallowing, double vision, or dropping eyelids.

Action: Obtain emergency medical care immediately. Fluoroquinolones can worsen myasthenia gravis symptoms and may be life-threatening. (1)

Interactions

Medicine or test	Effect	Action
Medicines or supplements	No current medicine-specific interaction list could be verified because the historical label may not reflect current data.	Give a pharmacist and prescriber a complete list of all prescription medicines, non-prescription products, supplements, and herbal preparations so they can check for interactions using a current product's information. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Current availability and alternatives

All current country approvals, brands, and supply status are unverified. A clinician must select a current product and determine appropriateness rather than rely on this historical information. (1)

Pregnancy and breastfeeding

Historical label information is not a substitute for current product prescribing information. Discuss treatment options, benefits, and risks with the responsible clinician. (1)

People at risk of tendon or nerve injury

Age, corticosteroid use, organ transplantation, renal impairment, and prior tendon problems can increase risk. A clinician must assess individual risk using current product-safety data. (1)

Monitoring

Before starting

Confirm a current product, indication, and exact prescribing information are being used, not this historical page.
Assess individual risk for tendon, nerve, CNS, cardiac, dysglycaemia, and myasthenia gravis problems.
Review all concomitant medicines and conditions with a current product's interaction data.
Confirm treatment duration and stop criteria according to current clinical guidance.

During treatment

Reassess for new tendon, nerve, CNS, skin, blood-glucose, and hypersensitivity symptoms at each review.
Evaluate treatment response and bacterial susceptibility according to current guidelines.
Monitor for diarrhoea or other signs that may indicate C. difficile-associated illness.

(1)

Storage

This historical page cannot provide current storage instructions. Follow the exact product packaging for any fluoroquinolone a clinician prescribes.

Historical U.S. label context

Clinician-facing context only. All information is derived from a U.S. DailyMed label last revised in 2013; current U.S. approval and supply are unverified. Do not use this page for treatment decisions.

United States (historical)

Indication: Historical labelled indications

Dose summary: No universal dose is displayed. Determine dose, interval, duration, and contraindications from a current product's exact prescribing information.

Renal context: Renal impairment requires individual assessment using a current product's full prescribing information. Do not infer a web-based adjustment. (1)

Mechanism of action

Hepatic guidance

Use a current product's prescribing information and specialist judgement; this page does not provide impairment-specific dosing.

Overdose note

Medication errors require product identification, dose reconstruction, poison-centre or specialist advice, and supportive monitoring. (1)

Frequently asked questions

What is gemifloxacin?

Gemifloxacin is an oral fluoroquinolone antibiotic that was historically labelled in the United States for certain susceptible respiratory bacterial infections. All information is derived from a label last revised in 2013. (1)

Why is the evidence described as historical or stale?

The most recent authoritative label available is from 2013, and current U.S. approval, supply status, and any brand availability have not been verified. This means the information may not reflect today's products or clinical practice. (1)

Is gemifloxacin currently available on the market?

Current supply and approval status are unverified. A clinician or pharmacist must confirm whether an authorised product is available in the relevant country and, if so, use the current prescribing information. (1)

What serious symptoms should I watch for with any fluoroquinolone?

Fluoroquinolones carry class warnings for tendon pain or rupture, peripheral neuropathy (nerve pain, numbness, tingling), central-nervous-system effects (seizures, confusion, mood changes), and worsening of myasthenia gravis. Report new or worsening symptoms to a clinician promptly. (1)

Can a clinician still prescribe a fluoroquinolone?

A clinician may choose a currently authorised product for a specific clinical situation when the expected benefit outweighs the risks for the individual, using current prescribing information. This historical page is not a recommendation to use any particular product or class. (1)

What is the mechanism of action of gemifloxacin?