Ofloxacin: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

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

Generic Medicine Info

Indications and Dosage

Intravenous
Pelvic inflammatory disease

Adult: 400 mg bid via slow infusion over at least 1 hour for 14 days.

Intravenous
Acute exacerbations of chronic bronchitis, Community-acquired pneumonia

Adult: 200 mg bid via slow infusion over at least 30 minutes.

Intravenous
Prostatitis

Adult: 200 mg bid via slow infusion over at least 30 minutes, may be increased according to severity to 400 mg bid infused over at least 1 hour. Treatment duration: 2-4 weeks (acute); 4-8 weeks (chronic).

Intravenous
Pyelonephritis

Adult: 200 mg bid via slow infusion over at least 30 minutes, may be increased according to severity to 400 mg bid infused over at least 1 hour. Treatment duration: 7-10 days, up to 14 days as necessary.

Intravenous
Complicated skin and soft tissue infections

Adult: 400 mg bid via slow infusion over at least 1 hour.

Intravenous
Complicated urinary tract infections

Adult: 200 mg bid via slow infusion over at least 30 minutes, may be increased according to severity to 400 mg bid infused over at least 1 hour. Treatment duration: 7-21 days.

Intravenous
Epididymo-orchitis

Adult: 200 mg bid via slow infusion over at least 30 minutes, may be increased according to severity to 400 mg bid infused over at least 1 hour. Treatment duration: 14 days.

Intravenous
Lower respiratory tract infections

Adult: 200 mg bid via infusion over at least 30 minutes, may be increased according to severity to 400 mg bid infused over at least 1 hour.

Ophthalmic
Bacterial conjunctivitis

Adult: As 0.3% eye drop solution: Instill 1-2 drops into the affected eye(s) 2-4 hourly for days 1 and 2, then instill 1-2 drops 4 times daily for days 3-7. Max treatment duration: 10 days.
Child: ≥1 year Same as adult dose.

Ophthalmic
Bacterial corneal ulcer

Adult: As 0.3% eye drop solution: Instill 1-2 drops into the affected eye(s) every 30 minutes while awake and 4-6 hourly after retiring for days 1 and 2. Starting on day 3, instill 1-2 drops hourly while awake for 4-6 additional days; thereafter, 1-2 drops 4 times daily until clinical cure is achieved.
Child: ≥1 year Same as adult dose.

Oral
Uncomplicated cystitis, Uncomplicated urinary tract infections

Adult: 200 mg 12 hourly for 3-7 days.

Oral
Acute exacerbations of chronic bronchitis, Community-acquired pneumonia, Uncomplicated skin and skin structure infections

Adult: 400 mg 12 hourly for 10 days.

Oral
Acute pelvic inflammatory disease

Adult: 400 mg 12 hourly for 10-14 days.

Oral
Prostatitis

Adult: 200 mg bid, may be increased to 400 mg bid according to severity. Treatment duration: 2-4 weeks (acute); 4-8 weeks (chronic). Alternatively, 300 mg 12 hourly for 6 weeks.

Oral
Skin and soft tissue infections

Adult: 400 mg bid.

Oral
Non-gonococcal cervicitis/urethritis due to Chlamydia trachomatis

Adult: 400 mg daily as single or in divided doses. Alternatively, 300 mg 12 hourly. Treatment duration: 7 days.

Oral
Complicated urinary tract infections

Adult: 200 mg 12 hourly for 10 days. Alternatively, 200 mg bid, may be increased to 400 mg bid according to severity for 7-21 days.

Oral
Uncomplicated gonorrhoea

Adult: 400 mg as a single dose.

Oral
Lower respiratory tract infections

Adult: 400 mg daily, increased to 400 mg bid if necessary.

Otic/Aural
Otitis media

Adult: Chronic suppurative cases with perforated tympanic membranes: As 0.3% otic solution: Instill 10 drops (1.5 mg) into the canal of the affected ear(s) bid for 14 days.
Child: ≥12 years Same as adult dose.

Otic/Aural
Acute otitis media

Child: With tympanostomy tubes: 1-12 years As 0.3% otic solution: Instill 5 drops (0.75 mg) into the canal of the affected ear(s) bid for 10 days.

Otic/Aural
Otitis externa

Adult: As 0.3% otic solution: Instill 10 drops (1.5 mg) into the canal of the affected ear(s) once daily for 7 days.
Child: 6 months to 13 years Instill 5 drops (0.75 mg) into the canal of the affected ear(s) once daily for 7 days; >13 years Same as adult dose.

Renal Impairment

Oral:
Patient on haemodialysis or peritoneal dialysis: 100-200 mg 24 hourly following usual initial dose.

CrCl (mL/min)	Dosage
<20	100 mg or half of the usual recommended dose 24 hourly following usual initial dose.
20-50	100-200 mg daily or the usual recommended dose 24 hourly following usual initial dose.

Intravenous:

CrCl (mL/min)	Dosage
<20, patient on haemodialysis or peritoneal dialysis	100 mg 24 hourly or 200 mg 48 hourly following usual initial dose.
20-50	100-200 mg 24 hourly following usual initial dose.

Hepatic Impairment

Oral/Intravenous:
Severe: Reduce dose. Max: 400 mg daily.

Administration

May be taken with or without food. Avoid antacids or supplements containing Fe or Zn w/in 2 hr before or after ofloxacin. Ensure adequate hydration.

Incompatibility

IV: Heparin.

Contraindications

Hypersensitivity to ofloxacin or to other quinolone antibacterials. History of tendon disorders associated with quinolone use, epilepsy or lowered seizure threshold.

Special Precautions

Patient with known/suspected CNS disorders (e.g. epilepsy, severe cerebral arteriosclerosis) or risk factors that may predispose to seizures or lower the seizure threshold; myasthenia gravis, rheumatoid arthritis, latent or diagnosed G6PD deficiency, risk factors for QT interval prolongation (e.g. congenital long QT syndrome, uncorrected hypokalaemia or hypomagnesaemia, heart failure, MI, bradycardia), history of aneurysm disease, pre-existing aortic aneurysm/dissection or its predisposing conditions (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu/giant cell arteritis, Behcet’s disease); psychiatric disease, history of psychotic disorder or risk factor for depression; diabetes. Organ transplant recipients. Not indicated for the treatment of syphilis as it may mask symptoms (oral). Renal and hepatic impairment. Children and elderly. Pregnancy and lactation.

Adverse Reactions

Significant: Tendon rupture or tendinitis, aortic aneurysm ruptures or dissection, CNS effects (e.g. seizures, tremors, dizziness, lightheadedness, increased intracranial pressure), hyperglycaemia, psychiatric reactions (e.g. hallucinations, toxic psychosis), phototoxicity. Rarely, peripheral neuropathy, QT interval prolongation, torsades de pointes, haemolytic reactions (G6PD deficient patients).
Cardiac disorders: Chest pain.
Ear and labyrinth disorders: Vertigo. Otic: Earache, application site reactions.
Eye disorders: Visual disturbance. Ophthalmic: Blurred vision, ocular burning or discomfort (transient), lacrimation, photophobia, foreign body sensation in eyes, chemical conjunctivitis, keratitis; eye discomfort, dryness, pain, pruritus or redness.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, constipation, dysgeusia, abdominal pain or cramps, flatulence, gastrointestinal distress, dry mouth.
General disorders and administration site conditions: Fever, infusion site reaction (IV).
Infections and infestations: Pathogen resistance, fungal infection.
Metabolism and nutrition disorders: Decreased appetite.
Nervous system disorders: Headache, dizziness, drowsiness.
Psychiatric disorders: Insomnia, agitation, sleep disorder, nervousness, somnolence.
Reproductive system and breast disorders: Vaginitis, genital pruritus.
Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, cough.
Skin and subcutaneous tissue disorders: Pruritus, rash.
Vascular disorders: Phlebitis (IV).
Potentially Fatal: Fungal or bacterial superinfection including C. difficile-associated diarrhoea (CDAD) and pseudomembranous colitis (prolonged use); liver failure, myasthenia gravis exacerbation, severe hypoglycaemia. Rarely, severe bullous skin reactions (e.g. toxic epidermal necrolysis, Stevens-Johnson syndrome), hypersensitivity reactions (e.g. anaphylaxis, anaphylactic shock).

Pregnancy Category (US FDA)

PO: C (Caution especially in 1st trimester); Ophth/Otic: C

Patient Counseling Information

This drug may cause drowsiness, dizziness and visual disturbances; if affected, do not drive or operate machinery. Avoid excessive exposure to sunlight or artificial UV light. Do not wear contact lenses during treatment of ophthalmic infections.

Monitoring Parameters

Monitor CBC, hepatic and renal function periodically (prolonged therapy). Perform culture and sensitivity tests and consult local recommendations before treatment initiation due to antibiotic resistance risks; test for syphilis at the time of gonorrheal diagnosis and 3 months later. Assess for signs and symptoms of glucose disturbances, CNS effects, and tendon problems. Monitor ofloxacin serum concentration for patient with severe renal impairment and on dialysis (IV).

Overdosage

Symptoms: Dizziness, confusion, impaired consciousness, increased QT interval, convulsive seizures, nausea, mucosal erosions. Management: Symptomatic treatment. May employ gastric lavage or administer adsorbents and Na sulfate during the 1st 30 minutes to remove any unabsorbed drug. Antacids may be given for protection of gastric mucosa. Elimination may be increased by forced diuresis. Monitor ECG.

Drug Interactions

Increased risk of tendon rupture or inflammation with concomitant use of corticosteroids. Increased risk of QT interval prolongation with Class IA and III anti-arrhythmics, TCAs, macrolides, antipsychotics. May increase the risk of bleeding when given with vitamin K antagonists (e.g. warfarin). Reduced absorption with Mg-, Ca- or Al-containing antacids, Zn or Fe preparations, sucralfate and didanosine chewable or buffered tab. Decreased clearance with drugs that affect the renal tubular secretion (e.g. probenecid, furosemide, cimetidine, methotrexate). May slightly increase plasma levels of glibenclamide. Theophylline and NSAIDs may cause pronounced lowering of cerebral seizure threshold.

Food Interaction

May enhance CNS effects with alcohol.

Lab Interference

May cause false-positive results in the determination of opiates or porphyrin levels in urine.

Action

Description: Ofloxacin is a fluoroquinolone antibacterial which inhibits bacterial topoisomerase IV and DNA gyrase enzymes required for DNA replication, transcription, repair, transposition and recombination.
Pharmacokinetics:
Absorption: Rapidly and well absorbed from the gastrointestinal tract. Well maintained in the tear-film after ophthalmic instillation. Bioavailability: Approx 98% (oral). Time to peak plasma concentration: 1-2 hours.
Distribution: Widely distributed into body fluids, including CSF; good penetration into tissues. Crosses the placenta and enters breast milk. Volume of distribution: 120 L. Plasma protein binding: Approx 20-32%.
Metabolism: Limited metabolism to desmethyl and N-oxide metabolites.
Excretion: Via urine (65-80% as unchanged drug; <5% as metabolites); faeces (4-8%). Elimination half-life: Approx 9 hours; Biphasic: Approx 4-5 hours and 20-25 hours.

Chemical Structure

Storage

Tab: Store between 20-25°C. IV solution/otic solution: Store between 20-25°C. Protect from light. Ophthalmic solution: Store between 15-25°C. Protect from light and excessive heat.

MIMS Class

Ear Anti-Infectives & Antiseptics / Eye Anti-Infectives & Antiseptics / Quinolones

ATC Classification

S01AE01 - ofloxacin ; Belongs to the class of quinolone antiinfectives. Used in the treatment of eye infections.
S02AA16 - ofloxacin ; Belongs to the class of antiinfectives used in the treatment of ear infections.
J01MA01 - ofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.

References

Akilen (Sanbe Farma). MIMS Singapore. http://www.mims.com/singapore. Accessed 14/04/2020.

Anon. Ofloxacin (Ophthalmic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/12/2019.

Anon. Ofloxacin (Otic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/12/2019.

Anon. Ofloxacin (Systemic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/12/2019.

Buckingham R (ed). Ofloxacin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/12/2019.

Joint Formulary Committee. Ofloxacin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 27/02/2020.

Ofloxacin 400 mg Tablets (Bristol Laboratories Ltd). MHRA. https://products.mhra.gov.uk/. Accessed 28/02/2020.

Ofloxacin Ophthalmic Solution (Altaire Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 03/12/2019.

Ofloxacin Otic Solution (Amneal Pharmaceuticals LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 03/12/2019.

Ofloxacin Tablet, Coated (Dr. Reddy’s Laboratories Limited). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 03/12/2019.

Prifloxin Tablet (Prime Pharmaceutical Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my/. Accessed 03/12/2019.

Rossi S (ed). Ofloxacin (Eye). Australian Medicines Handbook [online]. Adelaide. Australian Medicines Handbook Pty Ltd. https://amhonline.amh.net.au. Accessed 03/12/2019.

Tarivid IV Infusion Solution (Aventis Pharma Limited). MHRA. https://products.mhra.gov.uk/. Accessed 15/04/2020.

Disclaimer: This information is independently developed by MIMS based on Ofloxacin 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