Lomefloxacin hydrochloride
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]
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Overview
Lomefloxacin hydrochloride is a fluoroquinolone antibiotic that is FDA approved for the treatment of lower respiratory tract infections and urinary tract infections (UTI) in adult patients. Common adverse reactions include phototoxicity, diarrhea, nausea, dizziness, headache.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Lomefloxacin hydrochloride FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Lomefloxacin hydrochloride in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Lomefloxacin hydrochloride in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Lomefloxacin hydrochloride FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Lomefloxacin hydrochloride in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Lomefloxacin hydrochloride in pediatric patients.
Contraindications
- Maxaquin (lomefloxacin HCl) is contraindicated in persons with a history of hypersensitivity to lomefloxacin or any member of the quinolone group of antimicrobial agents.
Warnings
The safety and efficacy of lomefloxacin in pediatric patients and adolescents (under the age of 18 years), pregnant women, and lactating women have not been established. The oral administration of multiple doses of lomefloxacin to juvenile dogs at 0.3 times and to rats at 5.4 times the recommended adult human dose based on mg/m2 (0.6 and 34 times the recommended adult human dose based on mg/kg, respectively) caused arthropathy and lameness. Histopathologic examination of the weight-bearing joints of these animals revealed permanent lesions of the cartilage. Other quinolones also produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in juvenile animals of various species.
Photosensitivity
- Moderate to severe phototoxic reactions have occurred in patients exposed to direct or indirect sunlight or to artificial ultraviolet light (eg, sunlamps) during or following treatment with lomefloxacin. These reactions have also occurred in patients exposed to shaded or diffuse light, including exposure through glass. patients should be advised to discontinue lomefloxacin therapy at the first signs or symptoms of a phototoxicity reaction such as a sensation of skin burning, redness, swelling, blisters, rash, itching, or dermatitis.
- These phototoxic reactions have occurred with and without the use of sunscreens or sunblocks. Single doses of lomefloxacin have been associated with these types of reactions. In a few cases, recovery was prolonged for several weeks. As with some other types of phototoxicity, there is the potential for exacerbation of the reaction on re-exposure to sunlight or artificial ultraviolet light prior to complete recovery from the reaction. In rare cases, reactions have recurred up to several weeks after stopping lomefloxacin therapy.
- Exposure to direct or indirect sunlight (even when using sunscreens or sunblocks) should be avoided while taking lomefloxacin and for several days following therapy. Lomefloxacin therapy should be discontinued immediately at the first signs or symptoms of phototoxicity. Risk of phototoxicity may be reduced by taking lomefloxacin in the evening.
Seizures
- Convulsions have been reported in patients receiving lomefloxacin. Whether the convulsions were directly related to lomefloxacin administration has not yet been established. However, convulsions, increased intracranial pressure, and toxic psychoses have been reported in patients receiving other quinolones. Nevertheless, lomefloxacin has been associated with a possible increased risk of seizures compared to other quinolones. Some of these may occur with a relative absence of predisposing factors. Quinolones may also cause central nervous system (CNS) stimulation, which may lead to tremors, restlessness, lightheadedness, confusion, and hallucinations. If any of these reactions occurs in patients receiving lomefloxacin, the drug should be discontinued and appropriate measures instituted. However, until more information becomes available, lomefloxacin, like all other quinolones, should be used with caution in patients with known or suspected CNS disorders, such as severe cerebral arteriosclerosis, epilepsy, or other factors that predispose to seizures. Psychiatric disturbances, agitation, anxiety, and sleep disorders may be more common with lomefloxacin than other products in the quinolone class.
Infections
- The safety and efficacy of lomefloxacin in the treatment of acute bacterial exacerbation of chronic bronchitis due to S pneumoniae have not been demonstrated. This product should not be used empirically in the treatment of acute bacterial exacerbation of chronic bronchitis when it is probable that S pneumoniae is a causative pathogen.
- In clinical trials of complicated UTIs due to P aeruginosa, 12 of 16 patients had the microorganism eradicated from the urine after therapy with lomefloxacin. No patients had concomitant bacteremia. Serum levels of lomefloxacin do not reliably exceed the MIC of Pseudomonas isolates. The safety and efficacy of lomefloxacin in treating patients with pseudomonas bacteremia have not been established.
Hypersensitivity Reactions
- Serious and occasionally fatal hypersensitivity (anaphylactoid or anaphylactic) reactions, some following the first dose, have been reported in patients receiving quinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, or itching. Only a few of these patients had a history of previous hypersensitivity reactions. Serious hypersensitivity reactions have also been reported following treatment with lomefloxacin. If an allergic reaction to lomefloxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment with epinephrine. Oxygen, intravenous fluids, antihistamines, corticosteroids, pressor amines, and airway management, including intubation, should be administered as indicated.
Pseudomembranous colitis
- Pseudomembranous colitis has been reported with nearly all antibacterial agents, including lomefloxacin, and may range from mild to life-threatening in severity. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antimicrobial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of "antibiotic-associated colitis." After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against C difficile colitis.
QT interval prolongation/torsades de pointes
- Rare cases of torsades de pointes have been spontaneously reported during post-marketing surveillance in patients receiving quinolones, including lomefloxacin. These rare cases were associated with one or more of the following factors: age over 60, female gender, underlying cardiac disease, and/or use of multiple medications. Lomefloxacin should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving class IA (quinidine, procainamide), or class III (amiodarone, sotalol) antiarrhythmic agents.
Peripheral neuropathy
- Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving quinolones, including lomefloxacin. Lomefloxacin should be discontinued if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness, or is found to have deficits in light touch, pain, temperature, position sense, vibratory sensation, and/or motor strength in order to prevent the development of an irreversible condition.
Tendon effects
Ruptures of the shoulder, hand, Achilles tendon or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including lomefloxacin. Postmarketing surveillance reports indicate that this risk may be increased in patients receiving concomitant corticosteroids, especially the elderly. Lomefloxacin should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Patients should rest and refrain from exercise until the diagnosis of tendonitis or tendon rupture has been excluded. Tendon rupture can occur during or after therapy with quinolones, including lomefloxacin.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Lomefloxacin hydrochloride Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Lomefloxacin hydrochloride Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Lomefloxacin hydrochloride Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Lomefloxacin hydrochloride in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Lomefloxacin hydrochloride in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Lomefloxacin hydrochloride during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Lomefloxacin hydrochloride in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Lomefloxacin hydrochloride in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Lomefloxacin hydrochloride in geriatric settings.
Gender
There is no FDA guidance on the use of Lomefloxacin hydrochloride with respect to specific gender populations.
Race
There is no FDA guidance on the use of Lomefloxacin hydrochloride with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Lomefloxacin hydrochloride in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Lomefloxacin hydrochloride in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Lomefloxacin hydrochloride in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Lomefloxacin hydrochloride in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Lomefloxacin hydrochloride Administration in the drug label.
Monitoring
There is limited information regarding Lomefloxacin hydrochloride Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Lomefloxacin hydrochloride and IV administrations.
Overdosage
There is limited information regarding Lomefloxacin hydrochloride overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Lomefloxacin hydrochloride Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Lomefloxacin hydrochloride Mechanism of Action in the drug label.
Structure
There is limited information regarding Lomefloxacin hydrochloride Structure in the drug label.
Pharmacodynamics
There is limited information regarding Lomefloxacin hydrochloride Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Lomefloxacin hydrochloride Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Lomefloxacin hydrochloride Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Lomefloxacin hydrochloride Clinical Studies in the drug label.
How Supplied
There is limited information regarding Lomefloxacin hydrochloride How Supplied in the drug label.
Storage
There is limited information regarding Lomefloxacin hydrochloride Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Lomefloxacin hydrochloride Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Lomefloxacin hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Lomefloxacin hydrochloride Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Lomefloxacin hydrochloride Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.