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Basic Drug Info
Drug Name:Maxaquin
Manufacturer:G.D. Searle LLC
Other Info:Rx onlyLAB-0141-6.0



Clinical Trials:


Indications and Usage
Maxaquin (lomefloxacin HCl) film-coated tablets are indicated for the treatment of adults with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below: (See Dosage and Administration for specific dosing recommendations.)
Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

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.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

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 (See Dosage and Administration.)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.

(See PRECAUTIONS—Pediatric Use, Pregnancy and Nursing Mothers subsections.) 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.

(See Animal Pharmacology.)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.

(See Adverse Reactions.) Psychiatric disturbances, agitation, anxiety, and sleep disorders may be more common with lomefloxacin than other products in the quinolone class.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.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 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.

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