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Moximox

Moximox Special Precautions

moxifloxacin

Manufacturer:

Imedco Djaja
Full Prescribing Info
Special Precautions
Hypersensitivity: In some cases, hypersensitivity and allergic reactions can occur after the first dose of fluoroquinolones, including moxifloxacin, and should be immediately reported to a doctor.
Anaphylactic reactions, though very rare, can develop into life-threatening shock, even after the first dose. In this case, moxifloxacin therapy should be discontinued, and appropriate treatment (such as shock therapy) should be initiated.
Cases of bullous skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with moxifloxacin. Patients should immediately consult a doctor about the continuation of treatment if skin and/or mucosal reactions occur.
Cardiac Disorders: Women tend to have a longer baseline QTc interval compared to men, making them potentially more sensitive to drugs that can prolong the QTc interval.
Elderly patients may also be more susceptible to drugs affecting the QT interval.
Moxifloxacin, like other fluoroquinolones and macrolides, has been shown to prolong the QTc interval. ECG analysis in clinical trials indicates that the QTc prolongation with moxifloxacin is small (6 msec, ±26 msec, 1.4% compared to baseline). The incidence of potential QTc prolongation was not significantly different between the moxifloxacin group and the control group, including placebo. Because data regarding patients who may be prone to arrhythmias related to QTc prolongation is still limited, moxifloxacin should be used cautiously in patients using other medications that may lower potassium and magnesium levels.
If signs of cardiac arrhythmia occur during moxifloxacin treatment, the medication should be stopped, and an ECG should be performed.
QT prolongation can increase the risk of ventricular arrhythmias, including torsades de pointes. No cardiovascular morbidity or mortality due to QTc prolongation was observed with moxifloxacin treatment in clinical studies, although some predisposing conditions may increase the risk of ventricular arrhythmias.
Women and elderly patients may be more vulnerable to medications that prolong the QTc interval.
Hepatobiliary System: Cases of fulminant hepatitis leading to liver damage (including fatal cases) have been reported with moxifloxacin. Patients should contact their doctor before continuing treatment if signs and symptoms of liver damage appear.
Liver function tests should be performed if liver dysfunction occurs.
Due to limited clinical data, moxifloxacin is not recommended for patients with severe liver impairment (Child-Pugh C).
Renal Disorders: Elderly patients with renal impairment should use moxifloxacin with caution if they are unable to maintain adequate fluid intake, as dehydration may increase the risk of kidney failure.
Seizures: Quinolones are known to trigger seizures. Caution should be used in patients with central nervous system (CNS) disorders (e.g., lowered seizure threshold, a history of seizures, reduced cerebral blood flow, structural brain changes, or stroke), as these conditions may affect seizures or lower the seizure threshold.
Digestive System: Pseudomembranous colitis has been reported in association with broad-spectrum antibiotic use. Therefore, it is important to consider the diagnosis in patients experiencing severe diarrhea during or after moxifloxacin use.
Peristalsis inhibitors are contraindicated in patients with severe diarrhea.
Myasthenia Gravis: Moxifloxacin should be used cautiously in patients with myasthenia gravis as their symptoms may worsen.
Tendinitis and Tendon Rupture: Tendinitis and tendon rupture (primarily Achilles tendon), sometimes bilateral, can occur with quinolone treatments, including moxifloxacin, even within the first 48 hours of therapy. Cases have been reported up to several months after therapy ends. The risk of tendinopathy may be increased in elderly patients, during heavy physical activity, in patients treated with corticosteroids, in those with renal disorders, and in organ transplant patients.
At the first sign of tendinitis (e.g., swelling accompanied by pain or inflammation), the affected extremity should be rested, physical activity should be avoided, and the patient should immediately consult a doctor and discontinue antibiotic therapy.
Skin: Quinolones have been shown to cause photosensitivity. However, studies show that moxifloxacin does not have significant potential to induce photosensitivity. Nevertheless, patients should be advised to avoid excessive UV radiation or sun exposure during treatment with moxifloxacin.
Complex Pelvic Inflammatory Disease: For patients with complex pelvic inflammatory disease (e.g., tubo-ovarian abscess or pelvic abscess), where intravenous treatment is required, oral moxifloxacin is not recommended.
Pelvic Inflammatory Disease: Pelvic inflammatory disease may be caused by Neisseria gonorrhoeae, which is resistant to fluoroquinolones. Therefore, moxifloxacin should be given in combination with another appropriate antibiotic (e.g., cephalosporins), unless Neisseria gonorrhoeae resistant to moxifloxacin can be excluded. If clinical improvement is not achieved after 3 days of treatment, continued therapy should be reconsidered.
MRSA Infections: Moxifloxacin is not recommended for the treatment of MRSA infections. In cases of confirmed or suspected MRSA infection, treatment with the appropriate antibacterial agents should be initiated.
Peripheral Neuropathy: Cases of sensory or sensorimotor polyneuropathy resulting in paresthesia, hypoaesthesia, dysaesthesia, or weakness have been reported in patients receiving quinolones, including moxifloxacin. Patients treated with moxifloxacin should inform their doctor before continuing treatment if neuropathy symptoms such as pain, burning, tingling, numbness, or weakness occur.
Psychiatric Reactions: Psychiatric reactions can occur even after the first dose of fluoroquinolones, including moxifloxacin. In very rare cases, depression or psychotic reactions may progress to suicidal thoughts and self-harming behaviors such as suicide attempts. If these reactions occur, moxifloxacin should be stopped, and appropriate measures should be taken.
Moxifloxacin should be used cautiously in patients with psychotic disorders or a history of mental illness.
Genital Tract Infections: Due to the widespread and increasing prevalence of Neisseria gonorrhoeae infections resistant to fluoroquinolones, monotherapy with moxifloxacin should be avoided in patients with pelvic inflammatory disease, unless Neisseria gonorrhoeae resistant to moxifloxacin can be excluded. If resistant N. gonorrhoeae can be excluded, adding an appropriate antibiotic that is usually active against N. gonorrhoeae (e.g., cephalosporins) to moxifloxacin therapy should be considered.
Dysglycemia: Like other fluoroquinolones, moxifloxacin has been reported to cause blood glucose disorders, including hypoglycemia and hyperglycemia. Dysglycemia is particularly common in elderly diabetic patients receiving concurrent oral hypoglycemic agents (e.g., sulfonylureas) or insulin. Blood glucose levels should be closely monitored in diabetic patients.
Glucose-6-Phosphate Dehydrogenase Deficiency: Patients with or a history of glucose-6-phosphate dehydrogenase deficiency are susceptible to hemolytic reactions when treated with fluoroquinolones. Therefore, moxifloxacin should be used cautiously in these patients.
Galactose Intolerance, Lapp Lactase Deficiency, or Glucose-Galactose Malabsorption: Patients with rare inherited disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not use this medication.
Visual Disorders: If visual disturbances or other eye-related effects occur, consult an ophthalmologist immediately.
Excipients Information: For patients with sodium intake concerns (e.g., patients with congestive heart failure, kidney failure, nephrotic syndrome, etc.), the additional sodium load from the infusion solution should be considered.
Effects on Driving and Operating Machinery: Fluoroquinolones may affect a patient's ability to drive or operate machinery due to reactions in the central nervous system (CNS) (e.g., dizziness) and temporary or acute vision loss, as well as temporary loss of consciousness (syncope). Patients are advised to see how they react to moxifloxacin before driving or operating machinery.
Use in Children: Due to effects on animal cartilage, moxifloxacin is contraindicated in children and adolescents under 18 years of age.
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