COMPOSITION :
Each f/c caplet contains : Moxifloxacin hydrochloride equivalent to Moxifloxacin 400 mg.
DESCRIPTION :
Floximax (Moxifloxacin) is a synthetic broad spectrum antibacterial agent of the fluoroquinolone class that is active against both
Gram - positive and Gram - negative bacteria. It works by inhibiting DNA gyrase , topoisomerase II and topoisomerase IV which are
necessary for bacterial DNA replication, transcription and repair. Moxifloxacin is rapidly and almost completely abosrbed after oral
administration and peak plasma concentration reach to 3.1 mg/L within 0.5 - 4 hours after administration of dose of 400 mg and the
absolute bioavailability of Moxifloxacin is approximately 91% . About 40 - 42% of Moxifloxacin are bound to serum protein. The CSF
penetration of Moxifloxacin is 70 - 80 % in patients with meningitis . The half life is 11.5 - 15.6 hours . Approximately 45% of an oral
dose is excreted as unchanged drug ( 20% in urine and 25% in feces ) .
INDICATIONS & DOSAGE :
Floximax should be taken with plenty of liquid and may be taken with or without meals, the dose is 400 mg once every 24 hours, unless
otherwise the dose described by physician, the duration of therapy depends upon the type of infection as the following cases :
- Acute exacerbation of chronic bronchitis : 5 - 10 days.
- Acute sinusitis : 7 days.
- Pneumonia acquired outside the hospital : 7 - 14 days.
- Mild to moderate infection of the female upper genital tract (pelvic inflammatory disease), including infections of the fallopian tubes
and infections of the uterus mucous membrane : 14 days.
- Infections of the skin and soft tissue : 7 - 21 days.
RESTRICTIONS ON USE :
Contraindications
- Hypersensitivity to Moxifloxacin or other quinolones.
- Patients with heart failure , bradycardia , history of arrhythmias.
- Patients with disturbances of potassium ions or ECG changes (Congenital prolongation of QT interval)
- Patients with severe liver disease or increased liver enzymes or patients with history of tendons disorders related to quinolone
treatment.
- Patients below 18 years of age.
Precautions
- Caution should be taken in patients with epilepsy, mental health problems, mysthenia gravis or G6PD defeciency.
- In case of irregular heart beat, anaphylactic reaction, rapid and severe inflammation of the liver, change liver functions, convulsions,
symptoms of neuropathy such as tingling and numbness, severe persistent diarrhoea, stool with blood or sight disturbances during
taking Floximax, stop taking medicine and consult the physician.
- Patients with kidney problems should take sufficient amount of water to prevent dehydration.
- Patients should avoid prolonged exposure to sunlight which may affect the skin during treatment with Floximax.
Effects on the capacity to drive vehicles or use machines
Moxifloxacin may cause dizziness and it may cause sight disturbances, so drive vehicles or use machines should be avoided.
Use in Pregnancy & Lactation
Moxifloxacin is contraindicated during pregnancy due to the risk of abortion and birth defects and contraindicated during lactation
because it passes into the breast milk which may harm the child.
DRUG INTERACTIONS :
- Co-administration of Moxifloxacin with drugs that affect on the heart is contraindicated such as Antiarrhythmics drugs class Ia (e.g.
quinidine, hydroquinidine) and class III (e.g. amiodarone , sotalol ), antipsychotics (e.g. phenothiazines , haloperidol ), tricyclic
antidepressants, certain anti-infective (sparfloxacin, I.V adminstrated erythromycin, antimalarials halofantrine ), medicines that
decrease blood potassium levels (e.g. diuretics, some laxative or corticosteroids), some antihistamines ( terfenadine, astiemizole) I.V
administered vincamine, to avoid risk for altering heart rhythm.
- Any medicine containing magnesium or aluminium , zinc or iron or medicine containing sucralfate can reduce the action of
Moxifloxacin. Therefore, take Floximax 6 hours before or after taking the other medicine.
- Concomitant administration of Moxifloxacin with activated carbon reduces the absorption of Moxifloxacin.
- In case of concomitant administration of Moxifloxacin with oral anti-coagulants ( e.g. warfarin ), the patient should consult the
physician to monitor blood clotting times.
ADVERSE EFFECTS :
Some side effects mild to moderate in severity may appear when Floximax is taken such as : Headache, dizziness, QT prolongation in
patients with hypokalaemia, nausea, diarrhoea, abdominal pain, insomnia, tachycardia, dyspepsia, skin rash, joints and muscles pain,
increased blood sugar.
OVER DOSAGE :
Early adminstration of activated carbon can be useful to prevent excessive levels of Moxifloxacin in blood if an over dose has been
taken. ECG monitoring is recommended due to the possibility of QT interval prolongation and the patient should be given supportive
treatment.
STORAGE INSTRUCTIONS :
Store below 30oC, in a dry place.
PRESENTATION :
Floximax caplets : Pack of 5 films coated caplets and hospital packs of different sizes.
Floximax