📌 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 absorbed after oral administration, and peak plasma concentration reaches 3.1 mg/L within 0.5-4 hours after administration of a 400 mg dose, and the absolute bioavailability of Moxifloxacin is approximately 91%. About 40-42% of Moxifloxacin is 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 faeces).

📌 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 prescribed by the physician. The duration of therapy depends on the type of infection as follows:

• Acute exacerbation of chronic bronchitis: 5-10 days.
• Acute sinusitis: 7 days.
• Community‑acquired pneumonia: 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 uterine 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, or a 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 a history of tendon disorders related to quinolone treatment.
• Patients below 18 years of age.

Precautions

• Caution should be taken in patients with epilepsy, mental health problems, myasthenia gravis or G6PD deficiency.
• In the case of irregular heartbeat, anaphylactic reaction, rapid and severe inflammation of the liver, changes in liver function, convulsions, symptoms of neuropathy such as tingling and numbness, severe persistent diarrhoea, stool with blood, or sight disturbances during treatment with Floximax, stop taking the medicine and consult the physician.
• Patients with kidney problems should take sufficient amounts 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 driving or using machines should be avoided.

Use in Pregnancy & Lactation

Moxifloxacin is contraindicated during pregnancy due to the risk of abortion and birth defects, and is contraindicated during lactation because it passes into breast milk, which may harm the child.

📌 DRUG INTERACTIONS

• Co‑administration of Moxifloxacin with drugs that affect the heart is contraindicated, such as antiarrhythmic drugs Class Ia (e.g., quinidine, hydroquinidine) and Class III (e.g., amiodarone, sotalol), antipsychotics (e.g., phenothiazines, haloperidol), tricyclic antidepressants, certain anti‑infectives (sparfloxacin, IV‑administered erythromycin, antimalarials halofantrine), medicines that decrease blood potassium levels (e.g., diuretics, some laxatives or corticosteroids), some antihistamines (terfenadine, astemizole), and IV‑administered vincamine, to avoid the risk of altered 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 charcoal reduces the absorption of Moxifloxacin.
• In the case of concomitant administration of Moxifloxacin with oral anticoagulants (e.g., warfarin), the patient should consult the physician to monitor blood clotting times.

📌 ADVERSE EFFECTS

Some mild to moderate side effects 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, joint and muscle pain, and increased blood sugar.

📌 OVERDOSAGE

Early administration of activated charcoal can be useful to prevent excessive levels of Moxifloxacin in the blood if an overdose 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 30°C in a dry place.

📌 PHARMACEUTICAL FORMS

• Floximax caplets: Pack of 5 film‑coated caplets and hospital packs of different sizes.