Moxifl 400 mg
(Film-coated tablets)
MoxiflComposition:
Each film-coated tablet contains:
Active ingredients :
Moxifloxacin hydrochloride ..................... 436.33 mg (Eq. to Moxifloxacin 400 mg)
Inactive ingredients :
lactose monohydrate, croscarmellose sodium, magnesium stearate, microcrystalline cellulose.

Indications:
Treatment of the bacterial infections in patients of 18 years and older caused by bacteria susceptible to Moxifloxacin.

Oral Moxifloxacin should be restricted for use only when treatment with other antibiotics cannot be used, or have failed for treatment of the following indications :
Acute bacterial sinusitis
Acute exacerbations of chronic bronchitis.
Community acquired pneumonia, except severe cases
Moxifl therapy is not recommended for use in monotherapy of mild to moderate pelvic inflammatory disease but should be given in combination with another appropriate antibacterial agent (e.g. A cephalosporin) due to increasing Moxifloxacin resistance of Neisseria gonorrhea unless Moxifloxacin-resistant Neisseria gonorrhea can be excluded.

Moxifl should not be used to initiate therapy for any type of skin and skin structure infection or in severe community-acquired pneumonia.

Moxifl may also be used to complete a course of therapy in patients who have shown improvement during Initial treatment with intravenous Moxifloxacin for the treatment of the following indications:
Community-acquired pneumonia.
Complicated skin and skin structure infections.
Consideration should be given to official guidance on the appropriate use of antibacterial agents and prevalence of resistance.
Contraindications:
Hypersensitivity to Moxifloxacin, other quinolones or to any of the excipients.
Patients below 18 years of age.
Patients with a history of tendon disease/disorder related to quinolone treatment.
Both in preclinical investigations and in humans, changes in cardiac electrophysiology have been observed following exposure to Moxifloxacin, in the form of QT prolongation.
Effects on ability to drive and use machines:
No studies on the effects of Moxifloxacin on the ability to drive and use machines have been performed. However, fluoroquinolones including Moxifloxacin may result in an impairment of the patient's ability to drive or operate machinery due to CNS reactions (e.g. Dizziness; acute, transient loss of vision) or acute and short lasting loss of consciousness (syncope). Patients should be advised to see how they react to Moxifloxacin before driving or operating machinery.

Drugs & Food interactions:
Ranitidine, probenecid, oral contraceptives, calcium supplements, morphine administered parenterally, theophylline, cyclosporine or itraconazole : Clinical studies have shown that there are no interactions following concomitant administration of moxifloxacin with these drugs.
Cytochrome P450 enzymes: In vitro studies with human cytochrome P450 enzymes support this data. Considering these results a metabolic interaction via cytochrome P450 enzymes is unlikely.
Interaction with food: Moxifloxacin has no clinically relevant interaction with food including dairy products.
Use during pregnancy and lactation:
Pregnancy and lactation:
Pregnancy The use of Moxifloxacin during pregnancy must not be used. The safety of Moxifloxacin in human pregnancy has not been evaluated. Reversible joint injuries are described in children receiving some quinolones; however this effect has not been reported as occurring on exposed fetuses. Animal studies have shown reproductive toxicity. The potential risk for humans is unknown.

Lactation:
The use of Moxifloxacin during breast feeding is contraindicated. As with other quinolones, Moxifloxacin has been shown to cause lesions in the cartilage of the weight bearing joints of immature animals. Preclinical data indicate that Moxifloxacin passes into milk.

Dosage:
Adults:
One 400 mg film-coated tablet once daily.

Renal/hepatic impairment:
No adjustment of dosage is required in patients with mild to severely impaired renal function or in patients on chronic dialysis i.e. Hemodialysis and continuous ambulatory peritoneal dialysis.
There is insufficient data in patients with impaired liver function.

Other special populations:
No adjustment of dosage is required in the elderly and in patients with low body weight.

Children and adolescents:
Moxifloxacin is contraindicated in children and adolescents ( 18 years).
Efficacy and safety of Moxifloxacin in children and adolescents have not been established.

Method of administration:
Moxifl film-coated tablet should be swallowed whole with sufficient liquid and may be taken independent of meals. Duration of administration:
Moxifl should be used for the following treatment durations:
Acute exacerbation of chronic bronchitis 5 -10 days
Community acquired pneumonia 10 days
Acute bacterial sinusitis 7 days
Mild to moderate pelvic inflammatory disease 14 days Moxifl have been studied in clinical trials for up to 14 days treatment.
The recommended dose (400 mg once daily) and duration of therapy for the indication being treated should not be exceeded.
Storage:
Keep at temperature not exceeding 30°C.
Keep in dry place.
Keep out of reach and sight of children.

Presentation:
Carton box containing one Al / transparent PVC blister, of 5 film-coated-tablets and insert leaflet.