

Indication
¤ Moxifloxacin should only be used to treat these infections when usual antibiotics cannot be used or have not worked
¤ Moxival® is used in patients of 18 years of age and older for treating the following bacterial infections when caused by bacteria against which Moxifloxacin is active:
- Community Acquired Pneumonia
- Uncomplicated Skin And Skin Structure Infections.
- Complicated Skin And Skin Structure Infections.
- Complicated Intra-Abdominal Infections.
- Acute Bacterial Sinusitis.
- Acute Bacterial Exacerbation of Chronic Bronchitis

Composition
Each film-coated tablet of Moxival® contains:
- Moxifloxacin 400 mg

Dosage
¤ The recommended dose is one 400 mg film-coated tablet once daily.
¤ The film-coated tablet should be swallowed whole with sufficient liquid and may be taken with or without the meals.
Duration of administration:
¤ Moxifloxacin 400 mg film-coated tablets should be used for the following Treatment durations:
- Community Acquired Pneumonia 5 - 14 days
- Uncomplicated Skin And Skin Structure Infections. 7 days
- Complicated Skin And Skin Structure Infections 5 - 21 days
- Complicated Intra-Abdominal Infections. 5 - 14 days
- Acute Bacterial Sinusitis 7 days
- Acute Bacterial Exacerbation Of Chronic Bronchitis 5 days
- Moxifloxacin is a fluorinated-4-quinolone or fluoroquinolone antibacterial with a wider spectrum of activity than nalidixic acid and more favourable pharmacokinetics for use in systemic infection.
- Moxifloxacin works by killing bacteria that cause infections.
- Moxifloxacin is rapidly and well absorbed from the gastro-intestinal tract. Oral bioavailability is approximately 90% and a peak plasma concentration of about 4.2 μg/ml is achieved 1 to 2 hours after oral adminstration of 400 mg by mouth. Absorption not affected by the presence of food.
- The plasma half life is about 12 hours.
- Plasma protein binding 50%.
- Moxifloxacin is widely distributed in the body, it crosses the placenta and is distributed into breast milk.
- Approximately 45% of an orally administered dose is excreted as
unchanged drug (~20% in urine and ~25% in feces).
Each film-coated tablet of Moxival® contains:
- Moxifloxacin 400 mg
¤ Moxifloxacin should only be used to treat these infections when usual antibiotics cannot be used or have not worked
¤ Moxival® is used in patients of 18 years of age and older for treating the following bacterial infections when caused by bacteria against which Moxifloxacin is active:
- Community Acquired Pneumonia
- Uncomplicated Skin And Skin Structure Infections.
- Complicated Skin And Skin Structure Infections.
- Complicated Intra-Abdominal Infections.
- Acute Bacterial Sinusitis.
- Acute Bacterial Exacerbation of Chronic Bronchitis
Moxival® is contra-indicated in
- patients with a history of hypersensitivity to Moxifloxacin or other quinolone derivatives.
- If you are younger than 18 years of age.
- If you are pregnant or breast-feeding.
- If you have a severe liver disease or increased liver enzymes (transaminases) higher than 5 times the upper normal limit.
- If you have a salt imbalance in the blood (especially low levels of potassium or magnesium in the blood).
- If you have a weak heart (heart failure),bradycardia,abnormal heart
rhythms. - If you are taking other medicines that result in abnormal ECG changes
This is because Moxifloxacin can cause changes on the ECG, that is a
prolongation of the QT-interval, i.e., delayed conduction of electrical
signals
¤ If you are taking Moxival® and other medicines that affect your heart there is an increased risk for altering your heart beats. Therefore, do not take Moxival® together with the following medicines:
- Medicines that belong to the group of anti-arrhythmics (e.g.quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide)
- neuroleptics (e.g.phenothiazines, pimozide, sertindole , haloperidol , sultopride).
- tricyclic antidepressants
- some antimicrobials (e.g. sparfloxacin, intravenous erythromycin, pentamidine )
- antimalarials particularly halofantrine,
- some antihistamines (e.g. terfenadine,astemizole, mizolastine)
- and other medicines (e.g. cisapride, intravenous vincamine, and diphemanil).
¤ On the other hand, reduce the absorption of Moxival® and related drugs when given concomitantly with :
- Cations like aluminum, magnesium
- iron
( should be after or before 2 hours of Moxival® adminstration ).
As with other quinolones, side effects are usually:
- Gastro-intestinal disturbances include: nausea, vomiting, diarrhoea, abdominal pain and dyspepsia.
- Headache, dizziness, Hypokalemia
- Infections caused by resistant bacteria or fungi e.g.oral and vaginal infections caused by Candida.
- change of the heart rhythm (ECG) in patients with low blood potassium level.
- Hypersensitivity type reactions affecting the skin, in addition to rash and pruritis.
¤ The recommended dose is one 400 mg film-coated tablet once daily.
¤ The film-coated tablet should be swallowed whole with sufficient liquid and may be taken with or without the meals.
Duration of administration:
¤ Moxifloxacin 400 mg film-coated tablets should be used for the following Treatment durations:
- Community Acquired Pneumonia 5 - 14 days
- Uncomplicated Skin And Skin Structure Infections. 7 days
- Complicated Skin And Skin Structure Infections 5 - 21 days
- Complicated Intra-Abdominal Infections. 5 - 14 days
- Acute Bacterial Sinusitis 7 days
- Acute Bacterial Exacerbation Of Chronic Bronchitis 5 days
Moxival® should be used with caution in patients with:
- epilepsy ,myasthenia gravisor ,complicated infection of the female upper genital tract , glucose-6-phosphate dehydrogenase deficiency.
- During treatment, patients should not expose themselves to sunlight, UV rays (due to photosensitivity reactions.)
- Avoid driving or other activities requiring alertness.
- Moxival® Film coated tablet 400 mg (Blister of 5Tablets, Box of one blister).
- Store in a dry place at a temperature not exceeding 30° C.