Moxavidex broad spectrum antibiotic for acute bacterial sinusitis and community acquired pneumonia

Moxavidex                                                                                           Broad Spectrum Antibiotic
5 Film Coated Tablets

Company :

Pharmed healthcare for utopia Pharmaceuticals.

Composition :

Each film coated tablet contains:                                                     Active Ingredients:
Moxifloxacin hydrochloride 436.8 mg equivalent to 400mg
moxifloxacin .
Inactive Ingredients:
Lactose anhydrous – Avicel PH1 01- Povidon – Magnesium stearat
PEG 6000 – H.P.M.C-Titanium dioxide-Crosscarmellose sodium-Is

Pharmacological Action :

Moxavidex tablet has activity against a wide range of gram -positiv
and gram-negative bacteria, its action results from inhibition of
topoisomerase2 ( DNA gyrase ) and topisomerase 4 required for
bacterial replication, transcription, repair, and recombination.

Pharmacokinetics :

Absorption: Moxifloxacin, given as an oral tablet, is well absorbei
from the gastrointestinal tract. The absolute bioavailability of moxifloxacin is approximately 90 percent.
Distribution: Moxifloxacin is widely distributed throughout the body with tissue concentration often exceeding plasma concentration. Moxiftoxacin has been detected in the saliva ,nasal and bronchial secretions, mucosa of the sinuses ,skin blister ftuid, subcutaneous tissue, and skeletal muscle following oral administration of 400 m,
Metabolism: Moxiftoxacin is metabolized via glucuronide and
sulfate conjugation. The cytochrome p450 system is not involved i
moxiftoxacin metabolism ,and is not affected by moxiftoxacin. It is eliminated primarily in the feces. Proximately 14% of an oral dose is excreted in the urine.
Excretion: Approximately 45% of an oral doses of moxiftoxacin is
excreted uncharged drug (20% in the urine and 25%in feces), tote
of 96% ± 4% of an oral dose is excreted as either unchanged druc
or known metabolites.

Indications and Usage :

– Moxavidex tablets are indicated for the treatment of adults with
infections caused by susceptible strains of the designated
Microorganism in the following condition:
– Acute Bacterial Sinusitis.
– Acute Bacterial Exacerbation of Chronic Bronchitis.
– Community Acquired Pneumonia.
– Uncomplicated Skin and Skin Structure Infections.
– Complicated Intra-abdominal Infections.
– Complicated Skin and Skin Structure Infections.

Dosage and Administration :

– The dosage of moxiftoxacin is one 400 mg tablet taken orally
every 24 hours.
– The duration of therapy depends on the type of infection as
described below:
Infection                                                              Daily Dose     Duration     Acute Bacterial Sinusitis                                     400 mg     10 days
Acute Bacterial Exacerbation of Chronic Bronchitis  400 mg   5 days Community Acquired Pneumonia                     400 mg     7-14 day
Uncomplicated Skin and Skin Structure Infections   400mg     7 days  Complicated Skin and Skin Structure Infections   400 mg   7-21 day   Complicated Intra-abdominal Infections     400 mg        5-14 day
– Due to the designated pathogens Oral doses of moxiftoxacin should be administered at least 4 hours before or 8 hours after antacids containing, metal cations such as iron, and multivitamin preparations with zinc.

Contraindications :

Moxiftoxacin contraindicated in persons with a history of
hypersensitivity to moxitloxacin or any member of the quinolone
class of antimicrobial agents.

Pregnancy & Lactation :

Moxiftoxacin is contraindicated during pregnancy category C & lactati

Adverse Reactions :

Rarely adverse reaction such as: Nausea, diarrhea, dizziness,
headache, abdominal pain, vomiting, taste perversion, abnormal
liver function test, and dyspepsia Post marketing experience: Exacerbation of myasthenia gravis.

Drug-Drug Interactions :

There was no clinically significant effect of moxifloxacin on theophyline, warfarin, digoxin, or glyburide kinetics. However, as with all other quinolones, iron and antacids significantly reduce the bioavailability of moxifloxacin.

Precautions :

– In general quinolones may cause nervousness, insomnia, anxiety
or nightmares.
– Renal insufficiency: The pharmacokinetic parameters of moxifloxacin are not significantly altered by mild, moderate, or server renal impairment.
– The pharmacokinetics of moxifloxacin with moderate and severe
hepatic insufficiency have not been, adequately studied due to the
lack of clinical data, the use of moxifloxacin is not recommended
with moderate and severe hepatic insufficiency.

– Moxifloxacin should be administered at least 4 hours before or 8
hours after antacids containing, metal cations such as iron, and
multivitamin preparations with zinc.                                                        – QT Effects: Fluoroquinolones may prolong the QT interval in some
patients. Moxifloxacin should be avoided in patients with a history of
prolongation of the OT interval, patients with uncorrected electrolyte disorders (hypokalemia or hypomagnesemia), and patients receiving antiarrhythmic agents as quinidine.                         – Exacerbation of myasthenia gravis: Fluoroquinolones have
neuromuscular blocking activity and may exacerbate muscle
weakness in persons with myasthenia gravis. Postmarketing serious adverse events, including deaths and requirement for ventilator support, have been associated with fluoroquinolone use in persons with myasthenia gravis. Avoid fluoroquinolones in patients with known history of myasthenia gravis.                                                        – Quinolones should not generally be used in patients aged less than
18 years, pregnant women, or breast-feeding mothers unless the
benefits outweigh the risks.

Package :

Carton box contains 1 ( PVO I Aluminium) strip of 5 film coated
tablets with insert leaflet.

Storage :

– Store at a temperature not exceeding 30·c in a dry place.
– Keep out of reach of children.

Informations for Patient :

– Keep this leaflet. You may need to read it again.
– If you have any further question, ask your doctor or pharmacist.
– This medicine has been prescribed for you.
– Do not pass it on to other.
– It may harm them, even if their symptoms are the same as yours.
– If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.

Produced by :

Pharmed Healthcare for Utopia Pharmaceuticals.

موكسافيدكس لعلاج عدوى الانف والاذن والحنجرة والجيوب الانفية وعدوى الجلد والانسجة الرخوة