Cubimox 400 mg Tab

Cubimox 400 mg Tab

COMPOSITION

Each film-coated tablet contains Moxifloxacin Hydrochloride BP equivalent to Moxifloxacin 400 mg.

DESCRIPTION

Moxifloxacin is a synthetic broad spectrum, fluoroquinolone derivative antibacterial agent. Moxifloxacin has in vitro activity against a wide range of Gram-positive and Gram-negative microorganisms. The bactericidal action of Moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV required for bacterial DNA replication, transcription, repair and recombination.

INDICATION

Moxifloxacin is indicated for the treatment of adults (≥18 years of age) with infections caused by susceptible strains of the designated microorganisms in the conditions listed below :

 Acute Bacterial Sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae or Moraxella catarrhalis.

 Acute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Methicillin-susceptible Staphylococcus aureus or Moraxella catarrhalis.

 Community Acquired Pneumonia caused by Streptococcus pneumoniae (including multi-drug resistant strains), Haemophilus influenzae, Moraxella catarrhalis, Methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae or Chlamydophilia pneumoniae.

 Uncomplicated Skin and Skin Structure Infections caused by Methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes.

 Complicated Skin and Skin Structure Infections caused by Methicillin-susceptible Staphylococcus auras, Escherichia coli, Klebsiella pneumoniae or Enterobacter cloacae.

 Complicated Intra-Abdominal Infections including polymicrobial infections such as abscess caused by Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens,Bacteroides thetaiotaomicron or Peptostreptococcus species.

DOSAGE AND ADMINISTRATION

Adult: The dose of Moxifloxacin is 400 mg once every 24 hours. The duration of therapy depends on the type of infection as described below: 

SIDE EFFECTS

The following one or more side effects may be observed: Tendinopathy and tendon rupture, QT prolongation, hypersensitivity reactions, Clostridium difficile-associated diarrhea, peripheral neuropathy, photosensitivity, photo toxicity etc.

CONTRAINDICATIONS

Moxifloxacin is contraindicated in persons with a history of hypersensitivity to Moxifloxacin or any member of the quinolone class of antimicrobial agents and any component of this product.

PRECAUTIONS

Moxifloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Moxifloxacin should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon.

USE IN PREGNANCY AND LACTATION

Pregnancy Category C. Moxifloxacin is not recommended during pregnancy & lactation.

DRUG INTERACTIONS

No quinolone should be co-administered with any solution containing multivalent cautions (e.g. magnesium) through the same intravenous line. Antacids iron and adsorbents reduce absorption of Moxifloxacin. NSAIDs may increase the risk of CNS stimulation. Warfarin may increase the risk of bleeding.

OVERDOSAGE

In the events of an acute over dosage, the stomach should be emptied. The patients should be kept under observation and appropriate hydration should be maintained.

SUPPLY

Each box contains 24 tablets in Alu-Alu blisters.