JOYLOXIN FILM COATED TABLET 400MG [SIN15670P]

Product Info

JOYLOXIN FILM COATED TABLET 400MG

[SIN15670P]

INDICATIONS
JOYLOXIN tablets are indicated for the treatment of the following bacterial infections caused by bacteria susceptible to moxifloxacin.

• Acute bacterial sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae or Moraxella catarrhalis.

• Acute bacterial exacerbations of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydia pneumoniae or Moraxella catarrhalis.

• Community acquired pneumonia (of mild to moderate severity) caused by Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydia pneumoniae or Moraxella catarrhalis.

• Uncomplicated skin and skin structure infections caused by Staphylococcus aureus or Streptococcus pyogenes.

• Complicated skin and skin structure infections caused by methicillin-susceptible Staptococcus aureus, Escherichia coli, Klebsiella pneumoniae or Enterobacteriaceae.
  JOYLOXIN tablets should not be used to initiate therapy for any type of skin and skin structure infection or in severe community-acquired pneumonia.

• Mild to moderate pelvic inflammatory disease (i.e. infections of female upper genital tract, including salpingitis and endometritis), without an associated tubo-ovarian or pelvic abscess.

JOYLOXIN tablets are 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 gonorrhoeae.
Joyloxin 400mg tablets are indicated for the treatment of the above infections if they are caused by bacteria susceptible to moxifloxacin.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.

DOSAGE AND ADMINISTRATION
Posology (adults)
The recommended dose is 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. haemodialysis 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 bodyweight.

Paediatric population
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
The film-coated tablet should be swallowed whole with sufficient liquid and may be taken independent of meals.

Duration of administration
JOYLOXIN tablets should be used for the following treatment durations:

JOYLOXIN tablets have been studied in clinical trials for up to 14 days treatment.

Sequential (intravenous followed by oral) therapy
In clinical studies with sequential therapy most patients switched from intravenous to oral therapy within 4 days (community-acquired pneumonia) or 6 days (complicated skin and skin structure infections). The recommended total duration of intravenous and oral treatment is 7 –14 days for community-acquired pneumonia and 7 –21 days for complicated skin and skin structure infections. The recommended dose (400 mg once daily) and duration of therapy for the indication being treated should not be exceeded.

CONTRAINDICATIONS

1. Patients with a history of hypersensitivity to moxifloxacin, other quinolones or to any of the excipients.

2. Children and adolescents below 18 years of age (Efficacy and safety in children and adolescents have not been established).

3. Pregnancy and lactation.

4. Patients with impaired liver function (Due to limited clinical data).

5. Patients with transaminases increase > 5 fold ULN.

6. Patients with a history of tendon disease/disorder related to quinolone treatment.

7. Patients with known prolongation of the QT interval.

8. Patients with electrolyte disturbances (Particularly in uncorrected hypokalaemia).

9. Patients with bradycardia, a history of symptomatic arrhythmias.

10. Patients with heart failure with reduced left-ventricular ejection fraction.

11. Patients receiving anti-arrhythmics Class IA (for example quinidine, procainamide) or Class III (for example amiodarone, sotalol), antipsychotics, tricyclic antidepressive agents, certain antimicrobial agents (saquinavir, sparfloxacin, erythromycin IV, pentamidine, antimalarials particularly halofantrine), certain antihistaminics (terfenadine, astemizole, mizolastine), others (cisapride, vincamine IV, bepridil, diphemanil).