MOXIFLOXACIN-TEVA F.C. TABLET 400 MG

PHARMATHEN S.A. (GREECE)🇸🇬 Health Sciences Authority

Approval Date: Dec 1, 2015
Approval ID: a721c6d778e0b4f4
Company: PHARMATHEN S.A. (GREECE)
Type: Therapeutic

Approval Details

Approval Id: a721c6d778e0b4f4
Drug Name: MOXIFLOXACIN-TEVA F.C. TABLET 400 MG
Product Name: MOXIFLOXACIN-TEVA F.C. TABLET 400 MG
Approval Number: SIN14900P
Approval Date: 2015-12-01
Registrant: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
Licence Holder: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET, FILM COATED
Dosage: 4.2 Dosage and method of administration 4.2.1 Method of administration Film-coated tablet: The film-coated tablet should be swallowed whole with sufficient liquid and may be taken independent of meals. 4.2.2 Dosage Regimen Dose (adults): The recommended dose for Moxifloxacin is 400 mg once daily (1 film coated tablet) for the above mentioned indications and should not be exceeded. For complicated skin and skin structure infections, therapy should usually be initiated with intravenous formulation. When switching from intravenous to oral dosage administration, no dosage adjustment is necessary. Patients whose therapy is started with Moxifloxacin I.V. may be switched to Moxifloxacin Tablets when clinically indicated at the discretion of the physician. Duration of treatment: The duration of treatment should be determined by the severity of the indication or clinical response. The following general recommendations are made: Acute exacerbation of chronic bronchitis, 5 days Acute sinusitis, 7 days Uncomplicated skin and skin structure infections, 7 days Community acquired pneumonia (mild to moderate in severity) 10 days Community acquired pneumonia: total recommended duration for sequential administration (intravenous followed by oral therapy) is 7–14 days Complicated skin and skin structure infections: total treatment duration for sequential therapy (intravenous followed by oral therapy) is 7–21 days Mild to moderate pelvic inflammatory disease, 14 days The recommended duration of treatment for the indication being treated should not be exceeded. Moxifloxacin 400 mg film-coated tablets and 400 mg solution for infusion have been studied in clinical trials for up to 21 days (in complicated skin and skin structure infections). 4.2.3 Additional information on special populations: 4.2.3.1 Children and adolescents Efficacy and safety of Moxifloxacin in children and adolescents have not been established (see “Contraindications”). 4.2.3.2 Geriatric patients No adjustment of dosage is required in elderly. 4.2.3.3 Ethnic differences No adjustment of dosage is required in ethnic groups. 4.2.3.4 Patients with hepatic impairment No dosage adjustment is required in patients with mild or moderate impaired liver function. The use of moxifloxacin is not recommended in patients with severe hepatic impairment (Child Pugh C) (see “Special warnings and precautions for use” in Child Pugh C patients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 4.2.3.5 Patients with renal impairment No dose adjustment is required in patients with any degree of renal impairment (including creatinine clearance < 30 mL/min/1.73m2) and in patients on chronic dialysis i.e. hemodialysis and continuous ambulatory peritoneal dialysis.
Route Of Administration: ORAL
Indication Info: 4.1 Indications Moxifloxacin-Teva F.C. Tablet 400 mg are indicated for the treatment of the following bacterial infections caused by susceptible strains: <ul> <li>Respiratory tract infections: 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, Staphylococcus aureus, or Moraxella catarrhalis. Community Acquired Pneumonia (of mild to moderate severity) caused by Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Moraxella catarrhalis.</li> <li>Uncomplicated skin and skin structure infections caused by Staphylococcus aureus or Streptococcus pyogenes</li> <li>Complicated skin and skin structure infections caused by methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae or Enterobacter cloacae.</li> <li>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.</li> </ul> Moxifloxacin-Teva F.C. Tablet 400 mg 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 (eg. a cephalosporin) due to increasing moxifloxacin resistance of Neisseria gonorrhoeae. Moxifloxacin-Teva F.C. Tablet 400 mg are indicated for the treatment of the above infections if they are caused by bacteria susceptible to moxifloxacin. For a full list of susceptible strains, please refer to “Pharmacodynamic Properties” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Contraindications: 4.3 Contraindications Known hypersensitivity to moxifloxacin or other quinolones or any of the excipients. Pregnancy and lactation. 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. For reasons of drug safety, Moxifloxacin is therefore contraindicated in patients with: <ul> <li>Congenital or documented acquired QT prolongation</li> <li>Electrolyte disturbances, particularly in uncorrected hypokalaemia</li> <li>Clinically relevant bradycardia</li> <li>Clinically relevant heart failure with reduced left-ventricular ejection fraction</li> <li>Previous history of symptomatic arrhythmias</li> </ul> Moxifloxacin should not be used concurrently with other drugs that prolong the QT interval (see also “Interactions with other medicaments and other forms of interaction” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Moxifloxacin is contraindicated in patients with impaired liver function (Child Pugh C) and in patients with transaminases increase > 5 fold ULN.
Atc Code: J01MA14
Atc Item Name: moxifloxacin
Pharma Manufacturer Name: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Active Ingredients

MOXIFLOXACIN HCl 436.37 mg EQV MOXIFLOXACIN

400 mg

MOXIFLOXACIN HCL 436.37 MG EQV MOXIFLOXACIN

400 MG

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Dec 1, 2015

Approval ID

a721c6d778e0b4f4

Type

Therapeutic

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