MOXICLAV BIS DRY POWDER FOR ORAL SUSPENSION 457MG/5ML [SIN16453P]

Product Info

MOXICLAV BIS DRY POWDER FOR ORAL SUSPENSION 457MG/5ML

[SIN16453P]

4.1 Therapeutic indications

Moxiclav Bis should be used in accordance with local official antibiotic prescribing guidelines and local susceptibility data.

Moxiclav Bis suspension for twice daily oral dosing, is indicated for short term treatment of bacterial infections at the following sites when amoxicillin resistant beta-lactamase producing strains are suspected as the cause. In other situations, amoxicillin alone should be considered.

Upper respiratory tract infections (including ENT) e.g. recurrent tonsillitis, sinusitis, otitis media.

Lower respiratory tract infections e.g. acute exacerbations of chronic bronchitis, lobar and bronchopneumonia.

Urinary tract infections e.g. cystitis, urethritis, pyelonephritis.

Skin and soft tissue infections e.g. cellulitis, animal bites.

Susceptibility to Moxiclav Bis will vary with geography and time. Local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary.

Mixed infections caused by amoxicillin-susceptible organisms in conjunction with Moxiclav Bis susceptible beta-lactamase producing organisms may be treated with Moxiclav Bis suspension 457 mg/5 ml. These infections should not require the addition of another antibiotic resistant to beta-lactamases.

4.2 Posology and method of administration

Posology

Doses are expressed throughout in terms of amoxicillin/clavulanic acid content except when doses are stated in terms of an individual component.

The dose of Moxiclav Bis that is selected to treat an individual infection should take into account:

• The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• The severity and the site of the infection

• The age, weight and renal function of the patient as shown below.

The use of alternative presentations of Moxiclav (e.g. those that provide higher doses of amoxicillin and/or different ratios of amoxicillin to clavulanic acid) should be considered as necessary (see sections 4.4 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The usual recommended daily dosage is:

• 25/3.6 mg/kg/day in mild to moderate infections (upper respiratory tract infections e.g. recurrent tonsillitis, lower respiratory infections and skin and soft tissue infections).

• 45/6.4 mg/kg/day for the treatment of more serious infections (upper respiratory tract infections e.g. otitis media and sinusitis, lower respiratory tract infections e.g. bronchopneumonia and urinary tract infections).

No clinical data are available on doses above 45/6.4 mg/kg/day in children under 2 years.

There are no clinical data for Moxiclav Bis suspension 457 mg/5 mL to make dosage recommendations for children under 2 months old.

The tables below give dosage guidance for children.

Children aged 2 months to under 2 years

Children under 2 years should be dosed according to body weight.

Elderly

No dose adjustment is considered necessary.

Renal impairment

No dose adjustment is required in patients with creatinine clearance (CrCl) greater than 30 ml/min.
In patients with creatinine clearance less than 30 ml/min, the use of Moxiclav Bis presentations with an amoxicillin to clavulanic acid ratio of 7:1 is not recommended, as no recommendations for dose adjustments are available.

Hepatic impairment

Dose with caution and monitor hepatic function at regular intervals (see sections 4.3 and 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). There is, as yet, insufficient evidence on which to base a dosage recommendation.

Method of administration

Moxiclav Bis is for oral use.
Administer at the start of a meal to minimise potential gastrointestinal intolerance and optimise absorption of amoxicillin/clavulanic acid.
Treatment should not exceed 14 days without review.
Therapy can be started parenterally according to the SmPC of the IV-formulation and continued with an oral preparation.
Shake to loosen powder, add water as directed, invert and shake.
Shake the bottle before each dose (see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

For instructions on reconstitution of the medicinal product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications

• Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• History of hypersensitivity to beta-lactams, e,g. cephalosporins

• History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid (see section 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).