Moxiclav BIS Dosage/Direction for Use

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 Precautions).
The severity and the site of the infection.
The age, weight and renal function of the patient as shown as follows.
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 Precautions and Pharmacology: Pharmacodynamics under Actions).
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 as follows give dosage guidance for children. (See Table 3.)

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Children aged 2 months to under 2 years: Children under 2 years should be dosed according to body weight. (See Table 4.)

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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 Contraindications and Precautions). 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 Special precautions for disposal and other handling under Cautions for Usage).
For instructions on reconstitution of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.