CLAVUMED Film-coated tablet Ref.[115217] Active ingredients: Amoxicillin Clavulanic acid

Posology

For Oral Formulations

Tablets should be taken immediately before a meal.

Dosages

General Information

For infections caused by amoxicillin sensitive organisms the dosage is that approved for amoxicillin as the clavulanic acid component does not contribute to the therapeutic effect.

Adults

The adult dose for CLAVUMED 375 and 625 Tablets is one CLAVUMED 375 Tablet every eight hours at the start of a meal. For more severe infections and infection of the respiratory tract, the dose should be one CLAVUMED 625 Tablet every eight hours at the start of a meal. Since CLAVUMED 375, 625 and 1 g tablets contain the same amount of clavulanic acid (125 g as the potassium salt), two CLAVUMED 375 tablets are not equivalent to one CLAVUMED 625 tablet and two CLAVUMED 625 tablets are not equivalent to one CLAVUMED 1 g. Therefore, two CLAVUMED 375 tablets should not be substituted for one CLAVUMED 625 tablet or two CLAVUMED 625 tablets for one CLAVUMED 1 g tablet for the treatment of more severe infections.

Special populations

Impaired renal function

• Both amoxicillin and clavulanic acid are excreted by the kidneys and the serum half-life of each increases in patients with renal failure. Therefore, the dose may need to be reduced or the interval extended.
• Dosage adjustments are based on the maximum recommended level of amoxicillin.

The following schedule is proposed.

• Mild impairment (creatinine clearance greater than 30 ml/min): No change in dosage.
• Moderate impairment (creatinine clearance 10 to 30 ml/min): 1 Tablet every 12 hours.
• Haemodialysis decreases serum concentrations of both amoxicillin and clavulanic acid and an additional dose should be administered at the end of dialysis.

Dosage guide:

Method of administration

For oral use.

In overdose, side effects can be precipitated and/or be of increased severity (see section 4.8).

Symptoms

• Overdosage with amoxicillin is usually asymptomatic.
• Gastro-intestinal effects such as nausea, vomiting and diarrhoea may be evident and symptoms of water and electrolyte imbalance should be treated symptomatically.
• Adequate fluid intake and urinary output must be maintained to minimize the possibility of crystalluria.

Treatment

• Amoxicillin may be removed from the circulation by haemodialysis. The molecular weight, degree of protein binding and pharmacokinetic profile of clavulanic acid together with information from a single patient with renal insufficiency all suggest that this compound may also be removed by haemodialysis.

24 months.

Store at or below 25°C, protected from light and moisture.

KEEP OUT OF REACH OF CHILDREN.

Clavumed 375:

Aluminium strip pack containing 15 and 100 tablets in a carton.

Clavumed 625:

Aluminium strip pack containing 15 tablets in a carton.

Any unused medicine or waste material should be disposed of in accordance with local requirements.