CURAM FILM-COATED TABLET 625 MG [SIN10599P]

Product Info

CURAM FILM-COATED TABLET 625 MG

[SIN10599P]

4.1 Therapeutic indications
Amoxicillin/clavulanic acid is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information):

• Acute bacterial sinusitis (adequately diagnosed)

• Acute otitis media

• Acute exacerbations of chronic bronchitis (adequately diagnosed)

• Community-acquired pneumonia

• Cystitis

• Pyelonephritis

• Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis

• Bone and joint infections, in particular osteomyelitis

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2 Posology and method of administration
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 Curam 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 amoxicillin/clavulanic acid (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).

For adults and children ≥ 40 kg, this formulation of Curam provides a total daily dose of 1500 mg amoxicillin/375 mg clavulanic acid, when administered as recommended below.
Curam oral dosage recommendations for children below the age of 12 years are based on 25–50mg/kg body weight /day (based on amoxicillin component), depending on the severity of infection. If it is considered that a higher daily dose of amoxicillin is required, it is recommended that another preparation of amoxicillin/clavulanic acid is selected in order to avoid administration of unnecessarily high daily doses of clavulanic acid (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 duration of therapy should be determined by the response of the patient. Some infections (e.g. osteomyelitis) require longer periods of treatment. Treatment should not be extended beyond 14 days without review (see section 4.4 regarding prolonged therapy – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Adults and children ≥ 40 kg

Children 7 – 12 years
10 ml Curam 156.25 mg/5 ml suspension three times a day, or
5 ml Curam 312.5mg/5 ml suspension three times a day*

Children 2 – 7 years
5 ml Curam 156.25 mg/5 ml suspension three times a day*

Children 9 months – 2 years
2.5 ml Curam 156.25 mg/5 ml suspension three times a day*

Children 0 – 9 months
No suitable oral presentation is currently available for this age group.

* These dosages may be doubled in severe infections.

Children may be treated with Curam tablets or suspensions. Children aged 6 years and below should preferably be treated with Curam suspension.

No clinical data are available on doses of amoxicillin/clavulanic 4:1 formulations higher than 40 mg/10 mg/kg per day in children under 2 years.

Elderly
No dose adjustment is considered necessary.

Renal impairment
Dose adjustments are based on the maximum recommended level of amoxicillin.
No adjustment in dose is required in patients with creatinine clearance (CrCl) greater than 30 ml/min.

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).

Not all strengths/presentations are available locally.

Method of administration
Curam is for oral use.

Administer with a meal to minimise potential gastrointestinal intolerance.

Therapy can be started parenterally according the SPC of the IV-formulation and continued with an oral preparation.

4.3 Contraindications

• Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients

• History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam)

• 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)