XORIMAX 250MG COATED TABLETS [SIN13287P]

Product Info

XORIMAX 250MG COATED TABLETS

[SIN13287P]

4.1 Therapeutic indications

Xorimax is an oral prodrug of the bactericidal cephalosporin antibiotic cefuroxime, which is resistant to most β (beta)-lactamases and is active against a wide range of Gram-positive and Gram-negative organisms.

It is indicated for the treatment of infections caused by susceptible bacteria. Susceptibility to Xorimax will vary with geography and time, and it should be used in accordance with local official antibiotic prescribing guidelines and local susceptibility data (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Indications include:

• Upper respiratory tract infections for example, ear, nose, and throat infections, such as otitis media, sinusitis, tonsillitis, and pharyngitis

• Lower respiratory tract infections for example, pneumonia and acute exacerbations of chronic bronchitis

• Skin and soft tissue infections for example, furunculosis, pyoderma and impetigo

• Genito-urinary tract infections for example, pyelonephritis, cystitis, and urethritis

• Gonorrhoea, acute uncomplicated gonococcal urethritis, and cervicitis

4.2 Posology and method of administration

The usual course of therapy is seven days (range 5 – 10 days). The dosage and route of administration are suited to the severity of the infection, the sensitivity of the pathogen, and the condition of the patient.

Dosage in renal impairment:
Cefuroxime is primarily excreted by the kidneys. In patients with markedly impaired renal function, it is recommended that the dosage of cefuroxime be reduced to compensate for its slower excretion (see the table below).

Method of administration
Oral use.
Xorimax should be taken after food for optimum absorption.

Xorimax tablets should not be crushed and are therefore unsuitable for treatment of patients, such as younger children, who cannot swallow tablets. There is no experience of using Xorimax in children under the age of 3 months.

4.3 Contraindications

Hypersensitivity to cefuroxime 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.

Patients with known hypersensitivity to cephalosporin antibiotics.

History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems).