ZINNAT FOR SUSPENSION 125 MG/5 ML [SIN07013P]

Product Info

ZINNAT FOR SUSPENSION 125 MG/5 ML

[SIN07013P]

4.1 Therapeutic indications
ZINNAT is an oral prodrug of the bactericidal cephalosporin antibiotic cefuroxime, which is resistant to most 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 ZINNAT 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 obstructive pulmonary disease).

Genito-urinary tract infections (for example: pyelonephritis, cystitis and urethritis).

Gonorrhoea, acute uncomplicated gonococcal urethritis and cervicitis.

Skin and soft tissue infections (for example: furunculosis, pyoderma and impetigo).

4.2. Posology and method of administration
The usual course of therapy is seven days (range five to ten days). The dose of ZINNAT that is selected to treat an individual infection should take into account:

• The expected pathogens and their likely susceptibility to ZINNAT

• The severity and the site of the infection

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

The duration of therapy should be determined by the type of infection and the response of the patient, and should generally not be longer than recommended.

Dosage in adults:

Dosage in children:
There is no clinical trial data available on the use of ZINNAT in children under the age of 3 months.

The following two tables serve as a guideline for simplified administration from measuring spoons (5 ml) for the 125 mg/5 ml or the 250 mg/5 ml multidose suspension, and 125 mg or 250 mg single dose sachets.

10 mg/kg dosage

15 mg/kg dosage

To enhance compliance and improve the dosing accuracy in very young children, a dosing syringe can be supplied with a multidose bottle containing 50 ml of suspension. However, dosing in spoonfuls should be considered a more favourable option if the child is able to take the medication from the spoon.

If required, the dosing syringe may also be used in older children (please refer to the dosing tables below).

The recommended doses for the paediatric dosing syringe are expressed in ml or mg and according to body weight in the following tables.

10 mg/kg/dose (Paediatric dosing syringe)

15 mg/kg/dose (Paediatric dosing syringe)

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.
For optimal absorption, ZINNAT should be taken after food.

4.3 Contraindications
Patients with known hypersensitivity to cephalosporin antibiotics.