Cefim has been shown to be active against most strains of the following Gram-positive and Gram-negative organisms:

Streptococcus pneumonia, Streptococcus pyogenes, Streptococcus agatactiae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella (Branhamella) catarrhalis, Escherichia coli, Proteus mirabilis, Proteus vulgaris, Neisseria gonorrhoeae, Klebsiella pneumoniae, Klebsiella oxytoca, Pasteurella multocida, Providencia species, Salmonella species, Shigella species, Citrobacter diversus, Serratia marcescens.

Cefim is indicated in the treatment of the following:

-  Pharyngitis, tonsillitis and sinusitis.

-  Acute bronchitis and acute exacerbations of chronic bronchitis.

-  Otitis media.

-  Uncomplicated urinary tract infections.

-  Uncomplicated urethral or cervical gonorrhea.

Adults:

The recommended dose of Cefim is 400 mg daily. This may be given as a 400 mg capsule once daily or as 200 mg capsule every 12 hours.

For the treatment of uncomplicated urethral or cervical gonococcal infections, a single oral dose of 400 mg is recommended.

Children:

The recommended dose is 8mg/kg/day of Cefim suspension. This may be administered as a single daily dose or may be given in two divided doses, as 4 mg/kg every 12 hours.

Children weight more than 50 kg or older than 12 years should be treated with the recommended adult dose.

Renal impairment: Cefim may be administered in the presence of impaired renal function as follows:

Creatinine clearance                Dose

>60 ml/min                  standard dose (400 mg daily)

21-60 ml/min               75% of the standard dose (300 mg daily)

<20 ml/min                  half the standard dose (200 mg daily)

Reconstitution:    Invert bottle and shake powder loose. Add the volume of water stated on the bottle label and outer box in two portions shaking after each addition until a homogeneous suspension is achieved. When first reconstituted, allow to stand for five minutes to ensure full dispersion.

Before starting therapy with cefixime it should be ascertained if there have been any previous hypersensitivity reactions to cephalosporins or penicillins. In the event of allergic reactions administration of the drug should be suspended and the patient should receive opportune treatment. As pseudomembranous colitis may appear during treatment with broad-spectrum antibiotics (including macrolides, semi-synthetic penicillins and cephalosporins), the onset of this form of colitis should be taken into consideration during treatment with these drugs. Extreme care should be taken when administering cefim to patients with severe renal failure. In such cases the dose should be lower than the normally recommended one. Broad-spectrum antibiotics should be administered with extreme care to patients who have previously suffered from intestinal disorders as antibiotic therapy associated colitis could develop.

PRECAUTIONS:

Prolonged use of antibiotics may result in overgrowth of non-susceptible organisms.

- Probenecid may increase the effects of cefixime, and you may require a lower dose.

- Cefixime may increase the risk of bleeding if it is taken with Anticoagulants (warfarin). You may need a lower dose of warfarin or special monitoring during therapy with cefixime.

- When cefixime and carbamazepine are used together, the amount of carbamazepine in the blood stream may show an increase.

- Coadministration of aminoglycoside antibiotics with cefixime could produce additive nephrotoxic effects.

There are no adequate and well-controlled studies in pregnant women; therefore, this drug should be used during pregnancy only If, clearly needed.

It is not known whether Cefixime is excreted in human milk.

Not applicable

Side effects are mild and transient in nature; the following side effects have been reported:

- diarrhea

- abdominal pain

- nausea

- vomiting

- skin rashes

- urticaria

- Transient elevation in liver enzymes.

Gastric lavage may be indicated; otherwise, no specific antidote exists. Ceflxime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in healthy adult volunteers receiving single doses up to 2 g of Ceflxime did not differ from the profile seen in patients treated at the recommended doses.

Cefixime is an oral third generation cephalosporin which has marked in vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organisms.

Clinical efficacy has been demonstrated in infections caused by commonly occurring pathogens including Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae (beta-lactamase positive and negative), Branhamella catarrhalis (beta-lactamase positive and negative) and Enterobacter species. It is highly stable in the presence of beta-lactamase enzymes.

Most strains of enterococci (Streptococcus faecalis, group D Streptococci) and Staphylococci (including coagulase positive and negative strains and methicillin-resistant strains) are resistant to cefixime. In addition, most strains of Pseudomonas, Bacteroides fragilis, Listeria monocytogenes and Clostridia are resistant to cefixime.

The absolute oral bioavailability of cefixime is in the range of 22-54%. Absorption is not significantly modified by the presence of food. Cefixime may therefore be given without regard to meals.

From in vitro studies, serum or urine concentrations of 1 mcg/ml or greater were considered to be adequate for most common pathogens against which cefixime is active. Typically, the peak serum levels following the recommended adult or paediatric doses are between 1.5 and 3 mcg/ml. Little or no accumulation of cefixime occurs following multiple dosing.

The pharmacokinetics of cefixime in healthy elderly (age> 64 years) and young volunteers (11-35) compared the administration of 400 mg doses once daily for 5 days. Mean C_max and AUC values were slightly greater in the elderly. Elderly patients may be given the same dose as the general population.

Cefixime is predominantly eliminated as unchanged drug in the urine. Glomerular filtration is considered the predominant mechanism. Metabolites of cefixime have not been isolated from human serum or urine.

Serum protein binding is well characterised for human and animal sera; cefixime is almost exclusively bound to the albumin fraction, the mean free fraction being approximately 30%. Protein binding of cefixime is only concentration dependent in human serum at very high concentrations which are not seen following clinical dosing.

Transfer of ¹⁴C-labelled cefixime from lactating rats to their nursing offspring through breast milk was quantitatively small (approximately 1.5% of the mothers' body content of cefixime in the pup). No data are available on secretion of cefixime in human breast milk. Placetal transfer of cefixime was small in pregnant rats dosed with labelled cefixime.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.

Ethyl cellulose, stearic acid, dichloromethane, sucrose, colloidal anhydrous silica, sodium benzoate, xanthan gum, pharmaceutical flavour- pineapple flavour

not applicable

Store dry powder prior to reconstitution below 30ºC

Store reconstituted suspension under refrigeration.

Protect from light and moisture.

Keep out of the reach of children.

Cefim-100: bottle of 60 ml

Medicament is a product which affects your health, and its consumption contrary to instruction is dangerous for you.

* Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.

* The doctor and the pharmacist are experts in medicine, its benefits and risks.

* Do not by yourself interrupt the period of treatment prescribed for you.

* Do not repeat the same prescription without consulting your doctor.

KEEP MEDICINES OUT OF THE REACH OF CHILDREN