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Cili-CEF 100mg/200mg 3rd Generation

CiLi-CEF
Dry Suspension

( Cefixime)
30ml/60ml

PRESENTATION:
•    Pediatric Oral Suspension
CiLi-CEF granular dry powder contains 100mg of Cefixime USP in each 5 ml volume of reconstituted strawberry flavored suspension.
•    Forte Oral Suspension
CiLi-CEF granular dry powder contain of Cefixime USP in each 5 ml volume of reconstituted strawberry flavored suspension.

INDICATIONS:
CiLi-CEF is indicated in the treatment of the following infections caused by by the following micro-organisams  susceptible to CiLi-CEF.

MICROORGANISAM:
Streptococcus sp.
Streptococcus pneumonia
Neisseria gonorrhoeae
Neisseria meningitis
Moraxella ( Branhamella ) catarrhalis
Escherichia coli. Klebsiella sp.
Serratia sp.
Proteus sp.
Providencia sp.
Morganella morganii.
Haemophilus Influenzae
Haemophilus parainfluenzae
Salmonella sp.
Shigella sp.
Aeromonas hydrophila
Citrobacter freundii
Citrobacter diversus
Enterobacter sp
Acinetobacter  Lwoffi
Yersinia enterocolitica
Campylobacter jejuni

Infections
Respiratory tract infections

Infections of the upper and lower airways
Pulmonary infections of hacterial etiology
Bronchitis ( acute chronic )
Pneumonia
Bronchiectasis with infection
Secondry  infections in chronic respiratory diseases

Ear nose and throat infections
Otitis media
Sinusitis
Tonsillitis
Pharyngitis
Larynigitis

Gastrointestinal infections
Typhoid

Biliary tract infection
Infections of the biliary tract
Cholecystitis
Cholangitis

Urinary tract infections
Infections of the kidneys and efferent urinary tract
Complicated and uncomplicated urinary tract
Infections except prestatitis
Pyelonephritis
Cystitis
Genococcal urethritis
Uncomplicated gonorrhea (cervical / urethral)

Adult ( use for oral suspension)
The recommended dosage for adults is 400mg/daily. As a general guide for prescribing in children the following daily closes in term of volume of fort oral suspension.
Fort oral suspension
Children 1-4 years     2.5 ml daily
Children 5-9 years     5.0 ml daily
Children 10-12 years     7.5 ml daily
Adult +children over 12 years 10 ml daily
Paediatric oral suspension
Children 1-4 years     5 ml daily
Children 5-9 years     10 ml daily
Children 10-12 years     15 ml daily

The elderly
Elderly patients may be given the same dose as recommended for adults. Renal function should be assessed and dosage should be adjusted in severe renal impairment.

Dosage in renal impairment
CiLi-Cef may be administrated in the presence of impaired renal function. Normal dose and frequency may be given in patients with creatiinine  clearance of 2ml min of greater. In patients whose creatinine clearance is less then 20ml/min, it is recommended that a dose of 200ml once daily should not be exceeded the dose and regimen for patients who are maintained on chronic ambulatory peritoneal dialysis or heamodialysis should follow the same recommendation as that for patient with creatinine clearance of less then 20ml/min.

Contra-indications:
Patients with known allergy to the cephalosporin group of antibiotics.

Precautions & warnings
As a general rule the duration of treatment with this drug should be limited to a minimum period required for the treatment of the patient`s condition., after susceptibility of the micro-organisam to the drug has been confirmed. In order to prevent the emergency of drug – resistant micro-organisam.
Careful ingury should be  made to determine whether the patient has had previous hypersensitivity, to cephalosporins, penicllins or other drugs.
Particular care should be exercised in patient with a personal or familiar predisposition to allergic reaction such as bronchial asthma, rash or urticaria.
Particular care should be exercised in patient with sever gastrointestinal disturbances involving vomiting and diarrhea.
Particular care should be exercised in patient with severely impaired renal function, patient with poor oral nutrition, patient receiving  parenteral nutrition elderly patients or patients in a debilitated state.
Renal function should be monitored with particular care when combining cefixime with an aminoglycoside antibiotic, polymyxinB, colistin or high-dosed loop diuretics (e.g. furosemide).
This is applied espically to patients with pre existing renal impairment.
Adverse reaction to drugs are liable to occur more frequently in the elderly patients since they usually have physiological hypofunction.
Bleeding tendency due to vitamin K deficiency may occur in the elderly.

Use in pregnancy and breast feeding
Like other cephalosporins, Cilicef is included in therapeutic category B of FDS for use in pregnancy. Reproduction studies have been performed in mice and rats therapeutic dose up to 400 timethe human dose and have revealed no evidence of harm to the fetus due to cefixime. Because animal reproduction studies are not always predictive of human response this drug should be used during pregnancy only if clearly needed. It is not known whether cefixime in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with this drug.

Drug Interactions:
A prolonged prothrombin time has been reported in patients who had been administrated cefixime and anticoagulants of the coumarin-ype.

Overdosage
There have been limited clinical experiences overdose of cefixime to date.

Adverse Reactions
Anaphylactic reaction including shock. Internal swelling of the larynx with airways constriction fever, Stevens Johnson syndrome, rash erythema, (erythema multiform ) pruritus , leucopenia, eosinophilia, thrombocytopenia increases in Got, GPT and aikaline phosphatases. Serious colitis (such as pseudomembranous colitis), diarrhea, abdominal pain, vomiting, nausea, transient elevation in bvn or creatinine, headache and dizziness.

Pharmaceutical Precautions:
Store below 30C.
Protect from light and moisture.

Directions for reconstitution:
Please see carton for reconstitution.

Package quantity:
Powder for paediatric oral suspension (100mg / 5ml after reconstitution)
60ml bottle containing powder for preparation of 30ml / 60 ml suspension.
Powder for Forte Oral Suspension (200mg / 5ml after reconstitution) Bottle containing  powder for preparation of 60 ml Suspension. After reconstitution the colour of suspension is off white to light pink.
Use only on medical advice
Keep out of the reach of children.
For oral use only
Shake well before use.