CEFIM (CEFIXIME) Indications, Use In Pregnancy And Breast Feeding

Description:

Cefixime is a semi-synthetic oral cephalosporin antibiotic.
Third Generation Oral Cephalosporin Antibiotic

Clinical Pharmacology:
Mode Of Action:

Like all beta-lactam antibiotics, cefixime binds to specific penicillin-binding proteins (PBPs) located inside the bacterial collwall, causing the inhibition of the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterialcell wall autolytic enzymes such as autolysins: it is possible that cefixime interferes with an autolysin inhibitor

Indications:

An antibiotic commonly referred to as cefixime is an oral cephalosporin that exhibits strong bactericidal activity in vitro against bacterial species that are both Gram-positive and Gram-negative.
It is indicated for the treatment of the following acute infections when caused by susceptible micro-organism:Upper respiratory tract infections (URTI) e.g. Otitis media, sinusitis, pharyngitis & tonsillitis. Lower respiratory tract infections (LRTI) e.g. Bronchitis. Urinary tract infections (UTI) e.g. Cystitis, cystourethritis.uncomplicated pyelonephritis & uncomplicated gonorrhoea (cervical/urethral, rectal and pharyngeal)

Contra-Indications:

Patients with known hypersensitivity to cephalosporin antibiotics.

Precautions & Warnings:

Patients who have demonstrated a hypersensitivity to other medications ought to make use of cefixime with extreme caution. Patients who are sensitive to penicillins should take caution while administering cephalosporins because there is some indication of partial cross-allergenicity between the two medications. Patients have had severe reactions (including anaphylaxis) to both classes of drugsIf an allergic effect occurs with Cefixime the drug should be discontinued and the patient treated with appropriate agentsif necessary

Patients with significantly impaired renal function ought to consume cefixime with caution (see quantity in renal impairment).

Treatment with broad spectrum antibiotic alters the normal flora of the colon and may permit overgrowth of Clostridium indicate that a toxin produced by Clostridium difficile is a primary cause of antibiotic- associated diarrhoea pseudomembranous colitis is associated with the use of broad spectrum antibiotics (including macrolides, semi-synthetic Phons, lincosamides and cephalosporins), It is therefore important to consider its diagnosis among individuals who experience diarrhoea after taking antibiotics

Use In Pregnancy And Breast Feeding

Feeding: Reproduction studies have been performed in mice and rats at dose up to 400 times the human's dose and has revealed evidence of impaired fertility or harm to the foetus due to Cefixime. In rabbits, at doses up to 4 times the human dose was no evidence of a teratogenic effect, there was a high incidence of abortion and maternal death which is an Peace consequence of the known sensitivity of rabbits to antibiotic - induced change in the population of the microflora the intestine. There isn't enough reliable, well-controlled research on expectant mothers. Cefixime should therefore not bed in pregnancy or in nursing mothers unless considered essential by the physician.

Side Eftects

Cefim is generally well tolerated. The majority of adverse reactions observed in clinical trials were mild and self lighting in nature

Gastrointestinal Disturbance

Intestinal changes and diarrhoea are the most common side effects observed with Cefixime. Some cases of moderate to severediarmosa have been reported, this has occasionally warranted cessation of therapy. Cefixime should be discontinued if marked diarhoea occurs. Other less common gastrointestinal adverse effects include nausea, stomach pain, dyspepsia, vomiting, and flatulence.

Central Nervous System:

Headache and dizziness.

Hypersensitivity Reactions:

It has been noted that allergies might manifest as rash, prunitus, urticaria, drug fever, and arthralgia. These reactions usuallysubsided upon discontinuation of therapy.

Haematological And Clinical Chemistry:

Thrombocytopenia, leukopenia and eosinophilia have been reported. Thesereactions were infrequent and reversible. Mild transient changes in livor and renat function tests have been observed

Dosage & Method Of Administration:

The addition of food does not appreciably alter cefixime absorption. The typical treatment period is 5-14 days.

Adults And Children Over 12 Years:

The recommended adult dosage is 400mg daily administered as a single dose.

Children < 12 Years:

The recommended dosage for children is 8mg/kg/day administered as a single dose. The following daily dosages of paediatric oral suspension, expressed in terms of volume, are recommended as a general guide for dosing in children.

Children 1-4 Years: 100Mg Daily

Children 5-9 Years: 200Mg Daily

Children 10-12 Years.: 300Mg Daily

When calculating dosage for children between the ages of six months and one year, use a mg/kg basis. Children weighing more than 30kg or older than 12 years should be treated with the recommended adult dose. Cefixime's safety and effectiveness in children less than six months have not been shown.

The Elderly:

Adult dosage recommendations may be applied to elderly patients. In cases of severe renal impairment, dose should be modified and renal function evaluated.

Dosage in Renal Impairment:

Those inpatients with a creatinine clearance of 20 ml/min or higher may receive a regular dose and schedule. In patients whose creatinine clearance is less than 20ml/min. itis recommended that a dose of 200mg once daily should not be exceeded. The dose and regimen for patients who are maintained on chronic ambulatory peritoneal dialysis or haemodialysis should follow the same recommended dose asthat for patients with creatinine clearance of less than 20ml/min.

Directions For Reconstitution:

To reconstitute add one measure full of water (previously boiled and cooled) to the contents in the bottle, invert and shaketo wet the powder. Then add a further measure full of water and shake to make suspension. After reconstitution, thesuspension may be stored at room temperature for 7 days without significant loss of potency. Do not freeze. Discard any unused portion after 7 days. Dilution of the suspension is not recommended.

Presentation:

✓ Cefim 200mg Capsules: Blister of 10 capsules Blister of 10 capsules.

✓ Cefim 400mg Capsules: Blister of 5 capsules.

✓ Cefim suspension: Powder for paediatric oral suspension (100mg/5ml on reconstitution).
Powder for preparation of 30 ml suspension.
Powder for preparation of 60 ml suspension.

✓ Cefim DS suspension: Powder for paediatric oral suspension (200mg/5ml on reconstitution).

Detail
Cefim 200mg Capsule contains: Cofixime U.S.P....200mg
Cefim 400mg Capsule contains: Cefixime U.S.P...400mg.
Granules for paediatric oral suspension:
Cefim suspension:
Cefim fine granules contain 100mg of Cefixime USP in each 5 ml volume of reconstituted strawberry-flavored suspension
Cefim DS suspension
Cefim fine granules contain 200mg of Cefixime USP in each 5 ml volume of reconstituted strawberry-flavored suspension.

Manufactured by
Hilton Pharma (Pvt.) Ltd