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Logo FIXIME PAEDIATRIC 100 mg/5 mL

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form)

FIXIME PAEDIATRIC 100 mg/5 mL
Powder for Oral Suspension

COMPOSITION:
FIXIME Paediatric Powder for Oral Suspension:
When reconstituted as directed each 5 mL suspension contains 100 mg
cefixime and sodium benzoate 0,125% m/v as preservative.

PHARMACOLOGICAL CLASSIFICATION:
A20.1.1. Antimicrobial (Chemotherapeutic) agents - Broad and Medium Spectrum Antibiotics.

PHARMACOLOGICAL ACTION:
FIXIME is an orally active cephalosporin antibiotic which has in-vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organisms including Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae (beta-lactamase positive and negative), Moraxella (Branhamella)catarrhalis (beta-lactamase positive and negative). FIXIME is 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 FIXIME. In addition, most strains of Enterobacter and Pseudomonas, Bacteroides fragilis, Listeria monocytogenes and Clostridia are resistant to FIXIME.

INDICATIONS:
FIXIME is indicated for the treatment of the following infections when caused by susceptible micro-organisms.
Upper respiratory tract infections; e.g., bacterial pharyngitis, tonsillitis, otitis media.
Lower respiratory tract infections; e.g., bronchitis.
Urinary tract infections; e.g., acute cystitis.

CONTRA-INDICATIONS:
Allergy to cephalosporins.

WARNINGS:
FIXIME should be given with caution to patients who have shown hyper-sensitivity to other cephalosporins.
Cephalosporins should be given with caution to penicillin-sensitive patients, as there is some evidence of partial cross-allergenicity between the penicillins and the cephalosporins. Patients have had severe reactions (including anaphylaxis) to both classes of drugs.
If an allergic effect occurs with FIXIME the drug should be discontinued and the patient treated with appropriate agents if necessary.
FIXIME should be administered with caution in patients with markedly impaired renal function (See "Dosage in Renal Impairment").
Prolonged use of FIXIME may result in the over growth of non-susceptible organisms. FIXIME has been shown to alter the normal flora of the colon and may permit overgrowth of Clostridia. Studies indicate a toxin(s) produced by Clostridium difficile is the primary cause of antibiotic associated pseudomembranous colitis. The product should be discontinued if diarrhoea occurs.
See also "Side-effects and Special Precautions" below.

DOSAGE AND DIRECTIONS FOR USE:
Absorption of FIXIME is not significantly modified by the presence of food.
The usual course of treatment is 5 - 14 days.

Adults and Children over 12 Years: The recommended adult dosage is 200 - 400 mg daily given either as a single dose or in two divided doses. In lower respiratory tract infections, 400 mg daily is recommended. For upper respiratory tract infections and uncomplicated urinary tract infections, 200 mg once daily is usually effective.

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. (See "Dosage in Renal Impairment").

Children: The recommended dosage for children is 8 mg/kg/day administered as a single dose or in two divided doses. This should be always followed for children up to 2 years of age. As a general guide for prescribing in children over 2 years the following daily doses in terms of volume of paediatric oral suspension are suggested:
Children 2 - 4 years :         5 mL daily
Children 5 - 8 years :         10 mL daily
Children 9 - 12 years :         15 mL daily
Children weighing more than 50 kg or older then 12 years should be treated with the recommended adult dose. The safety and efficacy of cefixime has not been established in children aged less than 6 months.
Reconstitution of Powder for Paediatric Oral Suspension: Add 33 mL of water to the bottle containing powder for the preparation of 50 mL suspension, in two portions, shaking after each addition.

Dosage in Renal Impairment: Patients with impaired renal function may require a reduction in dose of FIXIME as follows:
        Creatinine Clearance
        (mL/min)/(mL/sec)
        DOSE
>60/1,00 Standard dosing at standard dosing interval
21-60/0,35-1,00 or haemodialysis patients 75% of standard dosing at standard interval
<20/0,33 or chronic abbulatory peritoneal dialysis (CAPD) patients 50% of standard dosage at standard dosing intervals

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Precautions:
Use in Pregnancy and Breast Feeding: Safe use in human pregnancy has not been established and it is not known whether FIXIME is excreted in human breast milk.
Interactions: Probenecid: Decreases renal tubular secretions resulting in increased and prolonged cephalosporin serum concentrations, prolonged elimination half-life, and increased risk of toxicity; however cefixime and probenecid might be used concurrently in the treatment of infections, such as sexually transmitted diseases (STDs) or other infections, in which high and/or prolonged antibiotic serum and tissue concentrations are required.
Platelet aggregation inhibitors: Hypoprothrombinemia induced by large doses of salicylates and/or cephalosporins, and the gastrointestinal ulcerative or hemorrhagic potential of nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, or sulfinpyrazone may increase the risk of haemorrhage.
A false positive reaction for glucose in the urine may occur with Benedict’s or Fehling’s solution or with copper sulphate test tablets but not with tests based on enzymatic glucose oxidase reactions. A false positive direct Coombs test has been reported during treatment with cephalosporin antibiotics, therefore it should be recognised that a positive Coombs test may be due to the medicine.

Side-effects:
Those indicating need for medical attention: Incidence less frequent or rare: Hypoprothrombinemia (unusual bleeding or bruising).
Pseudomembranous colitis (severe abdominal or stomach cramps and pain: abdominal tenderness; watery and severe diarrhoea, which may also be bloody; fever).
Incidence rare: Allergic reactions, specifically anaphylaxis (bronchospasm, hypotension).
Erythema multiforme, or Stevens-Johnson syndrome (blistering, peeling, or loosening of skin and mucous membranes; may involve the eyes or other organ systems).
Hypersensitivity (fever, skin rash, itching, redness, or swelling). These reactions usually subsided upon discontinuation of therapy.
Renal dysfunction (Decrease in urine output or decrease in urine contracting ability).
Serum sickness-like reactions (skin rash. joint pain. fever).
Seizure: especially with high dose and in patients with renal function impairment.
Those indicating need for medical attention only if they continue or are bothersome: Incidence more frequent: Oral candidiasis (sore mouth or tongue).
Gastro-intestinal reactions (mild diarrhoea, abdominal cramps, nausea or vomiting).
Vaginal candidiasis (vaginal itching and discharge).
Central Nervous System: Headache and dizziness.
Haematological and Clinical Chemistry: Thrombocytopenia, leucopenia and eosinophilia have been reported. These reactions were infrequent and reversible. Changes in liver and renal function tests have been observed.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side Effects".
No specific antidote exists. FIXIME is not removed from the circulation in significant quantities by dialysis. Treatment is symptomatic and supportive.

IDENTIFICATION:
Powder for Paediatric Oral Suspension: Bottles containing an off-white to cream coloured powder for reconstitution.
Reconstituted Suspension: Off-white to cream coloured suspension with a strawberry odour.

PRESENTATION:
Powder for Paediatric Oral Suspension (100 mg/5 mL): Bottles containing powder for preparation of 50 mL of suspension.

STORAGE INSTRUCTIONS:
Powder for Paediatric Oral Suspension: Store unreconstituted product below 25°C.
After reconstitution the suspension may be stored at room temperature (15°C - 30°C) for 14 days without significant loss of potency. Keep bottles tightly closed and shake well before use. Discard any unused portion after 14 days. Dilution of the suspension is not recommended.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
W/20.1.1./257

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Merck (Pty) Ltd
Reg. No 70/04059/07
11 Fedlife Park, Tonetti Street, Midrand 1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
4 June 1992

        F33006
        95A0299

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