INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo FIXIME 200 mg FILM COATED TABLETS

SCHEDULING STATUS:
Schedule 4

PROPRIETARY NAME:
(and dosage form)

FIXIME 200 mg FILM COATED TABLETS

COMPOSITION:
Fixime 200 mg:
Each film coated tablet contains 200 mg
cefixime

PHARMACOLOGICAL CLASSIFICATION:
Category 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, sinusitis.

Lower Respiratory Tract Infections; e.g., bronchitis.

Urinary Tract Infections; e.g., acute cystitis.

Uncomplicated gonorrhoea.

CONTRA-INDICATIONS:
Allergy to cephalosporins.

Fixime is contra-indicated in patients with renal impairment with a creatinine clearance below 60 mL/min.

WARNINGS:
Fixime should be given with caution to patients who have shown hyper-sensitivity to other medicines.

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 overgrowth 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.
For sinusitis the therapeutic dosage must be administered for 10 to 14 days.
Treatment of uncomplicated Gonorrhoea: The recommended dosage is 400 mg as a single oral dose.

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”).

Dosage in Renal Impairment: Fixime may be administered in the presence of impaired renal function. Normal dose and schedule may be given in patients with creatinine clearance of 20 mL/min or greater.
In patients whose creatinine clearance is less than 60 mL/min, it is recommended that a dose of 200 mg 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 recommendation as that for patients with creatinine clearance of less than 20 mL/min.

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: No significant interactions have been reported to date. 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:
Gastrointestinal Disturbances:
The most frequent side effects seen with Fixime are diarrhoea and stool changes. Moderate to severe diarrhoea has been reported. Other gastrointestinal side effects seen less frequently are nausea, abdominal pain, dyspepsia, vomiting and flatulence. Pseudomembranous colitis has been reported.

Central Nervous System: Headache and dizziness.

Hypersensitivity Reactions: Allergies in the form of rash, pruritus urticaria, drug fever and arthralgia have been observed. These reactions usually subsided upon discontinuation of therapy.

Haematological and Clinical Chemistry: Thrombocytopenia, leukopenia and eosinophilia have been reported. These reactions were infrequent and reversible. Changes in liver end renal function tests have been observed.

Miscellaneous: Other possible reactions include genital pruritus and vaginitis.

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:
White, convex, rectangular film coated tablets with rounded corners and bevelled edges and with a divided breakline on each side embossed with EM-72 on one side.

PRESENTATION:
Containers of 5 tablets and 10 tablets.

STORAGE INSTRUCTIONS:
Store below 30° C in the original pack or in containers which prevent access of light and moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
W/20.1.1./255

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Merck (Pty) Ltd
Reg. No 76/04059/07
11 Fedlife Park, Tonetti Street, Midrand 1685
Tel: (011) 315-1100

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
4 June 1992

Under license from Fujisawa Pharmaceuticals Limited, Osaka, Japan.
        F34106
        94D0694

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