INDICATIONS
Maxima is an orally active cephalosporin antibiotic, which has marked in vitro bactericidal activity against a wide variety of Gram positive & Gram negative organism. It is indicated for the treatment of the following acute infections when caused by susceptible microorganisms.
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).
In vitro activity: Clinical efficacy has been demonstrated in infections caused by commonly occurring pathogens including Streptococcus pneumoniae, Streptococcus Pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella species, (beta-lactamase positive & negative) & Enterobacter species. Maxima is highly stable in the presence of beta lactamase enzymes.
Maxima have been shown to be active in vitro against most strains of the following organisms; however, clinical efficacy has not been established. Streptococcus agalactiae, Haemophilus parainfluenzae (beta-lactamase positive & negative strains), proteus vulgaris, Pasteurella multocida (P, septica), Providencia species, Salmonella species, Shigella species, Citrobacter diversus & Serratia marcescens.
Most strains of Enterococci (Streptococcus faecalis, group D streptococci) & Staphylococcus (including coagulase positive & negative strains & methicillin
resistant strains) are resistant to Maxima. In addition most strains of Pseudomonas, Bacteroides fragilis, Listeria monocytogenes & Clostridia are resistant to Maxima.

CONTRAINDICATIONS
Patients with known hypersensitivity to cephalosporin antibiotics.

SIDE-EFFECTS
Maxima is generally well tolerated. The majority of adverse reactions observed in clinical trials were mild and self limiting in nature.
Gastrointestinal Disturbances: The most frequent side effects seen with Maxima are diarrhoea and stool changes. Some cases of moderate to severe diarrhoea have been reported; this has occasionally warranted cessation of therapy. Maxima should be discontinued if marked diarrhoea occurs. Other Maxima gastrointestinal side effects seen less frequently are nausea, abdominal pain, dyspepsia, vomiting and flatulence. Pseudo- membranous colitis has been reported (see above).
Central Nervous System: Headache and dizziness.
Hypersensitivity Reactions: Allergies in the form of rash, pruritis, urticaria, drug fever and arthralgia have been observed. These reactions usually subsided upon discontinuation of therapy.
Hematological and clinical chemistry:
Thrombocytopenia, leukopenia and eosinophilia have been reported. These reactions were infrequent and reversible. Mild transient changes in liver and renal function tests have been observed.
Miscellaneous:Other possible reactions include genital pruritis and vaginitis.

WARNING & PRECAUTIONS
Maxima should be given with caution to patients who have shown hypersensitivity to other drugs. Cephalosporins would be given with caution to penincillin-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 Maxima the drug should be discontinued and the patient treated with appropriate agents, if necessary.
Maxima should be administered with caution in patients with markedly impaired renal function (see dosage in renal impairment). Treatment with broad spectrum antibiotics alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of antibiotic-associatd diarrhoea.
Pseudomembranous colitis is associated with the use of broad-spectrum antibiotics (including macrolides, semi-synthetic penicillins, lincosamides and cephalosporins), it is therefore important to consider its diagnosis on patients who develop diarrhoea in association with the use of antibiotics. Symptoms of pseudomembranous colitis may occur during or after antibiotic treatment. Management of pseudomembranous colitis should include sigmoidoscopy, appropriate bacteriologic studies, fluids, electrolytes and protein supplementation. If the colitis does not improve after the drug has been discontinued, or if the symptoms are severe, oral vancomycin is the drug of choice for antibiotic associated pseudomembranous colitis produced by C. difficile. Other causes of colitis must be excluded.
Use in pregnancy and breast feeding:
Reproduction studies have been performed in mice and rats at doses up to 400 times the human dose and have no related evidence of impaired fertility or harm to the foetus due to Cefixime Trihydrate. In the rabbit, at doses up to 4 times the human dose, there was no evidence of a teratogenic effect; there was a high incidence of abortion and maternal death which is an expected consequence of the known sensitivity of rabbits to antibiotic-induced changes in the population
of the micro flora of the intestine. There were no adequate and well-controlled studies in pregnant women. Maxima should therefore not be used in pregnancy or in nursing mothers unless considered essential by the physician.

INTERACTIONS
No significant drug interactions have been reported to date. A false positive reaction for glucose in the urine may occur with Benedicts or Fehlings solutions or with copper sulphate test tables, 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 recognized that a positive Coombs test may be due to the drug.

DOSAGE & ADMINISTRATION
Absorption of Maxima 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 mg to 400 mg daily administered as a single dose.

The Elderly:
Elderly patients may be given the same dose as recommended for adults. Renal function should be assessed dosage should be adjusted in severe renal impairment.
Dosage in Renal Impairment:
Maxima may be administered in the presence of impaired renal function, Normal dose & schedule may be given to patients with creatinine clearance of 40 ml/min or greater. Patients whose clearance is between 20 and 40 ml/min or patients who are on renal hemodialysis may be given 75% of the standard dosage. Patients with creatinine clearance of less than 20 ml/min should be given 50% of standard dosage.

OVERDOSE
There is no experience with overdoses of Maxima. Adverse reactions seen at dose levels up 2 g Cefixime in normal subjects did not differ from the profile seen in patients treated at the recommended doses. Gastric lavage may be initiated in over dosage. No specific antidote exists. Maxima is not removed from the circulation in significant quantities by dialysis.

STORAGE
Protect from light, heat and moisture.
Shake well before use.
Keep all medicines out of the reach of children.

Pediatric Oral Suspension:
To reconstitute add one cup of boiled cold water to the contents in the bottle, invert and shake to make the suspension. After reconstitution, the suspension may be stored at room temperature for 7 days without significant loss of potency. Do not freeze. Keep bottle tightly closed & shake well before use. Discard any unused portion after 7 days. Dilution of the suspension is not recommended. Keep out of reach of children. For oral use only.

PRESENTATION
Maxima 200 mg tablets, Pack of 10’s.