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Selexid® tablets contain pivmecillinam hydrochloride 200 mg plus excipients in a white film coated tablet, embossed with a lion on one side and the number 137 on the other.
Selexid® is an orally active antibiotic. Chemically it is the pivaloyloxymethylester of the amidinopenicillanic acid, mecillinam. On oral administration it is well absorbed and subsequently hydrolysed in the body to mecillinam, the active antibacterial agent, by non-specific esterases present in blood, gastro-intestinal mucosa and other tissues.
Selexid® is highly active against most enterobacteriaceae, including E.coli, Klebsiella, Proteus, Enterobacter, Serratia, Salmonella, Shigella and Yersinia.
Selexid® is less active against gram positive bacteria and organisms such as Pseudomonas aeruginosa and Streptococcus faecalis are practically resistant to mecillinam.
Whilst Selexid®, like the penicillins and cephalosporins, interferes with the biosynthesis of the bacterial cell wall, the target of the inhibition is different. This different mode of action is probably responsible for the synergistic action that has been found, both in vitro and in vivo, between Selexid® and various penicillins and cephalosporins.
Peak serum levels of mecillinam averaging 5 µg/mL are reached after 1 hour following a dose of 10 mg/kg body weight in children and 400 mg in adults.
The serum half-life is 1.2 hours. The protein binding amounts to 5-10%. Approximately 50% of the administered dose is excreted as mecillinam in the urine within the first 6 hours. Mecillinam is partly excreted with bile, giving rise to biliary concentrations about 3 times the serum levels. Concurrent administration of probenecid delays the renal excretion of mecillinam, producing more sustained serum levels. The absorption of Selexid® is practically unaffected by taking the tablets with food.
Selexid® is indicated for treatment of infections caused by mecillinam-sensitive organisms, e.g. acute cystitis, complicated urinary tract infections, salmonellosis, shigellosis, enteropathic E. coli diarrhoea, gram-negative septicaemia, biliary infections, yersiniosis.
Selexid® tablets must be taken with at least half a glass of water and preferably taken with or immediately after a meal to avoid the risk of local ulceration.
Adults: The usual dose is 1-2 tablets 3 times daily according to severity of the infection.
In acute cystitis a treatment time of 3 days has been shown to provide high cure rates, whereas in complicated urinary tract infection the usual treatment time is 1-2 weeks.
For the patients with impaired renal function, the initial dose can remain unchanged as can the interval between doses. However, the amount administered as the maintenance dose should be changed according to the following criteria:
Creatinine Clearance Dosage Reduction
30 mL/min or greater Full dosage
between 10-30 mL/min 50% dosage
less than 10 mL/min 25% dosage
Penicillin and cephalosporin hypersensitivity. Selexid® is contra-indicated in patients with known carnitine deficiency and infants less than 3 months. Oesophageal strictures and/or obstructive changes in the gastrointestinal tract.
Selexid® tablets must be taken with at least half a glass of water and preferably taken with or immediately after a meal to avoid the risk of local ulceration.
During long term use, it is advisable to carry out routine liver and kidney function tests.
As with other antibiotics that are excreted mainly by the kidneys, raised blood levels of mecillinam may occur if repeated doses are given to patients with impaired renal function.
Selexid® should be used with caution for long-term or frequently repeated treatment, due to the possibility of carnitine depletion.
Concurrent treatment with valproic acid, valproate or other medication liberating pivalic acid should be avoided.
Selexid® is not expected to effect your ability to drive or use machinery.
The medicine, as mecillinam, crosses the placenta. Tests in two animal species have shown no teratogenic effects. Data on a large number of exposed pregnancies indicate no adverse effects on pregnancy or on the health of the foetus/new-born child. In accordance with current practices, pivmecillinam should only be prescribed when the expected benefits are considered to be greater than the potential risk. As with other penicillin's, small quantities might be traced in breast milk.
Selexid® is generally well tolerated, even by patients with reduced kidney function. Upper gastrointestinal disturbances such as nausea, vomiting and indigestion have occurred, more frequently when a dose is given on an empty stomach. Other side effects reported are diarrhoea and urticarial rash. Reduction in serum and total body carnitine has been reported. Anaphylactic reactions are rare.
Clearance of methotrexate from the body can be reduced by concurrent use of penicillins. The methotrexate dose may need to be adjusted.
Probenecid reduces the excretion of penicillins and hence increases blood levels of the antibiotic.
There has been no experience of overdosage with Selexid®. However, excessive doses are likely to induce nausea, vomiting and gastritis. Treatment should be restricted to symptomatic and supportive measures.
Store below 25°C.
Prescription Medicine.
10 x 200 mg tablets in tropical blister pack.
Selexid® tablets also contain cellulose microcrystalline, hydroxypropyl cellulose, magnesium stearate and hydroxypropyl methylcellulose.
CSL (New Zealand) Limited
666 Great South Rd
Central Park
Auckland
New Zealand
Ph: 0800 502 757
November 2001
Selexid® is a registered trademark of Leo Pharmaceutical Products.