Description:

Alexid belongs to a new class of penicillins – the amidinopenicillins – with antibacterial properties fundamentally different from those of the previously known acyl-aminopenicillins. Pivmecillinam is the oral form of this new amidinopenicillin. Alexid has selective and powerful antibacterial activity against Gram-negative bacilli, especially against those responsible for urinary tract infections. The spectrum of Alexid comprises E. coli, Klebsiella, Enterobacter, Proteus, Salmonella, Shigella, Yersinia, and some strains of Serratia marcescens. The in vitro activity of Alexid against E. coli is approximately 40 times higher than that of ampicillin. Contrary to other penicillins, Alexid is practically inactive against Gram-positive organisms. It is inactive against Pseudomonas aeruginosa. Alexid is bactericidal. It acts by interfering with bacterial cell wall synthesis, but the site of action differs from that of other penicillins. Consequently, cross-resistance between Alexid and other ß-lactam antibiotics is rare. On the contrary, ampicillin-resistant strains may well prove sensitive to Alexid, and synergistic antibacterial activity can be obtained from combinations of Alexid and other ß-lactam antibiotics, such as penicillins and cephalosporins.

Pharmacology:

Following oral administration, maximum serum concentrations are obtained in about one hour and therapeutically effective concentrations are maintained for 4-5 hours. Mean peak concentrations after oral doses of 200 mg, 400 mg, and 800 mg are 3 µg/ml, and 5µg/ml and 8 µg/ml respectively. Absorption is not affected by simultaneous food intake.

Composition:

Each film-coated tablet contains Pivmecillinam Hydrochloride BP 200 mg.

Indications:

Alexid is indicated for treatment of infections caused by mecillinam-sensitive organisms, e.g. acute cystitis, complicated urinary tract infections, salmonellosis, shigellosis, bloody diarrhoea, enteropathic E. coli diarrhoea, chronic or recurrent bacteriuria, Gram-negative septicaemia, biliary infections, yersiniosis.

Dosage & administration:

Adults: The usual dose is 200 mg to 400 mg 3 times daily according to severity of the infection. In acute uncomplicated cystitis, the initial dose is 400 mg, then 200 mg 3 times daily for 8 doses.

For chronic or recurrent bacteriuria: The dose is 400 mg 3 to 4 times daily. For salmonellosis, the usual dose for patients with enteric fever is 1.2 to 2.4 g daily for 2 weeks and 2-4 weeks for carriers. In complicated UTI the usual treatment period is 1-2 weeks. For prophylactic treatment of recurrent UTI, 200 mg every evening is recommended.

Children: Children weighing less than 40 kg should be given 20-60 mg/kg divided into 3-4 daily doses. Those weighing more than 40 kg should receive normal adult dose. In shigellosis the dose is 20 mg/kg 4 times a day for 5 days. For UTI and salmonellosis in children, the usual dose is 20-40 mg/kg/day and 30-60 mg/kg/day respectively in 3 or 4 divided doses. The tablets should be taken with at least 50-100 ml fluid. As the bioavailability is practically unaffected by simultaneous food intake, Alexid tablets are best taken with or immediately after a meal.

Renal impairment: Based on information available to date for 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:

Contraindications:

There have been no reports on allergy to Pivmecillinam among patients with a known history of hypersensitivity to penicillins and cephalosporins. Nevertheless, it seems reasonable to exclude such patients from treatment with Pivmecillinam until further experience has been gained.

Precautions:

As with other antibiotics, which mainly the kidneys excrete, raised blood levels in patients with reduced kidney function may occur on repeated dosing, unless the dosage is adjusted accordingly.

Side-effects:

Pivmecillinam is generally well tolerated, even by patients with reduced kidney function. Gastrointestinal disturbances in form of nausea, vomiting and diarrhoea may occur. Skin rashes have been reported in some cases, but the characteristic ampicillin-rash has never been observed, nor has there been any evidence of hepato-, nephro-, or ototoxicity. The occurrence of anaphylaxis, though not yet reported, cannot be entirely excluded.

Use in Children:

Use of Pivmecillinam in children less than 3 months of age should be avoided.

Use in Pregnancy:

The results of different studies suggest that Pivmecillinam can be used safely during pregnancy as no adverse birth effect was demonstrated in these studies.

Use in Lactation:

Safety of using Pivmecillinam during lactation has not been established. So the drug should be better avoided during lactation.

Overdosage:

There is no experience with overdosage of Alexid. Excessive oral doses are likely to cause nausea, vomiting, and gastritis. Treatment should be restricted to symptomatic and supportive measures. If necessary, haemodialysis will reduce the blood level.

Packing:

Box containing 2 X 10's tablets in Alu-Alu blister packing.