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ALEXID

ALEXID

Pivmecillinam Hydrochloride

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 of 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, e.g. 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 beta-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 beta-lactam antibiotics, such as penicillins and cephalosporins. 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, 5 µg/ml and 8 µg/ml respectively. Absorption is not affected by simultaneous food intake.

Product Details

Presentation

ALEXID Tablet: Each film coated tablet contains Pivmecillinam Hydrochloride BP 200 mg.

Pharmacology

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 of 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, e.g. 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 beta-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 beta-lactam antibiotics, such as penicillins and cephalosporins. 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, 5 µg/ml and 8 µg/ml respectively. Absorption is not affected by simultaneous food intake.

Indication

ALEXID is indicated for the 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.

Dosage & Administration

Adults: The usual dose is 1-2 tablets 3 times daily according to severity of the infections. In acute cystitis a treatment time of 3 days has been shown to provide high cure rates, whereas in complicated urinary tract infections the usual treatment time is 1-2 weeks. For prophylactic treatment of recurrent urinary tract infections 1 tablet every evening is recommended.
Children: Weighing less than 20 kg should be given 20-60 mg/kg 3-4 times daily into equally divided doses. Those weighing more than 20 Kg should receive normal adult dose. 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 data for patients with impaired renal function. the initial dose can remain unchanged and also can remain unchanged in the interval between doses. However, the amount administered as the maintenance dose should be changed according to the following criteria:






Creatinine ClearanceDosage Reduction
30 ml/minute or greaterFull dosage
Between 10-30 ml/minute50% dosage
Less than 10 ml/minute25% dosage

Contraindications

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

Side effects

ALEXID is generally well tolerated, even by patients with reduced kidney function. Gastro-intestinal 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, but it cannot be entirely excluded.

Packing

ALEXID Tablet: Box containing 50 tablets in alu/alu blister pack.

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