TAXIME 

(PHARMATEX ITALY`)

Composition

TAXIME  1g for I.M. use only - each vial contains: cefotaxime sodium 1,048 g equivalent to cefotaxime 1g.
Each 4 ml solvent ampoule contains: Lidocaine 40 mg (1%) , water for injection q.s. 4 ml.

PHARMACO-THERAPEUTIC CATEGORY
Antibacterial beta-lactam

Therapeutic indications
Taxime – a semisynthetic cephalosporin with a broad spectrum of bacterial activity – is administered parenterally.  It is active against Gram-negative organisms, mainly Escherichia coli, Haemophilus influenzae, Klebsiella spp., Proteus (indolo-positive and indolo-negative strains), Enterobacter, Neisseria spp., Shigella spp., Salmonella spp, Providencia spp., Citrobacter  and  Serratia spp. and against Gram-positive bacteria, especially coagulase-positive and negative, staphylococci (including penicillinase-producing strains), beta-haemolytic and other streptococci, particularly Str. pyrogens Str. Viridans and faecalis, Clostridium spp. It is highly stable in presence of beta-lactamases, both penicillinases and cephalosporinases.
In vitro activity against Pseudomonas and Bacteroides.
In severe infections caused by Pseudomonas spp. The addition of an aminoglycoside antibiotic may be indicated.
After intramuscular injection the peak serum drug concentration is achieved after about 30 minutes. The half-time is 1,2 hours, in elderly patients it is 1,7 hours. After administration in high doses the antibiotic penetrates into cerebrospinal fluid, especially in cases of meningitis. Binding with plasma proteins is 20-40%. The antibiotics passes into exudates and mother’s milk. About 60% of the dose is eliminated with urine unchanged, and about 20% is excreted as metabolites, mainly deacetyl derivative.
Among certain Gram-negative bacteria (e.g. Pseudomonas aeruginosa) some strains may be resistant to cefotaxime. Staphylococci resistant to methicillin (and cloxacillin) are always resistant to cefotaxime. Taxime treatment should be preceded by adequate bacteriological examinations.

Indications
Treatment of severe infections caused by bacteria sensitive to cefotaxime. Preventive administrations in cases of major operations for prophylaxis of postoperative hospital infections caused by Gram-positive and Gram-negative organisms. The main indications are:
respiratory infections, e.g. acute and chronic bronchitis, bacterial pneumonia, lung abscess;
urinary tract infections, e.g. acute and chronic pyelonephritis, cystitis and symptomatic bacteriuria;
soft tissue infections, such as cellulitis, erysipelas, peritonitis, abscesses and wound infections;
osteoarticular infections, such as osteomyelitis, bacterial arthritis;
infections in obstetrics and gynaecology, e.g. small pelvis inflamatory diseases;
gonorrhoea, especially cases with gonococci resistant to penicillin G;
other infections, including septicaemia and meningitis.

Contra-indications
Hypersensitivity to cefotaxime or other cephalosporins.
In patients with known hypersensitivity to Lidocaine avoid the use of the i.m. route with solvent containing Lidocaine.

Precautions for use
Caution should be exercised in patients with an history of allergic reactions, particularly drug allergy. Particular caution is necessary in patients with previous anaphylactic reactions to penicillin. In renal failure the doses should be reduced. Additionally, caution is needed in combined treatment and in pregnancy and lactation.
Taxime should never be use reconstituted with Lignocaine: by the Intravenous route; in infants; in patients with severe heart failure or patients with known hypersensitivity to the product.

Interactions
False positive results may be obtained in non-enzymatic tests for glycosuria. Increased nephrotoxicity was noted during combined treatment with aminoglicoside antibiotics or potent diuretics such as frusemide.

Pregnancy and lactation
Pregnancy: Taxime crosses the placental barrier, should not be administered specially during first trimester , without carefully weighing the expected benefit against possible risks.
Lactation: Taxime is excreted in the milk.

Dosage
The antibiotic is administered parenterally. The dosage and route of administration depend on the sensitivity of the pathogen, type of infections and patient’s conditions. The following dosage is recommended:

Neonates: 50 mg/kg  body  weight  daily   in 2 to 4 divided doses. The product must be administered only with solvent water for injection.
Childrens: 100-150 mg/kg   body   weight   daily   in 2-4 divided  doses intramuscularly or intravenously.
Adult: Maximal    doses:     200 mg/kg     body     weigh intramuscularly in 3-4 doses1-2 g  twice  daily  intramuscularly or intravenously. Maximal dose: 12 g daily in 3-4 doses.

 

infections type

 

daily dose

(grams)

 

frequency and route

of administration

 

Gonorrhoea

 

Prophylaxis

 

 

Uncomplicated infections

 

Moderately severe and severe

infections

 

Infections requiring high doses

 

Life-threatening infections

 

Renal Impairment

 

 

1

 

1

 

 

2

 

3-6

 

 

6-8

 

up to 12

 

initial 1

 

1 g i.m. (single dose)

 

1 g i.m. or i.v. (single dose)

30-90 min. after operation

 

1 g every 8 hours i.m., i.v.

 

1-2 g every 8 hours i.m., i.v.

 

 

2 g every 6-8 hours i.v.

 

2 g every 4 hours i.v.

 

half dosage for each frequency depending on the general conditions of the patient.

In patients with impaired renal function the dose should be reduced .

Intramuscular use of the product with Lidocaine solvent cannot be used with patient with known hypersensitivity to Lidocaine.

Mode of use

Vial size

Diluent to be added

500 mg I.M.-I.V. use

2 ml water for injection

1 g I.M. use only (if is used Lidocaine solvent)

4 ml water for injection with Lidocaine 40mg

1 g I.M.-I.V. use

4 ml water for injection

2 g I.V. or drip infusion use 

10 ml water for injection or fisiological infusion

intramuscular (i.m.) : 4 ml  of water for injection with lidocaine is added to Taxime vial (1g), shaken  for  obtaining  solution,  and  injected  deeply into glutaeus maximus muscle. The reconstituted solution with solvent containing Lidocaine cannot be administered for intravenous route;
intravenous (i.v.) :  4 ml of water for injection is added to Taxime vial  (1g) and  injected  slowly  intravenously or the solution is used for intravenous drip infusion during 20-60 minutes.

Side effects
The antibiotic is usually well tolerated, adverse effects occur relatively rarely, and are usually mild and transient. The most frequent among them are:
allergic reactions: rash, erythema, ithing, raised body temperature;
gastrointestinal disturbances, pseudomembranous colitis, diarrhoea, nausea, vomiting, granulocytopenia and more rarely agranulocytosis may develop over long administration period;
thrombophlebitis after intravenous injections, pain at the site of injections into the muscles.
Similarly as after other antibiotics long-term administrations may cause excessive growth of insensitive organisms, e.g. Candida, Clostridium difficile.

Overdosage
Particularly in renal insufficiency  there is a risk of reversible encephalopathy.

Storage
Store below 25°C – Protect from light.
Reconstituted solution – can be used up to 24 hours if kept an refrigeration
(+2°-+8°C). After 24 hours any unused solution should be discarded.

Shelf life

Shelf-life 36 months is indicated on the box and refers to the products packaged for dispensing and properly stored.

Manufacturer:
Mitim Srl – Via Cacciamali 34-38 – Brescia ( Italy).

Marketing Authorisation Holder: 
PHARMATEX ITALIA SRL -VIA APPIANI, 22 -  20121 – MILAN (ITALY)