SIRUMEK
(Cefuroxime)




COMPOSITION

1 vial of drug contains:

Active ingredient: cefuroxime (as cefuroxime sodium) 750 mg or 1500 mg.

Solvent: water for injections 6 ml or 15 ml.

THERAPEUTIC INDICATIONS

Treatment of infections before the infecting organism has been identified or when caused by sensitive bacteria:

- respiratory tract infections, e.g.bacterial pneumonia, acute and chronic bronchitis, infected bronchiectasis, lung abscess and post-operative chest infections;

- ear, nose and throat infections e.g. otitis media sinusitis, tonsillitis, pharyngitis;

- urinary tract infections e.g. acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria;

- gonorrhoea particularly when penicillin is unsuitable;

- skin and soft-tissue infections e.g. cellulitis, erysipelas and wound infections;

- bone and joint infections e.g. osteomyelitis and septic arthritis;

- pelvic infections;

- other infections including septicaemia, meningitis and peritonitis;

- Prophylaxis against infection in abdominal, pelvic, orthopaedic, cardiac, pulmonary, oesophageal and vascular surgery.

CONTRAINDICATIONS

- known hypersensitivity to cephalosporin antibiotics, penicillins and carbapenems.

ADVERSE EFFECTS

Gastrointestinal disorders:

Uncommon: Gastrointestinal disturbance.

Very rare: Pseudomembranous colitis.

Hepatobiliary disorders

Common: Transient rise in liver enzymes.

Uncommon: Transient rise in bilirubin.

Transient rises in serum liver enzymes or bilirubin occur, particularly in patients with pre-existing liver disease, but there is no evidence of harm to the liver.

Immune system disorders

Hypersensitivity reactions including:

Uncommon: Skin rash, urticaria and pruritus

Rare: Drug fever

Very rare: Interstital nephritis, anaphylaxis, cutaneous vasculitis

Skin and subcutaneous tissue disorders

Very rare: Erythema multiforme, toxic epidermal necrolysis and Stevens Johnson Syndrome.

Renal and urinary disorders

Very rare: Elevations in serum creatinine, elevations in blood urea nitrogen and decreased creatinine clearance.

Blood and lymphatic system disorders

Common: Neutropenia, eosinophilia.

Uncommon: Leukopenia, decreased haemoglobin concentration, positive Coomb's test.

Rare: Thrombocytopenia.

Very rare: Haemolytic anaemia.

Cephalosporins as a class tend to be absorbed onto the surface of red cell membranes and react with antibodies directed against the drug to produce a positive Coomb's Test (which can interfere with cross matching of blood) and very rarely haemolytic anaemia.

Infections

Rare: Candida overgrowth .

General disorders and administration site conditions

Rare: Transient pain at injection site.

Pain at the intramuscular injection site is more likely at higher doses. However it is unlikely to be a cause for discontinuation of treatment.

DOSAGE AND ADMINISTRATION

Sirumek can be used for I.V. and/or I.M. administration.

Adults

Many infections respond to 750 mg three times daily by I.M. or I.V. injection. For more severe infections the dose should be increased to 1.5 g three times daily given I.V.

The frequency of administration may be increased to 6-hourly if necessary, giving total daily doses of 3 to 6 g.

Children

30 – 100 mg/kg/day given as 3 or 4 divided doses. A dose of 60 mg/kg/day is appropriate for most infections.

Neonates:

Sirumek can be used for I.V. or I.M. administration.

Sirumek is administered to neonates aged:

≤ 7 days - 50 mg/kg every 12 hours

8-28 days - 50 mg/kg every 8-12 hours if the weight is ≤ 2 kg or

50 mg/kg every 8 hours if weight is > 2 kg

3 months and older: the recommended dose is 50-100 mg/kg/daily, depending on pathology.

Instruction on preparation of solution for intravenous and intramuscular administration

Solution for intramuscular administration

Add 3 ml of water for injections to 750 mg of the drug. Stir up carefully until suspension is constituted.

Solution for intravenous bolus administration

For preparation of solution:

750 mg of drug and at least 6 ml of water for injections;

1500 mg of drugs and at least 15 ml of water for injections.

Solution for intravenous fluid administration

For intravenous infusions 1500 mg of drug is dissolved into 15 ml of water for injections, and this solution is added to 50 ml or 100 ml of infusion solution. These solutions may be administered directly to vein during 3-5 minutes or to the infusion system tube during 30-60 minutes.

Gonorrhoea:

Adults: 1.5 g as a single dose (as 2 x 750mg injections given I.M. at different sites, e.g. each buttock).

Meningitis:

suitable for sole therapy of bacterial meningitis.

Adults:

3 g given intravenously every eight hours.

Infants and Children:

150-250 mg/kg/day given intravenously in 3 or 4 divided doses.

Neonates: The dosage should be 100 mg/kg/day given intravenously.

Prophylaxis of post-operative complications in adults:

The usual dose is 1500 mg given I.V. with induction of anaesthesia for abdominal, pelvic and orthopaedic operations. This may be supplemented with two 750 mg I.M. doses eight and sixteen hours later.

In cardiac, pulmonary, oesophageal and vascular operations, the usual dose is 1.5 g given I.V. with induction of anaesthesia, continuing with 750 mg given I.M. three times daily for a further 24 to 48 hours.

In total joint replacement, 1.5 g cefuroxime powder may be mixed dry with each pack of methyl methacrylate cement polymer before adding the liquid monomer.

Pneumonia and acute exacerbations of chronic bronchitis:

750 mg of drug every 8 hours (I.V. or I.M)

Skin and soft tissue infections: cellulitis, erysipelas and wound infections

750 mg of drug every 8 hours (I.V. or I.M)

Impaired Renal Function

It is necessary to decrease the dose in case of renal insufficiency.

It is not necessary to reduce the standard dose (750 mg - 1.5 g three times daily) until the creatinine clearance falls to 20 mL/min or below.

Creatinine clearance

T1/2 (hours)

Dose, mg

> 20 ml/min/1.73 м2

1.7-2.6

Standard dose decrease is not required

(750 mg-1500 mg 3 times daily)

10-20 ml/min/1.73 м2

4.3-6.5

750 mg 2 times daily

< 10 ml/min/1.73 м2

14.8-22.3

750 mg once daily

For patients on haemodialysis a further 750 mg dose should be given intravenously or intramusculary at the end of each dialysis. In addition to parenteral use, Sirumek can be incorporated into the peritoneal dialysis fluid (usually 250 mg for every 2 litres of dialysis fluid).

For patients in renal failure on continuous arteriovenous haemodialysis or high-flux haemofiltration in intensive therapy units, a suitable dosage is 750 mg twice daily. For low-flux haemofiltration follow the dosage recommended under impaired renal function.

SPECIAL INDICATIONS

Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactams.

Cephalosporin antibiotics at high dosage should be given with caution to patients receiving concurrent treatment with potent diuretics such as furusemide or aminoglycosides, as renal impairment has been reported with these combinations. Renal function should be monitored in these patients, the elderly, and those with pre-existing renal impairment.

As with other therapeutic regimens used in the treatment of meningitis, mild-to-moderate hearing loss has been reported in a few paediatric patients treated with cefuroxime sodium. Persistence of positive CSF cultures of Haemophilus influenzae at 18-36 hours has also been noted with cefuroxime sodium injection, as well as with other antibiotic therapies; however, the clinical relevance of this is unknown.

As with other antibiotics, use of cefuroxime may result in the overgrowth of Candida. Prolonged use may also result in the overgrowth of other non-susceptible organisms (e.g. enterococci and clostridium difficile), which may require interruption of treatment.

Sirumek has no effect on the results of urine glucose test by enzymatic method. When appropriate it may be used in combination with an aminoglycoside antibiotic, or in conjunction with metronidazole (oral, injectable or in suppositories), especially for prophylaxis in colonic or gynaecological surgery.

Sirumek contains sodium. It should be taken into consideration while administering the drug to patients following diet, due to the salts.

PREGNANCY AND LACTATION

Caution should be exercised while administering the drug during pregnancy.

Cefuroxime is excreted in human milk, and consequently caution should be exercised when cefuroxime axetil is administered to a nursing mother.

MANUFACTURED FORM AND PACKAGE

Sirumek 750 mg or 1500 mg №1 with a solvent.

Powder for solution for injections 750 mg or 1500 mg with a solvent.

1 vial with powder for solution and 1 ampoule with a solvent in a blister in a carton box with a leaflet.

Sirumek 750 mg or 1500 mg №10

Powder for solution for injections in a vial 750 mg or 1500 mg.

10 vials in a blister.

1 blister in a carton box with a leaflet.

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