Sratop 250 Mg/500 Mg/1 G Injection

SRATOP is indicated in the treatment of the following infections when due to susceptible micro-organisms.

• Respiratory tract infections due to S. pneumoniae, Klebsiella sp, H. influenzae, Staph. aureus (including penicillinase-producing strains), and Group A beta-haemolytic streptococci: Tonsillitis, pharyngitis, pneumonia, bronchitis, pulmonary abscess, empyema, pleurisy, sinusitis, laryngitis and otitis media.
• Skin, soft-tissue and postoperative infections due to Staph. aureus (including penicillinase-producing strains) and Group A beta-haemolytic streptococci and other strains of streptococci: Lymphangitis, abscesses, cellulitis, decubitus ulcers, mastitis. (Surgical procedures should be performed where indicated).
• Genitourinary tract infection due to E. coli, P. mirabilis, Klebsiella sp., and some strains of Enterobacter and enterococci: Pyelonephritis, cystitis and adnexitis.
• Other infections due to Staph. aureus (penicillin-susceptible and penicillin-resistant) and Group A beta-haemolytic streptococci, S. pneumoniae, P. mirabilis, E. coli, and Klebsiella spp.: Bacteraemia, septicaemia, endocarditis, osteomyelitis, peritonitis, puerperal sepsis.

NOTE: Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to SRATOP. If the tests show that the causative organism is resistant to SRATOP, other appropriate therapy should be instituted.

The following dosages are recommended, for administration of constituted SRATOP preferably by intravenous infusion or alternatively by slow intravenous injection (over 3 to 5 minutes) or by intramuscular injection.

For the treatment of mild-to-moderately severe bacterial infections, 1.5 to 2 g per day in equally divided doses, two or three times daily. For the treatment of severe bacterial infection, 3 - 4 g per day in equally divided doses two or three times daily. Higher and/or more frequent doses (up to 6 g daily) may be given in very severe, life-threatening infections. Doses of up to 12 grams have been used.

Children: The following dosage chart is a useful guide to SRATOP therapy in children.

• PERCENTAGE of ADULT DOSE

• AGE AND WEIGHT

• TOTAL DAILY DOSE

• MAXIMUM

• 100 % Adult (65 kg) 1.5 g to 6 g
• 75 % 12 years (40 kg) 1.125 g to 4.5 g
• 50 % 7 years (23 kg) 750 mg to 3 g
• 25 % 1 year (10 kg) 375 mg to 1.5 g
• 20 % 4 months (6.5 kg) 300 mg to 1.2 g

For in-between ages, in-between percentages are used e.g. at 10 years, 66 % and at three years 33 % of the adult dose.

Note: SRATOP may be nephrotoxic if given in excessive doses (more than 6 g daily in patients with normal renal function) or if administered without appropriate dosage reduction in patients with renal impairment.

SRATOP is contraindicated in patients hypersensitive to cephalosporins and its derivatives, or any components of the formulation.

Pseudomembranous colitis has been reported with broad spectrum antibiotics including SRATOP, therefore, it is important to consider its diagnosis in patients who develop diarrhoea in association with its use. Such colitis may be life-threatening and appropriate measures should be taken, including discontinuation of the SRATOP.

In individuals with a history of gastrointestinal disease, particularly colitis, broad spectrum antibiotics should be prescribed with caution.

Cefazolin as in SRATOP should be given with caution to penicillin sensitive patients. There is some clinical and laboratory evidence of partial cross-allergenicity of the penicillins and the cephalosporins. Careful inquiry should be made concerning previous hypersensitivity reactions of cephalosporins and penicillins, before SRATOP therapy is instituted.

Any patient who has shown some form of allergy particularly to medicines should receive antibiotics cautiously and no exception should be made in this regard to SRATOP. If an allergic reaction to SRATOP occurs the medicine should be discontinued and the patient treated with the appropriate therapy.

Prolonged use of SRATOP may result in the overgrowth of non-susceptible organisms. If superinfection occurs during therapy, appropriate measures should be taken.

SRATOP should be administered with caution in patients with impaired renal function, as in these patients lower daily dosage is required.

Safety and effectiveness for use in premature infants and infants under one month of age have not been established. As experience in premature infants and neonates is limited the use of SRATOP in these patients should only be undertaken with caution.

Intrathecal administration of SRATOP is not recommended. There have been reports of severe central nervous system toxicity including seizures when cefazolin was administered intrathecally.

SRATOP is presumed to be safe or unlikely to produce an effect on the ability to drive and use machines.

The renal tubular secretion of cephalosporins may be decreased by probenecid when used concurrently, resulting in increased and more prolonged cephalosporin blood levels.

The efficacy of oestrogen-containing contraceptives may be decreased by the concomitant administration of SRATOP.

Concomitant administration of cephalosporins and aminoglycoside antibiotics has been associated with increased nephrotoxicity.

A false positive reaction for glucose in the urine may occur with Benedictu2019s solution, Fehlingu2019s solution, or Clinitest tablets but not with enzyme based tests such as Clinistix and Tes-Tape.

Positive direct and indirect antiglobulin tests have occurred; these may also occur in neonates whose mothers received cephalosporins before delivery.

The safety of SRATOP in pregnancy and lactation has not been established. SRATOP has been found to readily cross the placental barrier into the cord blood and amniotic fluid. SRATOP is present in very low concentrations in the milk of nursing women.

SRATOP is presumed to be safe or unlikely to produce an effect on the ability to drive and use machines.

Immune system disorders: Less frequent: Rash, pruritus, urticaria, drug fever, anaphylaxis, hypersensitivity. Frequency not known: Angioedema.

Blood and the lymphatic system disorders: Frequent: Eosinophilia. Less frequent: Leukopenia, neutropenia, thrombocytopenia. Frequency not known: Thrombocythemia. Positive direct and indirect Coombsu2019 tests have occurred.

Hepato-biliary disorders: Frequency not known: Transient rises in AST, ALT and alkaline phosphatase levels. Transient hepatitis, cholestatic jaundice.

Renal and urinary disorders: Frequency not known: Transient rise in blood urea levels have been observed. Interstitial nephritis and other renal disorders. Most patients experiencing these reactions had been seriously ill and were receiving multiple medicine therapies. The role of SRATOP in the development of nephropathies has not been determined.

Gastrointestinal disorders: Frequent: Nausea and vomiting, diarrhoea, oral candidiasis. Less frequent: Symptoms of pseudomembranous colitis may appear either during or after antibiotic therapy. Frequency not known: Anorexia.

Skin and subcutaneous tissue disorders: Less frequent: Stevens-Johnson syndrome.

Reproductive system and breast disorders: Frequent: Vaginal candidiasis. Less frequent: Genital pruritus, vaginitis.

General disorders and administrative site conditions: Less frequent: SRATOP is well tolerated when administered by intravenous infusion, and the incidence of phlebitis with SRATOP is low. Although pain was infrequently reported after intramuscular injection, it was seldom severe. Cefazolin rarely produced tenderness, induration or fever. Frequency not known: Anal pruritus.

Inappropriately large doses of parenteral cephalosporins may cause dizziness, paresthesias and headache. With some cephalosporins, seizures may occur following overdosage, particularly in patients with renal impairment in whom accumulation is likely to occur. Dosage reduction is necessary when renal function is impaired. If seizures occur, the drug should be promptly discontinued; anticonvulsant therapy may be administered if clinically indicated. Haemodialysis may be considered in cases of overwhelming overdosage.

Laboratory abnormalities that may occur after an overdose include elevations in creatinine, BUN, liver enzymes and bilirubin, a positive Coombs' tests, thrombocytosis, thrombocytopenia, eosinophilia, leukopenia and prolongation of the prothrombin time. Treatment of overdosage should be symptomatic and supportive.