For the use of only a registered medical practitioner or hospital or laboratory

Cefpirome Sulphate for Injection eÉålÉmÉÏUÉåqÉ

Composition: Severe and persistent diarrhoea may occur with broad Each vial contains spectrum during treatment or in the weeks Cefpirome Sulphate following discontinuation. These episodes may be equivalent to Cefpirome...... 1gm symptomatic of pseudomembranous colitis (in most (A sterile blend of Cefpirome Sulphate cases, due to Clostridium difficile). This event, which is and anhydrous Sodium Carbonate) rare with , may be life-threatening.

CLINICAL PHARMACOLOGY Even if pseudomembranous colitis is only suspected, Cefpirome binds to one or more of the - administration of Cefpirome must be halted binding proteins (PBPs) which inhibits the final immediately. This type of colitis requires immediate transpeptidation step of synthesis in and appropriate treatment by a physician. Drugs that bacterial , thus inhibiting biosynthesis and inhibit intestinal motility (peristalsis) must not be arresting cell wall assembly resulting in bacterial cell taken in such cases. Insufficient clinical experience has death. Cefpirome is rapidly and widely distributed in been gained with Cefpirome in children body fluids and achieves excellent tissue penetration reaching concentrations which exceed the minimum INTERACTIONS inhibitory concentrations for most pathogens. As antibiotics may potentiate the nephrotoxic effects of certain drugs (eg: Bioavailability after i.m. administration is greater than aminoglycosides,loop diuretics) if administered 90%. The average peak (C5min) serum level after concomitantly, the possibility of such an interaction single i.v. doses of 1.0g was 80-90 mg/L. with cefpirome must be borne in mind. Pharmacokinetics were dose linear. The volume of distribution was 14-19L. No accumulation was seen Probenicid interferes with the renal tubular transfer of after multiple dosing. The elimination half-life in cephalosporins, delaying their excretions and serum was 1.8-2.2h. Serum protein binding was less therefore increasing their plasma concentrations. than 10% and was dose independent. Cefpirome was principally eliminated by the kidney; 80-90% of A false positive Coombs test result may be obtained in the administered drug was recovered in the urine. rare cases during treatment with cefpirome Radioactive counts recovered in the urine consisted of Glycosuria must be measured by enzymatic methods 98-99% unchanged cefpirome. Approximately 30% during treatment, given that non-enzymatic of a 1.0g dose was eliminated by haemodialysis techniques may produce a false positive reaction.

INDICATIONS Pregnancy and lactation • Infections caused by Cefpirome-sensitive The safety of cefpirome has not yet been established organisms: in pregnant women. Cefpirome must not be • Lower respiratory tract infections administered during pregnancy. Studies in several • Complicated upper and lower urinary tract animal species have shown no teratogenic or infections fetotoxic action. • Bacteraemia/Septicaemia • Infections in neutropenic & immunocompromised The safety of cefpirome has not yet been established patients. in lactating women. Therefore, breast-feeding should • Skin and soft tissue infections. be discontinued during treatment with Cefpirome • Severe infections in intensive care patients. ADVERSE REACTION CONTRAINDICATIONS Hypersensitivity reactions: Cefpirome must not be used in patients with Allergic skin reactions (rash, urticaria), Itching, drug hypersensivity to antibiotics of the cephalosporin fever and severe acute allergic (anaphylactic) group. Cefpirome must not be used during reactions may occur. pregnancy. Breast-feeding should be discontinued during treatment with Cefpirome. Gastrointestinal tract: Nausea and vomiting, abdominal pain, diarrhoea in SPECIAL WARNINGS AND PRECAUTIONS very rare cases pseudomembranous colitis. The occurrence of any allergic reaction necessitates discontinuation of treatment. The prescription of Effects on Liver function: cephalosporins requires prior interview, as cross- Raise in serum liver enzymes (ASAT, ALAT, LDH, allergy between and cephalosporins is alkaline phosphatase), increase in serum bilirubin. present in 5 to 10% of cases. Cephalosporins must be used with extreme caution in penicillin sensitive Effects on renal function: patients; lncreases in serum creatinine (in rare cases neccessitating discontinuation of treatment) and It is advisable to monitor renal function during urea. In rare instances, interstitial nephritis may occur treatment with combinations or cefpirome and with cephalosporins. diuretics of the furosemide or ethacrynic acid type and potentially nephrotoxic drugs such as certain Changes in blood constituents: (aminoglycosides in particular). In cases or Thrombopenia; eosinophilia; very rarely haemolytic impaired renal function, adjust the dosage .according anemia. As with other beta-lactam antibiotics to the creatinine clearance. (particularly if given over long periods), granulocytopenia and, more rarely, agranulocytosis A s w i t h o t h e r b e t a - I a c t a m a n t i b i o t i c may develop. granulocytopenia and, more rarely, agranulocytosis may develop, particularly if Cefpirome is given over longer periods.The blood cell count should therefore Local infections: be monitored for courses of treatment lasting far Inflammatory irritation and pain at the injection site. more than 10 days.

1 For the use of only a registered medical practitioner or hospital or laboratory

Cefpirome Sulphate for Injection eÉålÉmÉÏUÉåqÉ

Other Reactions: should be inserted rapidly. The amount of 100 ml Disturbance of taste may be experienced immediately solvent must be adhered to as precisely as possible. after injection. Headache may develop. In very few Foaming occurs on dissolution of cefpirome and the cases, convulsion. vial must be tilted gently from side to side for about 1 minute before cefpirome is entirely dissolved. Administration of antibiotics-including Cefpirome- especially if prolonged, may lead to the proliferation After reconstitution, Cefpirome can be stored for up of resistant micro organisms. The patient's condition to 6 hours at room temperature or for up to 24 hours must therefore be checked at regular intervals. at between 2°C to 8°C without undergoing any Should a secondary infection occur, appropriate significant physical or chemical changes. In order to measures must be taken avoid septic complication on injection it is recommended that care should be taken during DOSAGE AND ADMINISTRATION reconstitution to ensure aseptic handling and that the Dosage and mode of administration depend on the solution should be used immediately after severity of the infection, sensitivity of the pathogens, reconstitution. Aseptic handling is particularly and condition of the patients. important if the solution is not intended for Dosage in adult patients with normal renal function: immediate use.

Protect the reconstituted solution from direct sunlight. Same intensification of colour may occur during storage of the reconstituted solution. However, provided the recommended storage conditions are observed, this does not indicate a change in potency or safety.

Storage Children: 50mg/kg body wt. 8 to 12 hourly. Store in a cool dry place below 25OC. Protect from light & moisture. Dosage in patients with impaired renal function: Cefpirome is excreted predominantly via the renal How supplied route. In case of impaired renal function, dose Genpirome is available as vials of 1g along with 10 mL reduction is necessary to compensate for the slower sterile water for injection for reconstitution. excretion.No dose reduction is necessary in patients with a creatinine clearance below 50 ml/min. In For further details, please contact: patients with a creatinine clearance below 50ml/min, Medical Advisor: the dosage must be adjusted to the following Biocon Limited scheme: 20th KM, Hosur Road, Electronics City, Bangalore - 560 100. India TM - Trade Mark of Biocon Limited

Manufactured by: Zeiss Pharmaceuticals Pvt. Ltd. Plot No.72, EPIP, Phase-1, Jharmajri, Baddi (HP) 173205, Dist. Solan.

Dosage in elderly patients: No adjustment necessary Marketed by: except in cases of impaired renal function (see above). Biocon Limited 20th KM, Hosur Road, Duration of treatment: The duration of treatment Electronics City, Bangalore - 560 100. India depends on the patient’s clinical and bacteriological TM - Trade Mark of Biocon Limited response. “Mfd. under the technical guidance of Biocon Mode of administration: Intravenous route / Limited” Intramuscular route. To report adverse events and/or product complaints Intravenous injection of Cefpirome 1.0g: Dissolve the visit our website www.biocon.com or contents of one vial of Cefpirome 1.0g in 10 ml water call toll free No: 1800 102 9465 or e mail us at for injections, and then inject slowly within 3 to 5 [email protected] minutes.

Short intravenous infusion of Cefpirome 1.0 g: Dissolve the contents of one vial of Cefpirome 1.0 in 100 ml water for injections, and then infuse for 20 to 30 minutes. The following infusion solution can also be used alternatively for dissolution: 0.9% sodium chloride solution, Ringer's solution, standard electrolyte solutions, 5 and 10% glucose solution, 5% fructose solution, 6% glucose + 0.9% sodium chloride solution. Cefpirome must not be administered in sodium bicarbonate solution.

The vials containing the solvent and the powder for reconstitution should be held horizontally when BF/LL/0040/01 preparing the infusion solution, and the cannula

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