NOVACTAM 500/250MG VIAL; sulbactam, ampicillin, antibacterials .

ACTIVE-INGREDIENT OF NOVACTAM 500/250MG VIAL

EACH vail contains : ampicillin sodium 530 mg . Equivalent to ampicillin 500 mg . Sulbactam sodium 273 .56 . Equivalent to sulbactam 250 mg .

INDICATION OF NOVACTAM 500/250MG VIAL

novactam is indicated for the treatment of infections due to susceptible strains of the designed microorganisms in the conditions . Skin and skin structure infections ; caused by beta – lactamase producing strains of staphylococcus aureus , escherichia coli , klebseiella spp . ( including k. pneumoniae ) , proteus mirabilis , bacteroides fragilis , enterobacter spp ., and acinetobacter calcoacetius . note : for information on use in pediatric patients . intra-abdominal infections caused by beta-lactamase producing strains of scherichia coli , klebsiella spp . ( including k . pneumoniae ) , bacteroids spp . (including B. fragilis ) and enterobacter spp . gynecological infections caused by beta – lactamase produsing strains of escherichia coli and bacterodies spp . ( including B. fragilis ) . while novactam is indicated only for the conditions , infections caused by ampicillin – susceptible organisms are also ameenable to treatment with novactam due to its ampicillin content . therefore , mixed infections caused by ampicillin -susptible organisms and beta-lactamase produsing organisms susceptible to novactam should not require the addition of another antibiotic . appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to ampicillin and sulbactam . therapy may be insituted prior to obtaining the results from bacteriological and susceptibility studies , when there is reason to believe the infection may involve any of the beta – lactamase producing organisms . once the results are known , therapy should be adjusted if appropriate . to reduce the development of drug resistant bacteria and maintain effectiveness of novactam and other antibacterial drugs , novactam should be used only to treat to prevent infections that are proven or strongly suspected to be caused by susceptile bacteria . when culture and susceptibility information are available , they should be considered in selecting or modifying antibacterial therapy . in the absence of such data , local epidermiology and susceptibility patterns may contribute to the empiric selection of therapy .

DOSAGE OF NOVACTAM 500/250MG VIAL

Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet

Ask your pharmacist or doctor for help if you do not understand the instructions on the box .

The recommended dose is : –

novactam may be administered by either the iv or im routes ( following dilution ) . However , the intent of the pharmacy bulk package is for preparation of solutions for iv infusion only . For iv administration , the dose can can be by slow intravenous injection over at least 10-15 minutes or can also be delivered , in greater dilutions with 50-100 ml at least 10-15 minutes . novactam may be administered by deep intramuscular injection . the recommended adult dosage of novactam is 1.5 g ( 1 g ampicillin as the sodium salt 0.5 g sulbactam as the sodium salt ) to 3 g ( 2 g ampicillin as the sodium salt plus 1 g silbactam as the sodium salt ) every six hours . this 1.5 to 3 g range represents the total of ampicillin content plus the sulbactam content of novactam , and corresponds to a range of 1 g ampicillin /0.5 g sulbactam to 2 g ampicillin / 1 g sulbactam . the total dose of sulbactam should not exceed 4 grams per day . pediatric patients 1 year of age or older : the recommended daily dose of novactam in pediatric patients is 300 mg per kg of body weight administered via intravenous infusion in equally divided doses every 6 hours . this 300 mg/kg/day . the safety and efficacy of ampicillin and sulbactam administered via intramuscular injection in pediatric patients have not been established . pediatric petients weighting 40 kg or more should be dosed according to adult recommendations , and the total dose of sulbactam should not exceed 4 grams per day . the course of intravenous therapy should not routinely exceed 14 days . in clinical trails , most children received a course of oral antimicrobials following initial treatment with intravenous novactam . impaired renal function : in patients with impaired of renal function , the elimination kinetics of ampicillin and sulbactam are similary affected , hence the ratio of one of the other will remain constant whatever the renal function . the dose of novactam in such patients should be adminstered less frequently in accordance with the usual practice for ampicillin and according to the following recommendations . – novactam dosage guide for patients with renal impairment : – creatinine clearance (ml/min/1.73 m2 ) ≥ 30 : ampicillin /sulbactam half-life ( hours ) : 1 : recommended novactam dosage : 1.5-3.0 g q 6 h – q 8 h . – 15-29 : 5 : 1.5 – 3.0 g q 12 h . – 5-14 : 9 : 1.5 – 3.0 g q 24 h . when only creatinine is available , the folloeing formula ( based on sex , weight , and age of the patients ) may be used to convert this value into creatinine clearance . the serum creatinine should represent a steady state of renal function . males = weight (kg ) × ( 140 – age ) / 72 × serum creatinine . – females = 0.85 × above value . compatibility , reconstitution and stability : when concomitant therapy with aminoglycosides is indicated , novactam and aminoglycosides should be reconstituted and adminstered separately , due to the in vitro inactivation of aminoglycosides by any of the aminopenicillins .

OVER-DOSAGE OF NOVACTAM 500/250MG VIAL

neurological adverse reactions , including convulsions , may occur with the attainment of high csf levels of beta – lactams . Ampicillin may be removed from circulation by hemodialysis . The molecular weight , degree of protein binding and pharmacokinetics profile of sulbactam suggest that this compound may also be removed by hemodialysis .

CONTRA-INDICATION OF NOVACTAM 500/250MG VIAL

the use of Novactam is contraindicated in individuals with a history of an allergic reaction to any of the penicillins.

STORAGE OF NOVACTAM 500/250MG VIAL

Store in a dry place at a temperature not exceeding 30 °C.
PACK OF NOVACTAM 500/250MG VIAL
boxes of 1 vial of lyophyilized powder + 5 ml ampoule water for injection .
NOVACTAM 500/250MG VIAL MANUFACTURED BY
EGYPTIAN INT. PHARMACETICAL INDUSTRIES CO. E. I. P. I. CO. Tenth of RAMADAN CITY, INDUSTRIAL AREA .

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