Ampicillin + Sulbactam

Gynaecological infections; Intra-abdominal infections; Skin and skin structure infections, Orbital Cellulitis, Pelvic Inflammatory Disease, Pneumonia, Urinary Tract Infections

Parenteral Gynaecological infections; Intra-abdominal infections; Skin and skin structure infections Adult: Each vial contains 1.5 g (ampicillin 1 g and sulbactam 0.5 g) or 3 g (ampicillin 2 g and sulbactam 1 g): 1.5-3 g 6 hrly by deep IM or slow IV inj over 10-15 min or infusion over 15-30 min. Max: 12 g (8 g ampicillin and 4 g sulbactam) daily. Orbital Cellulitis 3 g (2 g ampicillin + 1 g sulbactam) IV q6hr Pelvic Inflammatory Disease 3 g (2 g ampicillin + 1 g sulbactam) IV q6hr Pneumonia Aspiration or community acquired: 1.5 g (1 g ampicillin + 0.5 g sulbactam) to 3 g (2 g ampicillin + 1 g sulbactam) IV q6hr for 5 or more days Hospital acquired: 3 g IV q6hr for 5 or more days Urinary Tract Infections Pyelonephritis: 3 g (2 g ampicillin + 1 g sulbactam) IV q6hr for 14 days

Parenteral Child: Skin Infections >1 year (<40 kg): 200 mg/kg/day IV divided q6hr; not to exceed 14 days of therapy >1 year (>40 kg): 1.5 g (1 g ampicillin + 0.5 g sulbactam) to 3 g (2 g ampicillin + 1 g sulbactam) q6hr; not to exceed 12 g/day Epiglottitis Children and adolescents: 100-200 mg ampicillin/kg/day IV divided q6hr Mild/Moderate Infection >1 month-1 year: 100-150 mg ampicillin/kg/day IV/IM divided q6hr >1 year: 100-200 mg ampicillin/kg/day IV/IM divided q6hr Meningitis/Severe Infections >1 month-1 year: 200-300 mg ampicillin/kg/day IV/IM divided q6hr >1 year: 200-400 mg ampicillin/kg/day IV/IM divided q6hr Peritonsillar and Retropharyngeal Abscess Children and adolescents: 200 mg ampicillin/kg/day IV divided q6hr

Renal impairment CrCl 5-14 mL/min/1.73 m²: 1.5 g (1 g ampicillin + 0.5 g sulbactam) to 3 g (2 g ampicillin + 1 g sulbactam) IV q24hr CrCl 15-29 mL/min/1.73 m²: 3 g (2 g ampicillin + 1 g sulbactam) IV q12hr CrCl > 30 mL/min/1.73 m²: No dose adjustment necessary

IV/IM Preparation Reconstitute with SWI or 0.5% or 2% lidocaine injection (IM) to obtain a 250 mg ampicillin-125 mg sulbactam/mL solution IM: Use within 1 hr after preparation IV: Further dilute to 3-45 mg/mL with appropriate diluent IV/IM Administration Administer around-the-clock to promote less variation in peak and trough serum levels Slow IV injection over at least 10-15 min or infusion over 15-30 min IM: Deep into large muscle mass

Hypersensitivity to drug or components Patients with previous history of cholestatic jaundice/hepatic dysfunction associated with ampicillin sulbactam

Use caution in patients with allergy to cephalosporins and carbapenems Adjust dose in renal failure Prolonged use is associated with fungal or bacterial superinfection Hepatic dysfunction, including hepatitis and cholestatic jaundice reported; hepatic toxicity is usually reversible; however, deaths have occurred; monitor hepatic function at regular intervals in patients with hepatic impairment A generalized dull red maculopapular rash may occur in 5-10% of children 3-14 days after initiating therapy; carefully evaluate the rash to differentiate a nonallergic ampicillin rash from a hypersensitivity reaction; it normally begins on the trunk and spreads over most of the body; it may be most intense at pressure areas, elbows, and knees Hepatotoxicity reported; monitor hepatic function at regular intervals in patients with hepatic impairment A high percentage of patients with infectious mononucleosis have developed rash during therapy; therapy is not recommended in these patients May cause severe skin reactions, such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), dermatitis exfoliative, erythema multiforme, and acute generalized exanthematous pustulosis (AGEP); if patients develop skin rash monitor closely and discontinued therapy if lesions progress Monitoring Parameters Monitor haematologic, renal and hepatic function w/ prolonged therapy. Monitor for signs of anaphylaxis during 1st dose. Regular monitoring of hepatic function in patients w/ pre-existing hepatic impairment at regular intervals.

B Pregnancy category: B Lactation: Excreted in breast milk; use caution

Increased and prolonged serum levels w/ probenecid. Increased incidence of rashes w/ allopurinol. May reduce effectiveness of oestrogen-containing OC. May increase risk of methotrexate toxicity. Bacteriostatic drugs (e.g. chloramphenicol) may interfere w/ the bactericidal effect of ampicillin. Additive effect w/ anticoagulants. Contraindicated (0) Serious - Use Alternative (13) BCG vaccine live cholera vaccine demeclocycline doxycycline eravacycline microbiota oral minocycline mycophenolate omadacycline oxytetracycline sarecycline tetracycline typhoid vaccine live

>10% IM injection site pain (16%) 1-10% Diarrhea (3%),IV injection site pain (3%),Thrombophlebitis (3%),Rash ( < 2%) <1% Abdominal distention,Black, "hairy" tongue,Candidiasis,Chest pain,Chills,Dysuria,Edema,Epistaxis,Erythema,Fatigue,Flatulence,Glossitis,Headache,Itching,Malaise,Mucosal bleeding,Nausea Pseudomembranous colitis,Seizure,Tightness in throat,Thrombocytopenia,Urine retention,Vomiting

Ampicillin binds to 1 or more of the penicillin-binding proteins (PBPs), thus inhibiting the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls. Sulbactam inhibits the activity of beta-lactamases and extends the spectrum of ampicillin to include beta-lactamase producing organisms.