ampicillin/sulbactam [IM/IV]

Adult Dosing

Skin and skin-structure infections, intra-abdominal and gynecologic infections caused by susceptible bacteria

1.5 g (1 g ampicillin/0.5 g sulbactam) - 3 g (2 g ampicillin/1 g sulbactam) IM/IV divided q6 hrs
Max: 12 g/day

Epiglottitis [Non-FDA approved]

1.5 g (1 g ampicillin/0.5 g sulbactam) - 3 g (2 g ampicillin/1 g sulbactam) IM/IV divided q6 hrs
Max: 12 g/day

Note:

Doses expressed as total ampicillin + sulbactam; 1.5 g ampicillin/sulbactam contains 1 g ampicillin + 0.5 g sulbactam

Pediatric Dosing

Skin and skin-structure infections caused by susceptible bacteria

Children 1 yr

<40 kg: 300 mg/kg/day IV divided q6 hrs; Max: 12 g/day
>40 kg: 1.5-3 g IV in divided doses q6 hrs; Max: 12 g/day
The course of IV therapy should not routinely exceed 14 days
Safety and efficacy of ampicillin/sulbactam administered via IM injection in pediatric patients have not been established

Epiglottitis [Non-FDA approved]

Children 1 yr

<40 kg: 300 mg/kg/day IV divided q6 hrs; Max: 12 g/day
>40 kg: 1.5-3 g IV in divided doses q6 hrs; Max: 12 g/day
The course of IV therapy should not routinely exceed 14 days

Note:

Doses expressed as total ampicillin + sulbactam; 1.5 g ampicillin/sulbactam contains 1 g ampicillin + 0.5 g sulbactam

[Outline]

Adult Dosing
Pediatric Dosing

Indications ⬆ ⬇

Treatment of infections caused by susceptible strains of designated microorganisms in the following conditions
Skin and skin structure infections
Intra-abdominal infections
Gynecological infections

Contraindications ⬆ ⬇

Hypersensitivity to any of the ingredients of the product
Mononucleosis

Black Box Warnings ⬆ ⬇

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment (Based on CrCl)

>30 mL/min: 1.5–3 g IV/IM in divided doses q6-8 hrs
15-29 mL/min: 1.5–3 g IV/IM bid
5-14 mL/min: 1.5–3 g IV/IM qd
Hemodialysis: 1.5–3 g IV/IM qd, preferably soon after dialysis

Hepatic Dose Adjustment

Hepatic impairment: Dose adjustments not defined

Warnings/Precautions ⬆ ⬇

See Supplemental Patient Information

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy, more likely to be occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens
Detailed inquiry should be made regarding previous hypersensitivity responses to penicillins, cephalosporins, or other allergens. Drug should be discontinued in the event of an allergic reaction or superimposed infection
Treatment with epinephrine and other emergency measures is required in serious acute hypersensitivity reactions
Prolonged use may result in fungal or bacterial superinfections, including C. difficile associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been reported to range from mild diarrhea to fatal colitis and can occur over two months after the administration of antibacterial agents
A high percentage of patients with infectious mononucleosis have developed skin rash during therapy. Therefore, the administration of ampicillin is not recommended in patients with mononucleosis
Periodic assessment of organ system function, including renal, hepatic, and hematopoietic, should be made during prolonged therapy
Avoid prescribing therapy in the absence of proven or strongly suspected bacterial infections or as a prophylactic indication as it may increase the risk of the development of drug-resistant bacteria

Cautions: Use cautiously in

Renal impairment
Cytomegalovirus infections
Acute lymphoblastic leukemia
Non-anaphylactic hypersensitivity to beta-lactams
Hyperuricemia

Supplemental Patient Information

Advise patients to contact their physicians if they develop watery and bloody stools any time from the beginning of therapy up to two or more months after therapy

Pregnancy/Breast Feeding ⬆ ⬇

Pregnancy Category:B

Breastfeeding: Probably safe. Ampicillin is acceptable to use during breastfeeding. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 4 March 2011). Manufacturer advises caution.

Adverse Reactions ⬆ ⬇

CNS: Seizures
GI: Pseudomembranous colitis, Clostridium difficile associated diarrhea, nausea, vomiting, hepatotoxicity, hairy tongue
DERM: Rashes, exfoliative dermatitis, toxic epidermal necrolysis
HEMA: Blood dyscrasias, eosinophilia, anemia, thrombocytopenia, agranulocytosis, leukopenia, hemolytic anemia
LABTESTS: Elevated liver enzymes, elevated BUN and Cr
LOCAL: Pain at IM site, pain at IV site, thrombophlebitis
GU: Interstitial nephritis, vaginitis
HYPERSENSITIVITY: Allergic reactions including anaphylaxis, serum sickness-like reactions, urticaria, erythema multiforme, Stevens-Johnson syndrome
MISC: Superinfection, angioedema, anaphylaxis

Clinical Pharmacology ⬆ ⬇

ampicillin

Anti-bacterial agents; destroys bacteria by inhibiting bacterial cell wall mucopeptide synthesis
Metabolized by the liver 10%; CYP450: unknown
Renally excreted, largely unchanged (75-90% )
Half-life: 1-1.5 hrs, 9-19 hrs (severe renal impairment)

sulbactam

Beta-lactamase inhibitor; destroys bacteria by inhibiting bacterial cell wall synthesis
Metabolized by the liver <25%; CYP450: Unknown
Renally excreted, largely unchanged (75-85%)
Half-life: 1 hrs, 9 hrs (severe renal impairment)

Brands and Availability ⬆ ⬇