Elsaad products
Member Login


New Products
Newsletter
 
 
Our Products
Product Name
:
AMPICTAM
Chemical Name
:
Ampicillin (Sodium) +Sulbactam (Sodium)
Therapeutic Category
:
Antimicrobial
Pharmacologic Category
:
Antibiotic, Penicillin
Pharmaceutical Form
:
Vial
Composition
:
Ampicillin (Sodium) 500mg+Sulbactam (Sodium) 250mg / Ampicillin (Sodium) 1000mg+Sulbactam (Sodium) 500mg / Ampicillin (Sodium) 2000mg+Sulbactam (Sodium) 1000mg
Dosing
 
Dosing: Adult

Doses expressed as ampicillin/sulbactam combination.

Susceptible infections: I.M., I.V.: 1.5-3 g every 6 hours

Amnionitis, cholangitis, diverticulitis, endometritis, endophthalmitis, epididymitis/orchitis, liver abscess, osteomyelitis (diabetic foot), peritonitis: I.V.: 3 g every 6 hours; Note: Due to high rates of E. coli resistance, not recommended for the treatment of community-acquired intra-abdominal infections (Solomkin, 2010)

Endocarditis: I.V.: 3 g every 6 hours with gentamicin or vancomycin for 4-6 weeks

Orbital cellulitis: I.V.: 1.5 g every 6 hours

Parapharyngeal space infections: I.V.: 3 g every 6 hours

Pasteurella multocida (human, canine/feline bites): I.V.: 1.5-3 g every 6 hours

Pelvic inflammatory disease: I.V.: 3 g every 6 hours with doxycycline

Peritonitis (CAPD): Intraperitoneal:

Anuric, intermittent: 3 g every 12 hours

Anuric, continuous: Loading dose: 1.5 g; maintenance dose: 150 mg

Pneumonia:

Aspiration, community-acquired: I.V.: 1.5-3 g every 6 hours

Hospital-acquired: I.V.: 3 g every 6 hours

Urinary tract infections, pyelonephritis: I.V.: 3 g every 6 hours for 14 days

 
 
Dosing: Pediatric

Susceptible infections: Children ≥1 year: I.V.: 100-400 mg ampicillin/kg/day divided every 6 hours (maximum: 8 g ampicillin/day) Note: The American Academy of Pediatrics recommends a dose of up to 300 mg/kg/day for severe infection in infants >1 month of age.

Epiglottitis: Children ≥1 year: I.V.: 100-200 mg ampicillin/kg/day divided in 4 doses

Mild-to-moderate infections: Children ≥1 year: I.V.: 100-200 mg ampicillin/kg/day divided every 6 hours

Peritonsillar and retropharyngeal abscess: Children ≥1 year: I.V.: 50 mg ampicillin/kg/dose every 6 hours

Severe infections: Children ≥1 year: I.V.: 200-400 mg ampicillin/kg/day divided every 6 hours

Dosing: Geriatric

Refer to adult dosing.
Dosing: Renal Impairment

Note: Estimation of renal function for the purpose of drug dosing should be done using the Cockcroft-Gault formula.

Clcr 15-29 mL/minute/1.73 m2: 1.5-3 g every 12 hours

Clcr 5-14 mL/minute/1.73 m2: 1.5-3 g every 24 hours

Intermittent hemodialysis (IHD) (administer after hemodialysis on dialysis days): 1.5-3 g every 12-24 hours (Heintz, 2009). Note: Dosing dependent on the assumption of 3 times/week, complete IHD sessions.

Peritoneal dialysis (PD): 3 g every 24 hours

Continuous renal replacement therapy (CRRT): Drug clearance is highly dependent on the method of renal replacement, filter type, and flow rate. Appropriate dosing requires close monitoring of pharmacologic response, signs of adverse reactions due to drug accumulation, as well as drug levels in relation to target trough (if appropriate). The following are general recommendations only (based on dialysate flow/ultrafiltration rates of 1-2 L/hour and minimal residual renal function) and should not supersede clinical judgment (Heintz, 2009; Trotman, 2005):

CVVH: Initial: 3 g; maintenance: 1.5-3 g every 8-12 hours
CVVHD: Initial: 3 g; maintenance: 1.5-3 g every 8 hours
CVVHDF: Initial: 3 g; maintenance: 1.5-3 g every 6-8 hours
Use
 

Treatment of susceptible bacterial infections involved with skin and skin structure, intra-abdominal infections, gynecological infections; spectrum is that of ampicillin plus organisms producing beta-lactamases such as S. aureus, H. influenzae, E. coli, Klebsiella, Acinetobacter, Enterobacter, and anaerobes

Adverse Reactions
 
>10%: Local: Pain at injection site (I.M.)
1% to 10%:
Dermatologic: Rash
Gastrointestinal: Diarrhea
Local: Pain at injection site (I.V.), thrombophlebitis

Miscellaneous: Allergic reaction (may include serum sickness, urticaria, bronchospasm, hypotension, etc)

<1% (Limited to important or life-threatening): Abdominal distension, candidiasis, chest pain, chills, dysuria, edema, epistaxis, erythema, facial swelling, fatigue, flatulence, glossitis, hairy tongue, headache, interstitial nephritis, itching, liver enzymes increased, malaise, mucosal bleeding, nausea, pseudomembranous colitis, seizure, substernal pain, throat tightness, thrombocytopenia, urine retention, vomiting

Contraindications
 

Hypersensitivity to ampicillin, sulbactam, penicillins, or any component of the formulations

Warnings / Precautions Drug
 
Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Serious and occasionally severe or fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy, especially with a history of beta-lactam hypersensitivity, history of sensitivity to multiple allergens, or previous IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria). Use with caution in asthmatic patients.

• Rash: Appearance of a rash should be carefully evaluated to differentiate a nonallergic ampicillin rash from a hypersensitivity reaction; rash occurs in 5% to 10% of children and is a generalized dull red, maculopapular rash, generally appearing 3-14 days after the start of therapy. It normally begins on the trunk and spreads over most of the body. It may be most intense at pressure areas, elbows, and knees.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Infectious mononucleosis: A high percentage of patients with infectious mononucleosis have developed rash during therapy; ampicillin-class antibiotics not recommended in these patients.

• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment recommended.

Interactions
 

Allopurinol: May enhance the potential for allergic or hypersensitivity reactions to Ampicillin. Risk C: Monitor therapy

Atenolol: Ampicillin may decrease the bioavailability of Atenolol. Risk C: Monitor therapy

BCG: Antibiotics may diminish the therapeutic effect of BCG. Risk X: Avoid combination

Chloroquine: May decrease the serum concentration of Ampicillin. Management: Choroquine prescribing information recommends separating administration of ampicillin and chloroquine by at least 2 hours to minimize any potential negative impact of chloroquine on ampicillin bioavailability. Risk D: Consider therapy modification

Fusidic Acid: May diminish the therapeutic effect of Penicillins. Risk D: Consider therapy modification

Lanthanum: May decrease the serum concentration of Ampicillin. Management: Administer oral ampicillin at least two hours before or after lanthanum. Risk D: Consider therapy modification

Methotrexate: Penicillins may decrease the excretion of Methotrexate. Risk C: Monitor therapy

Mycophenolate: Penicillins may decrease serum concentrations of the active metabolite(s) of Mycophenolate. This effect appears to be the result of impaired enterohepatic recirculation. Risk C: Monitor therapy

Probenecid: May increase the serum concentration of Penicillins. Risk C: Monitor therapy

Tetracycline Derivatives: May diminish the therapeutic effect of Penicillins. Risk D: Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 24 hours after cessation of antibacterial agents. Risk D: Consider therapy modification
Pregnancy
 
B
Pregnancy Implications

Adverse events have not been observed in animal studies; therefore, ampicillin/sulbactam is classified as pregnancy category B. Both ampicillin and sulbactam cross the placenta. When used during pregnancy, pharmacokinetic changes have been observed with ampicillin alone (refer to the Ampicillin monograph for details).

Lactation
 
Enters breast milk/use caution
Breast-Feeding Considerations

Ampicillin and sulbactam are both excreted into breast milk in low concentrations. The manufacturer recommends that caution be used if administering to lactating women. Nondose-related effects could include modification of bowel flora and allergic sensitization of the infant. The maternal dose of sulbactam does not need altered in the postpartum period. Also refer to the Ampicillin monograph.

Monitoring Parameters
 

With prolonged therapy, monitor hematologic, renal, and hepatic function; monitor for signs of anaphylaxis during first dose

Mechanism of Action
 

The addition of sulbactam, a beta-lactamase inhibitor, to ampicillin extends the spectrum of ampicillin to include some beta-lactamase-producing organisms; inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.

Pharmacodynamics / Kinetics
 
Ampicillin:

Distribution: Bile, blister, and tissue fluids; penetration into CSF occurs with inflamed meninges only, good only with inflammation (exceeds usual MICs)

Normal meninges: Nil; Inflamed meninges: 5% to 10%
Protein binding: 15% to 25%
Half-life elimination:
Children and Adults: 1-1.8 hours
Anuria/end-stage renal disease: 7-20 hours

Excretion: Urine (90% as unchanged drug) within 24 hours

 
Sulbactam:
Distribution: Bile, blister, and tissue fluids
Protein binding: 38%
Half-life elimination: Normal renal function: 1-1.3 hours

Excretion: Urine (~75% to 85% as unchanged drug) within 8 hours

 
   
 
Powered by: TSS-EST.COM