Ampicillin and sulbactam

Name: Ampicillin and sulbactam

Indications

UNASYN is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below.

Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli,2 Klebsiella spp.2 (including K. pneumoniae2), Proteus mirabilis,2 Bacteroides fragilis,2 Enterobacter spp.2, and Acinetobacter calcoaceticus.2

NOTE: For information on use in pediatric patients see PRECAUTIONSPediatric Use and Clinical Studies.

Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae2), Bacteroides spp. (including B. fragilis), and Enterobacter spp.2

Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli,2 and Bacteroides2 spp. (including B. fragilis2).

While UNASYN is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with UNASYN due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to UNASYN should not require the addition of another antibacterial.

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 UNASYN.

Therapy may be instituted 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 listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate.

To reduce the development of drug-resistant bacteria and maintain effectiveness of UNASYN and other antibacterial drugs, UNASYN should be used only to treat infections that are proven or strongly suspected to be caused by susceptible 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 epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

2Efficacy for this organism in this organ system was studied in fewer than 10 infections.

What is ampicillin and sulbactam?

Ampicillin and sulbactam are penicillin antibiotics that fight bacteria.

Ampicillin and sulbactam is a combination medicine used to treat many different types of infections caused by bacteria.

Ampicillin and sulbactam may also be used for purposes not listed in this medication guide.

How should I use ampicillin and sulbactam?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Ampicillin and sulbactam is injected into a muscle, or into a vein through an IV. You may be shown how to use an IV at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

Ampicillin and sulbactam is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

After mixing your medicine, you will need to use it within a certain number of hours. This will depend on the diluent and how you store the mixture (at cool room temperature, or in a refrigerator). Carefully follow the mixing and storage instructions provided with your medicine. Ask your pharmacist if you have questions.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Ampicillin and sulbactam will not treat a viral infection such as the flu or a common cold.

You may need frequent blood tests to check your liver function.

This medication can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using ampicillin and sulbactam.

Store at room temperature away from moisture and heat.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose may cause seizure (convulsions).

What are some things I need to know or do while I take Ampicillin and Sulbactam?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Very bad and sometimes deadly allergic side effects have rarely happened. Talk with your doctor.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take ampicillin and sulbactam.
  • If you have high blood sugar (diabetes), do not use Clinitest®. Use some other urine glucose testing like Clinistix® or Tes-Tape®.
  • Do not use longer than you have been told. A second infection may happen.
  • Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking this medicine.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using ampicillin and sulbactam while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Ampicillin and Sulbactam) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as a shot into a muscle or as an infusion into a vein over a period of time.
  • It may be given as a shot into a vein.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

What are some other side effects of Ampicillin and Sulbactam?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Loose stools (diarrhea).
  • Pain where the shot was given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Dosing Pediatric

Unasyn (ampicillin/sulbactam) is a combination product. Note: Dosage recommendations are expressed as mg of the ampicillin component.

Susceptible infections: Children and Adolescents: IV: 100 to 200 mg ampicillin/kg/day divided every 6 hours (maximum: 8 g ampicillin daily or 12 g ampicillin/sulbactam daily).

Epiglottitis: Children and Adolescents: IV: 100 to 200 mg ampicillin/kg/day divided in 4 doses

Intra-abdominal infection, complicated (off-label): Infants, Children, and Adolescents: IV: 200 mg ampicillin/kg/day divided every 6 hours; Note: Due to high rates of E. coli resistance, not recommended for the treatment of community-acquired intra-abdominal infections (IDSA [Solomkin 2010]).

Infective endocarditis, treatment (off-label use) (AHA/IDSA [Baddour 2005]): Infants, Children, and Adolescents:

Bartonella spp. (Native valve): IV: 200 mg ampicillin/kg/day in 4 or 6 divided doses with concomitant gentamicin for 4 to 6 weeks.

Enterococcus organism (resistant to penicillin/susceptible to aminoglycoside and vancomycin): IV: 200 mg ampicillin/kg/day in 4 divided doses with concomitant gentamicin for 6 weeks. Note: If enterococcus is gentamicin resistant, then >6 weeks of ampicillin-sulbactam therapy needed.

HACEK organism: 200 mg ampicillin/kg/day in 4 or 6 divided doses for 4 weeks.

Intravascular catheter-associated bloodstream infection (off-label use) (IDSA 2009): Infants, Children, and Adolescents:

Infants: IV: 100 to 150 mg ampicillin/kg/day in 4 divided doses

Children and Adolescents: IV: 100 to 200 mg ampicillin/kg/day in 4 divided doses

Mild to moderate infections: Children and Adolescents: IV: 100 to 200 mg ampicillin/kg/day divided every 6 hours (maximum: 8 g ampicillin daily or 12 g ampicillin/sulbactam daily)

Peritonsillar and retropharyngeal abscess: Children and Adolescents: IV: 200 mg ampicillin/kg/day in 4 divided doses

Severe infections: Children and Adolescents: IV: 200 mg ampicillin/kg/day divided every 6 hours (maximum: 8 g ampicillin daily or 12 g ampicillin/sulbactam daily)

Surgical (perioperative) prophylaxis (off-label use): Children ≥1 year: IV: 50 mg ampicillin/kg within 60 minutes prior to surgical incision (maximum: 2 g ampicillin or 3 g ampicillin/sulbactam per dose). Doses may be repeated in 2 hours if procedure is lengthy or if there is excessive blood loss (Bratzler 2013).

Monitoring Parameters

With prolonged therapy, monitor hematologic, renal, and hepatic function; monitor for signs of anaphylaxis during first dose. In patients with preexisting hepatic impairment, monitor hepatic function at regular intervals.

For Healthcare Professionals

Applies to ampicillin / sulbactam: injectable powder for injection

General

This drug was generally well-tolerated.[Ref]

Local

Very common (10% or more): Pain at IM injection site (16%)
Common (1% to 10%): Pain at IV injection site, thrombophlebitis, phlebitis
Postmarketing reports: Injections site reaction[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea
Uncommon (0.1% to 1%): Nausea, vomiting, flatulence, abdominal distension, glossitis
Frequency not reported: Pancreatitis, enterocolitis, pseudomembranous colitis
Postmarketing reports: Gastritis, stomatitis, black "hairy" tongue, Clostridium difficile associated diarrhea[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions to ampicillin (including urticarial rash, edema, hypotension, fever, eosinophilia, dyspnea, delayed hypersensitivity maculopapular rash, anaphylaxis, interstitial nephritis, Henoch-Schonlein purpura, focal glomerulonephritis, Stevens-Johnson syndrome)
Postmarketing reports: Serious and fatal hypersensitivity (anaphylactic) reactions[Ref]

Dermatologic

Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Itching, facial swelling, erythema
Frequency not reported: Ampicillin-associated bullous pemphigoid, linear IgA dermatosis, pseudoporphyria
Postmarketing reports: Erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, urticaria, exfoliative dermatitis[Ref]

Hematologic

Hemolytic anemia, thrombocytopenic purpura, and agranulocytosis were generally reversible when therapy was discontinued; may be hypersensitivity events.[Ref]

Frequency not reported: Decreased hemoglobin, decreased hematocrit, decreased red blood cells, decreased white blood cells, decreased neutrophils, decreased lymphocytes, decreased platelets, increased lymphocytes, increased monocytes, increased basophils, increased eosinophils, increased platelets, thrombocytopenia, leukopenia, red cell aplasia, anemia, atypical lymphocytosis
Postmarketing reports: Hemolytic anemia, thrombocytopenic purpura, agranulocytosis, positive direct Coombs test[Ref]

Nervous system

Uncommon (0.1% to 1%): Headache
Frequency not reported: Seizures, neurotoxic potential, worsening myasthenia gravis symptoms
Postmarketing reports: Convulsion[Ref]

Seizures have been reported in very ill patients with high serum levels of ampicillin. High cerebral spinal fluid (CSF) levels of some penicillins are potentially neurotoxic; the CSF levels of ampicillin rise significantly in meningitis.[Ref]

Hepatic

Frequency not reported: Increased AST, increased ALT, hepatitis, prolonged cholestasis
Postmarketing reports: Cholestatic hepatitis, cholestasis, hyperbilirubinemia, jaundice, abnormal hepatic function[Ref]

Metabolic

Frequency not reported: Increased alkaline phosphatase, increased lactate dehydrogenase, decreased serum albumin, decreased total protein[Ref]

Genitourinary

Uncommon (0.1% to 1%): Urine retention, dysuria
Frequency not reported: Urinary red blood cells, urinary hyaline casts[Ref]

Renal

Frequency not reported: Increased BUN, increased creatinine
Postmarketing reports: Tubulointerstitial nephritis[Ref]

Other

Uncommon (0.1% to 1%): Candidiasis, fatigue, malaise, chest pain, edema, chills, substernal pain, mucosal bleeding[Ref]

Respiratory

Uncommon (0.1% to 1%): Throat tightness, epistaxis

Some side effects of ampicillin / sulbactam may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Usual Adult Dose for Surgical Prophylaxis

American Society of Health-System Pharmacists (ASHP), IDSA, Surgical Infection Society (SIS), and Society for Healthcare Epidemiology of America (SHEA) Recommendations:
-Preoperative dose: 3 g IV or IM once, starting within 60 minutes before surgical incision
-Redosing interval (from start of preoperative dose): 2 hours

Comments:
-The dose is expressed as the total of ampicillin content plus sulbactam content (in a constant 2:1 ratio).
-A single prophylactic dose is usually sufficient; if prophylaxis is continued postoperatively, duration should be less than 24 hours.
-Readministration may be needed to ensure adequate serum and tissue drug levels.
-Drug should be readministered if procedure is longer than the redosing interval (from start of preoperative dose [not from start of surgery]); redosing may also be needed if drug half-life is shortened (e.g., extensive burns) or if prolonged/excessive bleeding during surgery; redosing may not be needed if drug half-life is prolonged (e.g., renal dysfunction).
-Before use, local susceptibility should be reviewed due to increasing resistance of E coli to this drug.
-Coadministration with other agents may be recommended, depending on type of procedure.
-Current guidelines should be consulted for additional information.

Uses: Recommended for surgical prophylaxis for the following procedures:
-Thoracic: Noncardiac procedures (including lobectomy, pneumonectomy, lung resection, thoracotomy); video-assisted thoracoscopic surgery
-Biliary tract: Open procedure; elective, high-risk laparoscopic procedure
-Colorectal
-Head and neck: Clean-contaminated cancer surgery; other clean-contaminated procedures (excluding tonsillectomy, functional endoscopic sinus procedures)
-Hysterectomy: Vaginal or abdominal
-Urologic: Clean without entry into urinary tract involving implanted prosthesis
-Plastic surgery: Clean with risk factors or clean-contaminated

Usual Pediatric Dose for Endocarditis

AHA and IDSA Recommendations:
Native or prosthetic valve enterococcal endocarditis due to beta-lactamase-producing strains resistant to penicillin and susceptible to aminoglycoside and vancomycin: 200 mg/kg (ampicillin content) IV per day in 4 equally divided doses
Maximum dose: 8 g/day (ampicillin content)
Duration of therapy: 6 weeks; longer than 6 weeks if strain is gentamicin-resistant

Native and prosthetic valve endocarditis due to HACEK microorganisms: 200 mg/kg (ampicillin content) IV per day in 4 to 6 equally divided doses
Maximum dose: 8 g/day (ampicillin content)
Duration of therapy: 4 weeks; 6 weeks for endocarditis involving prosthetic cardiac valve or other prosthetic cardiac material

Culture-negative endocarditis (including Bartonella endocarditis) with native valve: 200 mg/kg (ampicillin content) IV per day in 4 to 6 equally divided doses
Maximum dose: 8 g/day (ampicillin content)
Duration of therapy: 4 to 6 weeks

Comments:
-This drug should be used with gentamicin for treatment of native or prosthetic valve enterococcal endocarditis due to beta-lactamase-producing strains resistant to penicillin and susceptible to aminoglycoside and vancomycin; the strain is unlikely to be susceptible to gentamicin.
-HACEK microorganisms include H parainfluenzae, H aphrophilus, A actinomycetemcomitans, C hominis, E corrodens, and K kingae.
-This drug should be used with gentamicin for treatment of culture-negative endocarditis with native valve.
-Infectious diseases specialist should be consulted for culture-negative endocarditis.
-Pediatric dose should not exceed adult dose.
-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Pelvic Inflammatory Disease

AAP and US CDC Recommendations for Adolescents: 3 g IV every 6 hours

Comments:
-The dose is expressed as the total of ampicillin content plus sulbactam content (in a constant 2:1 ratio).
-This drug plus doxycycline are recommended as an alternative parenteral regimen; effective against C trachomatis, N gonorrhoeae, and anaerobes in patients with tubo-ovarian abscess.
-The patient's sexual partner(s) should also be evaluated/treated.
-Current guidelines should be consulted for additional information.

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