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ampicillin and sulbactam

Generic Name: ampicillin and sulbactam (am pi SIL in and sul BAK tam)
Brand Name: Unasyn, Unasyn ADD-Vantage

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.

What is the most important information I should know about ampicillin and sulbactam?

You should not use ampicillin and sulbactam if you are allergic to any type of penicillin antibiotic.

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What should I discuss with my healthcare provider before using ampicillin and sulbactam?

You should not use ampicillin and sulbactam if you are allergic to any type of penicillin antibiotic, or if you have:

  • a history of liver problems (hepatitis or jaundice) while using ampicillin and sulbactam.

To make sure ampicillin and sulbactam is safe for you, tell your doctor if you have:

  • liver disease;

  • mononucleosis (also called "mono");

  • kidney disease;

  • an allergy to a cephalosporin antibiotic such Ceftin, Cefzil, Keflex, Omnicef, and many others; or

  • any other allergies.

Ampicillin and sulbactam is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Ampicillin and sulbactam can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I use ampicillin and sulbactam?

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

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.

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.

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.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

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 should I avoid while using ampicillin and sulbactam?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking ampicillin and sulbactam and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Ampicillin and sulbactam side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • diarrhea that is watery or bloody;

  • thrush (white patches inside your mouth or throat);

  • sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, red or swollen gums, trouble swallowing;

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • swollen, black, or "hairy" tongue;

  • mild or occasional diarrhea;

  • vaginal itching or discharge;

  • mild skin rash; or

  • pain, swelling, bruising, or irritation around the IV needle.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Ampicillin and sulbactam dosing information

Usual Adult Dose for Skin or Soft Tissue Infection:

1.5 to 3 g IV or IM every 6 hours

Comments:
-The dose is expressed as the total of ampicillin content plus sulbactam content (in a constant 2:1 ratio).

Uses: For the treatment of skin and skin structure infections due to susceptible, beta-lactamase-producing strains of Staphylococcus aureus, Escherichia coli, Klebsiella species (including K pneumoniae), Proteus mirabilis, Bacteroides fragilis, Enterobacter species, Acinetobacter calcoaceticus

Infectious Diseases Society of America (IDSA) Recommendations:
-Incisional surgical site infection: 3 g IV every 6 hours
-Infection after animal bite: 1.5 to 3 g IV every 6 to 8 hours
-Infection after human bite: 1.5 to 3 g IV every 6 hours

Comments:
-This drug plus gentamicin or tobramycin are recommended as a combination regimen for treatment of incisional surgical site infections after intestinal or genitourinary tract surgery.
-The following should be considered when using this drug for an infection after a bite: Some gram-negative rods are resistant; this drug does not provide coverage for methicillin-resistant S aureus (MRSA).

Usual Adult Dose for Skin and Structure Infection:

1.5 to 3 g IV or IM every 6 hours

Comments:
-The dose is expressed as the total of ampicillin content plus sulbactam content (in a constant 2:1 ratio).

Uses: For the treatment of skin and skin structure infections due to susceptible, beta-lactamase-producing strains of Staphylococcus aureus, Escherichia coli, Klebsiella species (including K pneumoniae), Proteus mirabilis, Bacteroides fragilis, Enterobacter species, Acinetobacter calcoaceticus

Infectious Diseases Society of America (IDSA) Recommendations:
-Incisional surgical site infection: 3 g IV every 6 hours
-Infection after animal bite: 1.5 to 3 g IV every 6 to 8 hours
-Infection after human bite: 1.5 to 3 g IV every 6 hours

Comments:
-This drug plus gentamicin or tobramycin are recommended as a combination regimen for treatment of incisional surgical site infections after intestinal or genitourinary tract surgery.
-The following should be considered when using this drug for an infection after a bite: Some gram-negative rods are resistant; this drug does not provide coverage for methicillin-resistant S aureus (MRSA).

Usual Adult Dose for Intraabdominal Infection:

1.5 to 3 g IV or IM every 6 hours

Comments:
-The dose is expressed as the total of ampicillin content plus sulbactam content (in a constant 2:1 ratio).
-Current guidelines should be consulted for additional information.

Uses: For the treatment of intraabdominal infections due to susceptible, beta-lactamase-producing strains of E coli, Klebsiella species (including K pneumoniae), Bacteroides species (including B fragilis), Enterobacter species

Usual Adult Dose for Bacterial Infection:

1.5 to 3 g IV or IM every 6 hours

Comments:
-The dose is expressed as the total of ampicillin content plus sulbactam content (in a constant 2:1 ratio).

Uses: For the treatment of gynecological infections due to susceptible, beta-lactamase-producing strains of E coli, Bacteroides species (including B fragilis)

Usual Adult Dose for Endocarditis:

American Heart Association (AHA) and IDSA Recommendations: 3 g IV every 6 hours

Duration of therapy:
-Native or prosthetic valve enterococcal endocarditis due to beta-lactamase-producing strains resistant to penicillin and susceptible to aminoglycoside and vancomycin: 6 weeks; longer than 6 weeks if strain is gentamicin-resistant
-Native and prosthetic valve endocarditis due to HACEK microorganisms: 4 weeks; 6 weeks for endocarditis involving prosthetic cardiac valve or other prosthetic cardiac material
-Culture-negative endocarditis (including Bartonella endocarditis) with native valve: 4 to 6 weeks

Comments:
-The dose is expressed as the total of ampicillin content plus sulbactam content (in a constant 2:1 ratio).
-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 Haemophilus parainfluenzae, H aphrophilus, Actinobacillus actinomycetemcomitans, Cardiobacterium hominis, Eikenella corrodens, and Kingella 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.
-Current guidelines should be consulted for additional information.

Usual Adult Dose for Sinusitis:

IDSA Recommendations for Acute Bacterial Rhinosinusitis:
-Severe infection requiring hospitalization: 1.5 to 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).
-Recommended as a second-line regimen
-Current guidelines should be consulted for additional information.

Usual Adult Dose for Pelvic Inflammatory Disease:

US CDC Recommendations: 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 Chlamydia trachomatis, Neisseria gonorrhoeae, and anaerobes in patients with tubo-ovarian abscess.
-At least 24 hours of direct inpatient observation recommended for patients with tubo-ovarian abscesses.
-Oral therapy can generally be started within 24 to 48 hours after clinical improvement.
-The patient's sexual partner(s) should also be evaluated/treated.
-Current guidelines should be consulted for additional information.

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 Bacterial Infection:

Manufacturer Recommendations:
1 year or older:
-Less than 40 kg: 50 mg/kg (ampicillin component) IV every 6 hours
-At least 40 kg: 1.5 to 3 g IV every 6 hours
Duration of therapy: Should not routinely exceed 14 days

Comments:
-The dose for patients weighing at least 40 kg is expressed as the total of ampicillin content plus sulbactam content (in a constant 2:1 ratio).
-In clinical trials, most children received oral antimicrobials after initial treatment with IV ampicillin-sulbactam.
-The total sulbactam dose should not exceed 4 g/day.

Uses: For the treatment of skin and skin structure infections due to susceptible, beta-lactamase-producing strains of S aureus, E coli, Klebsiella species (including K pneumoniae), P mirabilis, B fragilis, Enterobacter species, A calcoaceticus

American Academy of Pediatrics (AAP) Recommendations:
1 month or older:
-Mild to moderate infection: 25 to 50 mg/kg (ampicillin component) IV every 6 hours
Maximum dose: 4 g/day (ampicillin component)

-Severe infection: 50 mg/kg (ampicillin component) IV every 6 hours
Maximum dose: 8 g/day (ampicillin component)

Comments:
-Recommended as alternative therapy for bacteremia and other serious infections due to methicillin-susceptible, penicillin-resistant S aureus
-IV route recommended for human or animal bite wounds. Since this drug does not provide coverage for MRSA, an additional agent should be considered for severe bite wounds.

Usual Pediatric Dose for Skin and Structure Infection:

Manufacturer Recommendations:
1 year or older:
-Less than 40 kg: 50 mg/kg (ampicillin component) IV every 6 hours
-At least 40 kg: 1.5 to 3 g IV every 6 hours
Duration of therapy: Should not routinely exceed 14 days

Comments:
-The dose for patients weighing at least 40 kg is expressed as the total of ampicillin content plus sulbactam content (in a constant 2:1 ratio).
-In clinical trials, most children received oral antimicrobials after initial treatment with IV ampicillin-sulbactam.
-The total sulbactam dose should not exceed 4 g/day.

Uses: For the treatment of skin and skin structure infections due to susceptible, beta-lactamase-producing strains of S aureus, E coli, Klebsiella species (including K pneumoniae), P mirabilis, B fragilis, Enterobacter species, A calcoaceticus

American Academy of Pediatrics (AAP) Recommendations:
1 month or older:
-Mild to moderate infection: 25 to 50 mg/kg (ampicillin component) IV every 6 hours
Maximum dose: 4 g/day (ampicillin component)

-Severe infection: 50 mg/kg (ampicillin component) IV every 6 hours
Maximum dose: 8 g/day (ampicillin component)

Comments:
-Recommended as alternative therapy for bacteremia and other serious infections due to methicillin-susceptible, penicillin-resistant S aureus
-IV route recommended for human or animal bite wounds. Since this drug does not provide coverage for MRSA, an additional agent should be considered for severe bite wounds.

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.

Usual Pediatric Dose for Sinusitis:

IDSA Recommendations for Acute Bacterial Rhinosinusitis in Children:
-Severe infection requiring hospitalization: 50 to 100 mg/kg (ampicillin component) IV every 6 hours
Maximum dose: 8 g/day (ampicillin component)

Comments:
-Recommended as a second-line regimen
-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Surgical Prophylaxis:

ASHP, IDSA, SIS, and SHEA Recommendations:
-Preoperative dose: 50 mg/kg (ampicillin content) IV once, starting within 60 minutes before surgical incision
Maximum dose: 2 g/dose (ampicillin content)

-Redosing interval (from start of preoperative dose): 2 hours

Comments:
-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; redosing may also be needed if drug half-life is shortened or if prolonged/excessive bleeding during surgery; redosing may not be needed if drug half-life is prolonged.
-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.
-Pediatric dose should not exceed adult dose.
-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

What other drugs will affect ampicillin and sulbactam?

Other drugs may interact with ampicillin and sulbactam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about ampicillin and sulbactam.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.02. Revision Date: 2014-12-15, 9:03:50 AM.

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