Ampicillin-Sulbactam 1.5gm Inj, 1vl
It is used to treat bacterial infections.
Drug Class
Antibiotic, Beta-lactamase inhibitor combination
Pharmacologic Class
Aminopenicillin + Beta-lactamase inhibitor
Pregnancy Category
Category B
FDA Approved
Jan 1986
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ampicillin-sulbactam is an antibiotic medication given by injection to treat serious bacterial infections. It's a combination of two drugs: ampicillin, which kills bacteria, and sulbactam, which helps ampicillin work better by protecting it from certain bacterial defenses.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered either as an injection into a muscle or as an infusion into a vein over a period of time. In some cases, it may be given as an injection directly into a vein.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage.
Missing a Dose
If you miss a dose, contact your doctor to determine the best course of action.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered either as an injection into a muscle or as an infusion into a vein over a period of time. In some cases, it may be given as an injection directly into a vein.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage.
Missing a Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Complete the full course of medication as prescribed, even if you start feeling better, to prevent the infection from returning and to reduce the risk of antibiotic resistance.
- Report any new or worsening symptoms to your healthcare provider.
- Maintain good hydration, especially if experiencing diarrhea.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
1.5 gm (1 gm ampicillin/0.5 gm sulbactam) to 3 gm (2 gm ampicillin/1 gm sulbactam) IV/IM every 6 hours
Dose Range:
1.5 - 3 mg
Condition-Specific Dosing:
severeInfections:
3 gm IV every 6 hours (maximum 12 gm/day, 8 gm ampicillin/4 gm sulbactam)
Pediatric Dosing
Neonatal:
Not established for all indications; typically 150 mg/kg/day (100 mg/kg ampicillin/50 mg/kg sulbactam) in divided doses every 12 hours (for <7 days old or <2 kg) or every 8 hours (for >7 days old and >2 kg)
Infant:
300 mg/kg/day (200 mg/kg ampicillin/100 mg/kg sulbactam) in divided doses every 6 hours
Child:
300 mg/kg/day (200 mg/kg ampicillin/100 mg/kg sulbactam) in divided doses every 6 hours (maximum 4 gm sulbactam/day)
Adolescent:
Adult dosing (1.5 gm to 3 gm IV/IM every 6 hours)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl >30 mL/min)
Moderate:
1.5 gm to 3 gm IV/IM every 12 hours (CrCl 15-29 mL/min)
Severe:
1.5 gm to 3 gm IV/IM every 24 hours (CrCl 5-14 mL/min)
Dialysis:
Administer after dialysis on dialysis days. For patients on continuous ambulatory peritoneal dialysis (CAPD) or hemodialysis, dose every 24 hours.
Hepatic Impairment:
Mild:
No specific adjustment needed
Moderate:
No specific adjustment needed
Severe:
No specific adjustment needed
Pharmacology
Mechanism of Action
Ampicillin is an aminopenicillin that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to cell lysis and death. Sulbactam is a beta-lactamase inhibitor that irreversibly binds to and inactivates a wide range of bacterial beta-lactamase enzymes, thereby protecting ampicillin from hydrolysis and extending its spectrum of activity against beta-lactamase-producing bacteria.
Pharmacokinetics
Absorption:
Bioavailability:
100% (IV/IM administration)
Tmax:
Not applicable (IV administration, peak levels achieved rapidly)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Ampicillin: 0.28-0.33 L/kg; Sulbactam: 0.24-0.36 L/kg
ProteinBinding:
Ampicillin: Approximately 28%; Sulbactam: Approximately 38%
CnssPenetration:
Limited (unless meninges are inflamed)
Elimination:
HalfLife:
Ampicillin: Approximately 1 hour; Sulbactam: Approximately 1 hour
Clearance:
Ampicillin: 200-300 mL/min; Sulbactam: 150-250 mL/min
ExcretionRoute:
Primarily renal (glomerular filtration and tubular secretion)
Unchanged:
Ampicillin: 75-85%; Sulbactam: 75-85%
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of IV administration)
PeakEffect:
Rapid (within minutes of IV administration)
DurationOfAction:
Dependent on half-life and dosing frequency (typically 6 hours due to q6h dosing)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
In rare cases, allergic reactions can be fatal.
Diarrhea and Bowel Problems
Diarrhea is a common side effect of antibiotics. However, in rare cases, a severe form of diarrhea called C. diff-associated diarrhea (CDAD) may occur, which can lead to life-threatening bowel problems. If you experience any of the following symptoms, contact your doctor right away:
Stomach pain
Cramps
Very loose, watery, or bloody stools
Do not treat diarrhea without consulting your doctor first, as it may worsen the condition.
Liver Problems
Rarely, this medication can cause liver problems, which can be fatal. If you notice any of the following symptoms, contact your doctor immediately:
Dark urine
Tiredness
Decreased appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Severe Skin Reactions
This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. These reactions can affect body organs and be life-threatening. If you experience any of the following symptoms, seek medical help right away:
Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in your mouth, throat, nose, eyes, genitals, or any areas of skin
Fever
Chills
Body aches
Shortness of breath
Swollen glands
Other Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it is essential to contact your doctor if you notice any of the following:
Diarrhea
Pain at the injection site (if given intramuscularly)
Reporting Side Effects
If you experience any side effects that bother you or do not go away, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
In rare cases, allergic reactions can be fatal.
Diarrhea and Bowel Problems
Diarrhea is a common side effect of antibiotics. However, in rare cases, a severe form of diarrhea called C. diff-associated diarrhea (CDAD) may occur, which can lead to life-threatening bowel problems. If you experience any of the following symptoms, contact your doctor right away:
Stomach pain
Cramps
Very loose, watery, or bloody stools
Do not treat diarrhea without consulting your doctor first, as it may worsen the condition.
Liver Problems
Rarely, this medication can cause liver problems, which can be fatal. If you notice any of the following symptoms, contact your doctor immediately:
Dark urine
Tiredness
Decreased appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes
Severe Skin Reactions
This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. These reactions can affect body organs and be life-threatening. If you experience any of the following symptoms, seek medical help right away:
Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in your mouth, throat, nose, eyes, genitals, or any areas of skin
Fever
Chills
Body aches
Shortness of breath
Swollen glands
Other Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it is essential to contact your doctor if you notice any of the following:
Diarrhea
Pain at the injection site (if given intramuscularly)
Reporting Side Effects
If you experience any side effects that bother you or do not go away, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent diarrhea (especially if bloody or watery, which could indicate C. difficile infection)
- New or worsening rash, hives, or itching
- Swelling of the face, lips, tongue, or throat
- Difficulty breathing or wheezing
- Severe abdominal pain or cramping
- Unusual bruising or bleeding
- Yellowing of the skin or eyes (jaundice)
- Dark urine or pale stools
- Signs of superinfection (e.g., oral thrush, vaginal yeast infection)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this drug, its components, or other medications, foods, or substances. Be sure to describe the allergic reaction and its symptoms.
If you are allergic to penicillin.
If you have been diagnosed with mononucleosis (mono).
If you have previously experienced liver problems or jaundice (turned yellow) while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing health conditions and medications.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this drug, its components, or other medications, foods, or substances. Be sure to describe the allergic reaction and its symptoms.
If you are allergic to penicillin.
If you have been diagnosed with mononucleosis (mono).
If you have previously experienced liver problems or jaundice (turned yellow) while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing health conditions and medications.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This drug may interfere with certain laboratory tests, so be sure to notify your healthcare providers and laboratory personnel that you are taking it.
If you have diabetes and regularly test your urine for glucose, consult with your doctor to determine the most suitable tests to use, as this medication may affect the results.
Do not take this medication for longer than prescribed, as this may increase the risk of a second infection.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of taking this medication to ensure the best outcome for you and your baby.
If you have diabetes and regularly test your urine for glucose, consult with your doctor to determine the most suitable tests to use, as this medication may affect the results.
Do not take this medication for longer than prescribed, as this may increase the risk of a second infection.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of taking this medication to ensure the best outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Neurological symptoms (e.g., seizures, confusion), especially in patients with impaired renal function
- Severe gastrointestinal upset (nausea, vomiting, diarrhea)
- Electrolyte imbalances
What to Do:
Seek immediate medical attention. Treatment is largely supportive. Hemodialysis may be used to remove ampicillin and sulbactam from the circulation in patients with severe renal impairment or overdose. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Methotrexate (decreased renal clearance of methotrexate, leading to increased toxicity)
- Oral typhoid vaccine (live attenuated) (antibiotics may inactivate the vaccine)
Moderate Interactions
- Allopurinol (increased incidence of skin rash with ampicillin)
- Probenecid (decreases renal tubular secretion of ampicillin and sulbactam, leading to increased and prolonged plasma concentrations)
- Oral contraceptives (may reduce efficacy of oral contraceptives, advise backup method)
- Anticoagulants (e.g., Warfarin) (may enhance anticoagulant effect by altering gut flora, monitor INR)
Monitoring
Baseline Monitoring
Renal function (BUN, serum creatinine, CrCl)
Rationale: To guide initial dosing and identify need for dose adjustment, especially in elderly or renally impaired patients.
Timing: Prior to initiation of therapy
Liver function tests (AST, ALT)
Rationale: To establish baseline and monitor for potential hepatotoxicity, though rare.
Timing: Prior to initiation of therapy
Complete Blood Count (CBC) with differential
Rationale: To establish baseline and monitor for potential hematologic abnormalities (e.g., leukopenia, thrombocytopenia) with prolonged therapy.
Timing: Prior to initiation of therapy
Routine Monitoring
Renal function (BUN, serum creatinine)
Frequency: Periodically, especially with prolonged therapy or in patients with pre-existing renal impairment
Target: Within patient's baseline or normal limits
Action Threshold: Significant increase from baseline or outside normal range; consider dose adjustment or discontinuation
Liver function tests (AST, ALT)
Frequency: Periodically, especially with prolonged therapy
Target: Within normal limits
Action Threshold: Significant elevation; consider discontinuation
Complete Blood Count (CBC)
Frequency: Weekly for prolonged therapy (>2 weeks)
Target: Within normal limits
Action Threshold: Significant decrease in WBC, platelets; consider discontinuation
Signs and symptoms of superinfection (e.g., C. difficile-associated diarrhea, candidiasis)
Frequency: Daily
Target: Absence of new infections
Action Threshold: Presence of new or worsening symptoms; initiate appropriate treatment
Symptom Monitoring
- Rash
- Diarrhea (especially severe or bloody)
- Nausea
- Vomiting
- Injection site pain/phlebitis
- Fever
- Signs of allergic reaction (hives, itching, swelling, difficulty breathing)
- Signs of C. difficile infection (abdominal cramps, watery diarrhea)
Special Patient Groups
Pregnancy
Generally considered safe for use during pregnancy (Pregnancy Category B). Animal studies have not shown harm to the fetus, but well-controlled studies in pregnant women are lacking. Use only if clearly needed.
Trimester-Specific Risks:
First Trimester:
No increased risk of congenital anomalies observed in human studies.
Second Trimester:
No specific risks identified.
Third Trimester:
No specific risks identified.
Lactation
Ampicillin and sulbactam are excreted in breast milk in low concentrations. Generally considered compatible with breastfeeding (Lactation Risk L2). Monitor breastfed infant for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic sensitization.
Infant Risk:
Low risk; potential for mild gastrointestinal upset or candidiasis in infant.
Pediatric Use
Dosing must be carefully calculated based on weight and age, especially in neonates and infants, due to differences in renal function and drug clearance. Close monitoring for adverse effects is crucial.
Geriatric Use
Dose adjustment is often necessary due to age-related decline in renal function. Monitor renal function closely. Elderly patients may be more susceptible to adverse effects such as C. difficile-associated diarrhea.
Clinical Information
Clinical Pearls
- Ampicillin-sulbactam is a broad-spectrum antibiotic effective against many Gram-positive, Gram-negative, and anaerobic bacteria, including beta-lactamase producing strains.
- It is commonly used for polymicrobial infections, such as intra-abdominal infections, gynecological infections, and skin and soft tissue infections.
- The 1.5 gm vial contains 1 gm ampicillin and 0.5 gm sulbactam. Dosing is typically expressed as the combined amount.
- Administer IV doses slowly over 15-30 minutes to minimize injection site reactions.
- Always check for penicillin allergies before administration, as cross-reactivity can occur.
- Probenecid can significantly increase ampicillin and sulbactam levels, which can be utilized therapeutically in some cases but requires careful monitoring.
Alternative Therapies
- Carbapenems (e.g., Meropenem, Imipenem-Cilastatin, Ertapenem)
- Cephalosporins (e.g., Ceftriaxone, Cefoxitin, Cefotetan)
- Fluoroquinolones (e.g., Moxifloxacin, Levofloxacin)
- Metronidazole (for anaerobic coverage, often combined with other agents)
- Clindamycin (for anaerobic and some Gram-positive coverage)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 1.5 gm vial
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic), Tier 3 (Brand if available)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional or pharmacist. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.