Ampicillin and Sulbactam 1 g; .5 g Injection, Powder, For Solution, 10 vials
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the beta Lactamase Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
The combination of ampicillin and sulbactam injection is used to treat certain infections caused by bacteria, including infections of the skin, female reproductive organs, and abdomen (stomach area). Ampicillin is in a class of medications called penicillin-like antibiotics. It works by stopping the growth of bacteria. Sulbactam is in a class of medications called beta-lactamase inhibitors. It works by preventing bacteria from destroying ampicillin. Antibiotics such as ampicillin and sulbactam injection will not work for colds, flu, or other viral infections. Using antibiotics when they are no...
Read the full MedlinePlus article ↗- This medication is used for three main types of bacterial infections: skin infections, abdominal infections, and gynecological infections. What makes it especially useful is that i...
- What kinds of infections does this antibiotic treat?
- You'll receive it by injection — either through an IV line directly into a vein or as an injection into a muscle. IV doses are given slowly, either as a direct injection over 10–15...
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $4.72 | — |
| Medicare Part B allowsASP · J0295 | $1.451 / J0295 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Unasyn 1 g/1; .5 g 00049-0013-83 | Roerig | 10 vials | — | AP | FDA listed | — |
| Ampicillin and Sulbactam 1 g/1; .5 gthis 00409-2689-01 | Hospira, | 10 vials | — | — | FDA listed | — |
| Ampicillin and Sulbactam 1 g/1.5g; .5 g/1.5g 00641-6116-10 | Hikma | 10 vials | — | AP | FDA listed | — |
| ampicillin and sulbactam 1 g/1; .5 g 25021-0142-20 | Sagent | 10 vials | — | AP | FDA listed | — |
| Ampicillin and Sulbactam 1 g/1; .5 g 44567-0210-10 | WG | 10 vials | — | AP | FDA listed | — |
| Ampicillin and Sulbactam 1 g/1; .5 g 55150-0116-20 | Eugia | 10 vials | — | AP | FDA listed | — |
| Ampicillin and Sulbactam 1 g/1; .5 g 55150-0178-99 | Eugia | 10 bottles | — | — | FDA listed | — |
| Ampicillin and Sulbactam 1 g/1; .5 g 71288-0031-21 | Meitheal | 10 vials | — | AP | FDA listed | — |
| Ampicillin and Sulbactam 1 g/1; .5 g 71872-7367-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Ampicillin Sodium and Sulbactam Sodium 1 g/1; .5 g 72485-0416-10 | Armas | 10 vials | — | AP | FDA listed | — |
| Ampicillin and Sulbactam 1 g/1; .5 g 72603-0220-01 | NorthStar | 1 injection | — | AP | FDA listed | — |
| ampicillin sodium and sulbactam sodium 1 g/1; .5 g 83270-0304-10 | ONESOURCE | 10 vials | — | AP | FDA listed | — |
| Ampicillin and Sulbactam 1 g/1; .5 g 83634-0109-20 | Avenacy, | 10 vials | — | AP | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00409-2689-01 You're viewing this | 10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21) | 2017-08-25 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Ampicillin and sulbactam for injection 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,* Klebsiella spp.* (including K. pneumoniae* ), Proteus mirabilis,* Bacteroides fragilis,* Enterobacter spp.,* and Acinetobacter calcoaceticus.* NOTE: For information on use in pediatric patients (see PRECAUTIONS - Pediatric Use and CLINICAL STUDIES sections).
Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae* ), Bacteroides spp. (including B. fragilis ), and Enterobacter spp.* Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli,* and Bacteroides spp.* (including B. fragilis* ). * Efficacy for this organism in this organ system was studied in fewer than 10 infections.
While ampicillin and sulbactam for injection is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with ampicillin and sulbactam for injection due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to ampicillin and sulbactam for injection 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 ampicillin and sulbactam for injection.
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 ampicillin and sulbactam for injection and other antibacterial drugs, ampicillin and sulbactam for injection 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.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Ampicillin and sulbactam for injection is administered intravenously. For intravenous administration, the dose can be given by slow intravenous injection over at least 10 to 15 minutes or can also be delivered in greater dilutions with 50 mL to 100 mL of a compatible diluent as an intravenous infusion over 15 to 30 minutes. (see DIRECTION FOR USE-Preparation of Intravenous Use section) The recommended adult dosage of ampicillin and sulbactam for injection is 1.5 g (ampicillin 1g and sulbactam 0.5 g) to 3 g (ampicillin 2 g and sulbactam 1 g) every six hours.
This 1.5 g to 3 g range represents the total of ampicillin content plus the sulbactam content of ampicillin and sulbactam for injection and corresponds to a range of 1 g ampicillin and 0.5 g sulbactam to 2 g ampicillin and 1 g sulbactam. The total dose of sulbactam should not exceed 4 g per day. Pediatric Patients 1 Year of Age or Older The recommended daily dose of ampicillin and sulbactam for injection in pediatric patients is 300 mg per kg of body weight administered via intravenous infusion in equally divided doses every 6 hours.
This 300 mg/kg/day dosage represents the total ampicillin content plus the sulbactam content of ampicillin and sulbactam for injection and corresponds to 200 mg ampicillin and 100 mg sulbactam per kg per day. Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations, and the total dose of sulbactam should not exceed 4 g per day. The course of intravenous therapy should not routinely exceed 14 days.
In clinical trials, most pediatric patients received a course of oral antimicrobials following initial treatment with intravenous ampicillin and sulbactam for injection (see CLINICAL STUDIES section). Impaired Renal Function In patients with impairment of renal function the elimination kinetics of ampicillin and sulbactam are similarly affected, hence the ratio of one to the other will remain constant whatever the renal function. The dose of ampicillin and sulbactam for injection in such patients should be administered less frequently in accordance with the usual practice for ampicillin and according to the following recommendations: TABLE 3: Ampicillin and Sulbactam for Injection Dosage Guide for Patients with Renal Impairment Creatinine Clearance (mL/min/1.73m 2 ) Ampicillin and Sulbactam Half-Life (Hours) Recommended Ampicillin and Sulbactam for Injection Dosage ≥ 30 1 1.5 g to 3 g every 6 to 8 hours 15 to 29 5 1.5 g to 3 g every 12 hours 5 to 14 9 1.5 g to 3 g every 24 hours When only serum creatinine is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance.
The serum creatinine should represent a steady state of renal function. Males weight (kg) x (140 - age) 72 x serum creatinine Females 0.85 x above value COMPATIBILITY, RECONSTITUTION AND STABILITY Ampicillin and sulbactam for injection sterile powder is to be stored at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] prior to reconstitution. When concomitant therapy with aminoglycosides is indicated, ampicillin and sulbactam and aminoglycosides should be reconstituted and administered separately, due to the in vitro inactivation of aminoglycosides by any of the aminopenicillins.
DIRECTIONS FOR USE 1.5 g ADD-Vantage® Vials: Ampicillin and sulbactam for injection in the ADD-Vantage® system is intended as a single dose for intravenous administration after dilution with the ADD-Vantage® Flexible Diluent Container containing 50 mL, 100 mL or 250 mL of 0.9% Sodium Chloride Injection, USP. 3 g ADD-Vantage® Vials: Ampicillin and sulbactam for injection in the ADD-Vantage® system is intended as a single dose for intravenous administration after dilution with the ADD-Vantage® Flexible Diluent Container containing 100 mL or 250 mL of 0.9% Sodium Chloride Injection, USP.
Ampicillin and sulbactam for injection in the ADD-Vantage® system is to b…
⛔ Contraindications ▾
CONTRAINDICATIONS The use of ampicillin and sulbactam for injection is contraindicated in individuals with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to ampicillin, sulbactam or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins). Ampicillin and sulbactam for injection is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with ampicillin and sulbactam for injection.
⚠️ Warnings ▾
WARNINGS Hypersensitivity Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. These reactions are more apt to occur in individuals with a history of penicillin hypersensitivity and/or hypersensitivity reactions to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins.
Before therapy with a penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, and other allergens. If an allergic reaction occurs, ampicillin and sulbactam for injection should be discontinued and the appropriate therapy instituted. Hepatotoxicity Hepatic dysfunction, including hepatitis and cholestatic jaundice has been associated with the use of ampicillin and sulbactam for injection.
Hepatic toxicity is usually reversible; however, deaths have been reported. Hepatic function should be monitored at regular intervals in patients with hepatic impairment. Severe Cutaneous Adverse Reactions Ampicillin and sulbactam for injection may cause severe skin reactions, such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), dermatitis exfoliative, erythema multiforme, and Acute generalized exanthematous pustulosis (AGEP).
If patients develop a skin rash they should be monitored closely and ampicillin and sulbactam for injection discontinued if lesions progress (see CONTRAINDICATIONS and ADVERSE REACTIONS sections). Clostridioides difficile -Associated Diarrhea Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including ampicillin and sulbactam for injection, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile .
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use.
Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Adult Patients Ampicillin and sulbactam for injection is generally well tolerated. The following adverse reactions have been reported in clinical trials. Local Adverse Reactions Pain at intravenous injection site – 3% Thrombophlebitis – 3% Phlebitis – 1.2% Systemic Adverse Reactions The most frequently reported adverse reactions were diarrhea in 3% of the patients and rash in less than 2% of the patients.
Additional systemic reactions reported in less than 1% of the patients were: itching, nausea, vomiting, candidiasis, fatigue, malaise, headache, chest pain, flatulence, abdominal distension, glossitis, urine retention, dysuria, edema, facial swelling, erythema, chills, tightness in throat, substernal pain, epistaxis and mucosal bleeding. Pediatric Patients Available safety data for pediatric patients treated with ampicillin and sulbactam demonstrate a similar adverse events profile to those observed in adult patients.
Additionally, atypical lymphocytosis has been observed in one pediatric patient receiving ampicillin and sulbactam. Adverse Laboratory Changes Adverse laboratory changes without regard to drug relationship that were reported during clinical trials were: Hepatic: Increased AST (SGOT), ALT (SGPT), alkaline phosphatase, and LDH. Hematologic: Decreased hemoglobin, hematocrit, RBC, WBC, neutrophils, lymphocytes, platelets and increased lymphocytes, monocytes, basophils, eosinophils, and platelets.
Blood Chemistry: Decreased serum albumin and total proteins. Renal: Increased BUN and creatinine. Urinalysis: Presence of RBC's and hyaline casts in urine.
Post-Marketing Experience In addition to adverse reactions reported from clinical trials, the following have been identified during post-marketing use of ampicillin sodium and sulbactam sodium or other products containing ampicillin. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency, or potential causal connection to ampicillin sodium and sulbactam sodium.
Infections and Infestations: Clostridioides difficile -associated diarrhea (see WARNINGS section). Blood and Lymphatic System Disorders: Hemolytic anemia, thrombocytopenic purpura, and agranulocytosis have been reported. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.
Some individuals have developed positive direct Coombs Tests during treatment with ampicillin and sulbactam for injection, as with other beta-lactam antibacterials. Gastrointestinal Disorders: Abdominal pain, cholestatic hepatitis, cholestasis, hyperbilirubinemia, jaundice, abnormal hepatic function, melena, gastritis, stomatitis, dyspepsia and black “hairy” tongue (see CONTRAINDICATIONS and WARNINGS sections). General Disorders and Administration Site Conditions: Injection site reaction.
Immune System Disorders: Serious and fatal hypersensitivity (anaphylactic) reactions (see WARNINGS section). Acute myocardial ischemia with or without myocardial infarction may occur as part of an allergic reaction. Metabolism and Nutrition Disorders: Hypokalemia Nervous System Disorders: Convulsion and dizziness Musculoskeletal and Connective Tissue Disorders: Arthralgia Renal and Urinary Disorders: Tubulointerstitial nephritis Respiratory, Thoracic and Mediastinal Disorders: Dyspnea Skin and Subcutaneous Tissue Disorders: Toxic epidermal necrolysis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), angioedema, Acute generalized exanthematous pustulosis (AGEP), erythema multiforme, exfoliative dermatitis, urticaria (see CONTRAINDICATIONS and WARNINGS sections), and linear IgA bullous dermatosis.
🔄 Drug Interactions ▾
Drug Interactions Probenecid decreases the renal tubular secretion of ampicillin and sulbactam. Concurrent use of probenecid with ampicillin and sulbactam may result in increased and prolonged blood levels of ampicillin and sulbactam. The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone.
It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients. There are no data with ampicillin and sulbactam and allopurinol administered concurrently. Ampicillin and sulbactam and aminoglycosides should not be reconstituted together due to the in vitro inactivation of aminoglycosides by the ampicillin component of ampicillin and sulbactam.
🔄 Drug / Laboratory Test Interactions ▾
Drug/Laboratory Test Interactions Administration of ampicillin and sulbactam will result in high urine concentration of ampicillin. High urine concentrations of ampicillin may result in false positive reactions when testing for the presence of glucose in urine using Clinitest™, Benedict's Solution or Fehling's Solution. It is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix™ or Testape™) be used.
Following administration of ampicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone and estradiol has been noted. This effect may also occur with ampicillin and sulbactam.
🤰 Pregnancy ▾
Pregnancy Reproduction studies have been performed in mice, rats, and rabbits at doses up to ten (10) times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to ampicillin and sulbactam. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed (see PRECAUTIONS - Drug/Laboratory Test Interactions section).
🧒 Pediatric Use ▾
Pediatric Use The safety and effectiveness of ampicillin and sulbactam for injection have been established for pediatric patients one year of age and older for skin and skin structure infections as approved in adults. Use of ampicillin and sulbactam for injection in pediatric patients is supported by evidence from adequate and well-controlled studies in adults with additional data from pediatric pharmacokinetic studies, a controlled clinical trial conducted in pediatric patients and post-marketing adverse events surveillance (see CLINICAL PHARMACOLOGY , INDICATIONS AND USAGE , ADVERSE REACTIONS , DOSAGE AND ADMINISTRATION , and CLINICAL STUDIES sections).
The safety and effectiveness of ampicillin and sulbactam for injection have not been established for pediatric patients for intra-abdominal infections.
🆘 Overdosage ▾
OVERDOSAGE Neurological adverse reactions, including convulsions, may occur with the attainment of high CSF levels of beta-lactams. Ampicillin may be removed from circulation by hemodialysis. The molecular weight, degree of protein binding and pharmacokinetics profile of sulbactam suggest that this compound may also be removed by hemodialysis.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY General Immediately after completion of a 15-minute intravenous infusion of ampicillin and sulbactam, peak serum concentrations of ampicillin and sulbactam are attained. Ampicillin serum levels are similar to those produced by the administration of equivalent amounts of ampicillin alone. Peak ampicillin serum levels ranging from 109 to 150 mcg/mL are attained after administration of 2000 mg of ampicillin plus 1000 mg sulbactam and 40 to 71 mcg/mL after administration of 1000 mg ampicillin plus 500 mg sulbactam.
The corresponding mean peak serum levels for sulbactam range from 48 to 88 mcg/mL and 21 to 40 mcg/mL, respectively. The mean serum half-life of both drugs is approximately 1 hour in healthy volunteers. Approximately 75 to 85% of both ampicillin and sulbactam are excreted unchanged in the urine during the first 8 hours after administration of ampicillin and sulbactam to individuals with normal renal function.
Somewhat higher and more prolonged serum levels of ampicillin and sulbactam can be achieved with the concurrent administration of probenecid. In patients with impaired renal function the elimination kinetics of ampicillin and sulbactam are similarly affected, hence the ratio of one to the other will remain constant whatever the renal function. The dose of ampicillin and sulbactam for injection in such patients should be administered less frequently in accordance with the usual practice for ampicillin (see DOSAGE and ADMINISTRATION section).
Ampicillin has been found to be approximately 28% reversibly bound to human serum protein and sulbactam approximately 38% reversibly bound. The following average levels of ampicillin and sulbactam were measured in the tissues and fluids listed: TABLE 1: Concentration of Ampicillin and Sulbactam for Injection in Various Body Tissues and Fluids Fluid or Tissue Dose (grams) Ampicillin/Sulbactam Concentration (mcg/mL or mcg/g) Ampicillin/Sulbactam Peritoneal Fluid 0.5/0.5 IV 7/14 Blister Fluid (Cantharides) 0.5/0.5 IV 8/20 Tissue Fluid 1/0.5 IV 8/4 Intestinal Mucosa 0.5/0.5 IV 11/18 Appendix 2/1 IV 3/40 Penetration of both ampicillin and sulbactam into cerebrospinal fluid in the presence of inflamed meninges has been demonstrated after IV administration of ampicillin and sulbactam.
The pharmacokinetics of ampicillin and sulbactam in pediatric patients receiving ampicillin and sulbactam are similar to those observed in adults. Immediately after a 15-minute infusion of 50 to 75 mg ampicillin and sulbactam/kg body weight, peak serum and plasma concentrations of 82 to 446 mcg ampicillin/mL and 44 to 203 mcg sulbactam/mL were obtained. Mean half-life values were approximately 1 hour.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Ampicillin and Sulbactam for Injection, USP (ampicillin sodium/sulbactam sodium) is supplied as a sterile white to yellowish dry powder in ADD-Vantage® Vials as follows: Each 1.5 grams ADD-Vantage® vial contains 1.5 g Ampicillin and Sulbactam for Injection, USP (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt). NDC 0409-2689-01-packed in trays of 10 vials. Each 3 grams ADD-Vantage® vial contains 3 g Ampicillin and Sulbactam for Injection, USP (equivalent to 2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt).
NDC 0409-2987-03-packed in trays of 10 vials. The 1.5 g Ampicillin and Sulbactam for Injection, USP ADD-Vantage® vials are only to be used with an ADD-Vantage® Flexible Diluent Container containing 0.9% Sodium Chloride Injection, USP, 50 mL, 100 mL or 250 mL sizes. The 3 g Ampicillin and Sulbactam for Injection, USP ADD-Vantage® vials are only to be used with an ADD-Vantage® Flexible Diluent Container containing 0.9% Sodium Chloride Injection, USP, 100 mL or 250 mL sizes.
Ampicillin and Sulbactam for Injection, USP sterile powder is to be stored at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] prior to reconstitution. ADD-Vantage® is a registered trademark of Hospira, Inc.
📦 Storage and Handling ▾
Ampicillin and Sulbactam for Injection, USP sterile powder is to be stored at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] prior to reconstitution. ADD-Vantage® is a registered trademark of Hospira, Inc.
📋 Description ▾
DESCRIPTION Ampicillin and sulbactam for injection, USP is a sterile antibacterial fixed-combination drug product consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate and has a molecular weight of 371.39.
Its chemical formula is C 16 H 18 N 3 NaO 4 S. The structural formula is: Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 4,4-dioxide.
Its chemical formula is C 8 H 10 NNaO 5 S with a molecular weight of 255.22. The structural formula is: Ampicillin and sulbactam for injection, USP parenteral combination, is available as a white to yellowish dry powder for reconstitution. Ampicillin and sulbactam for injection, USP dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL.
The pH of the solutions is between 8 and 10. Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL) are essentially colorless to pale yellow. The pH of dilute solutions remains the same.
Each 1.5 g ADD-Vantage® vial contains 1.5 g ampicillin and sulbactam for injection, USP (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt). The sodium content is 115 mg (5 mEq). Each 3 g ADD-Vantage® vial contains 3 g ampicillin and sulbactam for injection, USP (equivalent to 2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt).
The sodium content is 230 mg (10 mEq). chemical-structure-ampicillin chemical-structure-sulbactam
💬 Information for Patients ▾
Information for Patients Patients should be counseled that antibacterial drugs including ampicillin and sulbactam for injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When ampicillin and sulbactam for injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.
Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by ampicillin and sulbactam for injection or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibacterials which usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial.
If this occurs, patients should contact their physician as soon as possible.