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Сультасин

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Сультасин

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

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Overview of Сультасин

Quick Facts

Property Description
Active ingredient Ampicillin and Sulbactam
Form Lyophilized powder for injection solution
Pharmacological class Combined antibacterial drug
Common use Elimination of systemic bacterial infections
Origin Semi-synthetic combination

What Type of Medicine is Сультасин?

Сультасин (the trade name for the Ampicillin and Sulbactam combination) is a broad-spectrum antibacterial drug and a fixed-dose combination product used for the treatment of serious infections where resistance is suspected. Clinically recognized for its ability to overcome common bacterial resistance mechanisms, the combined entity is essential in hospital settings for managing severe infections. The World Health Organization (WHO) includes this compound on its Model List of Essential Medicines, confirming its role as a necessary and effective treatment option for public health. The preparation falls under the high-level pharmacological class of combined antibacterial preparation. Its origin is semi-synthetic, which combines the antibiotic Ampicillin with the synthetic enzyme inhibitor Sulbactam.

Composition and Role of Active Ingredients (Ampicillin and Sulbactam)

The definitive composition of this medicine includes two active ingredients: Ampicillin (the primary antimicrobial agent) and Sulbactam (the synergistic component). Ampicillin executes its bactericidal action by directly interfering with the synthesis of the bacterial cell wall. The role of Sulbactam is to neutralize beta-lactamase enzymes, which are produced by certain resistant bacterial strains to protect themselves from the antibiotic. This protective function ensures Ampicillin maintains its full antimicrobial force. The drug is supplied exclusively as a sterile lyophilized powder for injection solution, a specific dosage form required for parenteral intramuscular or intravenous route of administration. This combined pharmaceutical strategy provides a robust synergistic antibacterial effect, ensuring a reliable treatment option against serious systemic bacterial infections.

Regulatory References

  1. WHO AWaRe Classification
  2. Ampicillin and Sulbactam Injection: MedlinePlus Drug Information
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What side effects are possible with Сультасин?

Possible Side Effects and Safety Information

The safety profile of Сультасин (Ampicillin/Sulbactam) is officially documented by regulatory authorities, classifying documented adverse reactions primarily by frequency and affected organ system. This information is derived from clinical trials and post-marketing surveillance, strictly defining the medicine's risk profile.

Frequency-Classified Adverse Reactions

The following are examples of adverse reactions reported in official product labeling, categorized by frequency:

Classification System-Organ Class Example Reaction
Common General/Administration Site Pain at IM/IV Injection Site, Thrombophlebitis
Common Gastrointestinal Disorders Diarrhea
Common Skin and Subcutaneous Tissue Rash
Uncommon Nervous System Disorders Headache
Uncommon Infections and Infestations Candidiasis

Serious Adverse Reactions and Safety Constraints

Official labeling documents a risk of serious, clinically significant adverse reactions. These include Anaphylactic Reactions, which can be life-threatening, and severe skin disorders known as Severe Cutaneous Adverse Reactions (SCARs), such as Stevens-Johnson Syndrome (SJS). Serious gastrointestinal events like Clostridioides difficile-Associated Diarrhea (CDAD) are also documented, with potential for delayed onset.

Usage of this medicine is subject to strict contraindications:

  • A known history of a serious hypersensitivity reaction (e.g., anaphylaxis) to Ampicillin, Sulbactam, or any other beta-lactam antibacterial (including penicillins and cephalosporins).
  • A history of cholestatic jaundice or hepatic dysfunction associated with prior use of the Ampicillin/Sulbactam combination.

Population-Specific Safety Notes

The official safety information notes caution for specific populations. This medicine is not recommended for individuals with Infectious Mononucleosis due to a high incidence of non-allergic rash. Additionally, due to its primary renal elimination, caution is noted for patients with Renal Impairment.

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Overdose and Emergency Response

Overdose Scope

Overdose is officially associated with neurological adverse reactions, with convulsions (seizure) being the primary documented manifestation. These CNS adverse reactions are linked to the attainment of high cerebrospinal fluid (CSF) levels of the beta-lactams. A specific population at increased risk are patients with severe impairment of renal function, as regulatory data shows prolonged high serum levels due to affected elimination.

When to Seek Urgent Help (Mandatory Actions)

Official regulatory guidance mandates seeking emergency medical attention or calling a Poison Control Center immediately upon suspicion of overdose. Life-threatening symptoms—including collapse, severe trouble breathing, or inability to be awakened—are classified as urgent triggers that require calling emergency services immediately.

Management and Antidote Status

The official prescribing information states that no specific antidote is known for this overdose. Management procedures described in regulatory documents require symptomatic treatment and supportive care. For severe cases, hemodialysis is documented as a procedure that may be utilized to remove the active compounds from circulation.

Connection to the Overall Overdose Profile

Regulatory documents define the overdose profile by emphasizing the risk of CNS toxicity, specifically convulsions, and establishing strict requirements for seeking immediate medical help for acute, life-threatening symptoms. Management, as officially described, focuses on supportive care and the potential use of hemodialysis in the absence of a known specific antidote.

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Therapeutic Uses of Сультасин

What Сультасин Treats: Main Uses and Benefits

This medication is generally relevant in clinical settings that involve conditions presenting with systemic or localized discomfort, particularly those where heightened symptoms may occur. This combination is used for managing infections of the skin, female reproductive organs, and the abdomen. It is applied across domains where additional symptomatic support is needed in contexts involving heightened systemic burden.


This treatment is commonly used to help with conditions marked by increased physiological stress, primarily targeting symptoms related to systemic imbalance, such as high fever, or severe localized symptoms related to inflammatory or irritative states. It is often applied across domains where additional symptomatic support is needed in high-risk patient groups, including both adults and the pediatric population. The application in these areas helps address symptom clusters that may become intense or disruptive, and supports patients during episodes of heightened discomfort in scenarios requiring short-term symptom stabilization.


Quick Fact: Symptomatic Support

Property Description
Symptom focus Systemic imbalance (fever) and severe inflammation (pain/swelling)
Condition type Acute, complicated, and deep-seated bacterial infections
Symptomatic role Assists with maintaining functional stability during symptomatic periods
Usage context Hospital settings, post-surgical care, suspected resistance cases

Regulatory References

  1. NIH MedlinePlus overview of Ampicillin and Sulbactam Injection
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Eligibility and Restrictions for Use

Population Eligibility Rules for Ampicillin and Sulbactam

The eligibility for using Сультасин (Ampicillin and Sulbactam) is strictly defined by regulatory authorities based on patient history, age, and physiological status.

Absolute Contraindications

Use is prohibited for individuals with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to ampicillin, sulbactam, or any beta-lactam antibacterial drugs (penicillins or cephalosporins). It is also contraindicated in patients with a history of cholestatic jaundice or hepatic dysfunction specifically linked to prior use of this combination.

Restricted and Conditional Use

Population Group Eligibility Status
Infectious Mononucleosis Not recommended for administration.
Impaired Renal Function Use is restricted, requiring modification of the administration schedule.
Pregnancy/Lactation Use is conditional and should occur only if clearly needed.
Neonates/Premature Infants Requires caution due to underdeveloped urinary system.
Pediatric (Specific Uses) Safety and efficacy are not established for intra-abdominal infections or for skin infections in children younger than one year of age.
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What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Sul'tasin (Ampicillin/Sulbactam) primarily addresses how its components interact with agents affecting drug elimination and blood coagulation, as defined in official regulatory labeling.

Interacting Product Category Key Constraint and Regulatory Basis
Probenecid Concomitant use increases and prolongs the plasma concentrations of both ampicillin and sulbactam by decreasing their renal tubular secretion.
Anticoagulants (e.g., Warfarin) May alter the effects of anticoagulants; coagulation parameters require monitoring to manage the potential for altered patient coagulation status.
Allopurinol Concomitant use increases the risk of developing a rash.
Estrogen-containing Oral Contraceptives Efficacy may be reduced, potentially leading to contraceptive failure.
Bacteriostatic Drugs Drugs such as tetracyclines or chloramphenicol may interfere with the bactericidal effect of the penicillin component.

Use in patients with Infectious Mononucleosis is not recommended due to a high incidence of skin rash. Furthermore, high concentrations of ampicillin in the urine may lead to false-positive glucose reactions when using non-enzymatic urine glucose tests (e.g., Clinitest, Benedict's Solution, Fehling's Solution).

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Mechanism of Action

Сультасин (Sultamicillin) functions as a mutual prodrug that undergoes rapid hydrolysis in vivo to yield equimolar amounts of its two active components: ampicillin and sulbactam.

Ampicillin is a beta-lactam antibacterial agent. Its mechanism involves non-competitive inhibition of essential bacterial enzymes known as penicillin-binding proteins (PBPs), which are transpeptidases critical for the final stage of peptidoglycan synthesis in the bacterial cell wall. The irreversible acylation of the PBP active site by ampicillin prevents the cross-linking of peptidoglycan chains. This molecular action disrupts cell wall integrity, leading to osmotic imbalance, subsequent cell lysis, and systemic physiological modulation via bacterial population reduction.

Sulbactam is a beta-lactamase inhibitor. It functions as a suicide inhibitor, forming a stable, irreversible covalent complex with the active site of beta-lactamase enzymes produced by certain bacterial strains. This irreversible antagonism protects the ampicillin component from hydrolytic cleavage of its beta-lactam ring, thereby preserving ampicillin's interaction with the PBPs and expanding the overall system-level antibacterial profile.

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Dosage and Administration Information

How is Сультасин Used? (Official Administration Guidelines)

This medicine is administered exclusively in a clinical setting as a sterile powder requiring reconstitution and is governed by strict, regulatory-defined dosing rules. The administration must be performed by or under the direct supervision of a healthcare professional, as indicated in the prescribing information.

Administration and Dosing

Usage Guideline Official Instruction (Based on Labeling)
Route of Administration Restricted to Intravenous (IV) injection or infusion, or Intramuscular (IM) deep injection.
Standard Adult Dose 1.5 g to 3.0 g per administration, given in equally divided doses. The total daily dose of the Sulbactam component must not exceed 4 grams.
Dosing Frequency Typically administered every 6 or 8 hours. Less severe situations may allow for an every-12-hour schedule.
Duration of Use Treatment generally continues for 5 to 14 days, or for at least 48 hours after fever and other signs of infection have resolved.

Preparation and Special Use Requirements

  • Preparation: The medicine is supplied as a lyophilized powder that must be reconstituted and diluted with a compatible solution (e.g., Sterile Water for Injection) before use.
  • IV Administration: The dose must be delivered by slow injection over a minimum of 3 minutes or via intravenous infusion over a period of 15 to 30 minutes.
  • Renal Adjustment: Patients with significantly impaired kidney function require an extended dosing interval based on their Creatinine Clearance (CrCL). For example, patients with CrCL between 15 and 29 mL/min are adjusted to receive the dose every 12 hours.
  • Pediatric Use: For most infections in pediatric patients over one year of age, the total daily dose is 300 mg/kg of body weight (expressed as the total of ampicillin and sulbactam content) and is administered in equally divided doses every 6 hours.
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Recent Clinical Evidence

Research evidence / Overview of Studies for Сультасин

Evidence for Use in Skin and Intra-Abdominal Infections

Studies exploring this medicine's role in skin and soft tissue infections and intra-abdominal infections primarily consist of short-term randomized controlled trials (RCTs) and multicenter comparative studies. Researchers have explored outcomes related to clinical success rates, microbiological response, and the resolution of signs related to systemic imbalance, such as fever. Findings from these clinical studies describe patterns of measured clinical outcomes and microbiological response when observed against other antibiotic regimens. Studies report measurements of microbiological resolution in the observed populations within the defined treatment interval. However, limitations exist in the breadth of follow-up, as most reports focus on outcomes only during the short period immediately following the end of therapy, meaning that long-term patient-reported outcomes are not fully established.

Evidence for Use in Gynecological and Respiratory Infections

Research has also explored the use of this combination in the setting of gynecological and obstetrical infections. Here, randomized trials have studied its use both for infections that have developed and for outcomes related to infection risk following certain surgical procedures. Research describes measured clinical outcomes in these scenarios. Some comparative studies report mixed findings, suggesting that the clinical results may vary depending on the specific comparison drug and patient population studied.

For lower respiratory tract infections (LRTI) and pneumonia, evidence comes from systematic reviews and large-scale observational studies. Research has examined outcomes such as in-hospital mortality, overall clinical cure rates, and length of hospital stay. Some observational data, particularly in older adult populations, indicates patterns where initial treatment with this combination was associated with different in-hospital mortality measurements when compared to certain other antibiotics.

Research Gaps and Uncertainties

The research landscape includes foundational studies in core indications but contains areas where more information is needed. Comparative evidence is lacking for direct, modern, randomized trials against all of the newest antibiotic classes. For severe infections caused by highly resistant organisms, the reliance on retrospective and observational studies means that the evidence quality varies, and sample sizes were modest in many of these reports. Furthermore, subgroup findings are uncertain in some fragile patient populations, indicating that the generalizability of results needs careful consideration.

Key Studies & References

  1. Study Comparing the Safety and Efficacy of Tigecycline With Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Skin Infections (NCT00368537)
  2. The Impact of Cefepime and Ampicillin/Sulbactam on Preventing Post-Cesarean Surgical Site Infections, Randomized Controlled Trail
  3. Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Chorioamnionitis: a Randomized Controlled Trial (NCT00879190)
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Frequently Asked Questions (FAQ)

Common questions about Сультасин (FAQ)

Q: Can Сультасин cause drowsiness or affect driving?

A: Official information indicates that common side effects typically include pain at the injection site or diarrhea. While drowsiness is not commonly listed, headache has been reported under Nervous System Disorders. In rare instances, particularly in patients with kidney problems, serious nervous system side effects like seizures have been reported. Patients are generally advised to be aware of how they respond to the medicine.


Q: Can Сультасин affect the results of blood tests?

A: Regulatory documents state that Ampicillin, one of the components of this medicine, can potentially cause false-positive results when certain non-enzymatic urine glucose tests are used. There are no specific warnings documented regarding the results of common standard blood tests.


Q: Can Сультасин interact with birth control pills?

A: Yes, official prescribing information advises that using this medicine concurrently with estrogen-containing oral contraceptives may reduce the effectiveness of the birth control. This interaction has the potential to reduce the effectiveness of the contraceptive.


Q: Can Сультасин be used during pregnancy?

A: This medicine is classified by regulatory authorities as Pregnancy Category B. Animal studies have not demonstrated a risk to the fetus, but there are no adequate and well-controlled human studies. Its use during pregnancy is conditional and is generally reserved for situations where the potential benefit is determined to justify the potential risk.


Q: Is Сультасин safe for people with kidney problems?

A: The use of this medicine in patients with kidney impairment requires caution because the body’s ability to eliminate the drug is reduced. For patients with impaired kidney function, the official prescribing information states that the administration schedule requires adjustment based on the patient’s creatinine clearance to help prevent drug accumulation.


Q: What are the precautions for using Сультасин in people with liver conditions?

A: This medicine is strictly prohibited (contraindicated) for individuals with a history of jaundice or liver dysfunction specifically linked to a prior use of this combination drug. For patients with existing liver impairment, the product label advises that liver function tests may be performed at regular intervals during treatment.


Q: Can Сультасин affect mood or sleep?

A: Adverse reaction data lists headache as an uncommon side effect under Nervous System Disorders. Although effects on general mood or sleep are not explicitly documented as common, the development of rare, severe central nervous system reactions has been reported, especially with high levels of the drug in the body.


Q: Can Сультасин be used for skin infections?

A: Yes, regulatory documentation confirms that this medicine is officially approved for the treatment of infections involving the skin and skin structures. Its use is limited to those infections caused by bacteria that are known to be susceptible to the drug.


Q: Does Сультасин affect the gut flora (beneficial bacteria)?

A: Like most antibiotics, this medication can disrupt the normal, beneficial bacteria in the colon. This alteration is the mechanism that can lead to Clostridioides difficile-associated diarrhea (CDAD), which is documented as a serious adverse reaction.


Q: Is Сультасин suitable for children?

A: Official dosing recommendations are available for pediatric patients over one year of age for most general infections. However, the safety and effectiveness are not established for specific uses, such as intra-abdominal and skin infections, in children younger than one year.


Q: Is Сультасин used to treat all kinds of infections?

A: No, this medicine is a broad-spectrum antibacterial drug, but it is indicated only for the treatment of specific infections, such as those of the skin, abdomen, and reproductive system. Its use is confined to treating infections caused by susceptible bacterial organisms.


Q: For how long is Сультасин usually prescribed?

A: Official prescribing information states that the course of treatment generally lasts for 5 to 14 days. The duration is often tailored to continue for at least 48 hours after a patient’s fever and other objective signs of infection have successfully resolved.


Q: Are there any specific dietary restrictions when taking Сультасин?

A: There are no explicit restrictions listed in the official regulatory documentation regarding food or specific dietary intake while receiving the medication. There are no specific food-drug absorption interactions noted, as the medication is administered via injection rather than being taken orally.


Q: Is it normal to feel a bit nauseous when starting Сультасин?

A: Nausea is a reported adverse reaction associated with the use of this medicine. Gastrointestinal discomfort is a general possibility with antibiotic use, and the official labeling notes nausea as a possible effect.


Q: What happens if Сультасин is taken with anticoagulants (blood thinners)?

A: Official drug interaction information warns that using this medicine at the same time as anticoagulants, such as Warfarin, may alter the effects of the blood thinner. The use of this combination necessitates close monitoring of a patient's coagulation parameters by a healthcare professional.


Q: Are there any long-term side effects associated with Сультасин?

A: Most documented side effects occur during or shortly after the treatment period. However, rare, serious events like C. difficile-associated diarrhea have been reported to occur up to two months after a patient has stopped taking the medicine. There is limited data on very long-term effects beyond the typical 14-day treatment course.


Q: Why do some infections require an intravenous form of Сультасин?

A: The medication is supplied exclusively as a sterile powder for injection, meaning it must be given either intravenously (IV) or intramuscularly (IM). This route of administration is preferred for systemic and severe infections to achieve the necessary high drug concentrations quickly and reliably throughout the body.


Q: How long does Сультасин stay in your system after the last dose?

A: Pharmacokinetic data indicates that the active components, ampicillin and sulbactam, have an elimination half-life of approximately one hour in patients with normal kidney function. The drug is considered almost completely eliminated from the body after about five half-lives.


Q: Can Сультасин be used to prevent infections?

A: While it is primarily used to treat existing infections, regulatory guidance suggests its use may also be indicated for surgical prophylaxis, meaning it can be given to reduce the risk of infection following certain surgical procedures, such as gynecological surgery.


Q: Is Сультасин commonly used in a hospital setting?

A: Yes, due to its mandated administration via intravenous or intramuscular injection, its use is typically restricted to a clinical or hospital setting. Furthermore, the World Health Organization includes this drug combination on its Model List of Essential Medicines.

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How should Сультасин be stored and disposed of?

How to Store and Dispose of Sul'tasin

Official regulatory documentation specifies strict environmental conditions for the storage and disposal of Sul'tasin (Ampicillin and Sulbactam for Injection) dry powder.


Storage Requirements

Condition Regulatory Rule
Temperature Store the dry powder at controlled room temperature (20 C to 25 C / 68 F to 77 F), with excursions up to 30 C permitted.
Container Must be kept in the original, unopened container.
Protection Keep out of the sight and reach of children.
Stability The product has a limited shelf-life once reconstituted.

Disposal Instructions

Unused or expired Sul'tasin must be disposed of according to applicable local and federal regulations for pharmaceutical waste. Regulatory guidance explicitly states that the medicine must not be flushed down a toilet or poured down a drain.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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