Intralin

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Intralin

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

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.

Overview of Intralin

Quick Facts

Property Description
Active Ingredient Cefazolin sodium
Form Sterile powder for solution
Pharmacological Class First-generation cephalosporin antibiotic
Common Use Treatment and prevention of systemic bacterial infections
Origin Semisynthetic

What Type of Medicine is Intralin (Cefazolin)?

Intralin is a pharmaceutical preparation whose active component is Cefazolin sodium, belonging to the cephalosporin antibiotic group. It is a semisynthetic compound, meaning its structure is chemically derived from a naturally occurring core, designed to enhance its antibacterial properties. The drug's classification as a first-generation cephalosporin places it within the broader family of beta-lactam drugs, which are defined by a specific chemical structure critical to their function. Cefazolin is also one of the most widely used antibiotics for prophylaxis in surgery, indicating its strong, established profile in preventing infection in hospital settings.


Composition and Form of Intralin

Intralin is a single-ingredient product supplied as a sterile powder for solution, requiring reconstitution before use. The primary active component is Cefazolin, and this specific preparation is exclusively designed for parenteral administration, meaning it must be given by injection. This dosage form—a highly concentrated powder for injection—is necessary to ensure the immediate and reliable delivery of the Cefazolin directly into the patient's system. The drug's use is indicated for deep-seated infections and its strong activity against many Gram-positive organisms.


What is the General Purpose of Intralin?

The core purpose of Intralin is to exert a bactericidal action—it actively kills susceptible bacteria by targeting and disrupting their cell wall synthesis. This targeted activity makes Intralin essential for resolving harmful systemic bacterial infections and serving as a critical agent in perioperative prophylaxis, which is the prevention of infection during surgical procedures. By terminating the growth and survival of these bacterial pathogens, Intralin acts as a powerful therapeutic and preventative tool.

What side effects are possible with Intralin?

Possible Side Effects and Safety Information for Intralin

Intralin's official safety profile is established through continuous reporting to regulatory authorities like the U.S. Food and Drug Administration (FDA) and is focused primarily on identifying serious and unexpected events during its use. The overall understanding of the drug's risk is based on systematic monitoring of all adverse events and reactions for a reasonable possibility of a causal relationship to the drug.

Adverse Reaction Categories

Adverse events associated with the drug are categorized based on their seriousness and unexpectedness. Serious adverse reactions are defined as those resulting in outcomes such as death, a life-threatening event, inpatient hospitalization, persistent or significant disability, or a congenital anomaly/birth defect. Unexpected reactions are those not previously documented in the authoritative risk information.

Adverse Reaction Type Regulatory Focus
Serious & Unexpected Events requiring expedited reporting (e.g., within 7 or 15 days) to the regulatory authority.
Unexpected Fatal/Life-Threatening Most critical category, requiring the fastest reporting timeline.
Animal Study Findings Reports of mutagenicity, teratogenicity, or carcinogenicity suggesting significant human risk.

Clinically Significant Safety Considerations

Official documents mandate that safety information, including known and anticipated risks, and necessary precautions, is detailed in the Investigator's Brochure. Significant safety assessments often involve analyzing cumulative exposure data by population demographics such as age, sex, and race. Changes to the dose or duration of exposure in the clinical setting are regarded as significant changes that may affect the overall safety profile.

There are safety-related limitations which prohibit the promotion or representation of an investigational drug as safe or effective, underscoring the ongoing nature of safety evaluation during development.

Overdose and Emergency Response

Overdose Manifestations and Toxic Risk

Overdose manifestations for Intralin (Cefazolin) are primarily linked to the central nervous system (CNS) and result from the toxic accumulation of the medicine in the body. Officially documented manifestations include seizures, myoclonus, and encephalopathy, which presents as confusion or altered mental status. These effects are classified as severe and potentially life-threatening.

When to Seek Immediate Medical Help

The official prescribing information mandates that individuals experiencing any severe, acute neurological symptoms, such as the onset of a seizure, must seek immediate medical attention. This action is also required for signs of severe hypersensitivity reactions, such as anaphylaxis.

The profile highlights that impaired renal function is the key risk factor for toxic accumulation when the required dosage adjustment is not applied.

Overdose Context Constraint Required Emergency Action
Onset of Seizures Discontinuation of the medicine
Toxic Accumulation Symptomatic and supportive treatment

Supportive Management

In the event of overdosage, there is no specific antidote known for Cefazolin. Management focuses on reducing the toxic drug concentration and controlling symptoms. Supportive measures officially described include the use of anticonvulsant therapy to manage seizures. Additionally, hemodialysis is an established procedure that may be utilized to remove the accumulated drug, particularly in patients with severe renal impairment.

Therapeutic Uses of Intralin

Intralin (Cefazolin) is an injectable antibiotic generally used in clinical settings to provide supportive therapeutic benefit against serious bacterial infections and for preventative support in surgery. Its use is relevant for managing conditions where symptoms are linked to organ-specific functional stress and is applied in contexts involving heightened systemic burden.

The application of Intralin is relevant within clinical settings that involve acute or disruptive symptom patterns, falling primarily into two key therapeutic areas. Indications include conditions marked by significant symptomatic burden, such as septicemia (blood infection), serious pneumonia, deep localized issues like osteomyelitis, and advanced cellulitis, as well as perioperative prophylaxis in high-risk surgery.

Treatment and Support

Intralin is applied in addressing conditions characterized by significant symptomatic burden. The therapeutic benefit supports the management of symptoms associated with acute or episodic changes, which helps alleviate symptom clusters like high fever and chills, and is relevant for easing symptoms related to inflammatory states such as intense pain and swelling.

“The primary benefit is in assisting with maintaining functional stability and contributing to easing the overall symptom load by supporting general well-being during symptomatic phases.”

For surgical patients, its use assists with managing the risk of infection, which supports the patient during difficult episodes and contributes to easing distress during recovery.


Quick Fact: Relief for Infection Symptoms

Property Description
Main Therapeutic Role Symptom management in severe systemic bacterial conditions
Symptom Clusters Addressed High fever, chills, localized pain, and swelling
Primary Patient Benefit Supports easing the overall symptom load during acute episodes
Key Preventative Use Prophylaxis (prevention) of surgical site infections

Eligibility and Restrictions for Use

Who Can and Cannot Use Intralin (Cefazolin)?

The eligibility for Intralin is strictly defined by official regulatory labeling, focusing on patient history and physiological status.

Population Status Regulatory Rule
Contraindicated Patients with a known immediate hypersensitivity (severe allergy) to Cefazolin, the cephalosporin class, penicillins, or other beta-lactam antibacterial drugs.
Age Eligibility Approved for Adults and Pediatric patients aged 1 month and older. Use is not established for premature infants and neonates (under one month).
Conditional Use Patients with reduced renal function (e.g., adult Creatinine Clearance below 55 mL/min) are eligible only if the dosage is strictly reduced. Caution is required for nursing mothers and those with a history of colitis or gastrointestinal disease.
Pregnancy Status Classified as Pregnancy Category B, indicating no evidence of fetal harm in animal studies; caution is advised during use.

This official regulatory profile establishes absolute prohibition based on allergy history and conditional eligibility for populations with impaired renal function. Older adults are generally eligible but require monitoring of kidney function. The criteria reflect the standardized regulatory classification used in official government documentation.

What should I know about interactions with other medicines?

Intralin’s official interaction profile details specific pharmacokinetic and pharmacodynamic constraints as documented in regulatory labeling. This structure establishes the requirements and limitations for co-administration with other medicines and substances.

Interacting Medicinal Products

The drug’s renal excretion is primarily affected by other medicinal products that interfere with renal clearance. The co-administration of Probenecid is not recommended. This restriction is based on a pharmacokinetic interaction where Probenecid inhibits Cefazolin’s renal excretion, a process that results in increased and more prolonged Cefazolin blood levels.

Pharmacodynamic Interactions and Risks

The official profile documents two key pharmacodynamic risk categories:

  • Anticoagulant Agents: Co-administration with anticoagulant agents may be associated with a fall in prothrombin activity.
  • Aminoglycoside Antibiotics: Concurrent use with these agents may increase the risk of nephrotoxicity due to an additive effect.

Population and Formulation Constraints

The risk of adverse consequences related to drug accumulation is heightened in certain patient populations. For patients with Renal Impairment, failure to manage accumulation increases the risk of serious central nervous system effects, including seizures. Additionally, the sodium content of the parenteral formulation requires consideration for patients who must restrict sodium intake.

Mechanism of Action

The mechanism of action for Intralin (Cefazolin) is a highly targeted process designed to compromise the structural integrity of susceptible bacteria, leading directly to bacterial cell death.

Covalent Inhibition of Bacterial Cell Wall Construction

Cefazolin acts within the domain of enzyme-mediated structural regulation by targeting Penicillin-binding proteins (PBPs), which are bacterial enzymes essential for building the rigid cell wall. The drug achieves this by forming a permanent, covalent bond with the PBP active site, instantly halting the final steps of peptidoglycan cross-linking. This specific molecular interference initiates a cascade that culminates in the loss of mechanical strength and the physical instability of the bacterial cell structure.

The Mechanism of Bactericidal Lysis

The direct result of inhibiting cell wall construction is the failure to counteract high internal osmotic pressure, leading to the physical swelling and rupture (lysis) of the bacterial cell. This process is the core physiological consequence of Cefazolin's mechanism, resulting in a bactericidal effect—the definitive termination of bacterial cell viability. This mechanism is subject to limitations, primarily resistance developed through bacterial production of beta-lactamase enzymes that destroy the drug.

Dosage and Administration Information

How to Use Intralin (Intralipid) — Administration Guidelines

This information describes the standardized procedures for administering Intralin (a lipid injectable emulsion).

Administration Scope

Component Standard Instruction
Route of Administration Intravenous Infusion into a peripheral or central vein. High-osmolarity admixtures must use a central vein.
Dosing Schedule Dosage is calculated in grams of fat per kilogram of body weight per day (g/kg/day). Maximum doses vary by age and clinical status.
Preparation Requirements The emulsion must be visually inspected for phase separation, discoloration, or particulates. A 1.2 micron in-line filter is mandatory for administration.
Age-Group Rules Maximum daily dosages are 3 g/kg/day for neonates/infants and 2.5 g/kg/day for stable adults.

Procedural Structure

The protocol dictates a strict sequence to ensure proper use:

  1. Verify and Prepare: Inspect the container and emulsion for any separation or foreign matter; do not use the product if defects are observed.
  2. Calculate and Admix: The required dose is precisely calculated based on the patient's weight and age, and the product may be aseptically combined with other components for Total Parenteral Nutrition (TPN).
  3. Infuse and Time: Administration must utilize a 1.2 micron in-line filter via a dedicated line. The maximum infusion rate must be adhered to (e.g., le 0.1 g/kg/hr for adults), and the total infusion must be completed within a defined time limit (e.g., 12 to 24 hours).

This framework ensures the product is used in accordance with established specifications for intravenous administration, covering the product integrity check, dose determination, and physical delivery conditions.

Recent Clinical Evidence

Intralin: Recent Clinical Evidence


Evidence for Use in Surgical Infection Prevention (Perioperative Prophylaxis)

Cefazolin was studied for its use in research evaluating surgical site infection incidence during and immediately following surgery. This area of research relies on studies that include meta-analyses that consolidate findings from many Randomized Controlled Trials (RCTs). The central outcome measured was the incidence of surgical site infection (SSI), typically tracked for a defined time interval, such as up to 30 days after the operation. Studies reported measurements of the incidence of SSI when Cefazolin was used compared to control groups. Research highlights changes measured during the study period, with some trials assessing non-inferiority when Cefazolin was evaluated against other prophylactic antibiotics. What remains uncertain is the full applicability of some older RCT protocols to modern surgical practices and current standardized care.


Evidence for Treatment of Severe Systemic Infections (Septicemia and Pneumonia)

The evidence base for treating severe systemic infections, such as septicemia (blood infection) and serious pneumonia, differs in design from the surgical prophylaxis research. The evidence is largely derived from meta-analyses that reviewed many retrospective observational cohort studies. Research examined responses over defined time intervals, tracking outcomes like all-cause mortality and rates of infection relapse. Studies exploring short-term symptom changes reported measurements of these critical outcomes, suggesting patterns of resolution that were observed to be similar to those seen with traditional treatments. Certainty remains low in some areas of this research due to the reliance on observational data rather than prospective RCTs.


What is Still Uncertain About the Research for Intralin

Comparative evidence is lacking in some areas, and researchers have identified an ongoing need for more prospective RCTs to compare Cefazolin against other treatments for severe infections like MSSA bacteremia. The long-term effects are not fully established, as the duration of follow-up in many key trials was restricted to the acute and immediate post-treatment phases, meaning limited information for long-term outcomes is available. The certainty remains low regarding the meaning of certain laboratory observations (like the "inoculum effect") for deep-seated infections, as findings varied across studies. Findings describe group patterns, not personal outcomes, and research provides context but not individual predictions.

Frequently Asked Questions (FAQ)

Common questions about Intralin (FAQ)

Q: Is Intralin considered a first-line treatment for its indication?

Official documentation indicates that Cefazolin is used for various specific infections. For certain conditions, such as respiratory tract infections due to Streptococcus pyogenes, a different injectable penicillin may be listed as the preferred drug of choice. However, Cefazolin is described as effective for bacterial eradication in its approved uses.

Q: What are the common benefits people generally expect from Intralin?

The purpose of Intralin, which contains the active ingredient Cefazolin, is to resolve serious infections like septicemia and respiratory tract infections. The drug works by creating a bactericidal effect, meaning it actively kills susceptible bacteria. This targeted action is intended to clear the infection in the body.

Q: What is the difference between Intralin and its generic equivalent?

Intralin’s active ingredient is Cefazolin sodium. Generic versions of the medication contain this identical active ingredient. According to regulatory standards, generic versions must meet the same requirements for quality, strength, stability, and therapeutic effectiveness as the brand name drug.

Q: How long does it typically take for Intralin to start working?

Pharmacokinetic data from official regulatory sources indicates that Intralin reaches its peak serum concentrations rapidly after intravenous administration, typically within the first hour. This means the drug enters the bloodstream quickly to begin its effect. However, the time it takes to see clinical improvement depends on the specific infection.

Q: Is it true that Intralin may take several weeks to show its full effect?

Regulatory counseling information for antibacterial drugs emphasizes the importance of completing the full prescribed course of treatment. The importance of completing the full prescribed course of treatment is emphasized in patient counseling information to ensure effectiveness and minimize resistance. Feeling better early in the course does not mean the treatment is complete.

Q: What is the expected duration of treatment with Intralin?

The total treatment duration is determined by a healthcare professional based on the specific type and severity of the infection. For perioperative prophylaxis (infection prevention around surgery), treatment is often discontinued within a 24-hour period. However, in certain high-risk surgical procedures, the treatment course may be continued for up to 3 to 5 days.

Q: What are the possible consequences of stopping Intralin suddenly?

Official patient counseling information warns that not completing the full course of therapy or skipping scheduled doses may have two consequences. It can decrease the overall effectiveness of the treatment against the existing infection. Furthermore, it can increase the likelihood of antibacterial resistance developing in the bacteria.

Q: How long does Intralin stay in the body after the last dose?

Pharmacokinetic data in the official labeling describes the mean serum half-life of Cefazolin as approximately 1.8 hours after IV administration. A significant portion of the drug, about 70% to 80%, is then excreted unchanged in the urine within 24 hours following administration.

Q: What are the most commonly reported side effects of Intralin?

According to official adverse reactions reporting, the most common effects associated with Intralin are related to the gastrointestinal system. These may include mild nausea, vomiting, or diarrhea. Other commonly reported effects are general allergic reactions, such as skin rash or hives (urticaria).

Q: Are there any serious or rare side effects associated with Intralin?

The official Warnings and Precautions section lists several serious adverse reactions. These include the potential for Seizures, particularly in patients with kidney problems, as well as severe infections like Clostridioides difficile-associated Diarrhea (CDAD). Serious Allergic Reactions, such as anaphylaxis, have also been reported.

Q: What symptoms require immediate medical attention while taking Intralin?

Symptoms of serious adverse reactions, as detailed in patient counseling information, are noted as requiring prompt reporting to a healthcare provider. This includes signs of a severe allergic reaction (such as swelling of the face, tongue, or throat, or a spreading rash), seizures, or the onset of severe, persistent diarrhea. Diarrhea associated with CDAD may occur even months after the last dose.

Q: Is Intralin known to cause stomach problems like nausea or diarrhea?

Yes, the official adverse reactions information lists gastrointestinal problems as common effects associated with this medication. These frequently reported issues include nausea, vomiting, and diarrhea.

Q: Can Intralin be taken with over-the-counter (OTC) pain relievers?

Official labeling focuses on known interactions with prescription drugs like Probenecid and blood thinners, but does not list specific OTC pain relievers. Official regulatory documents require that patients inform their healthcare provider of all medications being used, including any OTC products.

Q: Does Intralin interact with common dietary supplements or herbal remedies?

The official regulatory labeling does not provide a specific list of interactions with common dietary supplements or herbal remedies. Regulatory documents specify that patients should inform their healthcare provider of all products being used, including any supplements, vitamins, minerals, and herbal products.

Q: Is there official guidance regarding drinking alcohol while taking Intralin?

Although Intralin does not have the strongest interaction known, clinical safety resources indicate that consuming alcohol while undergoing antibiotic treatment is generally discouraged due to the potential for adverse effects. Alcohol use during therapy may increase the potential for certain adverse effects, including a specific reaction similar to the effects of the drug Disulfiram.

Q: Is there a risk of interaction between Intralin and birth control pills?

Some clinical safety resources suggest that antibiotics in the cephalosporin class may potentially reduce the effectiveness of oral contraceptives (birth control pills). This is thought to occur through an alteration of the intestinal bacteria. Due to this potential interaction, some regulatory guidance notes that the use of an alternate or additional form of birth control may be considered during treatment.

Q: Can Intralin be used by people with high blood pressure?

The formulation of Intralin used for intravenous administration contains sodium. Official documentation requires this to be considered for individuals who must restrict their sodium intake, such as patients with hypertension (high blood pressure) or heart failure. Official documentation requires the dosage to be carefully considered by a healthcare professional in these populations.

Q: Is it important to take Intralin at the exact same time every day?

Intralin is given via IV infusion, and the total daily dose is divided into equal portions delivered at precise time intervals, such as every 6 or 8 hours. Official information states that maintaining the prescribed dosing schedule helps ensure effective concentrations in the bloodstream.

Q: Is Intralin a controlled substance?

No, Cefazolin sodium, the active ingredient in Intralin, is classified as a prescription-only medication. It is not listed or scheduled as a controlled substance by the DEA or other similar government regulatory bodies.

Q: How is Intralin different from other similar drugs in its class?

Intralin is defined as a first-generation cephalosporin antibiotic. The official product information explains that this class distinction means its antibacterial coverage is generally more limited than later generations of cephalosporins. It primarily exhibits strong activity against Gram-positive bacteria.

How should Intralin be stored and disposed of?

The storage and disposal of Intralin (Cefazolin) powder must comply strictly with official regulatory conditions to maintain product stability.

Storage Requirements

Item Labeled Regulatory Requirement
Temperature Store the unopened powder at controlled room temperature (below 25 C or 77 F) [FDA Label].
Protection Must be protected from light and stored in its original container [FDA Label]. The powder must not be frozen [EMA SmPC].
Stability The solution, once reconstituted, has limited stability and typically requires refrigeration ( 2 C to 8 C) for a time period specified in the labeled instructions [EMA SmPC].
Child Safety Keep this medicine out of the sight and reach of children [NIH MedlinePlus].

Disposal Instructions

Disposal of unused or expired Intralin must follow regulatory guidance for pharmaceutical waste. The product must not be thrown away via wastewater or household waste [EMA SmPC]. The best method for disposal is to use an official drug take-back program or discard according to local community pharmaceutical waste requirements [FDA: Disposal of Unused Medicines].

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

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