Negram

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Negram

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Method of action: Bactericidal, Bacteriostatic

Treatment option:

Medically reviewed

Rosario Oropesa

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 Negram

The medicine known by the trade name Negram is a synthetic antibacterial agent whose active ingredient is Nalidixic Acid. It is fundamentally defined by its specialized role as a urinary anti-infective, primarily used to eliminate specific bacterial populations within the urinary system.


Quick Facts About Negram

Property Description
Active ingredient Nalidixic Acid
Form Tablet, Oral suspension
Pharmacological class First-generation quinolone antibiotic
General purpose Urinary anti-infective
Origin Synthetic organic compound

What Type of Antibacterial is Negram (Nalidixic Acid)?

Negram belongs to the first-generation quinolone antibiotic class and is chemically derived from the 1,8-naphthyridine structure, establishing it as one of the original synthetic compounds in its antimicrobial group. The compound's function involves acting as a bactericidal agent by selectively interfering with the bacteria's process of duplicating their genetic material, specifically by inhibiting the enzyme DNA gyrase. This medicine works by destroying the bacteria's ability to reproduce. The product is a single active ingredient preparation, designed for targeted action. This classification places Nalidixic Acid distinctly from the later-developed fluoroquinolones, which possess structural modifications that typically afford them a broader spectrum of activity and enhanced tissue penetration.

How is Negram Supplied and What is its General Purpose?

Negram is formulated for oral administration, and is typically supplied to patients as a solid tablet or as a liquid oral suspension. The composition includes the Nalidixic Acid active ingredient alongside pharmaceutical excipients necessary for stability and proper absorption within the body. The general purpose of this medicine, dictated by its powerful bactericidal action and localized concentration, is to eliminate the susceptible bacterial populations responsible for infections. This agent is intended to resolve infections caused by targeted bacteria. The availability of both the tablet and the oral suspension ensures flexibility, accommodating various patient needs. Its foundational function is to defeat the invading microorganism, classifying it primarily as an agent for resolving bacterial-based conditions, such as acute or chronic infections of the urinary tract.

What side effects are possible with Negram?

Possible Side Effects and Safety Information for Negram (Nalidixic Acid)

This information describes the documented adverse reactions and safety constraints for Negram, based on official regulatory labeling.

Adverse Reaction Classification

Side effects are categorized by frequency and the body system affected (System-Organ-Class or SOC). The primary SOCs involved include Gastrointestinal Disorders, Nervous System Disorders, and Skin and Subcutaneous Tissue Disorders.

  • Common Reactions may include nausea, vomiting, abdominal pain, headache, and dizziness.
  • Dermatological Effects include rash, itching, and potential photosensitivity (increased sensitivity to sunlight), which necessitates discontinuation and avoidance of direct sun exposure.

Serious Adverse Reactions

Although rare, serious and clinically significant adverse reactions have been documented in official labeling, including:

  • Central Nervous System (CNS) Events: This encompasses convulsions (seizures), signs of increased intracranial pressure (especially in infants), and toxic psychosis.
  • Hypersensitivity: Severe, sometimes fatal, hypersensitivity reactions (anaphylaxis).
  • Neuromuscular Issues: Documented cases of tendon rupture (related to the quinolone class) and peripheral neuropathy.
  • Blood Disorders: Hemolytic anemia may occur, particularly in individuals with documented G6PD deficiency.

Safety Restrictions and Monitoring

Negram is contraindicated (should not be used) in patients with: a history of convulsive disorders, known Porphyria, or hypersensitivity to the drug. It is also contraindicated in infants under three months of age.

Population-Specific Precautions: Caution is advised when administering Negram to patients with significant renal or hepatic impairment. Due to risks of joint damage (arthropathy), use in pre-pubertal children requires careful consideration.

For treatment lasting more than two weeks, official documentation recommends periodic monitoring of blood counts and tests of renal and liver function.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with Negram (Nalidixic Acid) is associated with serious clinical events, and immediate medical attention is required if an overdose is suspected.


Documented Overdose Manifestations

The following signs and symptoms have been officially reported following exposure to higher than recommended doses:

  • Central Nervous System (CNS) Effects: Seizures (convulsions), toxic psychosis, increased intracranial pressure, aggressive or violent behavior, headache, lethargy, and drowsiness.
  • Systemic Effects: Nausea, vomiting, loss of appetite, and rapid, deep breathing (suggestive of metabolic acidosis).
  • Visual Disturbances: A change in the ability to see colors, particularly blue or yellow perception.

Required Emergency Actions

If an overdose is suspected, official instructions mandate that you contact a poison control center or emergency room immediately.

Action Domain Official Regulatory Statement
Antidote No specific antidote exists.
Management Treatment is symptomatic and supportive; procedures such as gastric lavage may be considered.
Resolution Overdose reactions, including severe CNS effects and metabolic acidosis, usually resolve within two to three hours due to the drug's rapid excretion.

Population-Specific Considerations

The risk of severe CNS toxicity, including increased intracranial pressure and toxic psychosis, is specifically noted in official labeling for both infants/children and elderly patients.

Therapeutic Uses of Negram

Main Uses of Negram

Negram, which contains the active ingredient nalidixic acid, is an antibacterial medication belonging to the quinolone class. It is primarily used to treat infections of the urinary tract. Unlike many other antibiotics that distribute widely throughout the body, nalidixic acid is rapidly absorbed and concentrated in the urine, making it specifically effective for conditions affecting the renal system.

Urinary Tract Infections (UTIs)

The medication is indicated for the treatment of both acute and chronic urinary tract infections. These infections typically involve the lower urinary tract, such as the bladder and urethra. Negram works by interfering with the DNA replication of specific types of bacteria, effectively stopping their growth and allowing the body's immune system to clear the infection.

Susceptible Pathogens

Negram is targeted toward a specific group of bacteria known as Gram-negative organisms. It is frequently used to address infections caused by common urinary pathogens, including:

  • Escherichia coli (E. coli): The most frequent cause of uncomplicated urinary tract infections.
  • Proteus species: Often associated with persistent or recurrent infections.
  • Klebsiella species: Common bacteria found in the digestive tract that can migrate to the urinary system.
  • Enterobacter species: Bacteria that may cause infections in various parts of the renal tract.

Benefits and Therapeutic Action

The primary benefit of Negram is its focused action within the urinary environment. Because the medication reaches high concentrations in the urine while remaining at relatively low levels in the bloodstream, it provides a localized antibacterial effect where it is needed most.

  • Bactericidal Activity: At therapeutic concentrations, the medication is capable of killing susceptible bacteria rather than just inhibiting their growth.
  • Symptom Relief: By reducing the bacterial load in the urinary tract, the medication helps alleviate the discomfort, burning, and urgency associated with active infections.
  • Targeted Treatment: Its specificity for Gram-negative bacteria makes it a useful option for patients with infections resistant to other classes of antibiotics, such as certain penicillins or sulfonamides.

Eligibility and Restrictions for Use

Who Can and Cannot Use Negram (Nalidixic Acid) — Official Regulatory Information

The eligibility for using Negram is strictly defined by official regulatory documentation, specifying certain populations for whom the medicine is either permitted or absolutely prohibited.


Eligibility Scope

Category Official Regulatory Statement
Populations for whom use is contraindicated Infants less than three months of age; Individuals with known hypersensitivity to the drug; Patients with Porphyria; Patients with a history of convulsive disorders or psychotic reactions to quinolones.
Age-related eligibility rules Use is established for pediatric patients 3 months and older and adults. Caution is advised for prepubertal children and older adults with potential for decreased renal function.
Condition-specific eligibility rules Use restricted/cautioned in patients with severe renal insufficiency or liver disease. Caution is also required for those with G6PD deficiency or severe cerebral arteriosclerosis.
Pregnancy and lactation eligibility status Pregnancy: Assigned Category C; safety not established for the first trimester. Lactation/Breastfeeding: Contraindicated by the manufacturer.

Connection to the overall eligibility profile

Regulatory documents define eligibility based on absolute contraindications concerning age, pre-existing neurological conditions, and metabolic status. Furthermore, eligibility is restricted through mandatory cautions for patient populations with impaired organ function (renal and hepatic) and certain genetic conditions, establishing the necessary population criteria for the safe use of the medicine.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Nalidixic Acid's official regulatory profile details several interactions that mandate restrictions, timing separation, or monitoring due to changes in drug exposure or enhanced pharmacodynamic effects.

Category Official Interaction Outcome or Restriction
Contraindicated Combination The combination with the alkylating agent Melphalan is contraindicated due to a risk of serious documented gastrointestinal toxicity, including intestinal necrosis.
Potentiation of Effects Co-administration with oral anticoagulants, such as Warfarin, potentiates their effects, evidenced by an alteration of the prothrombin time. This effect carries an enhanced risk in elderly patients.
Exposure Modification Co-administration with Probenecid decreases the urinary excretion of Nalidixic Acid, reducing the antibacterial concentration in the urine while increasing systemic plasma levels.
Musculoskeletal Risk The co-use of Corticosteroids is associated with an increased risk of tendon effects, including rupture, a risk which is noted as being increased in elderly patients.
Timing Requirement Antacids (containing magnesium, aluminum, or calcium) and Sucralfate must not be administered within the 2-hour period before or after Nalidixic Acid to prevent reduced drug absorption.
Avoidance Precaution The medicine should be avoided in patients receiving Class IA and Class III Antiarrhythmics due to the documented potential for QT c interval prolongation.

Connection to the overall interaction profile

Regulatory documents define Nalidixic Acid's interaction structure through mandated restrictions, including a formally contraindicated combination, and explicit timing requirements necessary to maintain adequate systemic exposure. The profile also highlights enhanced risks of pharmacodynamic effects, such as prolonged prothrombin time and tendon effects, particularly when co-administered with specific agents in the elderly population.

Mechanism of Action

Targeting the Core Bacterial Replication Machinery

The mechanism of Nalidixic Acid is centered on the selective inhibition of two critical bacterial enzymes: DNA Gyrase and Topoisomerase IV. The drug functions as an inhibitor by binding to the Gyrase-DNA complex and freezing it mid-action, specifically stabilizing the cleavage complex. This interaction impedes the crucial process of bacterial DNA supercoiling and unwinding that is required for replication.


Mechanism Cascade: Irreversible DNA Damage and Cell Death

The stabilization of the enzyme-DNA complex prevents the broken DNA strands from being re-ligated and repaired, leading to the rapid accumulation of catastrophic double-stranded DNA breaks within the bacterial cell. This irreparable genome damage results in a bactericidal effect. This molecular cascade results in the swift, irreversible elimination of susceptible microbial populations.


Constraints on Mechanism Effectiveness

The efficacy of this mechanism is constrained by microbial adaptation, primarily through genetic changes in the target. Mutations in the gyrA gene (the target enzyme subunit) can reduce the drug's binding affinity, functionally weakening the inhibitory mechanism. Furthermore, bacterial efflux pumps can actively expel the drug, lowering its effective intracellular concentration and reducing the functional extent of the bactericidal mechanism.

Dosage and Administration Information

How to Use Negram: Official Administration Guidelines

Negram, containing the antibacterial agent Nalidixic Acid, is exclusively administered by the oral route using either a tablet or an oral suspension formulation. The regimen is structured to ensure consistent levels of the agent are maintained, particularly within the urinary system, and is based strictly on the prescribing information.


Dosing and Frequency

The medication follows a fixed schedule of four equally divided doses per day (q.i.d.). The specific dose is determined by the patient's treatment phase:

Treatment Phase Adult Dose Pediatric Dose (ge 3 months)
Initial/Acute Therapy 1 gram per dose 55 mg/kg/day total dose
Maintenance/Prolonged Therapy 500 mg per dose 33 mg/kg/day total dose

The standard duration for an initial course of therapy is typically 7 to 14 days.


Administration Context and Special Conditions

The official usage guidelines detail specific instructions for optimal intake. The drug may be taken with or without meals, but patients are advised to drink fluids liberally throughout the treatment course.

A crucial administration requirement relates to concurrent substances: compounds containing calcium, magnesium, aluminum, iron, or zinc (including certain antacids and supplements) should not be taken within two hours before or after the Nalidixic Acid dose, as these interfere with drug absorption. Use of the medicine is not established and should be avoided in infants younger than three months. Furthermore, dose adjustments are explicitly required for individuals with severe renal impairment, where the dose should be halved if the creatinine clearance is 20 mL/min or less.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Negram

Evidence for Use in Acute and Chronic Urinary Tract Infections (UTIs)

The available research for Negram (Nalidixic Acid) includes Randomized Controlled Trials (RCTs) and early clinical studies. This research was studied for use in patients with both sudden, acute infections and those with longer-lasting, chronic conditions. These studies focused on conditions associated with acute or disruptive episodes caused by specific types of bacteria, primarily Gram-negative organisms that are susceptible to the medicine.

These studies monitored two key outcomes: Bacteriological Outcomes and Symptom Patterns. Bacteriological Outcomes was studied for by testing urine samples to see if the targeted bacteria were eliminated from the urinary system. Symptom Patterns was assessed by examining patient-reported experiences related to physical discomfort and outcomes describing episodic or acute changes in symptoms like painful urination (dysuria), frequency, and urgency. Research explored the use of the medicine across these defined time intervals to see how the infection and associated symptoms evolved.

Study Comparisons and Reported Outcomes

In the initial studies, Negram was evaluated in trials that compared it against either an inactive substance (placebo) or alternative antibacterial agents available during those research periods. These trials aimed to provide context for the medicine's activity. Studies explored how symptoms evolved in the observed populations and reported specific measurements of bacteriological outcomes in patients who received the medicine.

Findings from these comparisons describe patterns observed in the studies regarding the evolution of symptoms and the bacteriological outcomes of the specific susceptible pathogens. Research also examined the potential for the bacteria to develop resistance to the medicine during or shortly after the course of treatment. This provided data on the observed activity under the specific conditions of the research.

Research Gaps and What Remains Uncertain

One consistent limitation noted in the scientific literature is that resistance can be observed in some studies where susceptible bacteria change and become less responsive to the medicine during the course of treatment. Furthermore, there is limited information for long-term outcomes that track patients for many months or years, meaning the certainty remains low regarding very long-term recurrence rates. Because the medicine reaches its highest concentration in the urine, the research focus was limited to the urinary tract. This means comparative evidence is lacking for systemic or body-wide infections outside of this system.

Frequently Asked Questions (FAQ)

Common questions about Negram (FAQ)


Q: What is the difference between Negram and Cipro?

A: Negram’s active ingredient, nalidixic acid, is defined as a first-generation quinolone. Official classification places it distinctly from later-developed agents, such as the fluoroquinolones (which include ciprofloxacin). According to regulatory descriptions, fluoroquinolones typically possess structural modifications that afford them a broader spectrum of activity and enhanced tissue penetration compared to nalidixic acid.


Q: Is Negram safe for children?

A: Official prescribing information states that the safety and effectiveness of Negram have not been established in infants under the age of three months, and its use is contraindicated for this age group. Use in pediatric patients aged 3 months and older is established according to official regulatory information. However, use in prepubertal children requires careful consideration due to the risk of joint damage (arthropathy) observed in immature animals treated with this class of medicine.


Q: Do older adults react differently to Negram?

A: Official documents note that caution is required in older adults, especially those with potential for decreased renal function. The risk of potentiating the effect of oral anticoagulants (like Warfarin) and the risk of tendon effects when taken with corticosteroids are both specifically noted as being enhanced in the elderly population.


Q: Why is Negram prescribed instead of penicillin?

A: Negram is indicated for treating urinary tract infections caused by susceptible Gram-negative microorganisms. The choice between Negram and other antibacterial agents, such as penicillin, is a decision based on the specific type of bacteria causing the infection and the results of laboratory susceptibility tests.


Q: What are the signs of a serious allergic reaction to Negram?

A: The official product information documents the occurrence of severe, sometimes fatal, hypersensitivity reactions (anaphylaxis). Any sudden severe reaction, such as swelling or difficulty breathing, is consistent with a hypersensitivity event which is noted in the drug's safety profile.


Q: What information should I tell my doctor before starting Negram?

A: Regulatory documents indicate that use requires consideration of pre-existing conditions, such as a history of convulsive disorders, Porphyria, severe renal or liver impairment, G6PD deficiency, or concurrent use of specific medicines like antiarrhythmics or oral anticoagulants.


Q: Does Negram cause diarrhea?

A: The official labeling classifies Gastrointestinal Disorders as a primary body system affected by the medicine, listing common symptoms such as nausea, vomiting, and abdominal pain. Additionally, some regulatory warnings note the potential for Clostridium difficile-associated diarrhea (CDAD), which may occur with many antibiotic treatments.


Q: Is it safe to drive while taking Negram?

A: The drug's safety information describes potential effects on mental alertness, such as dizziness and visual disturbances, as well as rare but serious Central Nervous System (CNS) events. These effects may require consideration when driving or operating machinery.


Q: How quickly does Negram start working?

A: According to the official clinical pharmacology data, Negram is rapidly absorbed after administration. Peak levels of the active drug in the blood serum are typically reached approximately 1 to 2 hours after the dose, while peak drug levels in the urine average approximately 3 to 4 hours after administration.


Q: What happens if a dose of Negram is missed?

A: Official guidance typically describes a protocol in which if a dose is missed and it is almost time for the next dose, the missed dose is skipped. Regulatory information generally advises against doubling the dose to make up for one that was previously missed.


Q: Can Negram be crushed or split?

A: Official labeling provides instructions only for the whole tablet or the oral suspension form. The documentation does not provide instructions for crushing or splitting the tablets.


Q: Are there any known interactions between Negram and alcohol?

A: Official regulatory documents do not list alcohol as a direct, restricted interaction. However, the medicine's safety profile notes potential side effects like dizziness and cautions for use in patients with liver impairment.


Q: Is there a link between Negram and changes in blood sugar?

A: Yes, regulatory adverse reaction documentation indicates that the drug is known to cause hyperglycemia, which is a documented adverse reaction defined as high blood sugar.


Q: How does Negram compare to sulfa drugs for infections?

A: Negram (nalidixic acid) and sulfonamides (or sulfa drugs) are both antibacterial agents that have historically been used for uncomplicated lower urinary tract infections. Negram is part of the quinolone class, while sulfa drugs are chemically distinct. Clinical selection is determined by which agent the specific target bacteria is susceptible to.


Q: What should I do if my symptoms do not improve while taking Negram?

A: The official documentation addresses situations of unsatisfactory clinical response or relapse during therapy. In these cases, regulatory guidance indicates that cultures and sensitivity tests may need to be repeated for reassessment.


Q: Does taking Negram interfere with certain lab tests?

A: Yes, official prescribing notes indicate that nalidixic acid is known to cause false-positive results when certain diabetic urine testing products are used. Specifically, this interference occurs with the cupric sulfate-type tests, which are used to measure reducing sugars in the urine.


Q: What is the half-life of Negram?

A: According to official clinical pharmacology data, the half-life of the active drug in the serum is approximately 90 minutes. The half-life for the active drug in the urine is approximately 6 hours, which is reflective of its specialized role as a urinary anti-infective.

How should Negram be stored and disposed of?

How to Store and Dispose of Negram (Nalidixic Acid)

Storage Requirements

Negram must be stored under specific conditions to maintain stability. The medicine must be kept at room temperature, typically up to 30 C (86 F), and protected from both sunlight and moisture. Store the medicine in its original, airtight container. The liquid suspension form must not be frozen.

Safety and Disposal

For safety, Negram must be stored out of the reach of children. The medicine should not be saved for future use and any unused quantity must be properly disposed of. The preferred method is using a drug take-back program. If unavailable, unused medicine (which is not on the flush list) should be mixed with an unappealing substance, placed in a sealed bag, and then discarded in the household trash.

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

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