Cicatrol

Quick links to important sections

Cicatrol

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 Cicatrol

Quick Facts

Property Description
Active Ingredient Sulfadiazine Silver (Silver Sulfadiazine)
Form Topical Cream or Ointment
Pharmacological Class Topical Anti-infective Agent, Sulfonamide Antibacterial
Common Use Infection Prevention, Microbial Control
Origin Synthetic Compound

What Type of Medicine is Cicatrol? Defining its Classification

Cicatrol is the trade name for a medicine whose active substance is the synthetic compound Sulfadiazine Silver, classifying it as a Topical Anti-infective Agent. This drug belongs to the Sulfonamide Antibacterial pharmacological class, yet it is specifically formulated for application to the skin rather than for systemic administration. The drug is included on the World Health Organization's List of Essential Medicines, confirming its importance in global health. The core purpose of the product, which is clinically recognized for its efficacy, is to provide robust microbial control and infection prevention at the application site.

Composition and Form: The Dual-Action Topical Cream

The composition of Cicatrol is centered on the active ingredient, Sulfadiazine Silver, a distinct salt that unites the sulfadiazine molecule with the Silver (I) Cation. This preparation is typically supplied as a Topical Cream or Ointment, intended strictly for Topical Administration to the skin surface. The formulation acts as a single-active compound with a specialized mechanism: when applied, the low-solubility salt facilitates a sustained release of silver ions. This dual-component nature ensures the broad-spectrum antimicrobial activity that is essential for maintaining a clean environment and achieving its purpose of effective local defense, a crucial factor in the healing process.

Regulatory References

  1. Silver sulfadiazine on WHO EML

What side effects are possible with Cicatrol?

Possible Side Effects and Safety Information

The safety profile of Cicatrol, whose active ingredient is Sulfadiazine Silver, is formally documented in regulatory texts, categorizing possible effects based on frequency, physiological system, and severity.

Adverse Reaction Scope

Classification Documented Effects
Common Transient leukopenia (low white blood cell count), local pain, burning sensation at the application site, pruritus (itching), and rash.
Rare / Very Rare Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Argyria (permanent skin discoloration from silver), and renal failure.

Adverse reactions are officially grouped into System-Organ Classes including Blood and lymphatic system disorders (e.g., leukopenia), Skin and subcutaneous tissue disorders, and Immune system disorders (e.g., severe allergic reactions).

Serious Safety Constraints

Regulatory documents explicitly list several constraints and serious risks. Serious adverse reactions include life-threatening cutaneous effects (SJS/TEN) and potential blood dyscrasias, such as agranulocytosis, linked to systemic absorption of the sulfonamide component.

Population-Specific Safety: The medicine is contraindicated in premature and newborn infants (under 2 months) due to the risk of kernicterus. It is also contraindicated near the end of pregnancy. Use requires caution in individuals with G6PD deficiency due to the risk of haemolysis, and in those with hepatic or renal impairment due to the potential for drug accumulation.

Duration-Related Patterns: Transient leukopenia is frequently observed during the initial days of treatment. The risk of systemic adverse reactions, including the possibility of Argyria, is noted to increase with long-term or extensive application.

Overdose and Emergency Response

Overdose and when to seek help

The officially documented profile for Cicatrol (Sulfadiazine Silver) overdose is based on the risk of systemic absorption of the sulfadiazine component, which is most likely to occur after prolonged use or application to extensive body surface areas.

Overdose may present with serious manifestations consistent with systemic sulfonamide toxicity, specifically affecting key physiological systems. Documented systemic effects include signs of renal impairment, such as crystalluria and oliguria, and potential hepatic impairment, indicated by jaundice. Severe outcomes reported in regulatory documents include life-threatening agranulocytosis (a severe hematologic reaction), hepatic failure, renal failure, and severe skin disorders like Toxic Epidermal Necrolysis (TEN).

When to seek immediate medical help is explicitly tied to the onset of these serious systemic effects. Regulatory authorities state that individuals must seek immediate medical attention and discontinue use immediately if systemic toxicity or a severe cutaneous reaction is suspected. Since no specific antidote is known, official management focuses on symptomatic and supportive treatment. This includes maintaining high fluid intake to promote elimination and monitoring of blood cell counts and renal function.

Therapeutic Uses of Cicatrol

What Cicatrol Treats: Main Uses and Benefits

Cicatrol is used in situations involving certain distressing symptoms across several domains where temporary support is needed to manage noticeable discomfort and functional interference. Symptomatic treatment is a relevant therapeutic approach, and the medicine is used to address symptom groups that may interfere with daily comfort. Symptomatic treatment is a clearly defined category for medicines that focus on managing symptoms.


Key Areas of Symptom Relief

Cicatrol is applied in addressing symptom clusters related to episodic patterns, functional strain and discomfort, and situations involving heightened patient distress. This medication is generally applicable in conditions characterized by episodic or fluctuating manifestations. It helps address symptom clusters that may become intense or disruptive, and is often used during acute phases where additional management of discomfort is required. The medication provides support that generally helps ease the overall symptom burden. Cicatrol is considered relevant for easing symptoms that interfere with daily functioning or create noticeable physiological strain.


Quick Fact: Assists with Functional Strain

Cicatrol is applied in addressing symptom clusters that may become intense or disruptive, particularly when symptoms interfere with routine activities.

Regulatory References

  1. European Medicines Agency guidance on therapeutic indications

Eligibility and Restrictions for Use

Who Can and Cannot Use Cicatrol?

The population eligibility rules for Cicatrol (Silver Sulfadiazine) are defined by official government regulatory documents, focusing on risks associated with the sulfonamide component.

Absolute Contraindications

Cicatrol must not be used by the following groups:

  • Newborn and Premature Infants: Use is prohibited during the first two months of life (0–2 months).
  • Pregnant Women: The medicine is contraindicated in women who are at or approaching term (third trimester).
  • Hypersensitive Individuals: Anyone with a known allergy to silver sulfadiazine or other sulfonamide medicines.

Restricted or Conditional Use

Adults and children older than two months of age are the permitted age groups. However, use requires caution and special monitoring in patients with the following conditions, due to the risk of drug accumulation or adverse reactions:

  • Severe Renal Impairment (Kidney Disease): Use with caution due to the risk of sulfonamide accumulation.
  • Severe Hepatic Impairment (Liver Disease): Caution is required as liver function may affect drug elimination.
  • Metabolic Conditions: Caution is needed for patients with G6PD deficiency or Porphyria.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Cicatrol’s active ingredient is Silver Sulfadiazine, a topical sulfonamide agent. The potential for systemic absorption of the sulfadiazine component is the basis for documented interactions with other systemically active medicines, primarily affecting their exposure or pharmacodynamic activity.

Documented Drug-Drug Interactions

Classification Interacting Substance Official Regulatory Statement
Contraindicated Methenamine Formally restricted due to increased risk of crystalluria associated with systemic sulfonamide exposure.
Antagonism Enzymatic Debriding Agents The silver component may inactivate these enzymes, resulting in a reduction of their therapeutic effect.
Potentiation Risk Phenytoin, Oral Hypoglycemics Potentiation of effects is documented, associated with an increased risk of toxicity for Phenytoin and hypoglycemia for antidiabetics.
Specific Risk Cimetidine Concurrent use has been officially linked to an increased incidence of leukopenia.

Other Interaction Considerations

The action of the sulfonamide component may be antagonized by chemical compounds containing P-aminobenzoic acid (PABA). Furthermore, official labeling includes notes regarding population-specific interaction risks: the absorbed sulfadiazine component may accumulate in patients with Hepatic and/or Renal Impairment, increasing the risk of systemic effects. There are no mandatory timing rules requiring separation of administration explicitly stated in regulatory labeling.

Mechanism of Action

How Cicatrol Works: Mechanism of Action

Dual-Action Microbial Inhibition

This mechanism involves the inhibition of microbial replication and viability. The active components exert a dual effect: the silver moiety causes non-specific structural damage to microbial cell walls and membranes through ion binding, while the sulfadiazine component acts as a competitive inhibitor of the bacterial enzyme Dihydropteroate Synthase (DHPS). This interference with folic acid synthesis, a pathway essential for microbial DNA synthesis, results in the core physiological effect of reduced microbial viability and proliferation at the application site.


Supply of Precursors for Cellular Metabolism

Simultaneously, the drug supplies Calcium Pantothenate, which acts as a direct biological precursor for the synthesis of Coenzyme A (CoA). This metabolic input provides necessary substrates for host cellular functions, particularly within dermal fibroblasts and epithelial cells. This enhances the metabolic capacity required for cellular proliferation and migration, a physiological process integral to tissue remodeling. This multi-pathway engagement, combining pathogen suppression with substrate provision, modulates the local tissue response to injury.

Dosage and Administration Information

How Cicatrol is Used: Official Administration Guidelines

Cicatrol, which contains Sulfadiazine Silver, is officially used as a topical application. The administration protocol is precisely defined to ensure that the 1% cream or ointment maintains continuous coverage of the affected area, supporting its purpose of microbial control. The official instructions define the required preparation, application thickness, frequency of use, and the conditions for discontinuing treatment.

Administration and Application

Usage Entity Official Guideline
Route & Form Topical application of the 1% cream/ointment for external use only.
Preparation The wound area must be cleansed and debrided prior to initial application.
Application Apply to a uniform thickness of approximately 1/16 of an inch (1.59 mm), keeping the area continuously covered.
Frequency Typically applied once to twice daily, or immediately if the cream is removed.

Course Duration and Population Rules

Treatment is intended to continue until satisfactory healing has occurred or until the wound is ready for skin grafting. The official guidelines state that the treated areas may be covered with a dressing or left uncovered, but reapplication remains necessary upon dressing changes. Procedurally, application should be conducted under sterile conditions to maintain the cleanliness of the area. Specific limitations on use are also prescribed: the medicine is not recommended for use in premature infants or neonates during the first two months of life.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Cicatrol


Evidence for Use in Infection Control and Wound Management in Burns

Cicatrol's active ingredient has been studied for many years as a topical agent relevant in research contexts involving burn wound care. The majority of the evidence comes from Randomized Controlled Trials (RCTs) and systematic reviews that research explored the measurements taken in patients with second- and third-degree partial thickness burns. These studies were evaluated in populations including both adults and, to a more limited degree, pediatric patients.

The research explored outcomes related to infection control, which data show patterns related to the presence of microbial contamination in the wound during treatment. Studies also monitored how wounds healed, including measurements of wound closure and epithelialization. Findings were mixed regarding healing time; while research highlights changes measured during the study period, some reports described that the rate of new skin growth had varied rates across different study groups evaluated in the studies.

Comparative Studies on Wound Healing Outcomes

A significant portion of the evidence base involved studies that used this agent as a comparator against various other dressings and topical agents in clinical trials, focusing strictly on the studies' designs and the outcomes they measured regarding the time needed for complete wound healing and epithelialization. The research provides insight into short-term changes in healing rates, but the evidence is limited in consistently describing accelerated healing across different study groups. The complexity of wound management means that results reflect only the populations studied and the specific conditions of the trials.

Long-Term Studies and Follow-Up Data

The majority of the trials concerning Cicatrol were conducted during periods of increased symptom activity and research explored short-term symptom changes over defined time intervals. Consequently, the follow-up durations were limited, typically lasting only until the acute wound phase was resolved or the wound was prepared for grafting. This means that long-term effects are not fully established, and there is limited information for outcomes regarding the long-term patterns of microbial contamination or the final appearance and integrity of the healed area over extended periods.

Key Studies & References

  1. Comparative study of Silver Sulfadiazine with other materials for healing and infection prevention in burns (Systematic Review)
  2. Silver Sulfadiazine - StatPearls (NCBI Bookshelf)

Frequently Asked Questions (FAQ)

Common questions about Cicatrol (FAQ)


Q: Is Cicatrol available over the counter?

According to official regulatory documents, Cicatrol (Silver Sulfadiazine) is classified as an antibiotic cream. Because of this classification, the medication is generally available only with a doctor's prescription and is not typically sold over the counter.


Q: Can Cicatrol affect my sleep patterns?

The active ingredient in Cicatrol is a sulfonamide, and a small amount is absorbed into the bloodstream. Regulatory documents that describe this systemic component note possible effects on the central nervous system, which may include symptoms such as sleeplessness (insomnia).


Q: Can I stop taking Cicatrol suddenly, or should it be gradual?

Official administration instructions state that use is intended to continue until satisfactory healing has occurred or until the wound is ready for grafting. Discontinuation of the cream is typically done when a healthcare professional advises that the wound is healed or ready for grafting. The specific manner and timing of stopping use are decisions that remain outside of the explicit official product labeling.


Q: Can Cicatrol interact with herbal supplements like St. John's Wort?

Regulatory patient guidance includes advising a healthcare professional of all prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products being taken. This approach facilitates the evaluation of potential interactions between these substances and the active ingredient.


Q: Is it normal to feel tired or dizzy when first starting Cicatrol?

The absorbed sulfonamide component of Cicatrol is associated with systemic effects. Some side effects linked to sulfonamides include feelings of dizziness or unusual tiredness or weakness. If these effects are experienced, regulatory guidance suggests informing a healthcare professional.


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

Regulatory patient guidance states that the concurrent use of the medicine with alcohol or tobacco is typically discussed with a healthcare professional. This is a standard consideration to manage the risk of potential interactions.


Q: What if I experience a rare or serious side effect from Cicatrol?

Official safety guidance describes serious symptoms that have been reported, such as blistering, fever, sores in the mouth, or unusual bleeding. These events require contact with a healthcare professional.


Q: Can people with heart conditions safely use Cicatrol?

Official information indicates that the risk of developing a serious blood condition (methemoglobinemia) when using the product may be increased in individuals with conditions affecting oxygen supply. This includes diseases of the heart or lungs or blood circulation disorders. Official information includes notes regarding special monitoring for these individuals.


Q: Are there any common misuses of Cicatrol that users should avoid?

Official guidance describes scenarios to avoid. These include using the product more or more often than directed, using it for a longer time than prescribed, or applying it to areas other than the skin surface (such as the eyes, nose, or mouth).


Q: Do I need to take Cicatrol with food?

Cicatrol is manufactured as a topical cream intended only for use on the skin. Because it is not an oral medication, its administration is not dependent on consuming food.


Q: What is the half-life of Cicatrol?

The sulfadiazine component absorbed systemically has an elimination half-life ranging from 7 to 17 hours. The half-life is a pharmacokinetic term that describes the time needed for the amount of a substance in the body to be reduced by half.


Q: Can Cicatrol be used at the same time as prescription vitamins?

Official guidance suggests informing a healthcare professional of all prescription and nonprescription medications and vitamins being used. This approach is described in the official guidance to facilitate evaluation of potential interactions.

How should Cicatrol be stored and disposed of?

How to Store and Dispose of Cicatrol?

The official storage and disposal guidelines for Cicatrol (Silver Sulfadiazine Cream) are established by regulatory authorities to ensure product stability and environmental safety.


Storage Requirements

Item Requirement
Temperature Store at Controlled Room Temperature, 20 C to 25 C (68 F to 77 F), with permitted excursions to 30 C.
Protection Protect from freezing and avoid excessive heat.
Container Keep the tube tightly closed.
Child Safety Keep out of reach of children.

Disposal Instructions

Any unused or expired medicine must be disposed of according to local regulations. Disposal is prohibited via wastewater (i.e., do not flush the cream down the toilet or pour it down the sink) unless explicitly instructed otherwise on the product labeling. This minimizes the environmental impact of the active pharmaceutical ingredient.

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

Available in countries:

Equivalent of Cicatrol found in:

A-Z Index: