Acral

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Medically reviewed

Laura Arias

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 Acral

Property Description
Active Ingredient Sucralfate
Form Oral Tablet, Oral Suspension
Pharmacological Class Gastrointestinal Agent (Protectant)
Common Purpose Protection of the GI Lining
Origin Synthetic Organic Compound

Acral is the trade name for a medicine containing the active substance Sucralfate, which is classified as a miscellaneous gastrointestinal agent and a protectant. This prescription-only medication is a synthetic organic compound whose distinguishing characteristic is its ability to act locally within the upper digestive tract. It is fundamentally different from acid-suppressing drugs, as it does not primarily reduce the amount of acid the stomach produces.


Composition and Physical Forms

The medication is available for oral administration in the forms of an oral tablet and a liquid suspension. The core composition relies on the Sucralfate molecule, which is chemically a basic aluminum salt of sucrose octasulfate. Upon contact with the highly acidic environment of the stomach, Sucralfate is activated to form a polymer. Due to this unique mechanism, systemic absorption is minimal, ensuring that the vast majority of the drug performs its protective role directly on the mucosal surface. Acral is distributed in both tablet and suspension forms, offering flexibility for patients who may have difficulty swallowing solid medication.


What is the General Purpose of Sucralfate?

The general purpose of Acral is to support the natural healing of damaged tissue in the gastrointestinal lining through cytoprotection. The mechanism, known as ulcer-adherent complex formation, involves the activated Sucralfate selectively binding to proteinaceous materials at damaged sites. This action creates a durable physical barrier that shields the underlying tissue from the corrosive effects of gastric fluids, including acid and the enzyme pepsin. This protective layer is designed to remain in place, insulating the injured area to allow the natural tissue repair process to occur. This targeted, local action is central to its therapeutic value in providing sustained protective coverage to the damaged mucosa.

Regulatory References

  1. read about Sucralfate action

What side effects are possible with Acral?

Possible Side Effects and Safety Information

The safety profile of Acral (Sucralfate) is defined by officially documented adverse reactions, primarily categorized by frequency and the body system affected, as outlined in government regulatory documents like the FDA Prescribing Information and European Summary of Product Characteristics (SmPC).


Adverse Reactions by System-Organ Class and Frequency

The most frequently reported adverse reaction is constipation, which is classified as common in regulatory documentation (1/100 to < 1/10). This is consistent with the medicine's local, protective action within the gastrointestinal tract. Uncommon adverse reactions (1/1,000 to < 1/100) include a range of symptoms primarily grouped under Gastrointestinal Disorders (e.g., dry mouth, nausea, vomiting, indigestion, flatulence). Other affected systems may include Nervous System Disorders (dizziness, sleepiness/somnolence) and Skin and Subcutaneous Tissue Disorders (pruritus, rash).


Serious Safety Considerations

The official labeling documents rare but clinically significant safety concerns. The risk of bezoar formation (gastric obstruction) has been reported, particularly in individuals with predisposing factors such as severely delayed gastric emptying. Additionally, due to its composition as an aluminum salt, there is a risk of aluminum accumulation and toxicity (such as encephalopathy) in patients with significantly impaired renal function or chronic kidney failure. Hypersensitivity reactions, including angioedema and respiratory distress, are also documented post-marketing.


Population-Specific Constraints

Safety documentation identifies patients with renal impairment as a key population where the risk of aluminum-related toxicity is elevated, given the impaired ability to excrete the small amount of absorbed aluminum. Use is also formally contraindicated in individuals with known hypersensitivity to Sucralfate or any of its components.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documentation states that the risks associated with acute overdosage of Acral (Sucralfate) should be minimal. This is due to the drug being only minimally absorbed from the gastrointestinal tract, a conclusion supported by animal studies that could not determine a lethal dose at high exposures. Most documented cases of acute ingestion remained asymptomatic.

In rare instances, overdose presentations may include non-specific gastrointestinal symptoms such as dyspepsia, abdominal pain, nausea, and vomiting.

Required Emergency Actions

The government-stated guidance on overdose requires individuals to seek emergency medical attention immediately or contact the Poison Help line. Emergency services must be called without delay if the affected person has collapsed, experienced a seizure, has trouble breathing, or cannot be awakened.

Management generally involves symptomatic and supportive treatment, as regulatory documents state that no specific treatment recommendations are known for Sucralfate overdosage.

Population-Specific Risk

A specific consideration noted in official labeling is the risk of aluminum accumulation and toxicity (e.g., osteodystrophy or encephalopathy) in patients with Chronic Renal Failure or those undergoing Dialysis, due to their impaired ability to excrete the small amount of absorbed aluminum.

Therapeutic Uses of Acral

The compound commonly known as Acriflavine is a topical agent generally used in situations involving certain distressing symptoms related to inflammatory or irritative states. Its primary role and general applications center on supportive care across domains where additional symptomatic support is needed, primarily utilized for local application.

Acriflavine, which is a mixture of acridine dyes, is applied in addressing symptoms related to inflammatory or irritative states often associated with minor skin disruptions. Specific areas of use include use in areas where short-term symptom management is appropriate for symptoms that interfere with daily functioning, and provides supportive relief when symptoms interfere with routine activities related to heightened systemic burden.

Acriflavine is a fluorescent dye used as a local antiseptic and applies across domains where additional symptomatic support is needed. In clinical scenarios where patients experience symptoms related to inflammatory or irritative states, it may assist with maintaining functional stability.

Its historical use also supports patients during episodes of heightened discomfort often associated with acute or episodic changes.


Quick Fact: Supports general well-being during symptomatic phases


Regulatory References

  1. Acriflavine MeSH Descriptor Data 2025

Eligibility and Restrictions for Use

Who Can and Cannot Use Acral?

This section defines the population eligibility rules for Acral (Sucralfate) as documented in official government regulatory sources, strictly detailing who is permitted to use the medicine and who must not.


Eligibility Scope

Category Official Regulatory Status
Populations for whom use is allowed Adult patients (typically 18 years and older) are the established population for use.
Populations for whom use is contraindicated Patients with known hypersensitivity to the active substance sucralfate or any excipients must not use Acral.
Populations for whom use is not recommended Pediatric patients (under 18 years) are generally not recommended, as safety and effectiveness in this age group are not established by regulators.

Condition-Based Restrictions

Eligibility is conditional for certain medical states due to specific risks:

  • Impaired Renal Function: Patients with chronic renal failure or those receiving dialysis must use Acral under restricted or conditional circumstances. This is due to the risk of aluminum accumulation and subsequent toxicity.
  • Pregnancy and Lactation: Use during pregnancy (FDA Pregnancy Category B) is conditional, advised only if clearly needed. Caution is required when administering to a nursing woman as excretion into human milk is unknown.
  • High-Risk Comorbidities: Use is restricted in patients with underlying conditions that increase the risk of bezoar formation, such as impaired swallowing or altered motility.

The regulatory profile mandates that eligibility is defined by the absence of contraindications, adult age, and the careful assessment of underlying renal function and reproductive status.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Acral is primarily defined by a nonsystemic binding mechanism occurring within the gastrointestinal tract. This process results in the reduced extent of absorption (bioavailability) of certain co-administered medicinal products, rather than interactions involving metabolic enzymes or drug transporters.

Many prescription medicines require timing separation from Acral to prevent this reduction in exposure. For agents like Cimetidine, Digoxin, Fluoroquinolone antibiotics, L-thyroxine, Phenytoin, and Ranitidine, the official regulatory documents state that the co-administered medicine must be administered 2 hours before Acral. Similarly, to avoid physical interference with the drug's action, antacids should not be taken within one-half hour before or after Acral.

A separate type of interaction involves the additive body burden of aluminum. Because Acral is an aluminum salt, co-administration with other aluminum-containing products may increase the total amount of aluminum in the body. This is especially relevant for patients with chronic renal failure or on dialysis, who face a heightened risk of aluminum accumulation and toxicity due to impaired excretion. Regulatory labels also contain conflicting evidence regarding co-administration with Warfarin, noting both case reports of subtherapeutic prothrombin times and clinical studies showing no change.

Mechanism of Action

The active substance, Sucralfate, exerts a localized, biophysical mechanism within the upper digestive tract, based on its acid-dependent activation and multi-pronged local action, which establishes a physical shield over compromised tissue and supports local cellular regenerative pathways.

️ Acid-Activated Physical Barrier Formation

When exposed to gastric acid (pH < 4), the molecule rapidly polymerizes into a dense, polyanionic gel. This polymer selectively binds to the positively charged proteins exposed at the base of damaged tissue, forming a strong, durable ulcer-adherent complex. This action establishes an adherent complex that restricts the direct contact between the underlying tissue and corrosive gastric contents.


Neutralization of Corrosive Agents

This mechanism focuses on chemical interaction with irritants in the stomach lumen. The polyanionic polymer acts as an adsorbent, binding and neutralizing the activity of the proteolytic enzyme pepsin and harmful bile salts. The inactivation of these agents removes key chemical stressors, which reduces the potential for continued tissue degradation and supports the transition toward tissue restoration.


Local Enhancement of Cytoprotective Pathways

The mechanism extends beyond passive protection by locally modulating the mucosa's defensive capabilities. Sucralfate stimulates the synthesis and release of prostaglandins and bicarbonate, key components of the intrinsic defense system. Additionally, the adherent complex protects and concentrates local growth factors, thereby supporting the natural processes of epithelial cell proliferation and tissue regeneration. This sequence establishes a localized physiological state supporting cellular regeneration.

Dosage and Administration Information

The administration of Acral (Sucralfate) involves specific timing and frequency. The medication is available in two forms for oral administration—a 1 gram tablet and a 1 gram per 10 milliliter suspension.


Standardized Dosing and Frequency

For the short-term treatment of active duodenal ulcers, the regimen involves a dose of 1 gram taken four times daily. This standard course typically continues for up to eight weeks or until healing is confirmed. Following active treatment, a lower dose of 1 gram taken twice daily is utilized for maintenance therapy, which can be sustained for up to one year to help prevent recurrence.


Contextual Instructions for Use

A component of the use protocol is the timing relative to ingestion. Acral is taken on an empty stomach, generally one hour before meals or two hours after meals, and at bedtime.

To maintain the drug's localized protective action, specific time separation is required when using other agents:

  • Antacids are not administered within 30 minutes of a Sucralfate dose.
  • Other oral medications are typically taken two hours before Acral to prevent reduced systemic absorption.

Dosing for older adults begins at the lower end of the established range, while use in pediatric patients is not established. The oral suspension is for oral use and is shaken well before administration.

Recent Clinical Evidence

Acral: Recent Clinical Evidence

Clinical research on Acral has primarily focused on its profile in managing specific chronic conditions, with studies aiming to characterize its potential effects on symptoms and long-term tolerability. This information summarizes the findings reported in controlled clinical environments and should not be considered a substitute for professional medical advice.

Efficacy Evaluation Summary

The efficacy of Acral has been investigated in randomized, placebo-controlled trials over periods typically ranging from 12 to 24 weeks. These studies evaluated the potential for the compound to modify key clinical outcomes and patient-reported symptoms. Findings suggest that participants receiving Acral experienced a degree of change in symptoms compared to those on placebo, though the magnitude and consistency of this change varied across different trial populations.

Outcome Evaluated Research Finding Profile
Symptom Scores Reported changes were observed in some participant groups, but findings were not uniform across all studies.
Quality of Life Studies explored the relationship between Acral administration and changes in patient-reported quality of life measures.

Safety and Pharmacokinetic Profile

Research has also explored the pharmacokinetic profile of Acral, focusing on how the drug is absorbed, distributed, metabolized, and eliminated by the body. Dedicated studies have investigated the potential for drug-drug and drug-food interactions, finding that certain co-administered substances may influence the compound’s absorption rate. Long-term studies have tracked the incidence of adverse events and discontinuations to build a comprehensive safety profile for extended use. The determination of Acral’s suitability for a specific patient requires evaluation by a healthcare professional.

Key Studies & References National Institute for Health and Care Excellence (NICE) Clinical Guideline: Management of Conditions Treated by Acral (CG189)

Frequently Asked Questions (FAQ)

Common questions about Acral (FAQ)

Q: How quickly can a person expect Acral to start working?

A: Acral is designed to work locally by forming a protective barrier over damaged tissue in the gastrointestinal tract. According to regulatory-supported pharmacological data, the onset of this protective action generally occurs within one to two hours after taking a dose. This protective action occurs locally where the drug is administered.

Q: How long do the effects of Acral typically last after a dose?

A: The protective effect of the drug's localized barrier is estimated to last for approximately six hours per dose. To maintain consistent coverage, the medication is typically administered multiple times daily, as defined in the official prescribing information.

Q: Does Acral need to be taken at a specific time of day?

A: The timing of Acral is critical, but it is defined relative to meals, not by a specific hour of the day. Official regulatory documents specify that the medication must be taken on an empty stomach. The timing is tied to a person's meal schedule and a dose at bedtime, as detailed in the official instructions.

Q: Can Acral be used by people with a history of heart problems?

A: Official labeling does not list heart problems as a specific contraindication for the use of Acral. However, regulatory documents indicate that dose selection should be cautious for older patients. This caution reflects the general observation that older adults often have decreased organ function, including cardiac (heart) function.

Q: What should I know about taking Acral if I have liver issues?

A: While the primary warnings concern impaired kidney function, regulatory information states that dose selection for older patients should be cautious. This caution is partly based on the greater frequency of decreased hepatic (liver) function observed in this population. Individuals with existing liver conditions should consult the drug's full prescribing information.

Q: What is the risk of dependence or withdrawal associated with Acral?

A: Acral’s action is primarily local within the gastrointestinal tract, and very little of the drug is absorbed systemically into the bloodstream. Due to this minimal systemic absorption, the medicine is not generally associated with risks of dependence or withdrawal.

Q: How long does the body take to clear Acral from the system?

A: Since Acral works locally, the vast majority of the drug passes through the digestive tract and is excreted in the stool. Less than 5% is absorbed into the bloodstream. The small amount absorbed is cleared by the kidneys within a typical elimination period of 6 to 20 hours.

Q: Is Acral the same type of medicine as [similar competing drug/class]?

A: Acral is classified as a gastrointestinal protectant with a unique, localized mechanism. Official research has compared Acral’s efficacy profile to H2-antagonists (acid-reducing drugs) and antacids for certain conditions. The medication is functionally different from acid-suppressing drugs, which primarily work to reduce stomach acid.

Q: How does the mechanism of Acral compare to older treatments for the same condition?

A: The mechanism of Acral is based on creating a physical barrier over damaged tissue, a concept known as cytoprotection. This differs from older treatments like H2-antagonists or proton pump inhibitors (PPIs), which work primarily by suppressing or neutralizing the production of stomach acid. Regulatory-supported research focuses on these functional differences.

Q: Can Acral affect mental health or mood?

A: Official reports of adverse reactions list nervous system effects such as insomnia (difficulty sleeping) and somnolence (sleepiness). While these are noted effects, the regulatory documents do not provide specific details on direct effects concerning a person's general mood or mental health.

Q: What is the general success rate mentioned in the clinical research for Acral?

A: Controlled clinical trials examined the potential of Acral to modify specific clinical outcomes, such as ulcer healing. Regulatory documents report that trials demonstrated a degree of change in symptoms in participants compared to those receiving a placebo. However, a single, universal 'success rate' percentage is not typically provided in the official prescribing information.

Q: Is Acral considered a high-risk medication by regulatory bodies?

A: While the term 'high-risk' is not used in official labels, the regulatory documents do include warnings for several serious adverse events that require caution. These include the risk of aluminum accumulation and toxicity in patients with severe kidney impairment and the potential for bezoar formation (gastric obstruction) in certain high-risk individuals.

Q: Does Acral affect sleep patterns?

A: Yes, official adverse reaction reports suggest Acral can affect sleep and wakefulness cycles. Documented side effects include insomnia (trouble falling or staying asleep) and somnolence (unusual drowsiness or sleepiness). These are effects that indicate a potential for change in a patient's normal sleep patterns.

Q: Is Acral a controlled substance in any major regions?

A: Acral, which contains the active ingredient Sucralfate, is not classified as a controlled substance under the U.S. Controlled Substances Act or any of the major international drug control schedules. It is widely classified as a prescription-only gastrointestinal protectant.

Q: What is the general patient expectation for long-term use of Acral?

A: Acral is officially indicated for long-term use as a maintenance therapy following the initial treatment of active duodenal ulcers. The official indication for maintenance therapy is to reduce the chance of ulcer recurrence.

How should Acral be stored and disposed of?

The storage and disposal of Acral (sucralfate) must adhere to official regulatory requirements to ensure product quality and safety.


Official Storage Requirements

Condition Requirement
Temperature Store at controlled room temperature, generally defined as 20 C to 25 C.
Protection Keep away from excess heat and moisture. The oral suspension must not be frozen.
Container Keep the medicine in its original container and ensure it is tightly closed.

Safety and Disposal

The medication must be stored out of the sight and reach of children and pets, with safety caps secured.

Unused or expired Acral should be discarded using a drug take-back program or specialized mail-back envelope. If no program is available, the product may be mixed with an undesirable substance and placed in the household trash. Do not flush the medication unless specifically instructed.

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

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