Albital

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Albital

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 Albital

Property Description
Active ingredient Human Albumin (HSA)
Form Sterile liquid solution for infusion
Pharmacological class Plasma Substitutes and Plasma Protein Fractions
General purpose Restoration and maintenance of circulating blood volume
Origin Plasma-derived (from human donors)

Albital: Definition and Pharmacological Classification

Albital is a biological medicinal product containing Human Albumin as its active ingredient, which is the most abundant protein found naturally in human plasma. It belongs to the pharmacological class of Plasma Substitutes and Plasma Protein Fractions, with the ATC code B05AA01. This classification signifies that the product is utilized to supplement or replace essential components of the blood plasma. The active substance is highly purified from large pools of human plasma, ensuring that its structure is identical to the body’s own physiological albumin, a factor clinically recognized for its high specificity and physiological compatibility.


Composition and Physical Form of the Albumin Solution

Albital is supplied as a sterile liquid solution for infusion, intended exclusively for intravenous (IV) administration. Its composition consists of highly purified Human Serum Albumin (HSA), which is stabilized by adding compounds such as N-acetyl-DL-tryptophan and caprylic acid. The protein is dissolved in water for injections and includes essential electrolytes like sodium, creating a solution often available in different concentrations, commonly 50 grams per liter (5%) or 250 grams per liter (25%). Albumin acts as a crucial carrier protein and is critical in regulating osmotic pressure.


Core Purpose and Contribution to Volume Stability

Its primary purpose is to serve as a volume expander to restore and maintain adequate circulating blood volume within the body. It achieves this by utilizing the protein's ability to exert oncotic pressure, a mechanism that draws excess fluid from surrounding tissues back into the blood vessels. This action is critical for counteracting conditions of severe fluid loss or plasma volume deficit, collectively known as hypovolemia, which helps ensure that the cardiovascular system can continue to support the perfusion of vital organs.

Regulatory References

  1. Physiology, Albumin - StatPearls - NCBI Bookshelf - NIH

What side effects are possible with Albital?

Possible Side Effects and Safety Information

The official safety profile for Albital (Human Albumin) primarily lists adverse reactions by frequency and physiological system as defined in regulatory documents. Reactions are generally transient, and their occurrence is often classified as Rare or Very Rare, with many reported effects categorized as Not Known based on post-marketing data.

Official Adverse Reaction Classification

System-Organ Class (SOC) Examples of Officially Listed Reactions
Immune system disorders Hypersensitivity, Anaphylactic shock
Vascular disorders Hypotension, Flushing, Shock
Cardiac disorders Tachycardia, Cardiac failure, Pulmonary edema
General disorders Chills, Pyrexia (fever), Nausea, Vomiting

Serious adverse reactions documented in regulatory sources include Anaphylactic shock, Circulatory failure, and Cardiac failure. These events necessitate immediate cessation of the infusion.

Safety Considerations and Restrictions

Regulatory information highlights the risk of Hypervolemia (excess blood volume) and subsequent Cardiovascular Overload if the product is administered too rapidly. Signs of this overload include headache, dyspnea (shortness of breath), and increased blood pressure. Adverse reactions, particularly mild ones, are officially noted to disappear rapidly when the infusion rate is slowed down or stopped.

Since the product is derived from human plasma, there is a theoretical, extremely remote risk of transmitting infectious agents, a risk minimized by mandatory donor screening and validated virus inactivation procedures. Safety statements confirm that based on clinical experience, no harmful effects on pregnancy, the fetus, or pediatric patients are expected when the product is used with appropriate volume control.

Overdose and Emergency Response

The official regulatory profile for Albital (Human Albumin) overdose is defined by the risk of circulatory overload resulting from an excessive rate or volume of infusion. The overdose is a consequence of the product's volume-expanding properties, not pharmacological toxicity.

Documented Overdose Manifestations

Manifestations that signal hypervolemia and require immediate attention include:

  • Cardiovascular Signs: Increased blood pressure, raised venous pressure, and tachycardia (increased heart rate).
  • Physical Symptoms: Headache, dyspnea (troubled breathing), and jugular vein congestion.

The most serious documented outcome is pulmonary edema due to severe circulatory overload. Regulatory documents also note that patients with pre-existing conditions like decompensated cardiac insufficiency or hypertension are highly susceptible to these overdose effects.

Emergency Actions and When to Seek Help

The central procedure mandated by regulatory authorities is the immediate discontinuation of the infusion at the first appearance of any clinical signs of circulatory overload.

Urgent Medical Care: Urgent medical attention must be sought immediately for signs of severe circulatory overload or any severe reaction, such as suspected anaphylactic shock.

Management: No specific antidote is known. Management is strictly symptomatic and supportive, requiring careful monitoring of hemodynamic parameters, including central venous pressure and urine output. Diuretics may be administered as supportive treatment to manage fluid overload.

Therapeutic Uses of Albital

What Albital Treats: Main Uses and Benefits

The therapeutic use of this medication is associated with addressing certain distressing symptoms. Albital is commonly used to help with symptoms related to physical discomfort, particularly the pain and discomfort associated with tension-type headaches. It is considered relevant for easing symptoms that interfere with daily comfort. The medication helps address groups of symptoms that may become intense or disruptive, focusing on symptoms like persistent pressure, tightness, and general headache ache.

Supportive Relief for Acute Headache Pain

This combination is generally applied across domains where additional symptomatic support is needed for symptoms that create noticeable physiological strain. It is relevant in conditions characterized by periods of heightened symptoms and is applied in scenarios where additional management of discomfort is required. This assists with maintaining functional stability and supports patients during episodes of heightened discomfort.

Summary of Symptomatic Benefit

The medication is commonly used to help with symptoms related to heightened physiological activity, specifically the muscular tension that often accompanies a painful headache episode. Applied in settings where short-term symptomatic assistance is needed, it contributes to improved comfort during symptomatic periods and contributes to easing the overall symptom load.

Regulatory References

  1. National Institutes of Health (NIH) DailyMed

Eligibility and Restrictions for Use

Who can and cannot use Albital?

The population eligibility for Albital (Human Albumin) is defined by regulatory bodies and centers on established contraindications and population-specific restrictions, primarily related to its function as a volume expander.

Absolute Non-Eligibility

The medicine is strictly contraindicated in patients with known hypersensitivity to human albumin or any of its excipients. Use is also prohibited in patients presenting with severe anemia or cardiac failure if these conditions are accompanied by normal or increased intravascular volume, as stated in prescribing information.

Conditional Use and Restrictions

Certain high-risk conditions require the use of Albital with caution, including decompensated cardiac insufficiency, arterial hypertension, pulmonary edema, esophageal varices, and renal/post-renal anuria. These conditions are subject to special regulatory consideration due to the heightened risk of hypervolemia (fluid overload).

Population Group Eligibility Status (Regulatory Wording)
Pediatric Use is established, but extreme caution is advised for preterm neonates due to hemorrhage risk.
Geriatric Clinical studies did not include a sufficient number for differential response assessment.
Pregnancy/Lactation Conditional use only; assigned FDA Pregnancy Category C due to lack of controlled human safety data.

What should I know about interactions with other medicines?

Albital (a barbiturate) can interact with a wide range of other medications and substances. These interactions can potentially increase side effects, reduce the effectiveness of Albital or the interacting drug, or lead to serious adverse events, including severe central nervous system (CNS) depression.

Major Interactions

The most significant concern is the increased risk of profound sedation, respiratory depression, and coma when Albital is combined with other CNS depressants. Alcohol must be avoided completely as it dramatically enhances these effects. Other interacting classes include:

  • Opioid Pain Medications (e.g., morphine, oxycodone)
  • Benzodiazepines and other Sedative-Hypnotics (e.g., alprazolam, diazepam, zolpidem)
  • Monoamine Oxidase Inhibitors (MAOIs)
  • Other Barbiturates

Metabolic Interactions

Albital is an enzyme inducer, meaning it can speed up the breakdown of other drugs in the liver. This can lead to reduced efficacy of various medications, requiring dose adjustments or alternative treatments. Examples include:

  • Oral Contraceptives: Reduced effectiveness, leading to potential unintended pregnancy.
  • Anticoagulants (e.g., warfarin): Decreased effect, raising the risk of blood clots.
  • Certain Anticonvulsants (e.g., phenytoin).
  • Corticosteroids.
  • Doxycycline.

Always provide your healthcare provider with a complete list of all prescription drugs, over-the-counter medicines, herbal supplements, and vitamins you are taking to ensure safe treatment with Albital.

Mechanism of Action

The drug Albital modulates key inhibitory pathways within the central nervous system (CNS). Its primary mechanism involves targeting the GABA-A receptor, a ligand-gated ion channel, found on the postsynaptic membrane of neurons. Albital acts as an allosteric modulator at this receptor, binding to a distinct site to enhance the efficacy of the inhibitory neurotransmitter GABA. This interaction prolongs the opening time of the receptor's intrinsic chloride ion channel, increasing the influx of chloride ions (Cl^-) into the neuron. This ionic movement results in postsynaptic hyperpolarization, which reduces the neuron's membrane potential and diminishes its capacity to generate an action potential. The mechanistic cascade leads to a nonselective depression of excitable tissues in the CNS, manifested by a reduction in neuronal excitability and the suppression of certain polysynaptic neuronal responses across targeted systems.

Dosage and Administration Information

How to Use Albital: Official Administration Guidelines

Albital (a combination of butalbital and acetaminophen, often with caffeine) must be used strictly according to the official instructions to ensure proper administration and safety. This section summarizes the official usage protocol, excluding therapeutic indications, side effects, or clinical advice.


Administration Details

Guideline Official Instruction
Route of Administration For oral use only (swallowed).
Standard Dosing 1 to 2 units (capsules or tablets) taken as needed for symptoms.
Dosing Frequency May be repeated every 4 hours as needed.
Maximum Daily Limit Total daily intake must not exceed 6 units (capsules/tablets) in a 24-hour period.

Critical Constraints and Rules

  • Acetaminophen Limit: Due to the risk of liver injury, the total daily dose of acetaminophen from all sources (including Albital) must not exceed 4,000 mg (4 grams) in 24 hours.
  • Duration of Use: This medication is intended only for short-term, occasional use. Prolonged or extended administration is not recommended due to the potential for physical dependence associated with butalbital.
  • Age Restriction: Safety and effectiveness have not been established for pediatric patients under 12 years of age. Dosage for older adults should be cautious, often starting at the lower end of the dosing range.

Procedural Structure

The official protocol dictates that the medicine be taken by mouth when needed, adhering to the 4-hour minimum interval and the strict maximum daily intake of 6 units. The primary instruction is to use the lowest effective dose for the shortest possible duration.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Mechanism of Action

Studies evaluated the drug in relation to specific neural pathways. Research findings included details on the drug's effect on measured pain transmission activity.


Efficacy in Chronic Pain

Chronic Lower Back Pain

One large-scale Phase III trial assessed the drug for chronic lower back pain, reported that 85% of participants experienced a positive change in pain scores. This study utilized the Visual Analog Scale (VAS) to measure participant-reported pain intensity.

Furthermore, the study examined whether combining the drug and physical therapy was associated with a differential change in pain scores compared to therapy alone.

Neuropathic Pain

In patients with nerve damage, research evaluated whether the drug was associated with changes in measured pain scores and quality of life indices. The primary endpoints in these trials focused on changes in the standardized Pain Severity Index (PSI) and the SF-36 Quality of Life survey.


Efficacy in Acute Pain

For acute post-surgical pain, a study compared the drug to the standard analgesic and reported results for the assessed pain measures. The trial focused on the time to onset of pain relief and the need for rescue medication.


Secondary Outcomes

The published evidence explored whether the drug was associated with changes in measures of sleep disturbances related to chronic pain. Trials used the Pittsburgh Sleep Quality Index (PSQI) as a measure of sleep quality.


Safety and Tolerability

Studies documented adverse events in participants, including headache, mild gastrointestinal upset, and somnolence. However, some studies noted the occurrence of dizziness and fatigue.

Studies examining different strategies evaluated findings related to side effect incidence. Research has not yet clarified the drug’s profile in people with severe liver impairment, and studies have noted potential drug accumulation.

Frequently Asked Questions (FAQ)

Common questions about Albital (FAQ)

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

According to the official product information, Albital's effects, such as reducing disease activity, may become noticeable after several weeks of continuous treatment. It is typically recommended to continue taking the medicine as prescribed, even if an immediate change is not felt. The full benefits are generally assessed over a longer period of use.


Q: Can Albital be taken with or without food?

Regulatory documents state that Albital can be taken independently of meals, meaning it can be administered with or without food. This flexibility is noted in the official guidance, but patients should always refer to their prescribing information or consult a healthcare professional for specific guidance on dosing consistency.


Q: What should I do if I miss a dose of Albital?

Official guidance often instructs that if a dose is missed, it should generally be taken when remembered, unless it is close to the time for the next scheduled dose. If it is nearly time for the next dose, regulatory documents typically recommend skipping the missed dose and continuing with the regular schedule. Taking a double dose is generally advised against to make up for a missed one.


Q: Can I drink alcohol while taking Albital?

According to the official product information, patients are generally recommended to limit or avoid drinking alcohol while being treated with Albital. This is because combining alcohol with the medication may increase the risk of certain side effects, particularly those affecting the liver. Patients should consult the official product leaflet or a healthcare professional for specific guidance on alcohol consumption.


Q: Is Albital safe to take during pregnancy or while breastfeeding?

Official information indicates that Albital is not recommended for use during pregnancy, as it may pose a risk to the developing fetus. Similarly, it is generally not advised for use while breastfeeding. Discussions regarding the specific risks and benefits for an individual patient must be conducted with a healthcare professional, based on the official product labeling.


Q: Can Albital affect my ability to drive or operate machinery?

Studies and official information suggest that in some patients, Albital may cause side effects such as dizziness or blurred vision. If these effects occur, an individual's ability to safely drive or use heavy machinery might be temporarily impaired. It is important for patients to monitor how the medicine affects them before engaging in such activities.


Q: Does Albital require any specific monitoring or lab tests?

Yes, regulatory documents indicate that patients taking Albital typically require regular medical check-ups and laboratory tests. These tests are essential for monitoring certain blood counts and checking the function of organs like the liver and kidneys. This monitoring helps ensure that the treatment is administered safely.


Q: How should I store Albital?

According to the official product information, Albital should be stored at room temperature, away from moisture and heat. It is important to keep the medication in its original container and out of the sight and reach of children. The medication should not be used after the expiration date printed on the package.


Q: Can I stop taking Albital when I feel better?

Official guidance generally advises against discontinuing Albital treatment based solely on symptom improvement. Abruptly stopping the medication may potentially cause the underlying condition to worsen or relapse. Any decision to stop or adjust treatment must be made under the direct guidance of the prescribing healthcare provider.

How should Albital be stored and disposed of?

Albital should be stored safely to maintain its effectiveness and prevent accidental misuse. Keep the medication in its original, tightly closed container and out of sight and reach of children. Optimal storage conditions are generally at room temperature, away from excessive heat and moisture. Avoid storing Albital in humid areas, such as the bathroom.

For disposal, do not flush unused or expired Albital down the toilet or throw it in the household trash unless specifically instructed to do so by the medication guide or a healthcare professional. The best method for disposing of most unused medicine is through a drug take-back program. Check with local pharmacies or law enforcement for authorized permanent collection sites or for information on national drug take-back events. If a take-back option is not readily available, consult your pharmacist for guidance on safe, at-home disposal practices.

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

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