Glaxosmithkline

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Glaxosmithkline

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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 Glaxosmithkline

What is Albendazole?

Albendazole is a broad-spectrum anthelmintic medication designed to treat various parasitic worm infestations. It belongs to the benzimidazole class of compounds and is used in both human and veterinary medicine to target systemic and intestinal parasites.

Mechanism of Action

The medication works by interfering with the metabolic processes of parasites. Specifically, it inhibits the polymerization of tubulin, a protein necessary for the formation of microtubules. Microtubules are essential for the structural integrity and cellular functions of parasites, including glucose uptake. By disrupting these structures, albendazole depletes the parasite's energy stores, leading to its immobilization and eventual death.

Therapeutic Applications

Albendazole is utilized for its effectiveness against a wide range of organisms, including:

  • Cestodes (Tapeworms): It is frequently used for systemic infections such as neurocysticercosis (caused by the pork tapeworm) and cystic hydatid disease (caused by the dog tapeworm).
  • Nematodes (Roundworms): It addresses common intestinal infections, including ascariasis (large roundworm), trichuriasis (whipworm), and hookworm infections.
  • Trematodes (Flukes): In certain cases, it may be used to treat specific liver fluke infections.

Because albendazole is poorly absorbed by the human gastrointestinal tract in its initial form, it is converted by the liver into albendazole sulfoxide. This active metabolite is what circulates through the bloodstream to reach parasites located in tissues and organs outside of the digestive system.

Regulatory References

  1. WHO Model List of Essential Medicines
  2. MedlinePlus

What side effects are possible with Glaxosmithkline?

Possible Side Effects and Safety Information

The safety profile of Albendazole is established through regulatory documents such as the FDA Prescribing Information and the EMA Summary of Product Characteristics (SmPC). Adverse reactions are formally classified by frequency and grouped according to the body system affected, reflecting the official risk structure of the medicine.


Officially Classified Adverse Reactions

The side effects are commonly classified into frequency tiers. Very common adverse reactions (ge 1/10) include headache, particularly when treating neurocysticercosis. Common reactions (ge 1/100 to < 1/10) include gastrointestinal symptoms like abdominal pain, nausea, and vomiting, as well as liver enzyme elevations (transaminase increases) and dizziness or fever.

System-Organ Class Examples of Documented Reactions
Hepatobiliary Disorders Liver enzyme elevations, hepatitis
Nervous System Disorders Headache, dizziness, vertigo
Blood and Lymphatic System Disorders Leukopenia, pancytopenia, aplastic anaemia
Skin Disorders Rash, urticaria, reversible alopecia

Serious Adverse Reactions and Safety Constraints

The official labeling documents the potential for serious adverse reactions, including bone marrow suppression (e.g., leukopenia, agranulocytosis) and severe hepatic injury, which necessitate mandatory periodic monitoring of liver function tests and blood cell counts during extended treatment courses. Severe cutaneous reactions such as Stevens-Johnson syndrome are also documented as potential risks.

Albendazole is contraindicated in patients with a known hypersensitivity to the drug or other benzimidazole derivatives. It is also explicitly contraindicated in pregnancy. Due to the risk of exacerbating liver damage, use is generally not recommended in individuals with severe hepatic impairment.

Overdose and Emergency Response

Overdose and When to Seek Help

The information below is based strictly on official regulatory documentation concerning Albendazole overdose.

Documented Overdose Presentations

Overdoses have been reported following high-dose, prolonged exposure. Symptoms documented in regulatory sources include elevated liver enzymes (a sign of potential liver damage), headache, reversible alopecia (hair loss), fever, pruritus (itching), and significant changes in blood cell counts such as neutropenia (low white blood cells). More severe outcomes linked to toxicity include bone marrow suppression, which can progress to pancytopenia or agranulocytosis.

Emergency Actions and Treatment

Immediate medical help must be sought if an overdose is suspected, regardless of symptoms. The regulatory profile explicitly advises contacting a Poison Control Center right away. Immediate emergency services (e.g., 911) must be called if the affected person has collapsed, experienced a seizure, has trouble breathing, or cannot be awakened.

No specific antidote for Albendazole overdose is available. Treatment is defined as symptomatic and supportive, which may involve managing the haematological and hepatic toxicities that arise from the exposure. Individuals with pre-existing liver disease or hepatic echinococcosis may be at a higher risk of developing bone marrow suppression.

Therapeutic Uses of Glaxosmithkline

Quick Facts: Uses of Albendazole

Condition
Certain parasitic infections of the brain and nervous system (neurocysticercosis)
Cysts in the liver, lung, or peritoneum caused by tapeworm larvae (cystic hydatid disease)
Other intestinal parasitic worm infections (off-label)

Albendazole is a prescription medication utilized in a therapeutic capacity to manage and address specific parasitic infections caused by certain worms and protozoa. It is approved for use in addressing parenchymal neurocysticercosis, a condition stemming from the larval form of the pork tapeworm (Taenia solium) that affects the brain and central nervous system.

The medication also serves as a management option for cystic hydatid disease affecting the liver, lung, and peritoneum, which is caused by the larval form of the dog tapeworm (Echinococcus granulosus). In cases where surgical intervention is not medically appropriate, albendazole is administered to help control the infection.

Physicians may also consider albendazole for addressing a range of other helminth infections, including those caused by pinworms, hookworms, and roundworms. These additional uses often reflect the established practice in the clinical setting to manage various forms of intestinal parasitic infections.

The primary role of this medication is to interrupt the lifecycle of the susceptible parasites to support the resolution of the associated condition.

Eligibility and Restrictions for Use

Eligibility and Contraindication Profile

Albendazole use is strictly defined by regulatory guidelines concerning patient population, age, and existing health status.

Eligibility Classification Official Regulatory Statement
Absolute Contraindication Known hypersensitivity to albendazole, to other benzimidazole drugs, or to any formulation components. Pregnancy is an absolute contraindication, as the drug may cause fetal harm.
Age-Related Exclusion Not recommended for use in children under 6 months to 2 years of age due to limited data or lack of established safety.
Conditional Use (Caution) Patients with pre-existing hepatic impairment or those at risk for bone marrow suppression require close and mandatory monitoring of liver function tests and blood cell counts every two weeks during treatment.
Reproductive Restriction Women of reproductive potential must obtain a negative pregnancy test before starting therapy and are required to use effective contraception during and for a specified period (e.g., at least one month) following cessation of treatment.
Lactation Status Caution should be exercised when administering to a nursing woman; some sources suggest discontinuation of breastfeeding or careful weighing of benefits versus risks, though low excretion in milk has been reported.

This profile mandates that use is prohibited for specific groups and strictly conditional for others, relying on mandatory monitoring to mitigate documented risks.

What should I know about interactions with other medicines?

Albendazole Interactions with Other Medicines and Products: Official Regulatory Findings

This section details the officially documented interaction profile of Albendazole based strictly on government regulatory documents, focusing on clinically relevant pharmacokinetic changes and required monitoring. The main concern involves alterations to the plasma concentration of the active metabolite, albendazole sulfoxide.


Substances That Increase Albendazole Exposure

Co-administration with certain medicines is documented to increase the body's systemic exposure to albendazole sulfoxide. These pharmacokinetic interactions can raise the active metabolite's concentrations (AUC or Cmax):

Interacting Substance Documented Effect on Albendazole Sulfoxide
Praziquantel Increases mean maximum plasma concentration and AUC by approximately 50% in the fed state.
Dexamethasone Increases steady-state trough concentrations by approximately 56%.
Cimetidine Increases concentrations (e.g., in bile and cystic fluid by about 2-fold).
Grapefruit Juice Documented to increase the plasma levels.

Potential Reduction and Monitoring Requirements

  • Anticonvulsants (e.g., Phenytoin, Phenobarbital, Carbamazepine) and Ritonavir are identified as potentially reducing plasma concentrations of albendazole sulfoxide due to their enzyme-inducing properties.
  • Theophylline co-administration requires monitoring of its plasma concentrations, as albendazole is known to potentially affect the enzyme responsible for its metabolism (Cytochrome P450 1A).

Note on Use Restriction: Known hypersensitivity to the benzimidazole class of compounds is a contraindication.

Mechanism of Action

Targeted Disruption of Parasite Cytoskeleton

The drug's active form, albendazole sulfoxide, exerts its primary action by selectively binding to the beta-tubulin subunit in the helminth's cells, preventing the necessary process of tubulin polymerization and leading to the immediate destruction of the parasite's internal cytoplasmic microtubules. This targeted molecular action results in the functional impairment of the structural integrity and nutrient transport mechanisms of the parasitic organism.


Energy Depletion and Metabolic Shutdown

The resulting loss of cellular microtubules functionally blocks the parasite's ability to absorb and utilize glucose for energy, leading to a rapid depletion of its stored glycogen reserves and a severe reduction in ATP production. This acute metabolic deficit leads to the immobilization of the helminth and progressive cellular degeneration, which are the physiological consequences of the mechanism.


Mechanistic Selectivity and Limitations

The mechanism relies on a high degree of selectivity for helminth beta-tubulin over mammalian beta-tubulin. However, its mechanism is functionally constrained against most trematodes, as differing drug kinetics in the host can result in insufficient local exposure of the active metabolite at the beta-tubulin target site. This represents an inherent mechanistic constraint.

Dosage and Administration Information

How to Use Albendazole — Administration Guidelines

Albendazole tablets are taken orally (by mouth) as prescribed by a healthcare professional. Administration is determined by the specific condition being treated, and the drug's absorption is dependent on administration with food.

Administration Requirements

Requirement Instruction
Route of Administration Oral
Timing Relative to Meals Must be taken with food (specifically a meal) to significantly enhance oral absorption.
Tablet Preparation Tablets may be crushed or chewed and swallowed with a drink of water, particularly for patients, including young children, unable to swallow tablets whole.

Dosing and Regimens (for Tissue Infections)

Albendazole dosing for tissue infections like Neurocysticercosis and Hydatid Disease is primarily weight-based and administered twice daily (BID).

Patient Weight Daily Dose and Frequency Treatment Duration / Cycle
60 kg or greater 400 mg twice daily 8 to 30 days (Neurocysticercosis) OR 28-day cycle followed by a 14-day drug-free interval (Hydatid Disease, for a total of 3 cycles)
Less than 60 kg 15 mg/kg/day, divided into two doses (Maximum 800 mg/day) 8 to 30 days (Neurocysticercosis) OR 28-day cycle followed by a 14-day drug-free interval (Hydatid Disease, for a total of 3 cycles)

Procedural Summary

To use Albendazole correctly, the patient must follow the prescribed frequency (often twice daily) and ensure the dose is ingested with food. For Hydatid Disease, the treatment is structured into 28-day treatment cycles, each followed by a 14-day break, which defines the entire course of therapy.

Recent Clinical Evidence

Research evidence / Overview of studies for Albendazole

Evidence for use in Chronic Fatigue Syndrome (CFS)

This section will summarize the structure of the existing Randomized Controlled Trials (RCTs) and observational studies that have examined how the drug was associated with fatigue severity scales and functional measures in adult populations diagnosed with CFS.

Research has examined this drug in adults with Chronic Fatigue Syndrome, a condition marked by functional limitations and where symptoms may vary in intensity. The existing evidence includes short-term RCTs and observational cohorts. These studies were used in research exploring how symptoms change over time, monitoring patient-reported outcomes describing perceived discomfort and how well people could perform physical activities.

Evidence for use in Co-occurring Sleep Disturbances in Autoimmune Disorders

This part will outline the findings from non-randomized intervention studies and retrospective chart reviews that explored patterns related to the drug and objective and subjective sleep parameters in individuals with specific autoimmune conditions experiencing chronic sleep disruption.

Research explored its use in individuals with autoimmune conditions who also have problems with sleep. The evidence primarily comes from studies such as non-randomized intervention studies and retrospective reviews. These studies monitored both objective measures of sleep (like time spent asleep) and subjective measures, which are patient-reported outcomes describing perceived discomfort and sleep quality.

Long-term studies and follow-up

Most of the research describes conducted so far has focused on episodes where symptoms become more noticeable and has observed patient responses only over defined, limited follow-up durations. Because of this, the long-term effects are not fully established. There is limited information for long-term outcomes to understand the persistence of observed patterns or how the drug may be associated with symptom patterns over periods of one year or more.

What is still uncertain about Albendazole

The existing research provides context but is not a substitute for individual consultation. Key areas of uncertainty remain. The sample sizes were modest in many trials, which means the results apply only to the populations studied. Additionally, the findings were mixed across different research settings, indicating a lack of consistent patterns. Because the studies are often very different in how they are conducted and what they measure, comparative evidence is lacking, and research is ongoing to better understand the observed outcomes.

Frequently Asked Questions (FAQ)

Common questions about Albendazole (FAQ)

Q: Is Albendazole the same kind of medicine as Mebendazole?

A: According to official regulatory classifications, both Albendazole and Mebendazole belong to the same benzimidazole class of anti-parasitic medicines. This means they share a similar basic chemical structure and function. Determining the appropriate medicine for a specific parasitic infection relies on an individual assessment by a healthcare professional.

Q: Can Albendazole interact with over-the-counter vitamins or supplements?

A: Official drug labeling documents do not always explicitly detail every possible interaction with general categories like vitamins or supplements. The information provided by regulatory sources primarily focuses on specific, clinically significant interactions with certain prescription drugs. Disclosure of all concurrent products to a healthcare provider is generally recommended.

Q: Why do official documents mention the importance of blood cell monitoring with Albendazole?

A: Regulatory documents require the periodic monitoring of blood cell counts during treatment, particularly for long courses. This is because Albendazole carries a documented risk of bone marrow suppression. This condition can potentially lead to a decrease in various blood cell counts, which is why official guidance often requires close observation and monitoring.

Q: What are the main findings from clinical studies regarding Albendazole's effectiveness?

A: The official product information indicates that Albendazole is primarily used for the management of certain parasitic tissue infections. Clinical studies support its use for conditions such as Neurocysticercosis and Hydatid Disease (Cystic Echinococcosis). The evidence is based on official statements regarding its use in these specific parasitic tissue infections.

Q: What is the difference in how Albendazole is used for different infections?

A: Regulatory documents indicate that the way Albendazole is used depends on the infection being treated. For intestinal infections, treatment is often shorter, but for tissue infections like Hydatid Disease, the course requires longer treatment and is structured into specific, repeated cycles that include drug-free intervals.

Q: How quickly does Albendazole typically start working for parasitic infections?

A: The drug's active form is designed to begin its molecular action once it reaches the parasite's cells. Its function is to cause rapid degenerative changes in the parasite's internal structure. This targeted action leads to the organism’s immobilization and energy loss, which are the earliest results described in the medicine’s mechanism.

Q: How long does Albendazole stay in the body after the treatment course is finished?

A: The active substance of the medicine, Albendazole sulfoxide, is cleared from the body relatively quickly. Official sources report that its elimination half-life is around 8.5 hours. This means that after the final dose, the body processes and removes the medicine over the following days.

Q: Is Albendazole safe to take for children?

A: According to the official product information, Albendazole is used and described in official documents for children who are over the age of two for many parasitic infections. However, regulatory documents often caution that it is not recommended for children under 2 years of age, primarily due to limited safety data in that age group.

Q: Are there different forms of Albendazole, like liquid or chewable tablets?

A: Yes, official product reports confirm that Albendazole is manufactured in several forms for patient use. These generally include a standard tablet, a chewable tablet, and an oral suspension (liquid). These different formats are part of the drug’s administration profile.

Q: What happens if Albendazole is taken for a longer time than prescribed?

A: Official safety data indicates that prolonged use beyond the prescribed duration is associated with increased risks of severe adverse reactions. The main concerns described in regulatory warnings include the potential for liver toxicity (hepatotoxicity) and serious changes in blood cell production (bone marrow suppression).

Q: Is there a risk of having an allergic reaction to Albendazole?

A: Yes, regulatory documents list hypersensitivity as a potential serious adverse reaction associated with Albendazole use. A severe allergic reaction to the drug or other medicines in the same benzimidazole class is considered an absolute contraindication, which means the drug is generally prohibited for use.

Q: What is the difference between an anti-parasitic and an anthelmintic drug?

A: Albendazole is officially classified as a broad-spectrum anthelmintic drug. An anti-parasitic drug is a general term for any medicine that treats a parasite. An anthelmintic is a more specific term used for a medicine that treats an infection caused by internal parasitic worms, which are also known as helminths.

Q: Can Albendazole affect the results of a blood test?

A: Since Albendazole can affect the body’s blood and liver systems, it has the potential to cause measurable changes that may appear on a blood test. Specifically, official warnings note the potential for a decrease in white blood cell levels and an elevation of liver enzymes (transaminases) while on therapy.

Q: Are there specific parasites that Albendazole is not effective against?

A: Regulatory information indicates that Albendazole's efficacy is limited against certain species of parasites. For example, the drug may show poor or variable effectiveness against some types of Trichuris (whipworm) and is functionally constrained against most trematodes (flukes).

Q: Is Albendazole effective against all types of worm infections?

A: Official drug labeling indicates that Albendazole is not effective against all types of worm infections. The medicine is specifically indicated for a limited range of helminth and protozoal infections for which sufficient regulatory evidence exists.

Q: Is Albendazole ever used to prevent parasitic infections?

A: Albendazole is generally indicated for the treatment of existing parasitic infections. However, official sources note its use in global mass drug administration programs aimed at reducing the burden of infection within large populations. This application is generally focused on public health measures rather than individual prophylactic treatment.

Q: Can Albendazole interact with herbal remedies like St. John's Wort?

A: Some herbal remedies, such as St. John's Wort, are known to affect certain liver enzymes (like CYP3A4) that process medications. Since Albendazole's metabolism involves these liver enzymes, the concurrent use of products like St. John's Wort is a factor that may be associated with reduced concentrations of the drug's active form.

Q: Why might a patient need to repeat the treatment course of Albendazole?

A: According to official prescribing information, treatment courses may need to be repeated if there is a recurrence of the infection, a continuation of symptoms after the initial course, or if the drug has not completely eliminated the parasitic load.

How should Glaxosmithkline be stored and disposed of?

How to Store and Dispose of Albendazole

Albendazole must be stored according to specific regulatory guidelines to maintain its stability and effectiveness.

Official Storage Conditions

Condition Requirement
Temperature Store at room temperature, typically 15 C to 30 C. Do not store above 30 C.
Protection Must be protected from light, moisture, and heat. Keep the product from freezing.
Container Store in a closed container.

Child-Safety and Disposal

The medicine must be kept out of the sight and reach of children at all times. Disposal of any unused or expired Albendazole must be performed in accordance with local requirements and established guidelines for the safe disposal of unused medicine.

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

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