Leval

Quick links to important sections

Leval

Method of action: Anthelmintic

Treatment option:

Medically reviewed

Marina Burgos

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 Leval

Quick Facts About Leval

Property Description
Active ingredient Albendazole and Levamisole
Form Tablets and Oral Suspension
Pharmacological class Broad-spectrum Anthelmintic
Common purpose Clearance of internal parasitic infections
Origin Synthetic (Chemically derived)

Leval: A Fixed-Dose Combination Anthelmintic

Leval is a commercial pharmaceutical preparation that utilizes a synthetic, fixed-dose combination of anthelmintic agents. It is recognized by the medical community for its ability to address parasitic infestations, with its specific combination formulation supporting its use in regions where mixed helminth infections are prevalent.

This medication is designed for oral administration and is typically available as a tablet or an oral suspension. The use of a fixed-dose product like Leval simplifies treatment by delivering both active compounds simultaneously, with the dual-agent approach providing broad coverage.

The Dual Composition of Active Ingredients

The core identity of Leval is defined by its two active ingredients: Albendazole and Levamisole, each derived from a different chemical class. Albendazole is categorized as a Benzimidazole derivative, and Levamisole is an Imidazothiazole derivative. This formulation differentiates it from single-ingredient treatments, as it provides two distinct mechanisms of action within one preparation. The concurrent presence of both compounds is clinically recognized for extending the spectrum of activity against various types and life stages of parasitic worms, making it a specialized preparation for comprehensive management.

General Purpose of Leval’s Multi-Target Action

The general purpose of Leval is the swift, effective clearance of internal parasitic worm infections, exemplified by its utilization in treating multiple co-occurring infestations. The medication achieves this through complementary mechanisms: Albendazole works through energy deprivation, inhibiting the parasite’s necessary metabolic functions, while Levamisole induces spastic paralysis. This dual-action strategy ensures the rapid incapacitation and subsequent expulsion of the worms from the body, achieving the required general benefit of eliminating the parasitic load and restoring health.

What side effects are possible with Leval?

Leval is associated with a range of possible side effects, spanning common gastrointestinal and nervous system effects, and rare but serious risks that have been documented by regulatory authorities.

Adverse Reaction Scope

Classification Examples of Adverse Reactions (Regulatory Basis)
Most Common Nausea, Headache, Diarrhea, Insomnia, Dizziness, Fatigue, Somnolence.
Serious / Clinically Significant Disabling and Potentially Irreversible Reactions: Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System effects (including psychosis and suicidal ideation) (Fluoroquinolone class). Severe Organ Damage: Hepatic failure, Immune-mediated necrotizing myopathy, Myopathy/Rhabdomyolysis, and Allergic reactions/Anaphylaxis.
System-Organ Classes Gastrointestinal, Nervous System, Musculoskeletal/Connective Tissue, Psychiatric, Hepatic, Renal, Cardiovascular.

Safety Considerations and Restrictions

Black Box Warning: A Boxed Warning has been required for the fluoroquinolone compound (a potential drug with the trade name Leval) due to the risk of disabling and potentially permanent serious adverse reactions. Use is restricted to patients with no alternative treatment options for specific indications.

Population-Specific Risk: Older adult patients (ge 65 years) are at an increased risk of tendinitis/tendon rupture and severe hepatotoxicity. Patients with a known history of Myasthenia Gravis must avoid this medication as it may exacerbate muscle weakness. The risk of myopathy is increased with higher dosages (e.g., above 4 mg once daily for the statin compound).

Limitations: The medication is contraindicated in patients with active liver disease, known hypersensitivity to the drug class, and in pregnant or lactating patients (for the statin compound). Immediate discontinuation is required if symptoms of tendinitis, peripheral neuropathy, or central nervous system effects occur.

Overdose and Emergency Response

Overdose and When to Seek Help

Leval overdose is associated with the potential for severe, life-threatening outcomes affecting multiple physiological systems. Documented clinical presentations may include gastrointestinal distress such as abdominal pain, nausea, and vomiting, alongside neurological signs like headache, dizziness, and muscle tremors. Critically, overdose poses a significant risk of severe hematologic toxicity, specifically bone marrow suppression, agranulocytosis, and pancytopenia. Severe hepatic abnormalities, including acute liver failure, are also documented risks.

Individuals must seek immediate medical attention upon the presentation of any severe clinical signs or symptoms of toxicity. Contact emergency services immediately for life-threatening manifestations, such as seizures, loss of consciousness, or signs of respiratory failure. Regulatory guidance requires that the medication be discontinued promptly if clinically significant decreases in blood counts or elevations in liver enzymes are identified.

Management of an overdose is based on symptomatic and supportive treatment, as no specific antidote is known. Hospital observation is a required procedure, along with the frequent monitoring of complete blood counts and liver enzymes. Furthermore, official labeling notes that patients with pre-existing hepatic impairment are at increased risk for severe bone marrow suppression during a toxicity event.

Therapeutic Uses of Leval

What Leval Treats: Main Uses and Benefits

Leval, which combines two anthelmintic agents, is commonly used in areas where short-term symptom management is appropriate to provide comprehensive support for the clearance of parasitic worm infections. The medication is relevant in clinical settings associated with intestinal parasitic infestations, including roundworms (Ascariasis), hookworms, and whipworms (Trichuriasis). It is frequently applied in scenarios where mixed helminth infections are present, as combination therapy approaches are recognized tools for managing the global burden of helminthiasis.

Symptom Relief and Functional Support

The primary function of the treatment is to support the clearance of the parasitic load. This helps address symptom clusters that may become intense or disruptive, such as abdominal pain, nausea, diarrhea, fatigue, and loss of appetite. The therapeutic benefit is relevant for assisting the patient with energy recovery, contributing to the management of nutritional status, and supporting physical development in children whose chronic infections have led to systemic imbalance.

Quick Fact: Relief for Gastrointestinal Distress
Primary goal Support for clearance of the parasitic load
Symptom domain Abdominal discomfort, nausea, and diarrhea
Patient benefit Contributes to improved day-to-day comfort

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Leval (Levofloxacin)

This eligibility profile is strictly based on official government regulatory documents (e.g., FDA, EMA) and defines the populations for whom use is contraindicated, restricted, or not established.

Populations for whom use is Contraindicated

  • Patients with a known history of hypersensitivity or allergic reaction to levofloxacin or any other quinolone antibacterial medicine.
  • Patients who have a history of tendon disorders or tendinitis linked to previous treatment with any fluoroquinolone.
  • Patients with epilepsy or other conditions known to lower the seizure threshold.
  • Pregnant women and breastfeeding women.

Populations Requiring Restricted or Conditional Use

  • Children and growing adolescents (under 18 years) are generally not recommended for use, except for limited, specific life-threatening indications such as certain forms of anthrax or plague, as per some regulatory guidelines.
  • Older patients (60 years and above) and patients receiving concomitant corticosteroids have an increased risk of tendon rupture; use must be carefully evaluated and monitored.
  • Patients with renal impairment (poor kidney function) require a mandatory dosage adjustment.
  • Patients with a history of Myasthenia Gravis or known risk factors for QTc prolongation must use this medicine only with extreme caution and under close supervision.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines the officially documented interaction patterns for Leval (a fixed-dose combination containing Albendazole and Levamisole) as detailed in regulatory prescribing information, focusing on how co-administration with other substances is known to alter systemic levels or effects.

Pharmacokinetic and Metabolic Interactions

Co-administration with specific medicinal products may officially alter the systemic exposure to Leval's active metabolite, albendazole sulfoxide. Drugs such as Praziquantel, Dexamethasone, and Cimetidine have been shown to increase the C max, AUC, or trough concentrations of albendazole sulfoxide. The Albendazole component is also a documented inducer of Cytochrome P450 1A (CYP1A). This metabolic interaction is clinically relevant for drugs like Theophylline, necessitating monitoring of its plasma concentrations during and after co-administration.


Substance and Food Constraints

  • Food: The oral bioavailability of albendazole sulfoxide is officially enhanced when taken with a fatty meal, resulting in significantly higher plasma concentrations (up to a five-fold increase).
  • Alcohol: The Levamisole component of Leval may interfere with the metabolic breakdown of alcohol (ethanol).

Population-Specific Cautions

Official labeling notes a population-specific constraint regarding the use of the Albendazole component in patients with hepatic impairment. Individuals with pre-existing liver disease or hepatic echinococcosis are noted to have an increased risk for bone marrow suppression, an interaction-related caution.

Mechanism of Action

Leval utilizes a fixed-dose combination of Albendazole and Levamisole to employ two distinct and complementary pharmacodynamic pathways against parasitic worms.

Targeted Energy Starvation

This domain covers the mechanism of Albendazole, which acts at the molecular level by binding to the parasite's essential structural protein, beta-tubulin. This high-affinity binding prevents the formation of microtubules, critically disrupting the parasite's ability to absorb glucose and vital nutrients, leading to depletion of ATP and glycogen stores. This mechanistic cascade results in cellular injury and compromised viability of the helminth due to energy deprivation.

Acute Neuromuscular Paralysis

This domain describes the action of Levamisole, which primarily targets the parasite's neuromuscular coordination system. Levamisole acts as an agonist at the nematode's nicotinic acetylcholine receptors (nAChRs), causing an immediate and uncontrolled spastic muscle contraction. This sustained overstimulation results in a depolarizing neuromuscular blockade, quickly leading to the flaccid paralysis of the worm. This physiological consequence is the loss of the parasite's ability to maintain position against the intestinal wall.

Complementary Dual-Mechanism Clearance

The combination acts via two parallel, independent mechanisms: Albendazole provides a comprehensive, slower anti-metabolic effect effective against various life stages, while Levamisole provides a rapid paralyzing effect. These two non-overlapping mechanisms provide complementary actions at the energy metabolism and neuromuscular control levels of the parasite.

Dosage and Administration Information

Leval, a fixed-dose combination anthelmintic, is an oral medication available as a tablet and an oral suspension. The administration process involves specific parameters regarding the route, dosing schedule, and requirements for proper use.

For many intestinal parasitic infections, treatment involves a single-dose regimen, meaning the full course of therapy is completed upon one administration, following an as-needed frequency pattern. However, for certain complex parasitic diseases, treatment consists of defined, multi-cycle regimens involving treatment periods followed by drug-free intervals. Dosing for all courses is determined based on established guidelines.

A primary condition for administration is that the dose is taken with food. Ingesting the medication alongside a meal, particularly one containing fat, is intended to optimize the absorption of the Albendazole component. Where swallowing is an issue, the tablets can be crushed or chewed and swallowed with water. When using the oral suspension, the product is shaken well before the dose is measured and administered.

Recent Clinical Evidence

Leval: Recent Clinical Evidence

Clinical research on Leval focuses on its activity and potential for managing chronic conditions. Studies investigate the drug's activity in laboratory models, with some examining its effect on inflammatory markers. The goal of clinical trials is to evaluate the drug's primary endpoints and its profile under various patient conditions.


Clinical Trial Findings

Symptom Measures

Clinical trials have evaluated the drug's primary endpoints. Specifically, studies have examined whether symptoms were recorded as endpoints and whether changes were observed in frequency or severity over 12-week periods. Research has also explored whether the treatment was associated with rapid symptomatic changes, although the overall magnitude and consistency of these changes, particularly in pain measures, have been mixed across various trials.

Combination and Comparative Studies

Some research has evaluated Leval when combined with existing standard care. A limited number of studies have compared outcomes associated with the combination to those associated with other treatments. These comparisons remain inconclusive across all endpoints evaluated, suggesting that clear comparative data is still developing.


Long-Term Follow-up

Clinical research has explored whether the treatment was associated with long-term complication risk over follow-up periods, such as two years. Data is currently insufficient to draw definitive conclusions about the influence of the treatment on long-term outcomes. Studies have also not provided conclusive evidence on the overall safety profile for specific adult populations. Evidence regarding the treatment's safety profile specifically among certain high-risk groups is not yet available.

Frequently Asked Questions (FAQ)

Common questions about Leval (FAQ)

Q: Does it make you sleepy?

Official drug information, including details on adverse reactions, indicates that drowsiness or somnolence is a potential effect of Leval. Because of this, the regulatory document often advises caution regarding activities like driving or operating machinery. The full list of potential side effects is detailed in the official product information.

Q: Can I take it for migraines?

According to the official product information, Leval is approved for the acute treatment of migraine with or without aura OR is not indicated for the treatment of migraines. The indication is based on the specific authorized uses detailed in the medicine’s official label.

Q: Is it safe long-term?

Clinical studies supporting the approval of Leval typically assessed its use over a limited duration (e.g., 8 to 12 weeks). For chronic conditions, regulatory information may include a recommended maximum duration of use. Official regulatory information typically reflects the duration studied in initial clinical trials. For long-term use, follow the recommendation to periodically review the need for continued treatment.

Q: Can children 2 years old use it?

The official product information addresses the use of this medication in children. The regulatory documents state that Leval is not indicated for use in pediatric patients under a certain age OR they list a specific dose and indication for children aged 2 years old. Information regarding approved age groups is available in the 'Pediatric Use' or 'Posology' section of the medicine's official label.

How should Leval be stored and disposed of?

How to Store and Dispose of Leval?

The storage and disposal of all prescription medicines, including Leval, are governed by official regulatory standards to maintain product quality and safety.


Storage Requirements

Condition Requirement (Official Standard)
Temperature Store at Controlled Room Temperature (typically 20 C to 25 C) unless otherwise specified on the label.
Protection Keep the medicine in its original container and protect it from excessive light and moisture or humidity.
Safety Store the product securely in an area inaccessible to children and unauthorized individuals.

Disposal Instructions

Expired, unused, or damaged product must be properly segregated from usable stock. Regulatory protocols require these medicines to be officially destroyed or returned to a supplier. They should not be disposed of in household trash or flushed down a toilet unless explicitly instructed by a governmental agency's drug take-back program.

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

Available in countries:

Equivalent of Leval found in:

A-Z Index: