Levotuss

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Levotuss

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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 Levotuss

What is Levotuss? (Overview and Quick Facts)

Property Description
Active ingredient Levodropropizine (INN)
Form Syrup, Oral Solution
Pharmacological class Antitussive Agent (Cough Suppressant)
Common use Symptomatic relief of dry, non-productive cough
Origin Synthetic Compound

Defining Levotuss: Pharmacological Identity and Composition

Levotuss is a recognized brand for the pharmaceutical preparation that contains Levodropropizine as its single active substance. Levodropropizine is formally classified as an antitussive agent—a type of medication used to quell the cough impulse. This unique active ingredient is a synthetic compound, specifically the S-enantiomer of dropropizine, which defines its focused pharmacological properties.

Designed for oral administration, the medication is primarily available in liquid oral dosage forms, such as a syrup or an oral solution. These presentations are often formulated in an aqueous solution base to facilitate consistent ingestion.

What Type of Cough Medicine is Levodropropizine?

Levodropropizine is characterized as a non-opioid and non-narcotic antitussive, a key feature that distinguishes it from centrally acting cough suppressants, which carry different pharmacological profiles. Its mechanism of action is limited to a peripheral site, meaning its primary effect is localized to the sensory nerve fibers in the respiratory passages, rather than acting on the central nervous system (CNS).

The active ingredient is clinically recognized for its efficacy in suppressing the cough reflex. This indicates the medicine helps to diminish the frequency and intensity of the cough impulse. This activity makes the preparation a standard choice for the symptomatic relief of a persistent non-productive cough, also known as dry cough.

What side effects are possible with Levotuss?

Adverse Effects and Safety Information

Levotuss (Levodropropizine) is generally well-tolerated, with most reported adverse reactions being non-severe and resolving upon therapy discontinuation. The most frequently documented effects involve the gastrointestinal and nervous systems.

System-Organ Class Common/Uncommon Effects (approx. 1–5%)
Gastrointestinal Nausea, vomiting, diarrhea, heartburn, abdominal pain.
Nervous System Drowsiness (somnolence), dizziness, headache.

Very Rare and Serious Adverse Reactions

Very rare adverse events (occurring in less than 1 in 10,000 patients or of unknown frequency) include serious reactions such as allergic/anaphylactoid reactions (e.g., urticaria, angioedema, shock), tonic-clonic convulsions, syncope (fainting), cardiac arrhythmia (e.g., atrial bigeminy), and cholestatic hepatitis. A fatal case of epidermolysis (a severe skin condition) has also been reported in post-marketing surveillance. These severe symptoms warrant immediate medical attention.

Safety Restrictions and Warnings

The medicine is contraindicated in cases of hypersensitivity to the drug, during pregnancy and breastfeeding, and in patients with conditions involving excessive mucus production (bronchorrhea) or reduced mucociliary function (e.g., Kartagener's syndrome). Caution is advised for elderly patients and those with severe renal impairment (creatinine clearance <35 ml/min). Due to the risk of somnolence, patients should be cautious when driving or operating machinery.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory information for levodropropizine defines the overdose profile based on documented clinical signs and mandated emergency procedures. The instruction to seek medical help is tied directly to the presence of evident clinical signs following an overdose.

Documented Manifestations and Monitoring

Manifestations reported in regulatory labeling include temporary transitional tachycardia (rapid heart rate). Gastrointestinal effects, such as abdominal pain and vomiting, are also noted from isolated cases, though no significant undesirable effects were observed in studies of single doses up to 240 mg. During supportive care, special attention is required for monitoring the patient's cardiac, respiratory, renal, and hepatic functions, in addition to the fluid and electrolytic balance.

Required Emergency Actions

When evident clinical signs are present, the regulatory instruction is to immediately set up a symptomatic therapy and implement usual emergency measures. Management focuses on symptomatic and supportive therapies and measures, as no specific information is available on the treatment of overdosage, meaning no specific antidote is listed in the official label. Officially described procedures that may be adopted include gastric lavage, administration of active coal (activated charcoal), and use of parenteral liquid (IV fluids).

Therapeutic Uses of Levotuss

What Levotuss Treats: Main Uses and Benefits


Symptomatic Relief of Dry, Non-Productive Cough

The medication is applied for the symptomatic relief of non-productive cough (dry cough). This therapeutic approach is relevant in managing symptoms linked to common respiratory conditions, including acute bronchitis, chronic bronchitis, and Upper Respiratory Tract Infections (URTIs). Levodropropizine is applied in clinical settings that involve acute or disruptive symptom patterns associated with inflammatory states. The medication helps to ease the distressing, persistent, and often tickly cough, supporting the patient during difficult episodes.


Functional Benefit: Improving Sleep and Reducing Symptom Intensity

The medication is applied in addressing the frequency and intensity of coughing fits, which contributes to improved comfort during periods of heightened symptoms. By easing the cough, the medication may assist with reducing nocturnal awakenings and other functional strain, offering symptomatic relief that may help patients cope more steadily. The medication is commonly used across multiple age groups, including adults, adolescents, and children (typically over two years of age).

“The aim of symptomatic management is to ease the experience of frequent, irritating coughing episodes.”


Quick Fact: Therapeutic Focus
Symptom Category: Symptomatic management of persistent, non-productive (dry) cough.
Main Benefit: Supports general well-being during symptomatic phases by helping to ease nocturnal coughing.

Regulatory References

  1. ClinicalTrials.gov Study NCT03837938

Eligibility and Restrictions for Use

Eligibility for Levotuss (Levodropropizine)

The eligibility criteria for using Levotuss are strictly defined by regulatory documents, focusing on age, physical state, and pre-existing medical conditions.

Who is Allowed to Use It?

Use is generally established for adults and adolescents. The regulatory minimum age is two years, making the medicine approved for children over this threshold. The formulation is typically gluten-free, allowing use for patients with Celiac Disease.


Absolute Contraindications

Levotuss must not be used by patients who have a known hypersensitivity to the active substance or any excipients. It is absolutely contraindicated for all children under two years of age and for women who are pregnant or breastfeeding/lactating.

Contraindications also include specific respiratory and organ function issues:

  • Severe Hepatic Impairment (liver failure).
  • Conditions involving reduced mucociliary function (e.g., ciliary dyskinesia) or excessive bronchial secretion.

Restricted Use and Caution

Special caution is advised for elderly patients and individuals with severe renal impairment (creatinine clearance below 35 ml/min). Patients with diabetes mellitus must consider the sucrose content in the syrup formulation.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents define the interaction profile of Levotuss (Levodropropizine) primarily through pharmacodynamic effects and specific administration constraints.


Pharmacodynamic Interactions

Interacting Substance Category Official Regulatory Description
Sedative Drugs & Alcohol Co-administration may result in the potentiation of adverse effects, such as drowsiness and dizziness, as these substances and Levotuss can have additive CNS depressant effects. Caution is required, particularly for sensitive individuals.
Common Respiratory Treatments No established interaction has been demonstrated in clinical studies with medications frequently used for bronchopulmonary diseases, including β2-agonists, corticosteroids, methylxanthines, antibiotics, and mucoregulators.

Administration and Population Notes

Administration of the oral solution or syrup form is recommended to be taken away from meals due to a lack of data determining the influence of food on the drug's absorption. No specific medicinal product combination is formally classified as contraindicated based on interaction risk in the regulatory labels. Additionally, elderly patients should be treated with caution, as regulatory information notes the potential for changed pharmacokinetics related to age, which may alter the overall effect or interaction profile.

Mechanism of Action

Peripheral Sensory Nerve Signal Inhibition

Levodropropizine's primary action involves the targeted inhibition of the vagal afferent C-fibers—the sensory nerve endings in the airways responsible for detecting irritants. The molecule acts as a neuro-modulator, reducing the excitability and discharge rate of these peripheral fibers. This core mechanism reduces the frequency of afferent signals sent from the respiratory tract to the brain's cough center, resulting in an elevated physiological threshold for the reflex, consistent with the absence of CNS activity.


Modulation of Local Sensory Pathways

The drug's mechanism extends to modulating the local sensory neuropeptide system. Levodropropizine interferes with the calcium-dependent release of pro-tussive chemical mediators, notably Substance P, from the nerve endings. By dampening the impact of these mediators and engaging in ancillary antagonism at local H1-histaminic receptors, the drug's mechanism reduces signal output from peripheral sensory pathways, thereby contributing to a reduction in peripheral signaling pathway activity.

Dosage and Administration Information

Levotuss is intended for oral administration as a solution or syrup and requires the use of an approved dosing device for accurate volume measurement.

Standard Administration and Schedule

Patient Population Single Dose Maximum Frequency
Adults / Adolescents (12 years and older) 60 mg (10 ml of syrup) Up to three times daily
Children (2 years and older) Weight-dependent (1–2 mg/kg) Up to three times daily

Administration is constrained by a required minimum 6-hour interval between doses. To facilitate proper administration consistency, the medicine is generally directed to be taken away from meals.

Duration and Constraints

The treatment course is intended to be brief and is not to be used for indefinite periods. Clinical guidelines specify that the maximum duration of use must not exceed 7 days; administration should be discontinued immediately upon the resolution of the cough.

Population-Specific Use

Dosing for children over two years of age is determined by body weight, with the total daily dosage not exceeding 3 mg/kg. Standard guidance indicates that caution should be exercised when administering the medicine to older adults and to individuals with severe renal impairment (creatinine clearance < 35 ml/min).

Recent Clinical Evidence

Research Evidence / Overview of Studies

Phase III Clinical Data

The compound under investigation was the focus of several Phase III, double-blind, randomized clinical trials (RCTs). The research primarily focused on adults diagnosed with non-productive (dry) cough associated with acute or chronic bronchitis.

  • Trial A: Evaluation of Cough Frequency and Intensity Clinical trials evaluated the compound's potential to influence the frequency and severity of coughing, including nocturnal awakenings. Studies comparing the compound to placebo and other antitussive agents recorded a reduction in cough parameters in the treatment groups. Initial analysis recorded the difference in measured outcomes between the treatment group and the placebo group.

  • Trial B: Assessment in Extended Use and Safety Research also examined the compound's use in extended management, including the duration of potential effects on daily discomfort. These studies followed participants over a one-year period and evaluated the consistency of the findings over an extended period. Evidence remains limited on effects beyond 12 months.

Tolerability and Comparative Safety Profile

Central Nervous System Effects

Clinical data indicates that the compound works peripherally on the cough reflex. Studies comparing the compound to centrally-acting antitussives (like opioids) evaluated whether it affected respiratory responses to CO2 rebreathing tests in patients with chronic cough. Research recorded no significant influence on central respiratory output, unlike some other antitussive agents.

Reported Side Effects

Research has evaluated the compound's safety profile across multiple trials. The most commonly reported side effects included gastrointestinal distress, nausea, and headache. The study observed the duration and severity of these reported events.

Key Studies & References

  1. Efficacy of levodropropizine in the pediatric setting: a meta-analysis of published studies
  2. Levodropropizine: Comprehensive Review of the Peripheral Antitussive
  3. Phase III Study to Evaluate the Efficacy and Safety of HOB-048 CR Tab. in Comparison With HOB-048 Syrup in Patients With Cough Due to Acute or Chronic Bronchitis (NCT03489837)

Frequently Asked Questions (FAQ)

Common questions about Levotuss (FAQ)


Q: How long does the effect of Levotuss typically last?

Official administration instructions specify that there must be a minimum of six hours between each dose. This interval is set by regulatory documents to help ensure the medicine is used consistently and does not exceed the recommended maximum frequency.

Q: Does Levotuss make you drowsy or sleepy?

Yes, drowsiness (somnolence) and dizziness are noted as common side effects of this medicine. According to clinical studies, these effects were reported in approximately 4–5% of patients. Due to the potential for sleepiness, regulatory documents advise caution when performing activities like driving or operating machinery.

Q: Can I take Levotuss if I am taking over-the-counter pain relievers?

The official regulatory label does not list common, over-the-counter pain relievers as formal contraindications. Furthermore, no specific medicinal product combination is formally classified as prohibited based on interaction risk. Official guidance encourages patients to inform their healthcare provider of any other medicines being taken.

Q: Does Levotuss interact with common allergy medications?

Studies and official information indicate that there has been no established interaction demonstrated with antihistamines, which are frequently used as common allergy medications. This is also true for other treatments used for bronchopulmonary diseases, such as corticosteroids and antibiotics.

Q: Is it possible to develop a tolerance to Levotuss if used often?

Regulatory guidance emphasizes that this medicine is intended for short-term, symptomatic treatment only and is not meant for indefinite use. The medicine is regulated for short-term use only, and the label specifies the maximum duration should not exceed seven days. Tolerance development is not explicitly discussed in the labeling.

Q: What should I do if I notice a possible side effect while taking Levotuss?

Official patient information indicates that if a side effect persists or worsens, contacting a doctor or healthcare provider is advised. In the event of a very rare or serious adverse reaction, such as a severe allergic reaction, syncope (fainting), or cardiac arrhythmia, the regulatory documents note that immediate medical attention is required.

Q: What is the main difference between Levotuss and other common cough syrups?

Levotuss is characterized as a non-opioid and non-narcotic antitussive agent. The key distinction is that its mechanism of action is limited to a peripheral site in the airways, meaning it primarily affects the nerve fibers responsible for the cough reflex, rather than acting on the brain's central nervous system.

Q: Is Levotuss used for all types of coughs?

The medicine is indicated solely for the symptomatic relief of a non-productive (dry) cough. Official documents state that it should not be used by patients who have conditions involving excessive bronchial secretions, a condition also known as bronchorrhea. This confirms it is intended only for dry cough symptoms.

Q: Is it normal to feel a dry mouth after taking Levotuss?

Yes, dry mouth is listed as an adverse effect of this medicine. According to data from clinical trials, this effect occurred in less than 5% of patients.

Q: Can Levotuss be taken on an empty stomach?

Administration of the medicine is generally recommended to be taken away from meals (such as on an empty stomach). This instruction is provided in the regulatory information due to a lack of specific data determining the influence of food on the drug's absorption.

Q: Is Levotuss the same as Levotuss tablets or capsules?

According to official regulatory documents, the most common forms of this medicine are the liquid preparations, specifically the syrup and the oral solution. The official product information defines the active ingredient within these liquid dosage forms.

Q: What happens if I miss a time to use Levotuss?

Instructions for a missed dose generally advise against taking a double dose to make up for the one that was missed, as the minimum 6-hour interval must be respected.

Q: Can Levotuss cause an upset stomach or nausea?

Yes, the medicine is associated with common effects in the gastrointestinal system. These reported effects include nausea, vomiting, heartburn, and abdominal pain.

Q: Do studies show Levotuss is better for dry cough than wet cough?

The official indication for this medicine is strictly limited to the symptomatic relief of a non-productive (dry) cough. Furthermore, the medicine is contraindicated for use in conditions that involve excessive bronchial secretions, which indicates it is not appropriate for a wet, or productive, cough.

Q: How long after stopping Levotuss can I expect any side effects to clear up?

Official safety information indicates that most reported adverse effects are generally non-severe. These effects typically resolve upon discontinuation of the medicine.

Q: Does the time of day I use Levotuss matter for its effectiveness?

The key constraint on administration is the need to maintain a minimum interval of six hours between doses. The regulatory documents do not provide information indicating that the medicine is more or less effective depending on the time of day (e.g., morning versus night).

Q: Does Levotuss have any ingredients that are related to aspirin or NSAIDs?

The active ingredient, Levodropropizine, is formally classified as a synthetic antitussive agent. It is not chemically related to aspirin or to the class of drugs known as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).

Q: What are the most common reasons a doctor would prescribe or recommend Levotuss?

The primary reason a healthcare professional would recommend this medicine is aligned with its official therapeutic indication. That indication is the symptomatic relief of a persistent non-productive (dry) cough.

Q: Are there any clinical trials that specifically examined Levotuss in older adults?

Regulatory information notes that special caution should be exercised when the medicine is administered to older adults. This caution is based on the potential for altered pharmacokinetics (how the body processes the drug) due to age.

Q: Is Levotuss generally considered to have a low potential for misuse?

The medicine is characterized as a non-opioid and non-narcotic antitussive agent. This pharmacological classification distinguishes it from centrally-acting agents, such as some opioid-based cough suppressants, which are generally associated with a higher potential for misuse.

How should Levotuss be stored and disposed of?

How to Store and Dispose of Levotuss

Official regulatory documents define specific storage and disposal requirements for Levotuss (levodropropizine oral solution/syrup) to ensure product stability and environmental safety.

Storage Conditions and Stability

The medicine must be stored at a temperature not exceeding 30°C and must be protected from light. It is mandatory to keep the product in its original, tightly closed container and out of the sight and reach of children.

Once the bottle is opened, the in-use stability period is limited, and the product must be discarded after one month or six weeks, depending on the specific formulation.

Disposal Instructions

Unused or expired Levotuss must not be thrown away with household waste or disposed of via wastewater. Disposal must be carried out according to local, regional, and national regulations, typically by returning the unwanted medicine to a pharmacist for environmentally safe disposal.

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

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