Kreval

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Kreval

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 Kreval

Property Description
Active Ingredient Butamirate citrate
Form Syrup, Oral Drops, Tablets
Pharmacological Class Antitussive (Cough Suppressant)
Common Use Symptomatic relief of cough
Origin Synthetic (Non-opioid)

Defining the Non-Opioid Antitussive

Kreval is a medicinal preparation whose sole active component is Butamirate, typically formulated as Butamirate citrate, which functions to suppress the cough reflex. It is universally classified as an antitussive agent, meaning its primary role is to provide symptomatic relief from coughing.

Butamirate is a synthetic, small-molecule drug that is chemically distinct from narcotic compounds. Unlike traditional cough suppressants that rely on opioid derivatives, such as codeine, Butamirate is recognized as a non-opioid, non-narcotic agent. Its classification as a centrally acting, non-opioid antitussive is clinically recognized for its low potential for abuse or dependence. This unique profile sets Butamirate apart, making it a distinct choice for patients needing effective cough suppression without the constraints associated with codeine-based alternatives.


Forms and General Therapeutic Purpose

Butamirate is prepared as a single-ingredient product available for oral administration in multiple dosage forms, providing flexibility for different patient needs. The medicine is frequently available as a liquid, specifically as syrup or oral drops, and also as solid forms, including standard and sustained-release tablets.

The core general therapeutic purpose of Kreval is to calm and effectively suppress the unproductive, dry cough cycle. Its action involves a dual function, exhibiting both antitussive and modest bronchodilatory effects. This means the drug provides the benefit of calming the cough reflex while also potentially helping to relax and slightly widen the airways, a feature often highlighted in its pharmacological recognition.

Regulatory References

  1. (NIH Drug Summary)

What side effects are possible with Kreval?

Possible Side Effects and Safety Information

The official regulatory safety profile for Kreval (Butamirate citrate) outlines adverse reactions categorized primarily by frequency and the body system affected, according to established government labeling standards.

Frequency-Classified Adverse Reactions

The documented adverse reactions are classified in official regulatory documents as Rare (occurring in fewer than 1 in 1,000 patients). These reactions include Drowsiness, Dizziness, Nausea, Diarrhea, and Urticaria (itchy skin rash). Hypersensitivity reactions are also documented but are classified as Frequency Not Known (cannot be estimated from available data).

System-Organ Class Rare Adverse Reactions
Nervous System Disorders Drowsiness, Dizziness
Gastrointestinal Disorders Nausea, Diarrhea
Skin and Subcutaneous Tissue Disorders Urticaria (itchy skin rash)

Safety Restrictions and Special Populations

Official labeling mandates specific safety constraints. Concomitant use with expectorants must be avoided as the cough-suppressing action can lead to the dangerous stagnation of mucus in the respiratory tract. Furthermore, due to the risk of drowsiness and dizziness, caution is required when performing tasks related to mental alertness, such as driving or operating machinery.

Specific population-based restrictions are documented by regulatory agencies. The medicine is restricted for use during the first trimester of pregnancy and is officially not recommended during breastfeeding. Use in children under 3 years of age is also generally restricted. The documented adverse effects are generally considered reversible, meaning they disappear after dosage reduction or discontinuation of the medicine.

Overdose and Emergency Response

Overdose and When to Seek Help

The information regarding Butamirate citrate (Kreval) overdose is derived strictly from official government regulatory documents, focusing on documented manifestations and mandated emergency actions.


Documented Overdose Manifestations

Official labeling indicates that an overdose may present with a cluster of signs primarily affecting the central nervous and gastrointestinal systems. These documented manifestations include drowsiness (somnolence), dizziness, nausea, vomiting, and diarrhea. A significant physiological manifestation documented is hypotension (low blood pressure).


Required Emergency Actions and Management

In the event of suspected overdose, official regulatory statements mandate that the patient must seek immediate medical advice or consult a doctor. Emergency services or a poison center should be contacted right away. This urgency is required because no specific antidote is known for Butamirate citrate overdose, making prompt medical assessment essential.

Management of Butamirate overdose is strictly symptomatic and supportive. Procedural steps officially documented in regulatory information include the use of gastric lavage or administration of activated charcoal and saline laxatives. The patient requires appropriate monitoring as part of the supportive treatment protocol outlined in the official prescribing information.

Therapeutic Uses of Kreval

What Kreval Treats: Main Uses and Benefits

Kreval (Butamirate citrate) is a therapeutic agent primarily applied for the symptomatic management of cough. Its primary role supports relief in contexts where the cough reflex creates noticeable physiological strain. The active ingredient, Butamirate citrate, is commonly used for the symptomatic treatment of non-productive (dry) cough.

This medicine is generally applied across conditions presenting with acute episodes and symptoms related to inflammatory or irritative states. It is relevant for easing challenging manifestations, including the dry, hacking cough, the tickly, irritative cough, and the cough that causes sleep disturbance or functional strain. The clinical use generally covers acute respiratory episodes and situations requiring short-term symptomatic assistance. It offers symptomatic relief that may assist with managing difficult episodes and contributes to easing the overall symptom load.

Quick Fact: Relief for Irritative Cough Kreval is commonly used when symptoms cluster into patterns requiring supportive management, helping to calm persistent coughs that create functional strain.

Regulatory References

  1. Ethiopian Food and Drug Administration (EFDA) document

Eligibility and Restrictions for Use

Official Eligibility and Non-Eligibility for Kreval

Kreval (Butamirate citrate) eligibility is strictly defined by regulatory authorities based on age, physiological status, and concurrent conditions.


Populations Who Must Not Use Kreval (Contraindicated)

Classification Restriction Summary
Hypersensitivity Individuals with a known allergy to butamirate citrate or any formulation component.
Pediatric Age Children under 3 years of age are contraindicated for the syrup formulation (minimum age varies by dose form and region).
Therapeutic Conflict Patients concurrently using expectorants must avoid Kreval due to the risk of mucus retention and bronchial obstruction.
Metabolic Risk Contraindicated for patients with rare hereditary fructose intolerance if the specific formulation contains fructose or sorbitol.

Restrictions and Conditional Use

Classification Restriction Summary
Pregnancy Not recommended during the first trimester. May be used with caution in the second and third trimesters only if necessary.
Lactation Not recommended for use while breastfeeding due to insufficient data on excretion into milk.
Cough Type Use is limited to the symptomatic treatment of a non-productive (dry) cough.

What should I know about interactions with other medicines?

Contraindicated and Restricted Combinations

Kreval (Butamirate citrate) has documented interaction patterns that establish constraints on co-administration with specific medicinal products. These restrictions are classified based on the mechanism and potential outcome described in official regulatory documents.

Co-administration with expectorants or other mucus-clearing agents must be avoided. This is a pharmacodynamic contraindication because the cough-suppressing action of Kreval can lead to the stagnation of mucus in the respiratory tract. Stagnant mucus increases the formal risk of serious complications, including bronchospasm and airways infection.


Exposure-Modifying and Pharmacokinetic Constraints

A pharmacokinetic restriction exists involving certain enzyme-modifying agents. The use of Kreval should not be combined with strong enzyme inhibitors, as this carries a formal risk of increased plasma exposure of Butamirate citrate itself. This classification is based on the potential for reduced clearance of the active substance.

Furthermore, official regulatory documents state that medicinal products with a narrow therapeutic index should not be used together with Kreval. This constraint is based on the possible risk of altered exposure of the co-administered narrow-index agent.

A specific non-medicinal substance restriction also requires individuals to limit the intake of alcoholic beverages while using the medication.

Mechanism of Action

Butamirate citrate acts via a dual mechanism involving central nervous system pathway modulation and peripheral smooth muscle influence.

Modulating the Central Cough Center

Butamirate or its active components function as a central inhibitor, binding specifically to the non-opioid receptor site within the medulla oblongata's cough center. This interaction modulates the neural excitability of the entire reflex arc, resulting in the physiological consequence of elevating the cough threshold against incoming stimuli.

Complementary Peripheral Airway Relaxation

In addition to its central effect, the molecule influences the respiratory system through a modest relaxation of the bronchial smooth muscle. This peripheral action results in a reduction in airway resistance, a consequence that functions to complement the central neural modulation of the cough reflex.

Dosage and Administration Information

Butamirate citrate, marketed as Kreval, is strictly administered via the oral route across all approved dosage forms, which include syrup, oral drops, and sustained-release (SR) tablets. The usage pattern is defined by specific, high-level dosing schedules tailored to age group and formulation, which are intended only for the symptomatic period of the cough.


Standard Labeled Dosing Regimens

Population Dosage Form Frequency and Dose
Adults Syrup (7.5 mg/5mL) 15 mL (22.5 mg) taken up to 4 times daily.
Sustained-Release Tablet (50 mg) 50 mg tablet taken 2 to 3 times daily.
Adolescents (>12 years) Syrup (7.5 mg/5mL) 15 mL (22.5 mg) taken 3 times daily.
Children (6–12 years) Syrup (7.5 mg/5mL) 10 mL (15 mg) taken 3 times daily.
Children (4–6 years) Syrup (7.5 mg/5mL) 5 mL (7.5 mg) taken 3 times daily.

Administration Specifics and Duration

The medicine may be taken with or without food, offering flexibility in its daily schedule. When administering the liquid forms, an accurate measuring device must be used to ensure the prescribed volume is delivered. It is a mandatory administration instruction that sustained-release tablets must be swallowed whole to preserve the controlled release of the medication and must not be crushed or chewed.

Treatment should not be continued indefinitely; medical advice is required if the cough persists for longer than 4–5 days in adults or 3 days in children. A key restriction in administration is the caution against concomitant use with expectorants, as this antitussive action may lead to the accumulation of mucus.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Kreval

Research Evidence for Symptomatic Relief of Dry Cough

Butamirate citrate was studied in research that measured patient-reported outcomes for people experiencing a non-productive, or dry, cough. These studies often took the form of short-term Randomized Controlled Trials (RCTs) and comparative studies, with observation periods of about five to seven days in adults and children. Research monitored outcomes related to physical discomfort, including changes in cough severity and frequency, using patient-reported scales and physician assessments.

Studies report on the measured outcomes describing episodic or acute changes in the observed populations. Some trials explored outcomes related to cough-related sleep disturbance and differences measured between study groups. Findings were mixed, however, when evaluating measurements against other tested compounds or inactive treatments across the various studies. Research provides insight into short-term changes, but the overall evidence remains limited and heterogeneous.


Studies on Cough Associated with Acute Respiratory Infections

Butamirate citrate was observed in clinical trials and post-marketing surveillance analyses in the context of acute respiratory tract infections, such as tracheitis and bronchitis. These studies typically explored short-term symptom changes, monitoring outcomes describing episodic or acute changes and outcomes linked to inflammatory or irritative states over defined time intervals, usually up to 14 days.

Because cough associated with acute infections is often a self-limiting condition, the ability to isolate specific measured patterns remains challenging due to factors such as the high spontaneous resolution rate. Limited information for long-term outcomes exists, and the current body of evidence includes trials accumulated over several decades, meaning that robust, modern RCT data is limited.


Evidence in Specific Patient Populations

Butamirate citrate was evaluated in studies across different patient age groups, including both adults and children. The sample sizes were modest, and data for certain groups remain insufficient. Research conducted in patients with cough due to underlying chronic conditions, such as carcinomas, is limited, primarily using extremely small cohorts derived from subgroup analyses. The findings describe group patterns observed in this small data set, and the data are limited to the populations studied, resulting in low certainty.

Key Studies & References

  1. Butamirate Citrate Efficacy in Cough Suppression: A Comparative Analysis of Randomized Controlled Trials
  2. 4-way crossover Butamirate Citrate PK & Dose study, healthy volunteers (IRAS ID: 26907)

Frequently Asked Questions (FAQ)

Common questions about Kreval (FAQ)

Q: How quickly does Kreval usually start to have an effect?

A: Official studies indicate that the antitussive effect of Kreval may begin relatively quickly, often reported within 5 to 10 minutes after taking the syrup formulation. The primary substance reaches its highest level in the bloodstream after about 1.5 hours.

Q: Is it true that Kreval can make you feel sleepy?

A: Yes, official safety documents list drowsiness as a documented adverse reaction to Kreval. This effect is generally classified as rare, meaning it may affect fewer than 1 in 1,000 patients. Because of this potential effect, official labeling describes the requirement for caution when performing tasks related to mental alertness.

Q: What should I do if I experience a mild headache after starting Kreval?

A: While regulatory lists include common adverse reactions such as dizziness and nausea, headache is not typically listed as one of the official, frequency-classified side effects. Regulatory information indicates that documented adverse effects are generally described as reversible after reduction or discontinuation of the medicine.

Q: What is the difference between Kreval and similar medicines for the same condition?

A: Kreval is categorized by regulatory bodies as a non-opioid and non-narcotic antitussive agent. This classification means that it is not chemically related to opioid compounds and is classified as having a low potential for abuse or dependence.

Q: What happens if I forget to take my Kreval dose?

A: Patient leaflets commonly describe that the medicine may be taken as soon as it is remembered, unless it is almost time for the next scheduled dose. Regulatory information strictly cautions against taking a double dose to make up for the one that was missed.

Q: Is Kreval safe for use by older adults (seniors)?

A: The official dosing tables provide a standard regimen for Adults, without a specific contraindication based solely on advanced age. However, official documents note that caution is required due to the potential for accumulation if co-existing conditions, such as impaired liver or kidney function, are present.

Q: Is Kreval the kind of medicine that you have to taper off of?

A: As a non-opioid, non-narcotic agent, Kreval is associated with a low risk of dependence. Regulatory documents do not contain explicit instructions for tapering off the drug. Treatment is intended to be short-term for the symptomatic period of the cough, and it should not be continued indefinitely.

Q: What are the most common reasons people stop taking Kreval?

A: Official safety information indicates that documented side effects such as drowsiness, dizziness, nausea, and diarrhea are generally reversible. Official documents state that these side effects are generally reversible, meaning they resolve after the dosage is reduced or the medicine is discontinued.

Q: How long does the effect of one dose of Kreval typically last?

A: According to official pharmacokinetic data, the apparent elimination half-life of the active substance in the body is approximately 6 hours.

Q: What official body approved Kreval for use?

A: Kreval is an internationally available medicine, and the specific regulatory body responsible for its approval varies by country. This approval comes from national drug authorities, such as the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) in relevant territories, or other national agencies.

Q: Is Kreval known to interact with herbal supplements like St. John's Wort?

A: Official drug interaction warnings advise against the co-administration of Kreval with strong enzyme inhibitors. Regulatory warnings concerning enzyme inhibitors relate to any product that may affect drug metabolism, as this can increase the drug's exposure in the body.

Q: Can I take Kreval if I have diabetes?

A: Official documents note that certain liquid formulations of Kreval may contain sorbitol (a type of sugar substitute). Official information requires individuals with known sugar intolerances to consult a medical professional regarding the suitability of the formulation.

Q: Why is Kreval not recommended for people with kidney disease?

A: Official regulatory documents indicate that data is lacking in patients with impaired renal (kidney) or hepatic (liver) function. Official documents describe a potential for increased risk of adverse effects due to the accumulation of the drug and its metabolites.

Q: What is the function or purpose of the 'inactive ingredients' in Kreval?

A: The inactive ingredients, or excipients, are listed in regulatory documents as necessary components of the final product. Their purpose is generally to provide the medicine's structure, volume, flavor, and color, or to help stabilize the active substance. They do not have a therapeutic effect on the cough itself.

Q: Does Kreval lose effectiveness over time?

A: Official labeling advises that antitussive treatments should not be used for prolonged periods. This restriction is based on the nature of the cough being treated and the risk of mucus retention, not a loss of the drug's effectiveness. Official labeling states that a medical consultation is required if the cough continues beyond the stated duration.

Q: What kind of medical professional is usually the one to prescribe Kreval?

A: Kreval is classified as a prescription-only medicine in many countries. As such, it requires the authorization of a licensed medical professional, which may include a physician or, in certain markets, a specialized prescribing pharmacist.

Q: What is the half-life of Kreval?

A: According to the official pharmacokinetic properties section in regulatory documents, the apparent elimination half-life of the active substance is approximately 6 hours.

Q: Can men and women expect different effects from Kreval?

A: Clinical trials and regulatory data do not suggest or document any significant differences in the expected effect, safety, or recommended dosage based on the biological sex of the patient. Dosing is typically determined by age and, sometimes, body weight.

Q: What are the signs of a severe allergic reaction to Kreval?

A: While Hypersensitivity reactions are documented, patient information leaflets describe that immediate medical attention is necessary if signs of a severe allergic response occur. These may include a severe rash, sudden itching, swelling (especially of the face, throat, or tongue), or difficulty breathing.

Q: What does the patient information leaflet say about overdose?

A: Regulatory documents list symptoms of an overdose, which may include drowsiness, nausea, vomiting, diarrhea, dizziness, and unusually low blood pressure. Official guidance states that immediate medical attention is necessary for monitoring and supportive care.

How should Kreval be stored and disposed of?

How to Store and Dispose of Kreval (Butamirate Citrate)

The storage and disposal of Kreval must strictly follow the conditions defined in the official regulatory labeling to maintain product stability and safety.


Storage Requirements

Kreval must be stored at a temperature not exceeding 30 C and protected from both light and moisture. To maintain its integrity, the medicine must be kept in its original container with the closure tightly closed. As a mandatory safety precaution, Kreval must always be stored out of the sight and reach of children.


Disposal Instructions

Unused or expired Kreval must be disposed of according to local regulatory requirements for pharmaceutical waste. The product must not be discarded via household garbage or flushed into wastewater to prevent environmental contamination.

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

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