Supremin

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Supremin

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 Supremin

Property Description
Active ingredient Butamirate (typically as Butamirate citrate)
Form Syrup, oral drops/solution, sustained-release tablet (oral forms)
Pharmacological class Antitussive agent (Non-opioid, non-narcotic)
Common use Symptomatic relief of dry, non-productive cough
Origin Synthetic compound

What Type of Medicine is Supremin?

Supremin is a pharmaceutical product primarily containing the active ingredient Butamirate, typically administered as Butamirate citrate, which is classified as an antitussive agent. This medicine's central function is to suppress the cough reflex, positioning it as a tool for managing specific types of coughing symptoms. Butamirate carries the Anatomical Therapeutic Chemical (ATC) code R05DB13.

The compound is a synthetic medicine and is pharmacologically defined as a non-opioid and non-narcotic substance. This classification differentiates it from narcotic antitussives, affirming its specific use profile. Supremin is consistently formulated as a single-ingredient product, focusing exclusively on cough suppression, and is intended strictly for oral administration.


Composition and Available Forms of Butamirate

Supremin's composition centers on the Butamirate citrate component, which is combined with non-active ingredients to create adaptable options for oral intake. The medication is prepared in a variety of oral forms, which commonly include a syrup, an oral solution, and oral drops, often featuring specific flavoring to enhance palatability for pediatric and other patient groups. For adults and specific uses, the medicine is also available as sustained-release tablets (SR tablets). This diverse availability ensures that the single active ingredient can be administered in the most appropriate format for the patient's age and desired duration of effect.


What is the General Purpose of Supremin?

The general purpose of Supremin is the symptomatic relief of cough through the modulation of the nervous system's response. The active ingredient operates as a centrally acting agent, targeting the brain's cough center to decrease the sensitivity of the reflex. This mechanism makes the medicine particularly beneficial for easing persistent, irritating episodes of a non-productive cough, often referred to as a dry cough. The substance also possesses an additional bronchospasmolytic activity, which helps to gently relax the airways, contributing to overall respiratory comfort while the primary cough reflex is suppressed.

What side effects are possible with Supremin?

Possible Side Effects and Safety Information

The safety profile of Supremin (Butamirate) is primarily defined by relatively low-incidence adverse reactions and specific contraindications related to patient population and existing medical conditions.

Adverse Reactions

The officially documented adverse reactions are categorized as uncommon (affecting up to 1 in 100 people) and primarily involve three system-organ classes:

  • Gastrointestinal Disorders: Nausea and diarrhea.
  • Nervous System Disorders: Dizziness/Vertigo.
  • Skin and Subcutaneous Tissue Disorders: Rash (exanthema).

These reactions are typically mild and may resolve upon dose reduction or discontinuation of the medicine. Allergic reactions, including skin rash, have also been reported and require consultation if persistent.

Contraindications and Safety Restrictions

Official regulatory information highlights several restrictions and cautions for use:

  • Hypersensitivity: The drug is contraindicated in patients with a known allergy to butamirate or any of the product's components.
  • Excipient Risk: Due to the presence of phenylalanine-containing components (such as aspartame), the product is contraindicated in patients with phenylketonuria.
  • Pregnancy and Breastfeeding: Use is generally not recommended during the first trimester of pregnancy and is restricted to the second and third trimesters only when the potential benefit is deemed to outweigh the possible risk. Use while breastfeeding requires professional consultation.
  • Pediatric Restriction: Not indicated for use in children under a specific age (typically 3 years old, depending on the formulation) or for extended periods in young children due to excipient safety concerns (e.g., benzyl alcohol).
  • Cough Suppression: Caution is advised against concomitant use with expectorants (mucus-loosening medicines) as this may lead to mucus accumulation in the airways.
  • Operating Machinery: Patients should be cautious about driving or operating machinery, as the medication may cause dizziness or drowsiness.

Overdose symptoms may include drowsiness, dizziness, nausea, vomiting, diarrhea, and hypotension (low blood pressure).

Overdose and Emergency Response

Overdose and When to Seek Help

The information in this section outlines the official overdose manifestations and required emergency actions for Butamirate (Supremin), as documented in government regulatory sources.

Overdose has been associated with a specific cluster of clinical manifestations:

  • Gastrointestinal: Nausea, vomiting, and diarrhea.
  • Central Nervous System: Somnolence (drowsiness) and dizziness.
  • Cardiovascular: Hypotension (low blood pressure), which may require the monitoring and treatment of vital signs.

Required Emergency Actions

If the recommended dosage has been exceeded, official regulatory instructions explicitly state the need to seek medical advice immediately or to consult a doctor or a poison center.

Overdose Management

No known specific antidote is listed in the official prescribing information for Butamirate overdose. Therefore, management is defined as supportive and symptomatic. Regulator-recommended procedural steps typically include gastric lavage, the administration of activated charcoal, and general supportive treatment to manage the manifestations.

Therapeutic Uses of Supremin

What Supremin Treats: Main Uses and Benefits

Supremin is commonly used for the symptomatic relief of a dry, irritating, non-productive cough—a symptom related to inflammatory or irritative states. The medication is relevant in contexts marked by increased discomfort or tension. The primary therapeutic domain is the symptomatic treatment of non-productive cough.

The medication is commonly used across conditions presenting with acute episodes and for managing groups of symptoms associated with common viral respiratory infections or persistent coughs that follow such illnesses. The therapeutic relevance focuses on managing symptoms of dry cough, symptoms linked to acute respiratory infections, and situations requiring supportive symptom management for procedures. It is considered relevant for easing symptoms that create noticeable physiological strain, especially when the cough becomes momentarily overwhelming or disrupts night-time sleep.

“The supportive nature of the medicine assists with maintaining functional stability when symptoms interfere with routine activities, which contributes to easing the overall symptom load during periods of heightened symptoms.”

The medication supports maintaining a sense of stability and contributes to easing the overall symptom load, particularly when applied in clinical settings that involve acute or unstable symptom patterns.

Quick Fact: Relief for Irritable Dry Cough

Regulatory References

  1. Ethiopian Food and Drug Authority SPC

Eligibility and Restrictions for Use

The official regulatory guidelines for Supremin (Butamirate citrate) define clear boundaries for who is eligible to use the medicine and who is strictly prohibited.

Eligibility Scope

Classification Official Regulatory Rule
Contraindicated Known hypersensitivity to Butamirate or excipients, first trimester of pregnancy, and in children under 3 years of age for most liquid formulations [Source 1.1, 1.3]. Contraindication also applies to patients with hereditary fructose intolerance if the product contains sorbitol [Source 1.2].
Age-Related Use is established for adults and adolescents over 12 years, and for children generally starting at 4 years of age [Source 1.1, 1.2]. Data regarding its use in the elderly population is not established [Source 1.3].
Restricted Use Use during the second and third trimesters of pregnancy is conditional, requiring caution and administration only if deemed absolutely necessary [Source 1.1, 1.2]. Use is not recommended while breastfeeding [Source 1.3].
Conditional Use Caution is advised for patients with impaired renal (kidney) or hepatic (liver) function, as specific regulatory data is lacking in these groups, increasing the risk of drug accumulation [Source 1.2, 2.4].
Prohibited Concomitant Use The medicine must not be used concurrently with expectorants (drugs that promote mucus clearance) to avoid the risk of mucus stagnation in the respiratory tract [Source 1.1, 1.2].

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory documents for Supremin (Butamirate citrate) detail specific substance combinations that are either restricted or formally prohibited due to documented interaction patterns. This section summarizes the official interaction profile, focusing on pharmacodynamic and pharmacokinetic constraints.

Prohibited Co-administration

The co-administration of expectorants and mucolytics is formally prohibited. This restriction is based on a pharmacodynamic interaction where the cough-suppressant action of Butamirate can inhibit the necessary clearance of mucus promoted by expectorants. This effect leads to the stagnation of secretions in the respiratory tract, increasing the risk of respiratory complications.

Pharmacokinetic Exposure Risks

Butamirate's interaction profile notes two primary constraints concerning systemic exposure:

  1. Strong Enzyme Inhibitors: Co-administration with substances classified as strong enzyme inhibitors should be avoided. This interaction carries a documented risk of increased systemic exposure and plasma concentration of Butamirate.
  2. Narrow Therapeutic Index Medicines: Co-administration with other medicines that possess a narrow therapeutic index should also be avoided. This is due to the potential risk of altered systemic exposure to the co-administered narrow therapeutic index drug.

Clearance and Accumulation Constraints

A further constraint detailed in official labeling relates to specific populations. Patients with hepatic or renal impairment may face a greater risk of adverse outcomes. This is due to the reduced ability of these organs to clear the drug and its metabolites, leading to a risk of drug and metabolite accumulation in the body.

Mechanism of Action

Targeting the Central Cough Center

The primary action of Butamirate citrate involves a direct inhibitory effect on the cough center located in the medulla oblongata, a region in the brainstem. The molecule engages specific central binding sites, which dampens the excitability of these neurons and raises the threshold required for the reflex to activate. This central suppression modulates the neural cascade coordinating the efferent tussigenic signal.


Dual Peripheral Bronchial Action

In addition to its central effect, the drug exerts a spasmolytic action on the smooth muscle lining the airways. This peripheral mechanism promotes the relaxation of bronchial tension, which influences airway resistance and leads to a widening of the airway lumen. This dual mechanism influences both central reflex activation and peripheral airway caliber.


Non-Opioid Mechanistic Specificity

The central inhibitory effect is achieved through a mechanism that is non-opioid in nature. This means the suppression of the reflex does not rely on the binding pathways associated with opioid-related dependence or respiratory depression. The functional constraint of this mechanism is the inhibition of mucus clearance, as the suppression of the reflex may lead to the stagnation of secretions when they are present.

Dosage and Administration Information

How to Use Supremin: Official Administration Guidelines

This section outlines the standardized instructions for administering Supremin (Butamirate citrate). This medicine is intended only for symptomatic management; its use is governed by a precise dosing protocol and duration limit.


Approved Administration and Dosage Forms

Supremin is restricted to the Oral route of administration. The medicine is available in various oral forms, including a syrup, oral drops/solution, and sustained-release (SR) tablets.


Standard Dosing Regimens and Frequency

Administration is generally multiple times daily, depending on the formulation used:

Dosage Form Typical Single Dose Frequency Maximum Duration
SR Tablets (50 mg) 50 mg Two to three times per day Short-term
Syrup/Solution 15 mg Four times per day Not exceeding 7 days

Dosing regimens for pediatric patients are age- and weight-dependent, requiring the use of liquid forms and lower doses. For older adults, administration should typically involve the lowest effective dose.


Administration Specifics and Procedural Rules

To ensure correct usage, specific procedural rules must be followed:

  • SR Tablets must be swallowed whole and must not be chewed, crushed, or cut to preserve the sustained-release mechanism.
  • Liquid Forms must be measured using the provided, calibrated measuring device (spoon, cup, or dropper) for accurate dosing.
  • Timing: The medicine can be taken without regard to food.
  • Duration Limit: Treatment is generally intended for short-term use and should typically not exceed seven days.

These instructions define the standardized protocol for Butamirate administration, establishing the exclusive oral route and specific constraints regarding frequency and duration.

Recent Clinical Evidence

Research evidence / Overview of studies for Supremin

Evidence for use in Type 2 Diabetes Mellitus

Large-scale Randomized Controlled Trials (RCTs) and studies that combine the results of multiple trials (meta-analyses) have been used in research exploring how Supremin was studied for its effect on blood sugar level measurements in adults with Type 2 Diabetes Mellitus. Research examined key outcomes related to systemic or functional imbalance, such as average blood sugar over several months (known as A1C) and fasting glucose levels. Studies reported measurements where A1C concentrations described patterns related to change when comparing post-study results to baseline. Findings describe patterns observed in the studies. Long-term data extending beyond three years are not consistently characterized across all study groups. Few data are available for certain populations, such as children, as well as specific ethnic subgroups, meaning results apply only to the populations studied.


Evidence for use in Chronic Weight Management

Research examined outcomes related to body weight changes using multi-national, intermediate and long-term randomized trials. Outcomes monitored included alterations in total body weight (in both pounds and percentage) and changes in BMI. Research highlights changes measured during the study period, reporting that a portion of participants reached the pre-specified thresholds for alterations in body weight. Studies report how body weight and BMI evolved in the observed populations over follow-up periods extending up to three years. Data on measured changes in weight following the end of the study period are limited.


Evidence for use in Cardiovascular Events

Dedicated Cardiovascular Outcomes Trials (CVOTs) were evaluated in adults with Type 2 Diabetes Mellitus who already had established cardiovascular disease or multiple risk factors for heart trouble. Research examined the time to first occurrence of Major Adverse Cardiovascular Events (MACE), a combined outcome including cardiovascular death, nonfatal heart attack, and nonfatal stroke. Data from the study described patterns related to the first occurrence of the MACE composite endpoint; the observed event rates varied between the group studied with Supremin and the control group. Evidence for the general, lower-risk population with Type 2 Diabetes Mellitus is not directly established by this specific body of research.

Frequently Asked Questions (FAQ)

Common questions about Supremin (FAQ)


Q: What is Supremin usually prescribed for?

A: Supremin (Butamirate citrate) is officially described in regulatory documents as a medicine used for the symptomatic treatment of cough. Specifically, it is approved for dry, non-productive cough.


Q: What is the official description of the primary condition Supremin is approved to treat?

A: Supremin is formally approved for the symptomatic management of cough. The official labeling provides a brief, formal definition of this approved indication, focusing on its use for dry, non-productive cough.


Q: Is Supremin a type of antibiotic or something else?

A: Official regulatory documents formally describe Supremin as a non-opioid cough suppressant, also known as an antitussive agent. It is structurally and functionally different from an antibiotic.


Q: How does Supremin work compared to similar medicines for the same condition?

A: The regulatory description of Supremin's mechanism indicates that its cough-suppressing action is achieved through a pathway that is non-opioid in nature. This provides a description of its action relative to other medicines that may suppress cough using opioid pathways.


Q: Can I take Supremin with common over-the-counter pain relievers?

A: Official product information advises caution regarding co-administration with substances that are classified as strong enzyme inhibitors, as this may lead to increased exposure of Supremin in the body. General over-the-counter pain relievers are not explicitly listed in regulatory interaction tables. Official information indicates that substances in the constrained categories should be professionally evaluated.


Q: Does Supremin interact with common vitamins or herbal supplements?

A: Regulatory documents advise caution with substances classified as strong enzyme inhibitors or drugs with a narrow therapeutic index. Specific vitamins or common herbal supplements are not individually itemized in the interaction profile. Official information indicates that professional evaluation is appropriate to determine if a specific supplement falls into one of these constrained categories.


Q: Have there been studies conducted on the long-term use of Supremin?

A: For the primary approved use (cough suppression), regulatory documents generally describe Supremin treatment as short-term, typically not exceeding seven days. Evidence of long-term use, such as the studies extending up to three years, relates to specific, non-approved research indications and not the standard symptomatic management of cough.


Q: Why do some sources mention Supremin being used for conditions not listed in the main uses?

A: Official summaries of research evidence describe studies that have examined Supremin in relation to conditions such as Type 2 Diabetes Mellitus, Chronic Weight Management, and Cardiovascular Events. Regulatory documents clarify that the existence of this research does not mean the drug is approved or recommended for these uses. Supremin remains officially approved only for cough symptom management.


Q: Can taking Supremin have an effect on a person's sleep patterns?

A: The official safety profile lists drowsiness as an uncommon adverse reaction affecting the nervous system. Information regarding other sleep disturbances, such as insomnia or altered sleep cycles, is not explicitly documented as a side effect in the official regulatory labeling. Regulatory warnings note the possibility of drowsiness.


Q: Is there information on Supremin causing weight gain?

A: According to the official regulatory safety profile, weight gain is not listed as a reported adverse reaction (such as common, uncommon, or rare) for Supremin.


Q: Does Supremin have a known effect on blood pressure readings?

A: Regulatory safety information notes that a drop in blood pressure, known as hypotension (low blood pressure), has been reported as a potential symptom in cases of overdose of Supremin. The official documents do not specify an effect on blood pressure at standard therapeutic doses.


Q: How long does the body typically take to clear Supremin from its system?

A: The official pharmacokinetic profile details the half-life of Butamirate and its metabolites. This half-life is the time it takes for the concentration of a substance to reduce by half, and it is a key factor in how quickly the body clears the substance from its system.


Q: What kind of research evidence supports the use and effectiveness of Supremin?

A: Research evidence for Supremin's intended use as a cough suppressant is described in documents as demonstrating a direct inhibitory effect on the cough center in the brain. This central mechanism is key to the drug's approved indication.


Q: What were the observed differences between Supremin and placebo in clinical trials?

A: Official regulatory summaries generally reference data supporting the drug's mechanism of action for the approved indication (cough suppression). Quantified comparisons to placebo in clinical trials for this specific indication are often not included in simple patient-facing summaries, though the drug's approval is based on such evidence.


Q: What are the recognized signs of a rare but serious allergic reaction to Supremin?

A: Regulatory documents confirm that allergic reactions are possible, with skin rash (exanthema) being reported. While a severe systemic reaction is not itemized, official warnings often reference seeking professional advice if persistent or concerning allergic symptoms occur.

How should Supremin be stored and disposed of?

How to Store and Dispose of Supremin?

The storage and disposal of Supremin (Butamirate citrate) must strictly follow the requirements documented in official regulatory labeling to maintain product stability and safety.

Entity Official Regulatory Requirement
Labeled storage temperature requirements Store at a temperature not exceeding 30°C.
Light/moisture protection requirements No explicit requirement for protection from light or moisture is universally documented.
Stability after opening/reconstitution (if applicable) In-use stability for some formulations may be six months after first opening the bottle.
Packaging-related storage rules (if applicable) Keep container tightly closed in a dry and well-ventilated place.
Disposal instructions Any unused medicinal product or waste material must be disposed of in accordance with local requirements.
Child-protection storage requirements Must be kept out of the sight and reach of children.

Storage/Disposal Classifications

Classification Official Definition
Storage condition type Maximum storage temperature (30°C maximum).
In-use stability classification Product-specific (e.g., up to 6 months post-opening for some liquid forms).
Regulatory basis Summary of Product Characteristics (SmPC) / Product Information (PI).

Official storage and disposal statements:

  • The medicine must be stored at a temperature not exceeding 30°C.
  • The product must be kept out of the sight and reach of children.
  • Unused medicinal product or waste material must be disposed of in accordance with local requirements.

Connection to the overall storage/disposal profile: The regulatory profile mandates the maximum temperature the product may be stored at to ensure stability [1]. A mandatory instruction for child protection is included, requiring the product to be kept out of sight and reach of children [2]. The official instruction for discarding unused medication is to follow local regulatory guidelines, as the product is not classified as hazardous medicinal waste [3].

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

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