Clofend

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Clofend

Method of action: Cough And Cold Preparations

Treatment option:

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Clofend

What is Clofend? Defining a Non-Opioid Cough Suppressant

Property Description
Active ingredient Cloperastine (e.g., as fendizoate or hydrochloride salt)
Form Tablet, Syrup, Granules
Pharmacological class Non-opioid Antitussive (Cough Suppressant)
Common use Symptomatic relief of dry, unproductive cough
Origin Synthetic (Diarylmethane derivative)

What Kind of Drug is Clofend (Cloperastine)?

Clofend is a medicinal product containing the active ingredient Cloperastine, a synthesized chemical compound that is clinically recognized as a non-opioid antitussive. This classification signifies that the substance is specifically intended to suppress the cough reflex, operating via non-narcotic pathways, which differentiates it from traditional opioid-based cough suppressants. Cloperastine itself is a synthetic derivative of the diarylmethane chemical class, meaning it is chemically synthesized rather than naturally sourced. Its formulation often utilizes salts such as Cloperastine hydrochloride or the more stable Cloperastine fendizoate, a characteristic composition favored for optimizing drug absorption. The preparation is distinctively positioned for use across a broad patient group, often including children over two years of age (in liquid formulations), a differentiating factor in the antitussive market.

Compositional Form and General Purpose

The medication is formulated for oral administration and is widely available in several dosage forms, most commonly as tablets, syrups, and granules. These forms consist of the active Cloperastine salt combined with pharmaceutical excipients or aqueous carriers, frequently featuring agreeable flavors in the syrup format for ease of use. The primary general purpose of Clofend is to provide effective symptomatic relief for the persistent, dry, and unproductive cough, such as the hacking cough that often accompanies a common cold or mild respiratory infection. Cloperastine is effective in controlling the centrally driven cough reflex. By influencing the central mechanism that drives the reflex, the medication helps interrupt the irritating cough cycle, promoting patient comfort and facilitating sleep when the cough serves no necessary physiological clearing function.

Regulatory References

  1. Pharmacological and clinical overview of cloperastine in treatment of cough (PubMed Central)

What side effects are possible with Clofend?

Possible Side Effects and Safety Information

The official safety profile for Clofend (Cloperastine) is structured by government regulatory agencies based on the frequency and physiological location of documented adverse reactions. These effects are generally classified according to standard regulatory terminology (Common, Uncommon, Rare) and grouped by the System-Organ Classes they involve, such as Nervous System Disorders and Gastrointestinal Disorders.


Frequency-Classified Adverse Reactions

The most frequently reported effects listed in regulatory documents fall into the Common category, which includes Somnolence (drowsiness) and Dry mouth. Effects classified as Uncommon typically involve Dizziness and Fatigue. Rare reactions, observed in less than 1 in 1,000 patients, may include Tremor, Hallucinations, and various Skin reactions, such as urticaria.


Safety Considerations and Restrictions

The safety profile includes restrictions for specific situations and patient groups. The medicine is officially contraindicated in individuals with known hypersensitivity to the active ingredient or excipients. Regulatory labeling also notes that the sedative effects of Clofend may be potentiated when used concurrently with other central nervous system depressants. Furthermore, use with certain MAO inhibitors is specifically contraindicated.

Regarding special populations, official safety statements indicate that pediatric patients may have an increased potential for neurological reactions. Similarly, older adults may exhibit greater sensitivity to the central nervous system effects, necessitating careful consideration in these groups.

Overdose and Emergency Response

Overdose and When to Seek Help

Regulatory documentation provides specific information regarding the potential manifestations and required emergency response in a Clofend (Cloperastine) overdose. Severe or life-threatening scenarios necessitate immediate medical evaluation.

Documented Overdose Manifestations

Overdose may present with a range of effects primarily involving the Central Nervous System (CNS) and manifestations consistent with anticholinergic toxicity. Officially documented clinical signs and symptoms include drowsiness, hallucinations, excitation, and signs of impaired movement such as ataxia and a lack of motor coordination. The most severe manifestation documented in the regulatory summary is the potential for convulsions.

Required Emergency Actions

Immediate medical attention is necessary if an overdose is suspected, due to the potential for severe CNS outcomes. Regulatory guidance states that the management focuses on supportive care, as no specific antidote is known for this compound. Official procedural measures described for managing an overdose include symptomatic and maintenance treatment, alongside physical interventions such as performing stomach lavage with saline serum or inducing vomiting (emesis). Prompt medical intervention is required to initiate these supportive and maintenance measures.

Therapeutic Uses of Clofend

What Clofend Treats: Main Uses and Benefits

Clofend is primarily used to provide symptomatic relief for the dry, unproductive cough, which is characteristic of symptoms related to heightened physiological activity and airway irritation. The primary therapeutic purpose involves addressing the cough that is frequent, persistent, and offers no physiological purpose in clearing the lungs. It may assist with easing symptoms related to the cough reflex.

The medication is commonly used across conditions presenting with acute episodes and intermittent symptoms, including cough that accompanies the common cold, acute bronchitis, lingering post-infectious states, and specific symptom manifestations such as those caused by ACE inhibitors. It is applied in situations where additional symptomatic support is needed, and is used for managing symptoms that create noticeable physiological strain and contributes to easing the symptom load, whether the manifestations are acute or chronic. A key practical benefit is its relevance for symptoms that interfere with daily functioning, as it contributes to day-to-day comfort and supports general well-being during symptomatic phases, assisting with rest.


Quick Fact: Relief for Unproductive Cough

Used for conditions involving episodic or fluctuating manifestations where short-term symptomatic assistance is appropriate, primarily to contribute to day-to-day comfort during periods of heightened symptoms.

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Clofend — Official Regulatory Information

Eligibility Scope Detail from Regulatory Sources
Populations for whom use is allowed (as stated in label) Adults (Aged 18 and older) are permitted for use under standard labeled conditions [2.1]. Children aged 2 to 12 years are permitted for use with specific pediatric dosing in certain formulations [2.1].
Populations for whom use is not recommended (if applicable) Patients with a productive cough associated with copious bronchial secretions (catarrh) [2.1]. Elderly patients should use the medicine with caution due to increased sensitivity [2.1].
Populations for whom use is contraindicated Individuals with known hypersensitivity to the active substance or excipients [2.1]. Children under two years of age must not use this medicine [1.7, 2.1]. Pregnant and breastfeeding women are contraindicated [2.1, 4.2].
Condition-specific eligibility rules Use with caution is required for patients with glaucoma, prostatic hypertrophy, urine retention, or severe liver dysfunction [1.5, 2.2].
Eligibility-related restrictions Use is contraindicated when taking concomitant MAO inhibitors (Monoamine oxidase inhibitors) [2.1]. Caution is advised for patients with certain hereditary metabolic disorders due to excipients [2.1].

Eligibility Classifications (High-Level)

Classification Detail from Regulatory Sources
Eligibility severity classification (as defined in official documents) Contraindicated (Absolute Prohibition); Not Recommended (Strong Restriction); Use with Caution (Conditional Use); Permitted for use (Standard Use) [2.1].

Resulting Eligibility Structure

Official eligibility statements:

  • Clofend is contraindicated in patients with a known allergy to the drug or its components [2.1].
  • The medicine is contraindicated for use in children under two years of age [1.7, 2.1].
  • Use is contraindicated during both pregnancy and lactation [2.1].
  • Caution is advised for patients with glaucoma, prostatic hypertrophy, or severe liver impairment due to the risk of exacerbating these conditions [1.5, 2.2].

Connection to the overall eligibility profile: Official regulatory documents define who can and cannot use the medicine by establishing mandatory contraindications for specific allergies and co-medications, imposing strict age minimums for pediatric use, and prohibiting use during pregnancy and breastfeeding. The profile further mandates caution and medical supervision for specific pre-existing conditions that may require restricted use.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Clofend is structured around documented pharmacodynamic effects and specific prohibitions defined by regulatory authorities.

Interaction Classifications and Restrictions

Clofend is formally contraindicated for use in combination with Monoamine Oxidase Inhibitors (MAOIs). This restriction on concomitant use is documented in official prescribing information due to the risk of reciprocal effect enhancement.

Pharmacodynamic Interactions

A central documented interaction is the enhancement of the sedative effect. Co-administration with CNS depressors, which include alcohol, anxiolytics, antipsychotic drugs, barbiturates, hypnotics, narcotics, and some analgesics, may lead to this heightened central nervous system effect.

Due to its documented properties, Clofend may also have reciprocal effect enhancement with other anticholinergic drugs, such as tricyclic antidepressants, anti-Parkinson's agents, and various antihistaminic agents.

Other Product Restrictions

A specific constraint is placed on the concurrent use of Clofend with products that promote bronchial secretion clearance, namely expectorants and mucolytic drugs. This restriction addresses a documented physiological conflict where the antitussive action may interfere with the function of the expulsion agents. No specific pharmacokinetic interactions involving named CYP enzymes or drug transporters are formally detailed in the official interaction sections reviewed, and documentation indicates that food has no significant effect on absorption.

Mechanism of Action

How Clofend Works: The Pharmacodynamic Mechanism

The physiological action of Cloperastine influences the neurological processes that drive the cough reflex. Its mechanism is non-opioid and involves a dual-target activity to modulate central neural pathways.

Central Neural Excitability Modulation

This primary domain involves the central modulation of neuronal activity within the medullary cough center in the brainstem. The mechanism is driven by Cloperastine’s function as a Sigma-1 (sigma1) receptor agonist and a GIRK channel inhibitor, which collectively stabilize the neuron membranes and contributes to the increase in the physiological threshold for cough initiation.

Airway Signal Dampening and Systemic Constraints

A secondary action involves mild Histamine H1 receptor antagonism, which contributes to subtle bronchorelaxation. This action modulates peripheral afferent signaling that can initiate the reflex. The entire mechanistic profile is strictly focused on neural control systems and does not include any molecular action on mucus or airway secretions, functionally constraining the mechanism's application to physiological states not requiring expectoration.

Dosage and Administration Information

Clofend (Cloperastine) administration follows established guidelines for its oral use as a short-term symptomatic remedy. The active ingredient is formulated for ingestion and is typically available as a syrup, suspension, or tablet form. The method of use involves specific timing, frequency, and dose measurement to ensure consistency with product labeling.

Administration Patterns

Area of Instruction Guidance
Route of Administration The medication is intended for oral use.
Dosing Frequency The standard regimen is administered three times a day (TID).
Timing Administration is advised to occur before meals.
Preparation The syrup or suspension container must be shaken before use.

Labeled Dosing Regimens by Age

The specific volume and dose are dependent on the patient's age. The dosing schedule for the 3.54 mg/ml syrup/suspension strength is categorized by age:

  • Adults and Children over 12 years: 10 ml per single dose.
  • Children 6 to 12 years: 5 ml three times a day.
  • Children 2 to 6 years: 2.5 ml three times a day.

Use Constraints and Duration

The use protocol limits the administration of Clofend to short-term symptomatic treatment. The medicine must not be used in children under two years of age. This structured approach is intended to ensure the medication is used according to established protocols.

Recent Clinical Evidence

Research evidence / Overview of studies for Clofend

Evidence for Symptomatic Dry and Unproductive Cough

The research for Clofend was studied for use in the context of a dry or unproductive cough and has primarily utilized Randomized Controlled Trials (RCTs) and controlled clinical studies. These studies were applied in research contexts involving fluctuating or unstable symptoms, such as the persistent cough that often follows acute respiratory tract infections or occurs with acute bronchitis.

Research explored outcomes related to physical discomfort and outcomes reflecting daily functioning, specifically monitoring changes in the frequency and intensity of cough episodes. Findings describe the measurement patterns observed in these short-term studies. Research highlights changes measured during the study period, with some data show patterns related to how frequently patients reported coughing, which was associated in some studies with patient-reported outcomes describing perceived discomfort during sleep. The evidence contributes to the broader landscape of understanding short-term, acute cough symptoms.


Research on Specific Cough Etiologies, Including ACE Inhibitor-Induced Cough

Beyond the general acute cough, Clofend was also evaluated in studies examining certain specific cough scenarios. Research has explored Clofend's evaluation in adults with ACE inhibitor-induced cough, a specific type of persistent dry cough that may be observed following the use of certain medications for blood pressure or heart conditions.

The evidence supporting this specific cough etiology remains limited. The findings often derive from smaller patient cohorts or clinical overviews rather than large, dedicated RCTs, which contributes to limitations in the scope of evidence for this specific medication-related issue.


‍‍ Evidence in Special Patient Populations (Children and Adults)

Clofend was studied for its use in both adult and pediatric populations. Trials assessing short-term or episodic symptom patterns included cohorts of adults experiencing chronic or persistent cough and children, often over two years of age, who were experiencing acute cough associated with respiratory illnesses.

For children, studies monitored outcomes capturing phases of heightened symptom activity, using parent-reported outcomes describing perceived discomfort, particularly concerning nocturnal awakenings. Regulatory and scientific sources note that the evidence quality varies across studies, and data for certain young groups are not yet fully established compared to adult evidence.


⏱️ Long-Term Studies and Duration of Observation

The research for Clofend has primarily been relevant in trials assessing short-term or episodic symptom patterns, as its primary evaluation in research is focused on short-term symptomatic patterns of acute cough. The typical follow-up durations in the main clinical trials were limited, ranging from a few days up to one week.

Consequently, there is limited information for long-term outcomes and the durability of observed responses. Research provides context but not individual predictions regarding extended or maintenance use, as the studies primarily observed responses over defined time intervals that reflect acute symptoms.

Key Studies & References

  1. Levocloperastine: A Review on pharmacodynamics, clinical efficacy, tolerability and safety in the treatment of chronic cough (Review of controlled trials)
  2. Therapeutic Use of Levocloperastine as an Antitussive Agent (Review including pediatric and adult trials)
  3. Clinical Overview of Levocloperastine Trials (Comparative efficacy in various respiratory disorders)

Frequently Asked Questions (FAQ)

Common questions about Clofend (FAQ)

Q: How quickly does Clofend usually start working?

Studies and official information indicate that the symptomatic relief provided by Clofend may be observed shortly after treatment begins. Research evidence indicates that antitussive effects have been observed within the first day of treatment. This observation aligns with its intended use for short-term acute cough symptoms.

Q: Can Clofend be taken if I have a history of liver issues?

Official regulatory documents advise that caution is required when Clofend is used in patients with severe liver dysfunction. Official documents state that the medicine is reserved for use with caution in patients with severe liver dysfunction, necessitating careful medical supervision. This conditional use is defined by regulatory bodies.

Q: Are there any common foods or drinks that should be avoided with Clofend?

Official drug information indicates that food has no significant effect on the absorption of Clofend. Therefore, it can be taken without concern for food interactions. However, co-administration with alcohol may lead to an enhancement of the medicine's sedative effects, and this combined use is the subject of official cautions.

Q: What is the maximum amount of time Clofend is usually prescribed for?

The official use protocol for Clofend limits its administration to short-term symptomatic treatment of a dry cough. Regulatory information emphasizes that it is intended for acute symptoms, and its clinical evaluation in research trials has primarily focused on follow-up periods of up to one week.

Q: Why is Clofend sometimes used for conditions other than its main purpose?

While the primary, officially approved purpose of Clofend is for the symptomatic relief of dry, unproductive cough, research has explored its evaluation in specific cough scenarios, including in adults experiencing an ACE inhibitor-induced cough. This research explores its effects beyond the general acute cough indication.

Q: What is the reported duration of action for a single dose of Clofend?

The standard dosing frequency for the medicine is advised to be three times a day (TID). The standard dosing frequency of three times a day (TID) aligns with the expectation of effect maintenance across typical daily intervals. This pattern is defined in official administration documents.

Q: What is the general expectation for improvement when starting Clofend?

Research and clinical studies typically measure improvement in relation to changes in cough symptoms. The measured outcomes primarily include a reduction in the frequency and intensity of cough episodes, along with patient-reported outcomes describing better perceived discomfort during sleep.

Q: What if I miss a scheduled dose of Clofend?

Official guidance generally advises patients to continue with the next scheduled dose as planned. Regulatory guidance explicitly advises against taking a double dose to compensate for a forgotten dose. Specific instructions for handling a missed dose are provided in the patient information leaflet.

Q: Can Clofend affect mental clarity or memory?

Official safety documents list central nervous system (CNS) effects, such as common somnolence (drowsiness) and uncommon dizziness. Due to these effects, the label advises caution regarding activities requiring full mental alertness. This caution is based on the potential impact on cognitive functions.

Q: Is Clofend often prescribed for pain relief?

Clofend is officially classified as a non-opioid antitussive, meaning its pharmacological action is specifically intended to suppress the cough reflex. Its primary position in therapy is for the symptomatic relief of dry cough, not as a dedicated analgesic (pain reliever).

Q: Is Clofend a chemically related to any other well-known drug class?

The active ingredient, Cloperastine, is a synthetic derivative of the diarylmethane chemical class. It also exhibits mild Histamine H1 receptor antagonism, which connects it chemically to the properties of some older antihistamine drugs, although its main mechanism of action remains antitussive.

Q: What is the significance of the expiration date on Clofend packaging?

The expiration date is a critical regulatory requirement. It reflects the time period during which the product is determined to remain stable, potent, and safe when stored according to official instructions. Using the product beyond this date is generally not recommended by regulatory bodies.

Q: Can children use Clofend for conditions approved in adults?

Yes, official regulatory documents indicate that the medicine is approved for use in both adults and children over two years of age for the same primary condition: the symptomatic relief of dry, unproductive cough. The specific pediatric dosing regimen for children is detailed in the administration guidelines.

Q: Does Clofend need to be taken at a specific time of day?

The official guidance advises that administration is relative to meals, specifically recommending that it be taken before meals. The required dosing frequency is generally three times a day. The schedule is not typically tied to a specific time of day like morning or evening, as official guidance instead specifies timing relative to meals (before meals).

Q: What is the purpose of the different strengths Clofend is available in?

Clofend is formulated in different dosage forms, such as tablets, syrups, and granules, to ensure flexibility in administration. This allows for the use of specific pediatric dosing, accommodates ease of swallowing, and facilitates use across various patient populations.

Q: Is it okay to drive or operate machinery while taking Clofend?

Official documentation advises caution regarding activities that require mental alertness, such as driving or operating machinery. This official warning is mandatory due to the documented common side effects of the medicine, which include somnolence (drowsiness) and dizziness.

How should Clofend be stored and disposed of?

The storage and disposal of Clofend (Cloperastine) must adhere strictly to the conditions specified in official regulatory documents to maintain its stability and ensure public safety.

Storage Requirements

Condition Type Official Requirement
Temperature Limit Store at a temperature below 30 C.
Stability The unopened product maintains a shelf life of 5 years.
Protection Keep the product in its original container and out of the sight and reach of children (mandatory precaution).

Disposal Instructions

Official labeling for the product may state no special requirements for disposal. In this case, disposal must follow general government guidelines, which prioritize drug take-back programs. If a take-back option is unavailable, the expired or unused medicine should be mixed with an undesirable substance, placed in a sealed bag, and then thrown into the household trash, following US FDA recommendations for non-flushable, non-controlled medicines.

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

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