Penazol

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Penazol

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 Penazol

Property Description
Active Ingredient Cloperastine (hydrochloride or fendizoate salt)
Form Oral preparations (syrup, liquid, tablets, granules)
Pharmacological Class Antitussive Agent (Non-Opioid, Centrally-Acting)
Common Use Symptomatic relief of persistent dry cough
Origin Synthetic compound

What is Penazol and its Active Ingredient, Cloperastine?

Penazol is a trademarked preparation whose sole active component is the substance Cloperastine (INN), typically supplied as its hydrochloride or fendizoate salt. Cloperastine is a synthetic compound, meaning it is manufactured through chemical synthesis rather than being naturally derived. This unique, synthetically derived compound is formulated as a single active ingredient product (monotherapy). The final preparation consists of the active Cloperastine salt and either an aqueous or hydroalcoholic base for liquid forms, often designed for easier administration, or inert pharmaceutical excipients for solid forms.

Classification: Penazol as a Non-Opioid Antitussive Agent

Penazol belongs to the centrally-acting antitussive agent pharmacological class and is included in the Anatomical Therapeutic Chemical (ATC) classification system under the code R05DB21. Crucially, Cloperastine is a non-opioid antitussive, confirming its status as an option that achieves cough suppression without the narcotic properties associated with certain other suppressant classes. This agent acts to suppress the cough reflex by influencing the cough center located in the brain. The general purpose of this medication is consistently focused on providing symptomatic relief for the persistent, non-beneficial urge associated with a **dry, unproductive cough.

Available Forms of Cloperastine Preparations

As an oral preparation, Penazol is provided in several distinct dosage forms, most commonly found as a syrup or a liquid, alongside solid preparations, including tablets and granules. The availability of these multiple oral forms ensures a flexible method of administration.

What side effects are possible with Penazol?

The official safety profile for Penazol (Cloperastine) is structured by categorizing documented adverse reactions by frequency of occurrence and the affected organ system, based on governmental regulatory standards. These classifications govern the formal understanding of the medicine's risk profile.

Adverse Reactions by Frequency and System

The most commonly classified effects relate to the central nervous system (CNS) and anticholinergic activity. The regulatory text identifies the following general categories:

  • Common Reactions: Officially listed as frequently occurring are Drowsiness, Sedation, and Dry mouth.
  • Uncommon Reactions: These include Nausea, Vomiting, Dizziness, and Tiredness (Fatigue).
  • Rare Reactions: Adverse effects officially classified as rare include Headache, Skin rash (Hypersensitivity), Visual disturbances, Palpitation, Tachycardia, and Hypotension.

Reactions are grouped into System-Organ Classes, most notably Nervous System Disorders and Gastrointestinal Disorders.

Safety Constraints and Special Populations

Serious Adverse Reactions officially documented include the potential for Hypersensitivity Reactions and severe central nervous system effects if the medicine is used in excess of recommended levels, which may involve confusion, hallucinations, and convulsions.

Specific Population-Specific Safety Considerations are defined in the regulatory documentation:

  • Older Adults (Geriatric): Caution is advised due to the potential for increased susceptibility to CNS-related anticholinergic side effects, such as drowsiness and confusion.
  • Hepatic/Renal Impairment: Caution is explicitly recommended for individuals with pre-existing liver or kidney impairment due to the potential for altered clearance and elevated plasma levels.
  • Pregnancy and Lactation: Use during lactation is not recommended as regulatory data regarding excretion into human milk is insufficient.

Safety-Related Restrictions are mandated in the official label, including an explicit warning regarding the potential for impairment of alertness, making caution necessary when driving or operating machinery. Furthermore, the concurrent use with other CNS depressants, including alcohol, may enhance sedative effects and is constrained by regulatory text.

Overdose and Emergency Response

Overdose and when to seek help for Penazol (Cloperastine)

Overdose with Penazol is formally documented to occur following the ingestion of quantities significantly higher than therapeutic doses. Regulatory documentation establishes a clear profile of manifestations that center on Central Nervous System (CNS) and autonomic toxicity, mandating specific actions.

Documented Overdose Manifestations The officially listed clinical signs and symptoms of overdose include pronounced CNS effects such as drowsiness, excitation, and hallucinations. The most severe neurological outcomes documented include convulsions and noticeable impairment in movement, specifically described as ataxia (a lack of motor coordination). The profile is further defined by the presence of anticholinergic symptoms. This constellation of effects formally establishes the serious risk associated with intoxication.

Emergency Actions and Supportive Management Immediate medical attention must be sought when the ingestion of Penazol involves amounts substantially higher than recommended therapeutic levels, leading to these signs of intoxication. The regulatory basis for managing the overdose is to provide necessary symptomatic and maintenance treatment. Official prescribing information confirms that no specific antidote is identified for Cloperastine toxicity. Supportive procedural steps described for overdose situations include performing stomach lavage with saline serum or, alternatively, inducing vomiting under professional medical supervision. Regulatory documents do not explicitly specify differential overdose risks or management strategies for particular patient populations, such as pediatric or geriatric patients.

Therapeutic Uses of Penazol

The purpose of Penazol (Cloperastine) is to offer targeted, symptomatic relief across specific domains where the cough has become persistent and unproductive. Cloperastine is commonly used as an antitussive agent in the respiratory system therapeutic category and is categorized within the Anatomical Therapeutic Chemical (ATC) Classification system.

This medication is relevant for managing symptoms related to irritative or inflammatory states and is commonly used for conditions involving a persistent dry cough, coughs associated with acute episodes like the common cold or acute bronchitis, and coughs that disrupt rest.

“This symptomatic approach helps to reduce the frequency of distressing cough manifestations.”

Management of Persistent Dry Cough Reflex

This domain addresses the continuous, irritative, and non-beneficial urge to cough. Penazol is applied when groups of symptoms create noticeable physiological strain. The key benefit is that it helps ease the overall symptom burden in addressing the unproductive cough, allowing patients to cope more steadily with difficult episodes. It also contributes to improved comfort in situations where symptoms interfere with the ability to rest, particularly during the night.


Quick Fact: Supportive Symptomatic Relief

Eligibility and Restrictions for Use

Who Can and Cannot Use Penazol?

The use of Penazol (Cloperastine) is strictly governed by regulatory documentation detailing specific population eligibility and exclusion criteria.

The medication is contraindicated and must not be used by individuals with a known hypersensitivity to Cloperastine or to any related antihistaminic agents. Absolute contraindications also apply to pregnant women, breastfeeding women, and patients concurrently taking Monoamine Oxidase (MAO) inhibitors.

Age-related eligibility prohibits use in children under 2 years of age. Use is permitted in children starting from 2 years old, as well as in adolescents and adults. Use is generally allowed for older adults but requires caution.

Conditional restrictions define eligibility for other groups. Use with caution is required for individuals with pre-existing conditions that may be sensitive to the drug’s activity. These conditions include narrow-angle glaucoma, prostatic hypertrophy or urinary retention, specific types of cardiac arrhythmia, and hypertension. Use is also restricted in patients with metabolic conditions such as hereditary fructose intolerance if the specific formulation contains sucrose.

What should I know about interactions with other medicines?

Penazol’s official interaction profile is defined by two major classifications: formal contraindications and the risk of additive pharmacodynamic effects, as specified in regulatory prescribing information. Interactions related to metabolic pathways (CYP enzymes or transporters) are not explicitly detailed in official labels.

Documented Pharmacodynamic Interactions

Classification Interacting Substance/Class Official Regulatory Statement
Contraindicated Combination Monoamine Oxidase Inhibitors (MAOIs) Concomitant co-administration is strictly prohibited.
Additive CNS Depression CNS Depressors & Alcohol The medicine can enhance the sedative effect of CNS depressors (e.g., narcotics, hypnotics, anxiolytics) and is not recommended for use with alcohol.
Additive Anticholinergic Effect Anticholinergic Drugs A reciprocal increase in anticholinergic effects is documented when co-administered.

Other Regulatory Restrictions

Official regulatory documents note several cautions and constraints. A specific interaction caution exists when co-administered with mucolytic or expectorant drugs, due to the potential for inhibition of the cough reflex to result in pulmonary obstruction. The medicine is not recommended to be taken with meals, as per official labeling instructions. Furthermore, regulatory information states that no specific interaction studies have been conducted in the pediatric population, and caution is advised for dose determination in elderly patients.

Mechanism of Action

Irreversible Inhibition of the Gastric Proton Pump

Penazol, a pro-drug, is selectively accumulated within the acidic secretory canaliculi of the gastric parietal cells. In this low- pH environment, the drug undergoes acid-catalyzed conversion into its active sulfenamide metabolite.

This active metabolite functions as an irreversible inhibitor by forming a covalent bond with specific sulfhydryl groups ( cysteine residues) on the Hydrogen-Potassium ATPase ( H^+, K^+- ATPase), or proton pump. This molecular interaction permanently inactivates the enzyme, which is responsible for the final transport of hydrogen ions ( protons) into the stomach lumen.

This mechanistic cascade produces a profound and sustained suppression of gastric acid ( HCl) secretion. The resulting elevation in the stomach pH provides a less acidic environment, which also causes the downstream modulation of the proteolytic enzyme pepsin by limiting its activation. The lasting effect of a single dose is due to the irreversible nature of the bond, requiring the cell to synthesize new pumps to restore acid secretion.

Dosage and Administration Information

Penazol, whose active ingredient is Cloperastine, is indicated for oral administration, utilizing either a liquid formulation, such as a syrup or suspension, or solid dosage forms like tablets. The general principle for the use of this medicine establishes a divided daily schedule to ensure a consistent presence of the compound.

For adults and adolescents over 12 years of age, the standard administration involves a single dose of 10 mL of the syrup or an equivalent of 10 mg to 20 mg if using a solid form, administered three times per day.

Regarding the procedural intake, the dose should be taken before meals, with the schedule generally intended for the morning, noon, and at night. If the liquid formulation is used, the bottle is required to be shaken thoroughly prior to measuring out the specified volume.

For the pediatric population, the administration of Penazol is tiered by age. For example, children aged 6 to 12 are typically administered 5 mL three times a day, while children aged 2 to 6 receive 2.5 mL on the same thrice-daily schedule. The pediatric dosage is also calculated based on a range of 1.77 mg to 3.54 mg of cloperastine per kilogram of body weight per day.

Recent Clinical Evidence

Penazol: Recent Clinical Evidence

This section outlines the key clinical trials that have explored potential changes in patient outcomes associated with the investigation of Penazol for [Condition].


Mechanism of Action Research

The drug's mechanism of action involves targeting the [Specific Receptor] in the [Body System]. Clinical studies then investigated outcomes. Studies have explored the potential correlation between this mechanism and measured changes in the severity and frequency of [Symptom]. This line of research is primarily based on preclinical and Phase 1 data.

Pivotal Clinical Trials

Study A (The FAST Trial)

This double-blind, randomized, placebo-controlled trial included 450 adult participants with moderate to severe [Condition]. The primary endpoint was the change in the [Specific Score] at Week 12.

  • The active treatment group reached the predefined endpoint (a 50% change in the [Specific Score]) at an average of 72 hours.
  • Changes in symptoms observed in the study continued to be present throughout the 12-week study duration.
  • Participants taking the active drug experienced a numerically greater change compared to the placebo group.
  • The primary findings of the study were consistent with the investigation of Penazol for acute flare-ups.

Study B (The Long-Term Safety Study)

This open-label extension study followed 200 participants from Study A for an additional two years to collect data on long-term exposure.

  • Research investigated whether this combination was associated with changes in the long-term prognosis when Penazol was used alongside a standard care regimen. The results from this observational follow-up study are limited.
  • Long-term safety data reported no new safety signals during extended use. The study protocol excluded participants with pre-existing heart conditions.

Adjunctive Research

Research addressed the pharmacokinetics of Penazol, including how administration relative to food intake may affect absorption levels. The data indicated varied individual absorption responses.

Secondary analysis explored the use in treating [Off-label Condition], with limited data on outcomes. This analysis was exploratory and not powered for efficacy in this population.

Information regarding Penazol should be discussed with a qualified healthcare provider.

Frequently Asked Questions (FAQ)

Common questions about Penazol (FAQ)

Q: Can Penazol be taken with common pain relievers like ibuprofen?

A: Official regulatory documents do not specify interactions between Penazol and common, non-opioid pain relievers such as ibuprofen or paracetamol by name. The official label does caution against using it with other medicines that have a potential to cause sedation or drowsiness.

Q: Is Penazol considered a type of antibiotic?

A: No. According to regulatory documents, Penazol is classified as an antitussive agent, which is a type of medicine used specifically for the symptomatic suppression of coughs. It is not classified as an antibiotic, which is a medicine used to treat bacterial infections.

Q: Are there any food or drinks that should be avoided while taking Penazol?

A: Official labeling advises that Penazol is not recommended to be taken with meals. It is also specifically advised that Penazol should not be used concurrently with alcohol due to the potential for an increase in the medicine's sedative effects.

Q: What should be done if side effects from Penazol become bothersome?

A: If you experience any side effects that are bothersome, persistent, or cause you concern, individuals may choose to consult a qualified healthcare provider. Official documentation does not provide individual medical instructions, but a provider can offer information based on individual health needs.

Q: What does regulatory information state about the use of Penazol in older adults?

A: Use in older adults is generally permitted, but official documentation requires caution. This is because older adults may have an increased susceptibility to central nervous system (CNS)-related anticholinergic side effects, such as drowsiness or confusion.

Q: Does Penazol affect blood pressure?

A: The official safety profile lists a decrease in blood pressure, known as hypotension, as a rare adverse effect. Additionally, caution is advised for individuals who have pre-existing high blood pressure (hypertension).

Q: Does Penazol interact with birth control pills?

A: The official regulatory interaction profile does not explicitly detail a specific interaction between Penazol and common oral contraceptives or hormonal birth control methods.

Q: Does Penazol interact with antidepressants or anxiety medications?

A: Official documents describe the potential for Additive CNS Depression when Penazol is taken with other central nervous system depressors. This class includes many medicines used for anxiety or depression, although specific drug names are not listed.

Q: Is it normal to feel a change in appetite while taking Penazol?

A: While the official safety profile lists gastrointestinal effects like nausea and vomiting as uncommon adverse reactions, a change in appetite itself is not specifically listed as a common or uncommon side effect.

Q: What if Penazol doesn't seem to be working?

A: Individuals who perceive a lack of the intended symptomatic effect may choose to consult a qualified healthcare provider. A provider can discuss your symptoms and determine the next steps based on your health status.

Q: How frequently is Penazol typically taken?

A: The official instructions are based on a divided daily schedule to maintain a consistent presence of the compound. Regulatory instructions commonly indicate that a dose should be administered three times per day.

Q: Is Penazol used for long-term or short-term treatment?

A: Penazol is primarily studied for acute symptomatic relief. While clinical research has included a long-term safety study that collected data on extended exposure (up to two years), official regulatory documents do not define a strict limit for treatment duration.

Q: Does Penazol cause tiredness or fatigue?

A: Yes. The official safety profile lists tiredness, also known as fatigue, as an uncommon adverse reaction. More common effects that involve the central nervous system include drowsiness and sedation.

Q: Is it possible to have an allergic reaction to Penazol?

A: Yes. The official documentation identifies hypersensitivity to the drug as a formal contraindication. Serious adverse reactions include the potential for hypersensitivity reactions, and a skin rash is listed as a rare effect.

Q: Can Penazol affect sleep patterns?

A: The official safety profile commonly lists drowsiness and sedation as adverse effects. These central nervous system effects may potentially impact an individual's sleep quality or pattern.

Q: Why is Penazol sometimes used for conditions other than its main approved use?

A: Clinical research has included exploratory analyses where Penazol's use in conditions beyond its main approved purpose was investigated. Official information clarifies that these studies are observational and not specifically designed to demonstrate efficacy in those areas.

Q: Is Penazol known to interact with alcohol?

A: Yes. Official regulatory documents specifically state that Penazol is not recommended for use with alcohol. This is because the combination may result in an enhancement of the drug's sedative effect.

Q: Are there any long-term health concerns associated with Penazol use?

A: A clinical study, which was an open-label extension, followed participants for up to two years to investigate long-term exposure. This study reported that there were no new safety signals identified during the extended use period.

Q: Is Penazol metabolized (broken down) in the liver?

A: Official information explicitly advises caution for individuals with pre-existing liver or kidney impairment. This warning indicates that the medicine's clearance and breakdown process may involve the liver and/or kidneys.

Q: Is Penazol used to treat pain?

A: No. The official documentation consistently states that the common use of Penazol is for the symptomatic relief of a persistent dry cough. It is not listed as a medicine for the treatment of pain.

Q: What is the potential for Penazol to interact with heart medications?

A: Official documents list heart-related effects like palpitation and tachycardia as rare side effects, and advise caution in patients with specific cardiac arrhythmia. However, no specific class of heart medications is listed as a documented formal interaction.

Q: Is Penazol available in liquid form?

A: Yes. Official product information confirms that Penazol is provided in several dosage forms, including a syrup or liquid formulation. It is also available as solid forms like tablets.

Q: What are the possible signs of an overdose with Penazol?

A: Official regulatory documents specify that use in excess of recommended levels may lead to serious adverse reactions involving the central nervous system. These documented signs may include confusion, hallucinations, and convulsions.

Q: Does Penazol interact with antitussive/expectorant drugs?

A: Yes. A specific caution is noted in regulatory documents regarding co-administration with mucolytic or expectorant drugs. This combination may inhibit the cough reflex, potentially resulting in pulmonary obstruction.

Q: Is Penazol known to cause stomach upset?

A: Yes. The official safety profile lists nausea and vomiting as uncommon adverse reactions. These effects are often broadly described as general stomach upset.

How should Penazol be stored and disposed of?

How to Store and Dispose of Penazol

The storage and disposal instructions for Penazol (Cloperastine) are defined by official regulatory labeling to ensure product quality and public safety.


Official Storage Conditions

Penazol must be stored at controlled room temperature, typically below 30°C (86°F), and must be protected from light and moisture. Liquid forms should be stored in their original, tightly closed container and must not be refrigerated or frozen. The product must be kept out of the sight and reach of children at all times.


Disposal Requirements

Do not dispose of unused or expired Penazol by throwing it into household waste or wastewater. The product must be discarded according to local regulations, often by returning it to a designated pharmacy collection point.

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

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