Perdinal

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Perdinal

Medically reviewed

Rosario Oropesa

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 Perdinal

What is Perdinal?

Perdinal is a pharmaceutical formulation that combines two active therapeutic agents: paracetamol (also known as acetaminophen) and hyoscine butylbromide (also known as scopolamine butylbromide).

This combination is designed to address specific types of physical discomfort by utilizing two different mechanisms of action.

Composition and Components

  • Paracetamol: This component is categorized as an analgesic (pain reliever) and an antipyretic (fever reducer). It works primarily by inhibiting the production of prostaglandins in the central nervous system, which helps to elevate the body's overall pain threshold.
  • Hyoscine Butylbromide: This component is an antispasmodic agent. It belongs to a class of medicines called quaternary ammonium derivatives. Its primary function is to relax the smooth muscles found in the walls of the gastrointestinal, biliary, and urinary tracts.

Therapeutic Intent

Perdinal is utilized to manage pain associated with spasms of the smooth muscles. Because it addresses both the sensation of pain and the underlying muscle contraction, it is frequently used for conditions involving abdominal cramping or discomfort in the digestive or genitourinary systems. By relaxing the involuntary muscles and simultaneously reducing pain signals, the formulation aims to provide comprehensive relief for spasmodic episodes.

Regulatory References

  1. MedlinePlus Drug Information: Phenobarbital

What side effects are possible with Perdinal?

Possible Side Effects and Safety Information

The safety profile of Perdinal (Phenobarbital) is defined by its classification as a central nervous system (CNS) depressant. Adverse reactions are grouped by system-organ class and frequency, strictly following regulatory standards.

Common and Expected Adverse Reactions

The most frequently documented adverse effects, classified as Common in regulatory labeling, are related to CNS depression. These include drowsiness, somnolence, lethargy, and ataxia (impaired coordination). Other CNS effects may include confusion, nervousness, and paradoxical excitement, particularly noted in pediatric patients and older adults.


Serious Adverse Reactions and Key Constraints

The regulatory profile highlights several serious risks, which, though rare, are critical. These include life-threatening Severe Cutaneous Adverse Reactions (SCARs), such as Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). The risk of fatal hepatotoxicity (liver damage) is also documented, with children under the age of two having a higher documented risk.

Perdinal is associated with the potential for physical and psychological dependence upon prolonged use. Consequently, the abrupt cessation of the medication after chronic exposure is associated with a risk of a severe, potentially life-threatening withdrawal syndrome.

Safety constraints include contraindications for use in individuals with acute porphyrias, severe respiratory insufficiency, or severe hepatic or renal impairment. High-level safety notes advise that concurrent use with other CNS depressants may lead to additive CNS depression and increased respiratory risk.

Overdose and Emergency Response

Overdose and When to Seek Help

An overdose of Perdinal (Phenobarbital) is defined by official regulatory documents as leading to profound depression of the central nervous system (CNS) and cardiorespiratory systems, necessitating immediate emergency medical intervention.

Documented Overdose Presentations and Severe Outcomes

Overdose manifestations are primarily characterized by CNS depression, progressing from decreased alertness, stupor, confusion, slurred speech, and dizziness, to uncoordinated movement (ataxia) and potentially coma. Life-threatening consequences include severe respiratory depression, which can rapidly lead to apnea and respiratory arrest, and cardiovascular instability, causing profound hypotension and shock. Regulatory sources note that ataxia is an overdose manifestation commonly seen in children.

Required Emergency Actions and Management

  • Seek immediate medical attention and contact emergency services (e.g., Poison Help hotline) upon suspicion of overdose.
  • Immediate medical help is explicitly required if the person seems extremely tired or has breathing problems.
  • Management is strictly symptomatic and supportive. There is no specific antidote documented to reverse the effects of Phenobarbital.
  • Supportive measures listed in official documents include breathing support (mechanical ventilation), maintaining cardiovascular stability with intravenous fluids, and may involve gastrointestinal decontamination (activated charcoal) or monitoring serum barbiturate concentrations.

Therapeutic Uses of Perdinal

What Perdinal Treats: Main Uses and Benefits

Perdinal is commonly used to help manage symptoms and provides supportive therapeutic benefits by addressing severe symptom patterns related to nervous system excitability. The medication is applied when appropriate across domains involving significant symptom expression.

Primary Therapeutic Applications

Perdinal is relevant in conditions characterized by periods of heightened symptoms, primarily applied in the management of chronic epilepsy and other recurrent seizure disorders, as well as for the acute stabilization required during continuous convulsive emergencies, such as status epilepticus. Additionally, it provides short-term symptomatic assistance for acute agitation and apprehension, such as in the preoperative setting.

The therapeutic focus is always on managing symptoms that create noticeable physiological strain and interfere with daily functioning. The medication supports patients during difficult episodes by easing distress and contributes to easing the overall symptom load.

Perdinal provides support that helps ease the overall symptom burden related to recurrence, helping to address symptom clusters related to convulsions and assisting with maintaining functional stability. In acute settings, it supports the patient during difficult episodes by easing distress and is commonly used to help with immediate symptom stabilization.


Quick Fact: Focus on Acute Nervous Tension Symptoms

Perdinal is considered relevant in contexts marked by increased discomfort or tension, applied in scenarios where short-term symptomatic assistance is needed for agitation and preoperative apprehension.

Regulatory References

  1. NIH MedlinePlus overview on Phenobarbital

Eligibility and Restrictions for Use

Who can and cannot use Perdinal?

Perdinal's eligibility is determined by strict rules set forth in regulatory prescribing information, classifying patient populations into three main categories: allowed, restricted, and contraindicated.

Category Official Eligibility Status & Constraints
Allowed Populations Use is established for adults and for the management of seizures in pediatric patients, including infants and neonates.
Absolute Contraindications Perdinal must not be used in patients with known hypersensitivity to barbiturates or any component of the formulation. Use is prohibited in those with acute intermittent porphyria, severe respiratory depression, or marked impairment of liver function. Use is also contraindicated in patients with sleep apnoea or uncontrolled pain.
Conditional Restrictions The medicine must be administered with caution to elderly or debilitated patients due to the risk of confusion and oversedation. Conditional use is required for patients with renal impairment, existing liver disease, or those with a history of drug dependence or suicidal ideation.
Reproductive Status Use is not recommended during pregnancy due to the documented risk of fetal harm. Women of childbearing potential must use highly effective contraception. Lactation is not advised as the drug is excreted into breast milk.

What should I know about interactions with other medicines?

The metabolism of Perdinal (repaglinide) is primarily managed by the liver enzymes CYP2C8 and CYP3A4, making it susceptible to interactions with medicines that affect these enzyme systems.

Contraindicated and Restricted Combinations

Classification Interacting Product(s)
Contraindicated Gemfibrozil (due to significant increase in Perdinal exposure and severe hypoglycemia risk)
Not Indicated NPH-insulin (due to risk of serious cardiovascular adverse reactions)

Combinations Requiring Close Monitoring and Dose Adjustment

Co-administration with inhibitors of CYP2C8 and CYP3A4, such as Clopidogrel, Cyclosporine, and certain antifungals like Itraconazole and Ketoconazole, may increase the concentration of Perdinal in the body. This requires careful dose limitation and increased frequency of blood glucose monitoring to prevent hypoglycemia. When combined with Clopidogrel, for instance, the total daily dose of Perdinal must be strictly limited.

Conversely, inducers of CYP2C8 and CYP3A4, such as Rifampin, may decrease Perdinal's effectiveness and could require an increase in Perdinal dosage based on monitored glucose response.

Additionally, drugs that may mask the typical signs and symptoms of low blood sugar, such as beta-blockers, require heightened monitoring to detect and manage hypoglycemia.

Mechanism of Action

How Perdinal Works: Mechanism of Action

Perdinal works by simultaneously addressing the fundamental balance between inhibition and excitation in the Central Nervous System (CNS). Its actions are centered on two primary mechanistic domains, resulting in a net shift toward reduced neuronal activity.


Targeting Inhibitory and Excitatory Receptors

Perdinal engages in a dual receptor mechanism by acting on both the main inhibitory and excitatory ion channels. It functions as a positive allosteric modulator of the GABA A receptor, enhancing the activity of the body's primary inhibitory neurotransmitter, GABA. Concurrently, it acts as a non-competitive antagonist at N-methyl- D-aspartate receptors (NMDARs), physically blocking the channels used by the main excitatory neurotransmitter, glutamate. This immediate molecular adjustment initiates the process of reduced neural signaling.


Systemic Reduction of Neuronal Signaling

The dual action initiates a cascade that results in a net shift toward reduced neuronal excitability. By promoting chloride ion influx (inhibition) and suppressing calcium ion influx (excitation), the drug increases the neuronal firing threshold throughout the CNS. This widespread systemic reduction in neural communication results in core physiological consequences, including depressed arousal, decreased motor tone, and altered activity in neural circuits.

Dosage and Administration Information

How Perdinal is Used in Clinical Practice

Perdinal (Phenobarbital) is administered using specific protocols determined by the clinical scenario, primarily utilizing the oral or parenteral (injection) routes. The choice of route is guided by the required speed of action; the oral route is standard for long-term maintenance, while the intravenous (IV) and intramuscular (IM) routes are reserved for acute or preoperative needs.

For chronic anticonvulsant management, the usual adult dosage is 60 mg to 200 mg daily. Due to the drug’s long elimination half-life, the full daily dose is often administered as a single dose at bedtime, though two or three divided doses may also be used. Full anticonvulsant effects may take two to three weeks to develop when therapy is initiated without an IV loading dose.

Administration Context Adult Dosing Regimen Procedural Constraint
Maintenance Anticonvulsant 60 mg to 200 mg daily (oral) Administered once daily or in divided doses.
Acute Status Epilepticus 15 mg/kg to 20 mg/kg loading dose (IV) IV injection rate must not exceed 60 mg/minute.
Preoperative Sedation 100 mg to 200 mg (IM) Given via deep intramuscular injection.

Usage instructions include high-level considerations for specific patient populations. Older adults and patients with hepatic or renal impairment generally require the selection of a lower starting dose due to potential for reduced clearance. Following prolonged therapy, Perdinal must be gradually reduced over a period of at least one week to prevent the onset of acute withdrawal symptoms upon discontinuation.

Recent Clinical Evidence

Research evidence / Overview of studies for Perdinal

Evidence for Use in Chronic Epilepsy and Recurrent Seizure Disorders

This section will summarize the structure of the clinical evaluation for the maintenance treatment of recurrent seizures, outlining the types of randomized controlled trials (RCTs), systematic reviews, and long-term observational studies that have been conducted in this area.

Research examined the long-term management of recurrent seizures by conducting randomized controlled trials (RCTs). These trials compared its administration against other established antiseizure medications, while systematic reviews and meta-analyses were applied in studies examining the consistency of findings across different research groups. In addition to clinical trials, researchers monitored patients over many years using long-term prospective observational studies to evaluate outcomes reflecting daily functioning or activity level. Research examined changes in seizure frequency and outcomes describing perceived discomfort and functional stability over time. Findings were mixed regarding the long-term effects on cognitive and behavioral measures in children. Consistency across studies is not fully established.


Evidence for Use in Acute Convulsive Emergencies (Status Epilepticus)

This section focuses on the research evaluating Perdinal in acute, continuous convulsive situations, describing the structure of acute intervention trials and multi-center retrospective analyses that examined time-sensitive outcomes.

In the acute setting of continuous convulsive emergencies, Perdinal was evaluated in randomized controlled trials (RCTs) that compared its administration to other emergency intravenous agents. The research context for this application has been described as highly supportive for regulatory review, particularly the studies exploring administration when initial therapies had not achieved control. The research examined outcomes related to seizure termination rate within specified acute timeframes, as well as the rate of maintenance of a seizure-free state over 24 hours. Studies monitored long-term neurological outcomes and functional status tracked over mid-term periods.


Evidence for Use in Short-Term Symptomatic Assistance

This section will outline the limited study base available for Perdinal’s use in providing short-term assistance for acute nervous tension, describing the reliance on case series, audits, and small observational reports.

Perdinal was observed in contexts marked by increased discomfort or tension, such as the preoperative setting or during periods of acute agitation. This research largely consists of limited case series and small observational studies—there is a lack of robust randomized controlled trials for this specific application. Studies explored outcomes related to physical discomfort and acute changes, including the time taken to achieve symptom stability. The evidence base for acute agitation and short-term assistance is categorized as Low.

Key Studies & References

  1. Phenobarbital (MedlinePlus) - Drug Information
  2. Phenobarbital Drug Label / Prescribing Information (e.g., DailyMed)

Frequently Asked Questions (FAQ)

Common questions about Perdinal (FAQ)

Q: How quickly do people typically start to feel a difference after starting Perdinal?

The onset of effect can vary based on the intended purpose. For sedation, the effect typically begins about one hour after taking an oral dose.

However, if the medication is being used for long-term seizure management, official information indicates that the full anticonvulsant effect may take approximately two to three weeks to fully develop in the body.

Q: Are there any common over-the-counter medications that should not be taken with Perdinal?

Official warnings advise against concurrent use with other Central Nervous System (CNS) depressants. This is because combining Perdinal with these products can lead to enhanced CNS-depressant effects, such as extreme drowsiness or respiratory issues.

Official guidance states that individuals should consult with a healthcare professional before combining Perdinal with other medications, particularly those that cause sleepiness, like certain cold or allergy medicines.

Q: Is there a known link between Perdinal and sleep changes/insomnia?

Yes, official regulatory labels list both insomnia (difficulty sleeping) and somnolence (drowsiness) among the reported side effects. This reflects the drug's activity as a CNS depressant, which can result in varying effects on sleep.

Patients experiencing persistent changes in sleep patterns are typically advised to discuss these with their healthcare professional.

Q: Do studies suggest Perdinal works better for certain groups of people than others?

Regulatory documents mention that some groups may react differently to the drug's effects. For instance, pediatric patients and older adults are cautioned against due to the potential for increased sensitivity.

In some of these cases, the drug may cause paradoxical excitement or confusion rather than the intended sedative or anticonvulsant effect. For this reason, official information indicates that a lower starting dose is generally selected for older adults to manage potential sensitivity.

Q: How important is it to finish the full prescription of Perdinal?

Official documents state that Perdinal must be gradually withdrawn over a period of time, as abrupt discontinuation after chronic use is associated with the risk of severe withdrawal symptoms, including convulsions.

This required process of gradual reduction over at least one week ensures the patient’s safety when therapy is being concluded.

Q: What official warnings are attached to Perdinal regarding driving or operating machinery?

Regulatory warnings explicitly caution that the drug may impair the mental and/or physical abilities required for potentially hazardous tasks, such as driving a car or operating machinery.

This warning is based on the drug's primary action as a Central Nervous System (CNS) depressant, which can cause side effects like drowsiness, dizziness, and impaired coordination.

Q: What is the generally expected duration of the effects of a single dose?

Perdinal is classified as a long-acting barbiturate, indicating its effects are sustained over many hours.

The duration of action for a single dose is typically noted in official product information to range from 10 to 12 hours.

Q: Can Perdinal affect mood or cause emotional changes?

Regulatory documents list various neurological and psychiatric disturbances among the reported effects. These include emotional disturbances, confusion, nervousness, and agitation.

In some cases, especially in children and older adults, the medication can lead to paradoxical excitement, which involves increased agitation instead of the intended calming effect.

Q: Does Perdinal contain any ingredients that might trigger a common allergy (e.g., lactose)?

The official product label details all active and inactive ingredients used in the formulation, which may include excipients like lactose or starch. Individuals with known hypersensitivities to any component of the drug are advised not to use the product.

Individuals with known allergies are advised to review the full ingredient list with a healthcare provider.

Q: Do regulatory agencies classify Perdinal as high-risk or low-risk?

Perdinal (Phenobarbital) is categorized by the U.S. Drug Enforcement Administration (DEA) as a Schedule IV Controlled Substance.

This classification reflects that the drug carries a potential for abuse and dependence, which is managed through strict prescribing controls.

Q: Why are baseline tests sometimes required before starting Perdinal?

The drug is contraindicated (prohibited) for use in patients with severe hepatic (liver) or renal (kidney) impairment.

Because of this, the contraindications related to severe liver and kidney impairment indicate that clinicians must assess organ function prior to or during treatment with Perdinal.

Q: What is the general consensus on Perdinal's efficacy from research studies?

Perdinal is clinically recognized for its ability to stabilize brain activity. Its efficacy stems from its mechanism of action: enhancing the brain's main inhibitory neurotransmitter, GABA (gamma-aminobutyric acid).

This action is recognized for elevating the seizure threshold and dampening rapid, irregular electrical signaling in the brain.

Q: What happens if a dose of Perdinal is missed?

Patient information leaflets commonly describe taking the missed dose as soon as it is remembered, unless it is nearly time for the next scheduled dose, in which case the missed dose should be skipped.

Patients are advised not to take extra medicine or double a dose to make up for a missed one. The appropriate guidance for a missed dose is provided by the prescribing health professional or in the patient information leaflet.

Q: Is it normal to feel a change in appetite after starting Perdinal?

Loss of appetite (anorexia) is among the adverse reactions that have been reported by patients using this medication. However, it is not consistently noted as one of the most common initial side effects listed in regulatory documents.

Q: Does Perdinal cause any known effects on laboratory blood tests?

Yes, chronic use of Perdinal has been associated with the possibility of developing megaloblastic anemia, a type of blood cell disorder.

Additionally, the drug may cause changes in certain serum enzyme levels, such as bilirubin.

Q: Does alcohol consumption present a significant interaction risk with Perdinal?

Yes, regulatory warnings explicitly advise against the consumption of alcohol while taking Perdinal. Alcohol is a Central Nervous System (CNS) depressant.

Combining it with Perdinal can dangerously amplify CNS-depressant effects, increasing the risk of severe side effects like extreme sedation and respiratory depression.

Q: Is it okay to take Perdinal with food, or should it be on an empty stomach?

While the regulatory label does not provide a general instruction to avoid food, it notes that the absorption rate of some formulations may be increased if they are taken on an empty stomach.

Guidance on meal timing should be followed as directed by the prescribing health professional.

Q: Is feeling a slight headache a common initial reaction to Perdinal?

Headache is listed among the general adverse reactions reported by patients using this drug.

Headaches that are severe or do not resolve are typically a reason to consult a healthcare professional.

Q: Does Perdinal have any official warnings related to sun exposure?

The drug's official regulatory profile does not list photosensitivity or official warnings related to sun exposure as a common or required precaution.

Q: Can Perdinal be split or crushed, according to the manufacturer?

The manufacturer of the tablet form provides specialized compounding instructions for preparing an oral solution, which involves crushing the tablets.

However, unless instructed otherwise by a healthcare professional, the tablet is intended to be swallowed whole to ensure the medication is released as designed.

How should Perdinal be stored and disposed of?

How to Store and Dispose of Perdinal?

Perdinal (Phenobarbital) must be stored and disposed of according to strict regulatory requirements to maintain stability and ensure safety.

Storage Requirements

Condition Requirement
Temperature Store at Controlled Room Temperature: 20 C to 25 C (68 F to 77 F).
Protection Protect from light and moisture. Injectable solutions must not be used if discolored or if precipitate is present.
Security Keep in a tightly closed, child-resistant container and out of the sight and reach of children. Store in a safe place to prevent theft.

Disposal Instructions

Unused or expired product should be disposed of according to national and local regulations. The preferred method is using an official drug take-back program. The product must not be allowed to enter sewers or ground water. Opened injectable solutions must be discarded immediately after use.

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

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