Пипольфен

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Пипольфен

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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 Пипольфен

Property Description
Active ingredient Promethazine hydrochloride
Form Tablets, Syrup, Injection Solution
Pharmacological class First-generation H1-Antihistamine
Common purpose Allergy relief, Sedation, Anti-nausea
Origin Synthetic chemical entity

What Type of Medicine is Пипольфен (Promethazine)?

Пипольфен is a widely recognized pharmaceutical product whose active ingredient is Promethazine hydrochloride, a substance categorized as an essential medicine. It is primarily categorized as a first-generation H1-antihistamine and belongs to the class of phenothiazine derivatives.

This classification is significant because this older class of antihistamines readily crosses the blood-brain barrier. As a result, Promethazine has effects that extend beyond standard allergy relief, including significant sedation and strong antiemetic (anti-nausea and anti-vomiting) properties. These characteristics are central to the drug's pharmacological action, particularly its ability to suppress nausea and vomiting.

Composition and Physical Forms

The drug is a single-ingredient medication, containing only Promethazine as the therapeutically active substance, which is a synthetic chemical entity. To accommodate various patient needs and clinical situations, Promethazine is produced in multiple dosage forms, including oral tablets, liquid syrups or solutions, and sterile solutions designed for parenteral (injection) administration. The availability of these distinct forms (e.g., oral vs. injectable) is a key feature that supports its use in diverse settings, from routine oral use to scenarios where rapid absorption is necessary.

What is Пипольфен Generally Used For?

Based on its dual action—histamine blocking and central nervous system (CNS) activity—Promethazine is generally used to provide effective relief from allergic reactions and to leverage its calming and anti-nausea benefits. A typical application involves its use in managing symptoms associated with motion sickness during travel, demonstrating its versatility. The overall therapeutic goal is to suppress the allergic response, while also acting as a strong sedative to help promote rest, and as a primary agent for preventing or managing nausea and vomiting. Its pharmacological versatility makes it suitable for a wide range of situations where simultaneous allergy control, reduced nausea, and rest are necessary.

What side effects are possible with Пипольфен?

Possible Side Effects and Safety Information

This section outlines the officially documented adverse effects and safety characteristics of Пипольфен ( Promethazine), based strictly on regulatory documents such as those from the FDA and EMA.


Officially Documented Side Effects

The most commonly expected adverse reaction is sedation (or somnolence), which is classified as Very Common in official regulatory documentation. Other frequently noted effects are primarily related to its antihistamine and anticholinergic properties:

  • Nervous System Effects: Drowsiness, Dizziness, Confusion, Headaches.
  • Anticholinergic Effects: Dry mouth, Blurred vision, Urinary retention.
  • Other: Photosensitivity (avoidance of sun exposure is recommended).

Serious Adverse Reactions and Safety Constraints

Regulatory agencies cite several serious, though rare, adverse reactions and specific usage constraints:

  • Fatal Respiratory Depression: This is a major regulatory concern, leading to the drug being contraindicated in pediatric patients under two years of age and used with extreme caution in those with compromised respiratory function (e.g., sleep apnea, severe COPD).
  • Systemic Risks: Documented serious reactions include Neuroleptic Malignant Syndrome (NMS) and potential Blood Dyscrasias (e.g., Agranulocytosis), which may require blood count monitoring during prolonged use. Severe tissue injury has also been associated with improper injection administration.
  • Contraindications: The medicine is formally contraindicated in comatose states and in individuals with a known hypersensitivity to Promethazine or other phenothiazine derivatives.
  • Caution Required: Use requires caution in specific conditions such as narrow-angle glaucoma, prostatic hypertrophy, severe coronary artery disease, and impaired liver function.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with this medication (Promethazine/Пипольфен) can lead to serious central nervous system and cardiovascular effects, requiring immediate medical attention. In adults, overdose typically presents with profound drowsiness or coma, seizures, and agitation or delirium. Cardiovascular manifestations can include rapid heart rate (tachycardia) and low blood pressure (hypotension).

Anticholinergic effects are also common, characterized by large, fixed pupils, dry mouth, flushed skin, and difficulty urinating. In children, paradoxical excitement, hallucinations, and involuntary movements may be more prominent. Infants and young children are at a particularly high risk for severe respiratory depression (slowed or stopped breathing).

If an overdose is suspected, immediate medical assistance is required. Do not wait for symptoms to worsen. Contact local emergency services or a poison control center right away. Treatment for overdose is supportive and symptomatic, focusing on maintaining cardiovascular stability and respiratory function.

Therapeutic Uses of Пипольфен

The medication is applied across three primary therapeutic domains where short-term supportive management is appropriate, assisting in the management of distressing symptoms during acute episodes. These main uses include the management of allergy, anti-emesis, and sedation. This information is relevant for patients seeking assistance with symptomatic relief across key domains, including managing seasonal and perennial allergic manifestations, addressing nausea and active vomiting (e.g., motion sickness or post-procedural emesis), and providing short-term sedation to relieve anxiety before medical interventions.

Therapeutic Symptom Management

The medication is helpful in situations where symptomatic relief may assist patients in managing difficult episodes of allergic hypersensitivity. It helps address symptom clusters that may appear suddenly or fluctuate, such as itching, hives, sneezing, and runny nose. It is also commonly used when symptoms create noticeable physiological strain, and is relevant in contexts such as motion sickness or following anesthesia. It is commonly used when symptoms intensify and supportive relief is needed. This provides support that helps ease the overall symptom burden associated with procedural stress and may assist with managing the need for rest.


Quick Fact: Relief for Emetic and Allergic Symptoms The medication is commonly used across conditions presenting with acute episodes where short-term symptomatic assistance is needed for both pronounced allergic and anti-nausea effects.

Regulatory References

  1. NIH StatPearls overview on Promethazine

Eligibility and Restrictions for Use

Official Population Eligibility for Promethazine

The eligibility profile for Promethazine (the active ingredient in Пипольфен) is strictly defined by regulatory authorities based on age, physiological status, and pre-existing conditions.

Eligibility Status Defined Population Regulatory Basis
Absolutely Contraindicated Pediatric patients less than two years of age Risk of fatal respiratory depression
Absolutely Contraindicated Patients in a comatose state or with CNS depression Risk of severe CNS impairment
Absolutely Contraindicated Individuals with known hypersensitivity to the drug Prevention of severe allergic reaction
Not Recommended Women who are breastfeeding Excreted into human milk

Age-Related Rules: Use is contraindicated below the age of two years. Caution is mandated for children aged two years and older, requiring the use of the lowest effective dose. Older adults (ge 65 years) may require a reduced dosage and special caution due to increased sensitivity to anticholinergic effects and the risk of postural hypotension.

Conditional Use Requirements: The medicine must be used with caution in patients with: impaired hepatic function or renal insufficiency, a history of epilepsy or seizure disorders, cardiovascular disease, and conditions sensitive to anticholinergic effects such as narrow-angle glaucoma or prostatic hypertrophy. Use should be avoided in patients with compromised respiratory function, such as those with sleep apnea.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile of Promethazine is primarily defined by its strong pharmacodynamic effects and specific regulatory constraints. The most significant interactions involve Central Nervous System ( CNS) Depressants, including alcohol, narcotics, and barbiturates, which are officially documented to intensify and prolong the sedative effects upon co-administration. This requires specific conditions for combined use: for narcotics and barbiturates, official labeling mandates a reduction in the dose of the co-administered CNS depressant by at least one-half to one-quarter.

Co-administration with Monoamine Oxidase Inhibitors ( MAOIs) prolongs and intensifies the anticholinergic and CNS depressant effects. Promethazine also potentiates the effects of other Anticholinergic Agents, which may increase the risk of paralytic ileus. Furthermore, Promethazine is documented to lower the convulsion threshold when used alongside anticonvulsants.

Regulatory Constraints and Procedural Rules:

  • The use of Epinephrine is officially prohibited for the treatment of hypotension resulting from a Promethazine overdose.
  • The co-administration with Beta Blockers (e.g., Propranolol) is documented to increase the plasma concentrations of both agents due to an inhibition of metabolism.
  • A mandatory timing rule requires that this type of antihistamine be discontinued for at least 72 hours before a patient undergoes allergen skin testing.
  • The medication has the potential to cause false results in immunological pregnancy tests.

This summary strictly reflects the high-level interaction patterns and mandated regulatory conditions detailed in government prescribing information.

Mechanism of Action

The mechanism of action for Пипольфен (Promethazine) involves acting as a competitive antagonist across several key receptor systems within both the central and peripheral nervous systems.

Modulating H1 Histamine Signaling

The drug primarily operates by blocking Histamine-1 ( H1) receptors in central and peripheral tissues. This blockade interrupts the histamine-mediated signaling sequence, influencing the histaminergic pathway's signaling dynamics.

Influencing Central H1 and Cholinergic Pathways

In the Central Nervous System (CNS), the drug engages mechanisms that regulate arousal by blocking central H1 receptors. It also exhibits considerable antagonistic activity on muscarinic cholinergic receptors, which modifies early molecular steps in parasympathetic signaling and affects the central histaminergic arousal system.

Antagonizing Dopamine-2 Receptors

The drug supports the regulation of pathways associated with the central control of emesis by blocking Dopamine-2 ( D2) receptors in the brain’s Chemoreceptor Trigger Zone (CTZ). This D2 receptor antagonism prevents the binding of circulating emetic mediators to the Chemoreceptor Trigger Zone, which modulates the initiation of the emetic reflex.

Dosage and Administration Information

Promethazine is administered across multiple distinct routes, including Oral (tablets or syrup), Rectal (suppositories), and Parenteral (injection) routes. The intramuscular (IM) route is generally utilized as the preferred parenteral method. The specific dosage and frequency are determined by the intended high-level purpose.

For managing allergic conditions, the typical adult dosing pattern is often a single 25 mg dose taken once daily, generally at bedtime. Alternatively, a divided regimen may be used, such as 6.25 mg to 12.5 mg administered up to three times per day and on retiring. When used for managing acute anti-nausea symptoms, the adult initial dose is 25 mg, followed by 12.5 mg to 25 mg repeated every 4 to 6 hours as needed. Oral forms may be taken with food or milk to help reduce potential gastrointestinal upset.

Promethazine is primarily intended for short-term use during acute episodes. For specific populations, cautious dose adjustment principles are applied. Dosing for pediatric patients (over 2 years of age) is calculated based on body weight, and the lowest effective dose should be used. Older adults are generally started on the lower end of the adult dose range. The intravenous (IV) route requires dilution of the solution and must be administered very slowly (not exceeding 25 mg per minute).

Recent Clinical Evidence

Пипольфен: Recent Clinical Evidence

Пипольфен (promethazine) is an antihistamine with additional properties that have led to its study in diverse clinical settings, often in combination with other medications. Research typically focuses on its use as an adjunctive agent.


Role as an Adjunctive Therapy

Studies have assessed promethazine's role when combined with analgesics (pain relievers). Findings from preclinical and some clinical research suggest that using promethazine alongside certain NSAIDs (Nonsteroidal Anti-inflammatory Drugs) or opioids may be associated with an increase in the analgesic effect of the primary pain medication. This has been explored as a potential strategy to lower the required dose of the primary analgesic, though specific clinical guidelines are still evolving.


Use in Postoperative Care

Clinical trials frequently examine promethazine's utility in the postoperative setting.

  • Nausea and Vomiting (PONV): Research confirms its effectiveness in preventing or treating Postoperative Nausea and Vomiting (PONV), often compared to other antiemetic agents.
  • Sedation: Due to its sedative properties, promethazine is commonly studied for its ability to induce pre- and postoperative sedation, promoting a quiet, easily aroused sleep state.
  • Opioid Sparing: In some trials, its use as an antiemetic and sedative in the recovery period was associated with a reduction in the total requirement for rescue opioid medication.

Other Investigational Areas

Beyond its primary uses, promethazine's properties as an H1-receptor blocker have led to its inclusion in research on various conditions, including motion sickness prevention and certain specialized toxicological countermeasures, though these are typically not its main clinical focus.

Key Studies & References

  1. Promethazine - StatPearls (NIH Bookshelf): Comprehensive review of indications, mechanisms, and off-label uses.
  2. The Effect of a Combination Treatment Using Palonosetron, Promethazine, and Dexamethasone on the Prophylaxis of Postoperative Nausea and Vomiting and QTc Interval Duration in Patients Undergoing Craniotomy under General Anesthesia: A Pilot Study (Antiemetic combination research).

Frequently Asked Questions (FAQ)

Common questions about Пипольфен (FAQ)


Q: Can children use Пипольфен?

Regulatory documents state that the drug is formally contraindicated, meaning official documents specify it should not be used, in pediatric patients under two years of age. This is due to the risk of potentially fatal respiratory depression (severe breathing problems). For children aged two years and older, official prescribing information notes that the lowest effective dose should be used, with caution.


Q: Is Пипольфен the same as Promethazine?

Yes, Пипольфен is a widely recognized brand name for a medicinal product that contains the active ingredient Promethazine hydrochloride. When reading official information, the terms are often used to refer to the same pharmacological substance.


Q: Is it true that Пипольфен can interact with alcohol?

Yes, official regulatory documents state that taking this drug with alcohol is known to intensify and prolong the sedative and Central Nervous System ( CNS) depressant effects. For this reason, official information documents that use with alcohol should be avoided.


Q: Does Пипольфен interact with cold and flu medications?

Official information generally warns that this drug can potentiate the effects of other anticholinergic agents or CNS depressants, which are common ingredients in cold and flu products. Official information indicates that checking the ingredient list may be helpful to avoid combining agents with similar effects.


Q: Can I take pain relievers like paracetamol with Пипольфен?

According to official patient guidance, taking this drug with common pain relievers such as paracetamol (acetaminophen) is generally considered acceptable. However, official guidance notes that checking the full ingredient list is necessary to ensure one is not accidentally taking too much of a similar substance.


Q: Are there different forms of Пипольфен available (e.g., tablets, injection)?

Yes, the active ingredient in Пипольфен is manufactured in multiple official dosage forms. These typically include oral tablets, liquid syrups or solutions, and sterile solutions that are intended for administration by injection.


Q: What are the key points in the research evidence summary for Пипольфен?

Research evidence primarily supports its use in three areas: 1) the prevention and treatment of Postoperative Nausea and Vomiting ( PONV), 2) promoting sedation (a calming, easily aroused sleep state), and 3) as an adjunctive agent that may be associated with increased pain relief when combined with primary analgesics.


Q: What are the concerns about using Пипольфен during pregnancy?

Regulatory documents state that controlled studies on pregnant women have not been performed. Official guidance indicates that use during pregnancy is only considered if the potential benefits are thought to justify the potential risks, as official data is limited.


Q: How quickly does Пипольфен start to work after taking it?

Official prescribing information indicates that the onset of clinical effects is generally apparent within 20 minutes following oral administration. Following administration by injection (intravenously), the onset of effects is much faster, typically occurring within 3 to 5 minutes.


Q: How long does the effect of Пипольфен usually last?

According to official drug information, the effects of the drug generally last for approximately 4 to 6 hours after a dose. In some specific cases or for certain uses, the effects may persist for a longer duration, up to 12 hours.


Q: Is Promethazine safe for use in older adults?

Official guidance documents that older adults are generally started on the lower end of the adult dose range. Caution is mandated in this population due to increased sensitivity to anticholinergic effects (such as dry mouth) and a heightened risk of postural hypotension (dizziness upon standing).


Q: Is Пипольфен habit-forming or addictive?

Official sources generally document that the drug is unlikely to cause addiction or physical dependence when taken as prescribed. However, the product is primarily intended for short-term use, and prolonged use generally requires review by a healthcare professional.


Q: What is the risk of overdose with Пипольфен?

The risk of overdose is a serious regulatory concern. Symptoms of overdose may include severe drowsiness, coma, agitation, confusion, seizures, irregular heartbeat, and difficulty breathing. Immediate medical attention should be sought if an overdose is suspected.


Q: Is a prescription always required for Пипольфен?

The regulatory status of the drug varies significantly between different countries and regions. In some countries, all formulations are only available with a prescription, while in others, specific lower-strength products may be available over-the-counter ( OTC) with pharmacist advice.


Q: What should I do if I experience a severe, rare side effect?

If a severe or rare side effect is experienced, official safety information indicates that immediate contact with emergency medical services or a healthcare professional should be sought. Patients are also encouraged to report suspected adverse reactions directly to their country’s regulatory body.


Q: Are there any specific foods or drinks to avoid while taking Пипольфен?

No specific foods are documented as requiring avoidance when taking this drug. However, official information notes that the consumption of alcohol should be avoided due to its interaction and the potential for intensified side effects.


Q: What are the visual disturbances sometimes reported with Пипольфен?

Documented adverse effects on vision include blurred vision and, in rare instances, double vision. These effects are often related to the drug's anticholinergic properties, which affect muscles in the eye.


Q: Can I take another antihistamine if I am already taking Пипольфен?

Co-administration with other antihistamines is officially documented as increasing the risk of adverse effects, such as intensified drowsiness, blurred vision, and dry mouth. Combining medications of this type typically requires careful monitoring by a healthcare professional.


Q: What is the recommended approach if Пипольфен causes stomach upset?

To help reduce the potential for stomach upset or gastrointestinal irritation, official prescribing information notes that the oral forms of the drug may be taken with food or milk.


Q: Is the 'paradoxical reaction' (excitement/restlessness) a known effect of Пипольфен?

Yes, regulatory documentation cites that, especially in children, the drug may paradoxically cause excitability, restlessness, or agitation. This is an adverse reaction that is the opposite of the expected sedative effect.


Q: What happens if I miss a scheduled dose of Пипольфен?

Official patient instructions generally advise that the missed dose should be skipped and the next dose should be taken at the usual scheduled time. Taking an extra dose to compensate for a forgotten one is generally advised against.


Q: What makes Пипольфен different from other antihistamines?

Пипольфен is distinguished as a first-generation H1-antihistamine that readily crosses the blood-brain barrier. This leads to its additional properties of strong Central Nervous System ( CNS) sedation and anti-nausea/anti-vomiting properties, which are not characteristic of newer antihistamines.


Q: Does Promethazine affect the results of allergy skin tests?

Yes, official regulatory constraints mandate that this type of antihistamine must be discontinued for at least 72 hours before a patient undergoes allergy skin testing. Its presence in the body has the potential to interfere with and cause false results in these diagnostic tests.


Q: Are there official reports of withdrawal symptoms from Пипольфен?

Official patient information advises that if the drug has been taken for a long period of time and is stopped suddenly, some patients may potentially feel dizzy, sweaty, or sick, or experience a racing heart and trouble sleeping. Due to this potential, slow withdrawal may sometimes be advised by a healthcare professional.


Q: Is the injectable form of Пипольфен used for the same conditions as the tablets?

Yes, the official indications for use—such as for the management of allergic conditions, anti-nausea/vomiting, and sedation—are generally the same across the different formulations. The choice of tablet versus injection is based on the patient’s clinical status and the need for a rapid effect.

How should Пипольфен be stored and disposed of?

Official Storage and Disposal Requirements

Storage and disposal instructions for Promethazine ( Пипольфен) are defined by regulatory labeling to ensure product stability and environmental safety.

Requirement Category Regulatory Standard
Temperature Range Store at controlled room temperature, typically 20 C to 25 C (68 F to 77 F).
Container & Protection Keep the container tightly closed and protected from light.
Child Safety Store the product locked up and dispense in a container with a child-resistant closure.
Disposal Dispose of expired or unused product and its container at an approved waste disposal facility, following all Federal, State, and Local regulations. Environmental release, including draining or flushing, is prohibited.

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

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