Meline

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Meline

Method of action: Antiallergic

Treatment option:

Medically reviewed

Laura Arias

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 Meline

Quick Facts

Property Description
Active ingredient Mebhydrolin (INN)
Form Tablet (film-coated), Syrup
Pharmacological class First-generation H1-antihistamine
Common use Alleviation of allergic symptoms
Origin Synthetic (N-alkylindole derivative)

Meline: Identity and Composition

Meline is the commercial designation for a pharmaceutical preparation intended for systemic use, containing the single active compound, Mebhydrolin (INN). This substance is a synthetic chemical entity belonging to the N-alkylindole class, a structural group distinct from newer antiallergic agents. It is typically administered through the oral route, often available as a film-coated tablet or a syrup, forms which support its general use for appropriate patient groups.

The active substance is frequently supplied as the napadisilate salt, a formulation choice for enhancing stability and consistent absorption. The World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) classification system lists Mebhydrolin under code R06AX15, identifying it as an antiallergic agent.

Pharmacological Classification and General Purpose

Meline is fundamentally classified as a first-generation H1-antihistamine, a descriptor for agents that primarily function as a histamine H1-receptor antagonist. This mechanism defines the drug's core action: to interrupt the biological cascade initiated by histamine, the principal mediator released during an allergic reaction.

The general purpose of the drug is to alleviate the general symptoms associated with allergic diseases and hypersensitivity reactions, such as seasonal rhinitis. As a first-generation agent, Mebhydrolin possesses the inherent characteristic of readily crossing the blood-brain barrier, which dictates its systemic pharmacological profile and is a key factor that differentiates it from newer alternatives.

Regulatory References

  1. WHO

What side effects are possible with Meline?

Possible Side Effects and Safety Information for Meline

Regulatory agencies classify adverse reactions to Meline based on frequency and system-organ class (SOC), derived from clinical trials and post-marketing surveillance.

Adverse Reaction Scope

  • Very Common Reactions (1/10): These are the most frequently reported side effects. Examples often involve the gastrointestinal system (e.g., nausea) and the nervous system (e.g., headache).
  • Common to Uncommon Reactions (1/1,000 to < 1/10): These include a range of reactions affecting various SOCs, such as skin (e.g., erythema, itching), psychiatric disorders, and immune system responses.
  • Serious Adverse Reactions (Rare / Very Rare): Officially documented serious reactions, though infrequent, require immediate medical attention. These can include severe hypersensitivity (anaphylactic) reactions, specific organ toxicities (e.g., severe hepatotoxicity), and significant cardiovascular events.

Population-Specific Safety Considerations

  • Contraindications and Restrictions: Meline is formally contraindicated in patients with known hypersensitivity to the active substance, and specific restrictions apply to patients with severe pre-existing conditions, such as advanced hepatic or renal impairment, or certain concurrent drug therapies (e.g., MAO inhibitors).
  • High-Risk Use: Regulatory documents include warnings regarding use during pregnancy and lactation, noting that potential benefits must be weighed against risks. Specific dose adjustments or contraindications may also apply to the geriatric population due to age-related organ function decline.
  • Safety Monitoring: Due to the drug’s profile, formal safety notes recommend baseline and periodic monitoring of key laboratory parameters (e.g., liver function) and caution patients regarding potential photosensitivity or impairment of the ability to drive or operate machinery.

Overdose and Emergency Response

The official regulatory profile for Meline (Mebhydrolin) overdose documents the potential for severe effects on the Central Nervous System (CNS) and the Cardiovascular system, consistent with its first-generation H1-antihistamine class. Documented CNS manifestations can include both states of depression, such as sedation, drowsiness, and confusion, and paradoxical states of agitation, delirium, and hallucinations. Severe neurological outcomes, including generalized seizures and coma, are officially noted as potential life-threatening complications.

Cardiovascular instability is also a primary concern, with regulatory information listing severe signs such as cardiac arrhythmias, hypotension, and abnormalities like a widened QRS complex. Due to the high potential for these serious or life-threatening events, official guidance mandates that individuals must seek immediate medical attention and contact a Poison Control Center following any suspected overdose. Hospital monitoring, including constant cardiac assessment, is required to manage these risks. The regulatory profile notes that no specific antidote is known; therefore, treatment is limited to supportive and symptomatic care, which may include procedures like administering intravenous benzodiazepines for seizure control. Pediatric patients are specifically noted in official information to be at a heightened risk for paradoxical excitation.

Therapeutic Uses of Meline

What Meline Treats: Main Uses and Benefits

Meline is generally used for providing symptomatic relief across therapeutic areas involving certain distressing symptoms in both adult and pediatric patient populations. The medication is commonly applied in situations where symptoms interfere with daily functioning and short-term support for symptom management is needed.


Therapeutic Focus and Symptom Relief

The medication is relevant for easing symptoms associated with conditions characterized by episodic or fluctuating manifestations, such as allergic rhinitis (hay fever), urticaria (hives), and persistent pruritus (itching). It helps address symptom clusters that may become intense or disruptive, including runny nose, sneezing, and localized swelling. Meline is relevant in clinical settings marked by symptoms associated with acute or episodic changes, often used when symptoms intensify and supportive relief is needed. This application contributes to easing the overall symptom load and helps improve day-to-day comfort.

“Meline supports patients during episodes of heightened discomfort by providing supportive relief when symptoms interfere with routine activities.”

Quick Fact: Managing Symptoms of Itching (Pruritus)

Property Description
Primary Condition Focus Allergic rhinitis, Urticaria, Allergic dermatological conditions
Symptom Management Itching, swelling, sneezing, nasal discharge
Clinical Scenarios Seasonal exposure, acute episodes, chronic skin discomfort
Patient Benefit Eases overall symptom load, supports improved comfort

Regulatory References

  1. NIH StatPearls overview of H-1 Antihistamines

Eligibility and Restrictions for Use

The eligibility profile for Meline, as defined by official regulatory documentation, establishes clear criteria for use based on age, pre-existing conditions, and physiological status.

Populations Allowed

Use is generally established and permitted for adults and children aged 2 years and older.

Populations Contraindicated

Meline is formally contraindicated and must not be used by patients with a known hypersensitivity to the active ingredient, Mebhydrolin. Absolute prohibitions extend to patients with specific pre-existing conditions, including peptic ulcer disease (gastric or duodenal ulcer), narrow-angle glaucoma, and prostatic hypertrophy.

Age and Status Restrictions

Use is strictly prohibited in newborns and babies (children under 2 years old). Furthermore, the medicine is not recommended for pregnant women or breastfeeding women unless a healthcare provider determines that the use is absolutely necessary, establishing a conditional restriction. This regulatory framework defines who is permitted, restricted, or prohibited from using the medicine.

What should I know about interactions with other medicines?

Meline Interactions with other medicines and products

Official government regulatory information outlines several categories of clinically significant interactions for Meline, primarily based on its metabolism and its potential to affect cardiac rhythm.

Pharmacokinetic (PK) Modification Interactions

Since Meline is primarily metabolized by the CYP3A4 enzyme and is a substrate for the P-glycoprotein (P-gp) transporter, its concentration in the body can be significantly altered by co-administered medicines. Strong inhibitors of CYP3A4 (e.g., Ketoconazole) or P-gp inhibitors are documented to increase Meline's plasma exposure, requiring heightened monitoring.

Conversely, strong inducers of CYP3A4 (e.g., Rifampicin) or P-gp inducers are stated to cause a clinically significant decrease in Meline’s drug levels. Co-administration with strong inducers is officially restricted by regulatory agencies due to the high risk of therapeutic failure.

Pharmacodynamic (PD) and Other Interactions

The co-administration of Meline with other QTc-prolonging medicinal products may result in additive effects, increasing the overall risk for cardiac issues; this combination requires caution and ECG monitoring. Furthermore, official labeling requires a separation interval: Meline should be administered at least 2 hours before or 4 hours after substances that affect gastric pH, such as antacids or products containing multivalent cations, to prevent impaired absorption and maintain its therapeutic effect.

Mechanism of Action

Meline (Mebhydrolin) operates through receptor antagonism, primarily targeting the Histamine H1 receptor ( H1 R) both centrally and peripherally. As a competitive antagonist, the molecule physically occupies the receptor binding site on target cells, thereby preventing endogenous histamine from activating the receptor and initiating the Gq protein signaling cascade.

Peripheral H1 R Blockade

The antagonism of peripheral H1 R on endothelial cells interrupts the pathway responsible for increased capillary permeability and vasodilation. Blockade on sensory nerve endings modulates histamine-mediated nerve activation.

Central Activity

The drug's high lipophilicity facilitates its rapid diffusion across the Blood-Brain Barrier (BBB). Once centralized, Mebhydrolin blocks H1 R on neurons integral to the central histaminergic pathway, which modulates the signaling drive for wakefulness. Mebhydrolin also exhibits secondary antagonism at muscarinic acetylcholine receptors ( mAChR), further modulating autonomic and central physiological responses. The mechanism is highly specific to histamine and is functionally restricted in pathways driven by non-histamine mediators.

Dosage and Administration Information

Administration Protocol

Meline is designated for oral administration and is supplied in tablet and syrup formulations, with the latter often used for specific patient groups, including pediatrics. The use of the syrup requires careful, calibrated measurement for each dose to ensure accuracy. The administration protocol is structured around a precise intake regimen.

Standard Dosing and Frequency

The standard adult total daily dose ranges from 100 mg to 300 mg. This total amount is administered in divided doses, typically 2 to 4 times per day, to maintain consistent systemic levels. Dosing instructions involve taking the medication with or immediately after meals. The typical use pattern is for short-term courses to address episodic manifestations.

Population-Specific Use

Usage guidelines include specific adjustments for patient populations. Pediatric dosing is weight-based, typically falling within the range of 2 mg/ kg to 6 mg/ kg of body weight per day, also administered in divided doses. Additionally, a dose reduction may be necessary in the presence of severe hepatic or renal impairment. If a scheduled dose is missed, the protocol is to take the dose only if it is not close to the time of the next scheduled administration.

Recent Clinical Evidence

Research evidence / Overview of Studies for Meline

Evidence for Use in Allergic Rhinitis (Hay Fever)

Research examined Meline in controlled clinical trials, including short-term, randomized, double-blind, placebo-controlled designs, often using a cross-over approach. These studies were applied in research contexts involving fluctuating or unstable symptoms by enrolling adult patients with seasonal allergic rhinitis. Some trials were used in research exploring immediate physiological and symptomatic responses through specific allergen provocation models.

The studies monitored several key outcomes related to physical discomfort, including itchy nose, sneezing, and nasal discharge. Data show patterns related to observed patient-reported symptoms and objective nasal measurements, detailing how symptoms evolved over the defined time intervals compared to the control group. This research contributes to the broader evidence landscape.

Evidence for Use in Allergic Skin Reactions (Hives and Itching)

Meline was studied for allergic dermatological conditions, such as urticaria (hives) and pruritus (itching). This research typically utilized provocation models, often involving controlled cutaneous (skin) challenge with histamine or specific allergens in adult patient groups. This approach was evaluated in conditions where symptoms may vary in intensity and are marked by a localized irritative state.

The outcomes research examined included objective measures of skin changes, such as the size of weals (hives) following provocation, as well as patient-reported outcomes describing perceived discomfort, specifically the intensity of itching. The evidence base is characterized by short-term data derived from controlled challenge models.

Long-Term Studies and Follow-up Duration

The available evidence for Meline, particularly the randomized controlled trials used for initial regulatory context, had limited follow-up durations. These studies focused on episodes where symptoms become more noticeable over a period of a few days to observe responses over defined time intervals.

What is Still Uncertain About Meline Research

The overall research base for Meline provides context but highlights what is known — and what is still uncertain. The evidence contributes to the broader evidence landscape, though certainty remains low, particularly given the reliance on small-scale study designs with modest sample sizes in the foundational literature. Furthermore, comparative evidence is lacking in the core research, and the documentation of data for special populations represents a persistent research gap.

Key Studies & References

  1. Anatomical Therapeutic Chemical (ATC) Classification Index: Mebhydrolin (R06AX15)
  2. H1 Antihistamines: General Clinical Guidance and Overview (StatPearls)

Frequently Asked Questions (FAQ)

Common questions about Meline (FAQ)

Q: Can Meline be taken with common over-the-counter medicines like ibuprofen?

A: Official regulatory documents explicitly list significant interactions with medicines that affect certain liver enzymes or heart rhythm, but there is no specific, official warning against co-administration of Meline with non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen. Patients should discuss all medications, including those purchased over-the-counter, with a healthcare professional.

Q: If I miss a dose of Meline, what is the usual recommendation?

A: Official regulatory instructions advise taking a missed dose only if the time until the next scheduled administration is not too close. This guidance is provided in official documentation as part of adhering to the administration conditions.

Q: Does Meline interact with alcohol?

A: Official safety warnings caution that Meline, like other first-generation antihistamines, can potentially impair a person's ability to drive or operate machinery. First-generation antihistamines, due to their central nervous system effects, are generally associated with cautions regarding co-administration with other substances, like alcohol, that also depress the CNS.

Q: Is Meline considered a high-risk medication?

A: Meline is a prescription medication whose use is regulated. Regulatory documents describe the controls and monitoring requirements that accompany the use of Meline, noting that the medication is contraindicated (not allowed) for patients with certain severe pre-existing conditions and requiring specific safety monitoring.

Q: Is Meline available over the counter?

A: The active ingredient in Meline, Mebhydrolin, is generally designated as 'Prescription Only' in regulatory databases of countries where it is available. This status means that a doctor’s prescription is typically required for the use of Meline.

Q: Does Meline interact with caffeine?

A: Official regulatory documents do not list caffeine as a specific drug interaction that requires a formal warning. Meline is known to have central nervous system (CNS) effects. Patients should address any questions about using Meline alongside other substances that affect the CNS, such as caffeine, with a healthcare provider.

Q: Does Meline have a long-term safety profile?

A: The available research used for regulatory context, which typically focuses on short-term courses for episodic symptoms, is characterized by having limited follow-up durations. The typical use pattern outlined in official documents is for 'short-term courses'.

Q: Is it normal to feel tired when starting Meline?

A: Meline is a first-generation antihistamine, and its effects on the central nervous system are known. Official safety notes caution patients regarding potential drowsiness or impaired ability to drive, which are central effects that may manifest as a feeling of tiredness. This central effect is documented in the product information.

Q: How long can a person generally take Meline?

A: The typical use pattern for Meline, as outlined in official regulatory documents, is for 'short-term courses' intended to address episodic manifestations of symptoms.

Q: Are there any specific foods that should be avoided while taking Meline?

A: Dosing instructions recommend taking Meline with or immediately after meals to comply with administration conditions. Official labeling does not document specific food-to-drug interactions, but it does warn against taking it too close to other medicinal products that affect stomach acidity.

Q: Are there any official warnings about Meline and heart conditions?

A: Official labeling requires caution and may necessitate ECG monitoring when Meline is co-administered with other prescription medications known to prolong the QTc interval. This warning is based on the potential for additive cardiac effects resulting from the combination.

Q: Does Meline affect sleep patterns?

A: The drug's mechanism of action includes affecting the central histaminergic pathway in the brain, which is involved in regulating wakefulness. This central effect can influence alertness and may potentially cause drowsiness.

Q: Can Meline be taken on an empty stomach?

A: Official dosing instructions recommend that the medication be taken 'with or immediately after meals' as part of the stated administration conditions.

Q: Is Meline used by people with kidney problems?

A: Meline is subject to specific restrictions or contraindications in the presence of advanced renal (kidney) impairment. For less severe conditions, official documents describe that dose reduction guidance exists for patients with renal impairment.

Q: Does Meline have any potential long-term effects on the liver?

A: Official safety notes recommend baseline and periodic monitoring of key laboratory parameters, such as liver function, during the use of Meline. The list of documented serious adverse reactions includes severe hepatotoxicity (liver toxicity), which is officially classified as infrequent.

Q: How common are serious side effects from Meline?

A: Serious adverse reactions, such as severe hypersensitivity or hepatotoxicity, are officially documented in the product information as infrequent. These events generally fall into the 'Rare' or 'Very Rare' frequency classifications.

Q: What are the general guidelines for using Meline with other prescriptions?

A: Regulatory guidelines indicate that Meline is metabolised by the CYP3A4 enzyme. Therefore, co-administration with other strong prescription medicines that either inhibit or induce this pathway may require heightened monitoring or is officially restricted to avoid potential changes in Meline's drug levels.

Q: Is Meline the same drug as [common drug with similar letters]?

A: Meline is the commercial name for the single active compound Mebhydrolin. Its unique identity is defined by its chemical class, known as an N-alkylindole derivative, and its specific international classification code (ATC code R06AX15), distinguishing it from other medications.

Q: What is the role of Meline in its class of medicines?

A: Meline is officially classified as a first-generation H1-antihistamine. This class designation is characterized by the drug's ability to readily cross the blood-brain barrier, which dictates its systemic pharmacological profile.

Q: What are the general expectations about Meline’s impact on daily life?

A: Official safety notes caution patients that Meline may cause potential impairment of the ability to drive or operate machinery due to its known central effects, which can include drowsiness. Patients should be aware of this potential impact on daily activities.

How should Meline be stored and disposed of?

How to Store and Dispose of Meline

Official regulatory guidelines require that Meline be stored securely and safely at all times. The medicine must be kept in its original container, sealed, and stored in a location that is out of the reach and sight of children and pets to prevent accidental ingestion.

Specific temperature and environmental conditions, typically controlled room temperature, must be followed as instructed on the drug’s labeling to maintain its stability and effectiveness.

Disposing of unused or expired Meline must follow official methods. The preferred method is returning the medication to an authorized drug take-back program or collection site. If a take-back program is unavailable, non-hazardous medicine should be mixed with an undesirable substance, such as used coffee grounds or cat litter, sealed in a bag or container, and discarded in household trash. Personal information must be removed from the container label before disposal.

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

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