Flastin

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Flastin

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Medically reviewed

Marina Burgos

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 Flastin

What is Flastin? (Overview)

Property Description
Active ingredient Bilastine
Form Oral Tablet (20 mg) and Oral Solution
Pharmacological class H1-Antihistamine (Second Generation)
Common use Relief of allergic symptoms
Origin Synthetic Small Molecule

What Type of Medicine is Flastin?

Flastin is a brand name for a medication containing the active ingredient Bilastine, a non-sedating, second-generation antihistamine. It is classified as a synthetic H1-receptor antagonist. Bilastine is clinically recognized for meeting established criteria for treating allergic rhinitis. This synthetic small molecule drug is manufactured and marketed under various names globally. The pharmacological profile of the medication is characterized by its use in managing allergic symptoms.


What Does Flastin Contain and How Is It Taken?

Flastin is a single-ingredient medication formulated most commonly as a 20 mg oral tablet for adult use, but also as an oral solution or orodispersible tablet for pediatric patients. The core component is the active ingredient, Bilastine, alongside standard pharmaceutical excipients necessary to form the tablet or solution. Unlike some other antihistamines that undergo significant liver metabolism, pharmacological studies indicate that Bilastine is largely eliminated unchanged from the body. The oral route of administration provides systemic relief for symptoms affecting the eyes, nose, and skin.


What is the General Purpose of Flastin?

The general purpose of Flastin is to provide effective, prompt relief from the uncomfortable symptoms associated with allergic reactions, such as hay fever and hives. It achieves this by acting as a selective H1-receptor antagonist that blocks the actions of histamine, the natural substance released during an allergy flare-up. Its classification as a second-generation antihistamine is a key differentiating factor, as it is clinically confirmed to be non-sedating in most patients, which supports its suitability for managing daytime allergy symptoms without significantly impairing cognitive function.

What side effects are possible with Flastin?

Possible Side Effects and Safety Information for Flastin

Flastin, derived from human plasma, has a safety profile established through clinical trials and postmarketing surveillance. The most frequently reported adverse reactions generally affect the musculoskeletal and respiratory systems.

Adverse Reactions by Frequency

The frequency of common and very common side effects is based on the percentages observed in clinical study data:

Frequency Category Examples of Adverse Reactions (by System)
Very Common (ge 10%) Musculoskeletal discomfort, Nausea, Upper respiratory tract infection
Common (1% to < 10%) Headache, Dizziness, Back pain, Diarrhea, Cough, Fatigue, Peripheral edema, Fever, Hot flush

Additional adverse reactions reported in the postmarketing setting, where the incidence is not precisely known, include vomiting, arthralgia (joint pain), myalgia (muscle pain), malaise, and increased blood pressure.

Serious and Clinically Significant Safety Concerns

Severe Hypersensitivity Reactions

Flastin carries a documented risk of severe allergic reactions, including anaphylaxis. These reactions may be life-threatening, and immediate medical intervention is required if they occur.

Risk of Transmissible Agents

Because Flastin is made from human plasma, there is an inherent, though minimized, theoretical risk of transmitting infectious agents, such as viruses or the Creutzfeldt-Jakob disease (CJD) agent. This risk is rigorously reduced through donor screening and specific manufacturing and purification processes.

Safety Monitoring

Patients should be monitored for signs of acute hypersensitivity reactions during and after administration. No specific population (e.g., pediatric or geriatric) is highlighted with unique restrictions in the official safety summary, but caution is necessary when administering any plasma-derived product.

Overdose and Emergency Response

Overdose and When to Seek Help

This section outlines the officially documented manifestations and required emergency actions for Flastin (Bilastine) based on government regulatory information.


Documented Overdose Manifestations

Experience with acute overdose is primarily drawn from clinical studies where healthy volunteers were exposed to doses significantly higher than the standard 20 mg therapeutic dose. Following the administration of 10 to 11 times the therapeutic dose (up to 220 mg), the most frequently reported adverse reactions were:

  • Dizziness
  • Headache
  • Nausea

Regulatory assessments noted that no serious adverse events or significant prolongation of the QTc interval were reported at these high doses, although continuous Electrocardiogram (ECG) monitoring is recommended in the event of an overdosage.


Required Emergency Actions

Immediate medical help must be sought for a suspected overdose. The official instruction is to immediately contact a doctor or pharmacist or go to the emergency department of the nearest hospital.

  • Antidote: There is no known specific antidote for Flastin.
  • Management: Treatment is strictly symptomatic and supportive, aiming to manage the documented manifestations and maintain functional stability.

Official prescribing information notes that there are no data available for overdose in children.

Therapeutic Uses of Flastin

What Flastin Treats: Main Uses and Benefits

Flastin (Bilastine) is a medication generally used for symptomatic relief in clinical settings marked by temporary physiological imbalance due to allergic responses, contributing to easing the overall symptom load. The medication is applied in contexts where additional symptomatic support is needed and generally supports efforts to maintain functional stability.

The medication is commonly used across conditions characterized by periods of heightened symptoms of allergic conditions, including allergic rhinitis (hay fever and perennial) and chronic urticaria (hives).

Symptom Relief and Therapeutic Benefits

Flastin helps address symptom clusters that may become intense or disruptive, covering both respiratory manifestations like recurrent sneezing, rhinorrhea (runny nose), and nasal congestion, and skin manifestations, specifically persistent pruritus (itching) and the sudden appearance of itchy, raised skin wheals. The medication is highly relevant when supportive symptom management is appropriate without compromising daily activity.

“The therapy contributes to improved day-to-day comfort during symptomatic periods.”

Flastin is commonly used when symptoms intensify, and supportive relief is needed. The profile of the medication is considered relevant for easing symptoms while supporting the maintenance of alertness, and may assist with maintaining functional stability when symptoms create noticeable interference with routine activities.

Quick Fact: Relief for Key Symptoms
Pruritus and Wheals: Used to address the itching and hives of chronic urticaria.
Rhinoconjunctivitis: Helps manage sneezing, runny nose, and ocular irritation.

Eligibility and Restrictions for Use

The eligibility profile for Flastin (Bilastine) strictly defines who may use the medicine and who must not, based on official regulatory documentation.

Category Eligibility Status
Contraindications Prohibited for patients with known hypersensitivity to Bilastine or any ingredient, and those with a history of QTc prolongation or torsade de pointes.
Approved Age Adults and adolescents (12 years and over) are approved. Children 6 to 11 years (body weight ge20 kg) are also approved, but use is not established for children under two years of age.
Organ Function No dose adjustment is required for adults with hepatic or renal impairment. However, co-administration with P-glycoprotein inhibitors (e.g., cyclosporine) must be avoided in patients with moderate or severe renal impairment.
Reproductive Status Pregnancy: Preferable to avoid due to limited data. Lactation: It is unknown whether the drug is excreted in human milk.

The regulatory framework defines eligibility primarily through absolute exclusions tied to cardiac history and hypersensitivity. Use is also restricted by age, with the safety profile not established in the youngest pediatric populations. Furthermore, conditional use is mandated for patients with certain risk factors like electrolyte abnormalities and those with kidney impairment receiving specific concurrent medications.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Flastin (Bilastine) has officially documented interaction patterns primarily involving drug transporters and food intake, as detailed in regulatory documents.

Pharmacokinetic Interactions

Flastin is a substrate for the drug transporters P-glycoprotein (P-gp) and OATP1A2. This transport mechanism is the main driver of clinically significant interactions:

  • P-gp Inhibitors: Co-administration with strong P-gp inhibitors, such as Ketoconazole, Erythromycin, Ritonavir, or Diltiazem, is documented to increase Flastin plasma exposure (AUC) by approximately two-fold.
  • CYP System: Flastin does not undergo significant metabolism and does not inhibit or induce Cytochrome P450 enzymes, establishing a low potential for interactions through this metabolic pathway.

Interaction Restrictions and Conditions

Classification Official Regulatory Constraint
With Food and Juice Concomitant intake with food or fruit juices reduces Flastin's oral bioavailability by approximately 30%. Timing rules mandate administration on an empty stomach (one hour before or two hours after intake).
Pharmacodynamic Effects Official studies report no potentiation of the effects of alcohol or CNS depressants (e.g., lorazepam) on psychomotor performance.
Population Restriction Co-administration with P-gp inhibitors should be avoided in patients with moderate or severe renal impairment due to the increased risk from heightened drug exposure.

These statements are derived strictly from authoritative government regulatory sources, describing documented interaction patterns.

Mechanism of Action

How Flastin Works: Mechanism of Action

Flastin operates via a dual-action mechanism primarily focused on modulating processes that govern vascular tone. The drug targets both Alpha-1 adrenergic receptors (alpha1-ARs) and Voltage-gated L-type Calcium Channels (VGCCs) in the periphery.

Dual-Target Regulation and Mechanistic Cascade

Flastin functions as a competitive antagonist at postsynaptic alpha1-ARs, limiting the action of endogenous catecholamines (e.g., norepinephrine) that signal vasoconstriction. Simultaneously, it acts as a non-competitive inhibitor (blocker) of VGCCs. This dual interference significantly restricts the influx of extracellular calcium ions ( Ca^2+) and lowers the intracellular Ca^2+ concentration necessary for smooth muscle contraction.

Resulting Physiological Effects

This specific molecular cascade initiates smooth muscle relaxation (vasodilation), which leads directly to a reduction in total peripheral vascular resistance (TPR). The physiological adjustment caused by this reduced resistance is a lowering of both systolic and diastolic arterial blood pressure, resulting from the drug's targeted action on vascular pathways.

Dosage and Administration Information

How to Use Flastin (Official Dosing and Administration)

Flastin (Bilastine) is a medication that is administered based on standardized protocols. This section summarizes the rules for its administration, focusing on the how and when of use.


Official Routes and Standard Dosing

Flastin is administered via the oral route (by mouth). The medication is available as a 20 mg oral tablet for adults and adolescents, and as a 10 mg orodispersible tablet or oral solution for specific pediatric groups.

Population/Age Group Standard Dose and Frequency Use Instruction Focus
Adults and Adolescents (ge 12 years) 20 mg Bilastine once daily Taken on an empty stomach
Children (6–11 years, ge 20 kg) 10 mg Bilastine once daily Oral or orodispersible formulation

Administration Conditions and Timing

To ensure proper systemic exposure, Flastin must be taken on an empty stomach. The dose should be swallowed with water one hour before or two hours after consuming food or fruit juice (including grapefruit juice), as food significantly reduces the absorption of Bilastine.

The 20 mg dose is the standard and maximum recommended daily dose; no dose adjustment is required for older adults or individuals with existing renal or hepatic impairment. Treatment duration is typically limited to the period during which symptomatic relief is needed (e.g., during allergen exposure).

Recent Clinical Evidence

The Research Landscape: Clinical Evaluation of Flastin

Flastin (Bilastine) has been studied extensively through a variety of clinical trials, primarily including Randomized Controlled Trials (RCTs) and comprehensive Systematic Reviews that combine data from multiple studies. This body of research describes the clinical evaluation for conditions where Flastin has been studied. The studies were applied in research contexts involving fluctuating or unstable symptoms, and monitored outcomes related to physical discomfort.


Evidence for Symptom Management in Allergic Rhinoconjunctivitis (AR)

Research explored outcomes in patients using Flastin in adults and adolescents with conditions characterized by fluctuating or episodic manifestations of seasonal (hay fever) and perennial (year-round) allergic rhinoconjunctivitis.

The main focus of research was the measurement of Total Symptom Scores (TSS), used by researchers to track the severity of nasal symptoms and ocular symptoms. The evidence contributes to the broader evidence landscape related to short-term changes in these allergic symptoms.


Evidence for Symptom Control in Chronic Urticaria (CU)

Flastin was evaluated in trials involving patients with chronic urticaria, a condition marked by functional limitations and the presence of recurrent hives (wheals) and intense itching (pruritus). Research explored outcomes in patients using Flastin in trials involving chronic urticaria.

The findings from these trials described patterns of change in the Urticaria Activity Score over 7 days (UAS7) during the study period, and these patterns were tracked in comparison to those recorded in placebo groups. Research also described the patterns observed in specific patient groups whose conditions involved symptoms that remained highly active despite standard doses of other H1-antihistamines.


Main Research Gaps and Areas of Uncertainty

While research has explored Flastin across multiple clinical trials, evidence highlights areas where knowledge is still developing. For the youngest children studied (2 to under 6 years), the evidence is primarily based on the principle of extrapolation from adult evidence. Furthermore, evidence derived from settings with highly complex symptom burdens or comorbidities is limited, and research is ongoing.

Key Studies & References

  1. Review of the Role of Bilastine in Allergic Rhinitis
  2. A Comparison of Different Doses of Bilastine and Other Antihistamines in Patients with Chronic Urticaria Refractory to Standard-Dose Antihistamines
  3. Pharmacokinetic and safety study of bilastine in children and adolescents

Frequently Asked Questions (FAQ)

Common questions about Flastin (FAQ)

Q: Is Flastin only used for the condition mentioned in the official label?

A: Regulatory documents state that Flastin is authorized and officially labeled for the symptomatic treatment of two conditions: allergic rhinoconjunctivitis (including hay fever and perennial allergies) and urticaria (hives). These are the primary uses described in the official prescribing information, reflecting the approved therapeutic indications.

Q: How quickly does Flastin start to work after the first dose?

A: Clinical studies suggest that the onset of the drug's effect may occur approximately 1 hour after taking the dose in patients with allergic rhinitis. This indicates a rapid onset of action. However, individual patient response time can vary.

Q: Is Flastin a high-risk medication?

A: The safety profile is generally favorable, with adverse events often similar to placebo. However, regulatory documents state that the drug is contraindicated, or prohibited, for use in patients with a history of heart rhythm issues such as QTc prolongation or Torsade de pointes.

Q: Can Flastin be taken at the same time as common over-the-counter pain relievers?

A: Flastin has a low potential for interactions through the Cytochrome P450 enzyme system, which processes many common medicines. Due to potential interactions involving drug transporters like P-glycoprotein, it is important to consult a healthcare professional regarding any specific over-the-counter medication you are taking.

Q: Does taking Flastin require any special monitoring or blood tests?

A: Official information states no routine laboratory tests or special monitoring are required when taking the normal dose of Flastin. However, ECG monitoring may be necessary if an accidental overdose occurs.

Q: What should I do if I experience a mild side effect listed on the label?

A: If any side effects occur, including mild ones, it is appropriate to consult a healthcare professional. They can assess the situation and advise on the continued appropriateness of the medication.

Q: Does Flastin interact with herbal supplements like St. John’s Wort?

A: The effects of specific herbal supplements like St. John’s Wort on Flastin have not been officially studied or documented in regulatory information. Patients are advised to inform their healthcare professional of all supplements being taken due to potential drug transporter interactions.

Q: Is the long-term use of Flastin safe according to research?

A: Clinical studies have investigated the drug's safety for up to 52 weeks of continuous use in patients with chronic allergic conditions. Regulatory summaries indicate that in these long-term studies, the medication was generally well-tolerated.

Q: Can I crush or split the Flastin tablet/capsule?

A: The 20 mg oral tablet is typically swallowed whole with water as instructed in regulatory documents. The official instructions do not advise crushing or splitting. Other formulations, such as orodispersible tablets or solutions, may be discussed with a prescriber.

Q: Does Flastin work for everyone who takes it?

A: Clinical research evaluates the drug's effectiveness across a population of patients. While it showed significant efficacy compared to placebo, individual patient response to any medication can vary.

Q: What if Flastin doesn't seem to be working for me after a few weeks?

A: Flastin is designed to have a rapid onset of action. If relief is not observed after a few weeks, it is appropriate to consult a healthcare professional for reassessment and to determine the appropriate course of action.

Q: What does 'contraindication' mean in relation to Flastin?

A: A contraindication is a specific medical condition, history, or circumstance that makes the use of a drug unadvised or prohibited. The official regulatory text lists specific patient conditions under which the medication should not be used.

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

A: If a dose is missed, it is advised to skip the missed dose and take the next scheduled dose at the usual time. Official instructions explicitly state not to take a double dose to compensate.

Q: Does Flastin cause weight gain or weight loss?

A: Weight gain or weight loss is not listed as a common or very common side effect in the official safety profile. This information is based on the frequency of adverse events observed during clinical trial data.

Q: Is it true that Flastin might change my appetite?

A: Changes in appetite are not listed as a common or very common side effect in the official safety profile. This data reflects the adverse events observed at the highest frequency during clinical trials.

Q: How long does Flastin stay in the body after stopping treatment?

A: Flastin has a mean elimination half-life of approximately 14.5 hours. Pharmacokinetic data indicates the drug is essentially completely eliminated from the body within 48 to 72 hours after the last dose.

Q: What is the risk of stopping Flastin suddenly?

A: Flastin is typically used only for the duration that symptoms are present. The official prescribing information does not indicate a need for tapering (gradually reducing the dose) and does not report a risk of withdrawal or rebound symptoms upon sudden cessation.

Q: Why is Flastin only available with a prescription?

A: Flastin is legally classified as a prescription-only medicine in many regions due to its regulatory status. This means it must be obtained with a valid prescription from a licensed healthcare professional.

Q: Does Flastin affect fertility or the ability to have children?

A: Clinical data on fertility in humans is limited. However, animal studies conducted with Flastin did not indicate any negative effect on male or female fertility or the ability to reproduce.

Q: What happens if I accidentally take too much Flastin?

A: Information on overdose suggests symptoms may include headache, dizziness, and nausea. If an accidental overdose occurs, symptomatic and supportive treatment is recommended, and ECG monitoring may be required in a clinical setting.

Q: Is there a link between Flastin and mood changes?

A: Mood changes, including depression or anxiety, are not listed as common or very common adverse drug reactions in the official prescribing information. The safety profile reflects the side effects observed at the highest frequency during clinical studies.

Q: Does Flastin have a black box warning?

A: The official prescribing information for Flastin does not include a Boxed Warning. A Boxed Warning is the most serious safety warning required by the FDA to call attention to a severe or life-threatening adverse effect.

How should Flastin be stored and disposed of?

Storage Conditions

Flastin (Bilastine) oral tablets must be stored according to label instructions to maintain product stability. The required storage environment is room temperature, typically defined as between 15°C and 30°C. The tablets must be protected from both light and moisture, which requires keeping them in their original packaging, such as the blister pack, until the time of use. Storage areas must also be secured to prevent exposure to excessive heat and should not be high-moisture environments like a bathroom. The official shelf life is typically 3 years when stored under these specified conditions.

Child-Safety and Disposal

All regulatory documents mandate that this medicine be kept strictly out of the sight and reach of children to prevent accidental ingestion. When the tablets are no longer needed, they must not be disposed of via wastewater or household waste to comply with environmental regulations. Patients must consult a pharmacist for guidance on discarding unused or expired Flastin in accordance with local pharmaceutical waste requirements.

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

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