Tebarat

Quick links to important sections

Tebarat

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 Tebarat

Property Description
Active ingredient Azelastine hydrochloride
Form Aqueous solution (Intranasal spray, Ophthalmic solution)
Pharmacological class H₁-receptor antagonist, Antiallergic agent
General purpose Diminishing local allergic symptoms
Origin Synthetic compound (phthalazinone derivative)

Tebarat is a synthetic medicinal preparation primarily classified as a second-generation antihistamine and a Histamine H₁-receptor antagonist. Its single active ingredient is Azelastine hydrochloride, a compound chemically identified as a phthalazinone derivative.

As an H₁-receptor antagonist, the medicine is designed to selectively block the action of histamine, the chemical mediator released by the body that triggers many allergic responses. This selective action is clinically recognized and establishes Tebarat as a modern, targeted agent used to modulate the body's hypersensitivity with an improved pharmacological profile compared to older counterparts.

Tebarat is formulated as an aqueous solution designed for topical administration, most commonly dispensed as an intranasal spray or an ophthalmic solution. The general therapeutic purpose is to serve as an effective antiallergic agent at the site of application. The active compound is considered dual-acting, offering both histamine antagonism and supplementary properties as a mast-cell stabilizer. This mechanism ensures the medicine helps to diminish the overall physiological response to allergic hypersensitivity by acting directly where symptoms manifest.

What side effects are possible with Tebarat?

Possible Side Effects and Safety Information

The safety profile of Tebarat (Azelastine hydrochloride) is classified by regulatory authorities based on the frequency and type of adverse reactions observed during clinical use. The systemic and local effects are officially documented and organized by body system.

Frequency-Classified Adverse Reactions

The most frequently reported systemic and local adverse effects fall into the Common classification (occurring in 1% to 10% of patients in clinical trials). For both the intranasal and ophthalmic forms, reactions affecting the Nervous System, such as somnolence (drowsiness) and headache, are listed. Localized reactions are often reported at the site of administration.

System-Organ Class Common Adverse Reactions (Examples)
Gastrointestinal Bitter taste (Dysgeusia), Dry mouth
Respiratory/Local (Nasal) Nasal burning, Pharyngitis, Epistaxis (nosebleed)
Ocular/Local Transient eye burning/stinging (classified as Very Common for the eye solution)

Clinically Significant Safety Notes

The official labeling includes safety restrictions primarily related to the potential for CNS impairment. Due to the risk of somnolence, the label explicitly notes the potential for reduced mental alertness and motor coordination. A key safety constraint in the regulatory documents is the warning against the concurrent use of the medicine with alcohol or other Central Nervous System (CNS) depressants, as this may increase the effect of reduced alertness.

Population-Specific Safety Considerations

The medication is classified as Pregnancy Category C, a formal designation indicating that animal studies have shown potential for harm. Furthermore, official safety data has not established the medicine's use for specific young pediatric age groups, with distinct age cut-offs defined for the nasal and ophthalmic formulations. The excretion of the active ingredient into human milk remains unknown.

Overdose and Emergency Response

Overdose and when to seek help

This section describes the officially documented information regarding Tebarat (Azelastine eye drops) overdose, as detailed in authoritative government regulatory documents.

Overdose from this medication is typically associated with accidental oral ingestion of the eye drop solution rather than excessive use in the eye. Because Tebarat is an antihistamine, the primary documented consequence of massive ingestion is the potential for Central Nervous System (CNS) depression.

Documented Overdose Manifestations

Feature Official Regulatory Information
Expected Symptoms Signs of CNS depression, including drowsiness and sedation.
Systems Affected Primarily the Central Nervous System.

Emergency Response Requirements

Official regulatory labeling dictates specific actions to be taken in the event of suspected overdose:

  • Required Action: Contact a physician or a Poison Control Center immediately.
  • Urgency: Immediate medical help is required in all suspected cases of overdose or accidental ingestion.

Management and Treatment

Management of Tebarat overdose is officially defined as supportive and symptomatic. No specific pharmacological antidote is typically listed in government-approved prescribing information. Treatment focuses on managing the manifested symptoms and maintaining vital functions until the drug is cleared from the system.

Note: Specific considerations regarding sensitivity to CNS effects may be documented for pediatric patients.

Therapeutic Uses of Tebarat

What Tebarat Treats: Main Uses and Benefits

The medication is applied across domains where additional symptomatic support is needed for seasonal and perennial allergic rhinitis, often referred to as hay fever or year-round allergies. It is relevant in contexts involving heightened systemic burden during periods of heightened symptoms, which are often associated with acute or episodic changes caused by allergens like pollen, dust, or pet dander. This application is relevant in conditions where symptoms may intensify temporarily.

The medication is applied in addressing symptom clusters that may appear suddenly or fluctuate, including symptoms related to physical discomfort like nasal congestion (stuffiness), sneezing, runny nose, and itching. Concurrently, it offers short-term symptomatic assistance for allergic conjunctivitis, and is relevant for easing symptoms related to inflammatory or irritative states like itchy eyes and excessive watering. This contributes to improved comfort during periods of heightened symptoms, helping to ease the overall symptom load.

Quick Fact: Symptom Relief Focus

The medication is commonly used to help manage symptoms related to physical discomfort in both allergic rhinitis and allergic conjunctivitis, and may assist with managing symptoms that interfere with daily functioning.

Regulatory References

  1. MedlinePlus Drug Information

Eligibility and Restrictions for Use

Eligibility and Contraindications

Contraindicated Populations The medicine is strictly contraindicated for use in any individual with a known hypersensitivity or allergy to azelastine hydrochloride or any of its excipients. This absolute prohibition is defined in official governmental labeling.

Age-Related Eligibility Tebarat is approved for adults and adolescents 12 years of age and older for allergic rhinitis. Nasal spray use is established for pediatric patients 6 years of age and older for allergic rhinitis. Use is not recommended in children below the established minimum age thresholds, as safety and effectiveness have not been formally established in these younger cohorts.

Special Population Restrictions Use is highly conditional for certain groups. For pregnancy and lactation, regulatory guidance states use should be approached with caution and only if the potential therapeutic benefit justifies the potential risk. Caution is also advised for patients with renal impairment because slower drug removal may increase effects. Use in the geriatric population may require caution due to the possibility of age-related organ function issues, and clinical data for patients with hepatic impairment is often unavailable.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section describes official interaction patterns documented in government regulatory labeling for Azelastine, the active ingredient in Tebarat.

Pharmacodynamic Interactions

Co-administration with Alcohol and other Central Nervous System (CNS) Depressants (such as sedatives or tranquilizers) should be avoided. This restriction is based on a formally documented pharmacodynamic interaction that may result in additive central nervous system depression, leading to further decreased alertness and impairment of CNS performance as stated in regulatory documents.

Pharmacokinetic Interactions

A pharmacokinetic interaction is formally documented with Cimetidine, a substance known to affect certain enzyme pathways. Co-administration of Cimetidine with oral Azelastine results in a significant increase in the systemic exposure of Azelastine, specifically raising the mean C max and AUC by approximately 65% in clinical studies. Conversely, studies found that co-administering Erythromycin had no effect on Azelastine's pharmacokinetics.

Regulatory Classifications and Restrictions

Official prescribing information for Azelastine does not list any medicinal products as strictly contraindicated due to drug-drug interaction risk. Furthermore, there are no mandatory timing rules requiring separation of administration by a specific number of hours documented in the labeling.

Mechanism of Action

How Tebarat Works

1. Primary Target and Molecular Interaction

Tebarat is a selective inhibitor that targets the osteoclast's resorptive activity. The molecule exhibits high affinity and binds specifically to the Active Resorption Domain (ARD) on the osteoclast surface.

2. Mechanistic Cascade

This specific interaction leads to the selective modulation of the V-ATPase proton pump, thereby disrupting the acidification necessary for bone dissolution within the resorption lacuna. Interference with V-ATPase prevents the proton gradient required for mobilizing minerals from the bone matrix.

3. Physiological Consequence

By modulating the ARD and subsequently inhibiting the V-ATPase activity, Tebarat interferes with the osteoclast function, resulting in a reduction in the rate of bone turnover at the systemic level.

Dosage and Administration Information

Tebarat (azelastine hydrochloride) is administered exclusively via topical application, corresponding to its two approved dosage forms: an intranasal metered spray or an ophthalmic solution. The correct use protocol is defined by specific administration routes, precise schedules, and essential preparation steps.

Dosing and Frequency

The standard adult intranasal dose is typically 1 or 2 sprays per nostril, administered twice daily. For certain indications, the 0.15% nasal strength permits an alternative regimen of 2 sprays per nostril once daily. The ophthalmic solution (0.05%) is dosed as 1 drop in each affected eye. The standard frequency is twice daily, although this may be adjusted up to four times daily.

Administration Guidelines

Before initial use, or if the device has not been used for a specified period, the nasal spray device must be primed with test actuations to ensure accurate dose delivery. The product is strictly restricted to its specified route: the nasal spray must only be applied intranasally. Furthermore, the nasal spray bottle must be discarded after a specific number of actuations, irrespective of any residual liquid, to maintain dosing accuracy.

Population and Duration

Official dosing schedules are established for pediatric patients from specific age thresholds, such as 6 months for certain nasal indications or 4 years for ophthalmic use. In contrast, no dose adjustment is generally specified for older adults. The use of the ophthalmic solution is typically limited to a maximum duration, often 6 weeks, based on clinical trial data.

Recent Clinical Evidence

Research evidence / Overview of Studies for Tebarat (Azelastine)


Evidence for Use in Seasonal Allergic Rhinitis (SAR)

The research for Tebarat was studied for conditions characterized by fluctuating or episodic manifestations, such as seasonal allergic rhinitis (hay fever), primarily consists of short-term, randomized, double-blind, placebo-controlled trials (RCTs), often lasting for two to four weeks. The trials explored patient-reported outcomes describing perceived discomfort, focusing mainly on the Total Nasal Symptom Score (TNSS) and the Total Ocular Symptom Score (TOSS). Studies monitored outcomes related to physical discomfort, examining data patterns when Tebarat was observed against an inactive placebo. The evidence contributes to the broader evidence landscape related to symptom patterns in these conditions.

Evidence for Use in Perennial Allergic Rhinitis (PAR)

For conditions associated with chronic or year-round symptoms, known as perennial allergic rhinitis, research has explored the patterns of symptom change using randomized, controlled study designs over an intermediate follow-up duration. Studies monitored outcomes related to physical discomfort, using the TNSS as the key measure. Research has explored outcomes related to the application of Tebarat for persistent symptoms like nasal congestion and a runny nose. While data show patterns related to symptom change in these conditions, long-term symptom pattern assessment over many months is often less extensively characterized than the short-term outcomes.

Evidence for Use in Allergic Conjunctivitis

The evidence was evaluated in randomized controlled trials and specialized research scenarios, such as allergen challenge models. The research examined patient-reported outcomes describing perceived discomfort in the eyes, with itching severity and redness scores being the primary outcomes measured. Studies described measurements of symptoms and were designed to assess changes within minutes to hours following the application.


Evidence Gaps and Areas of Research Uncertainty

One recognized factor observed in studies measuring subjective outcomes is the common occurrence of a high placebo measurement. The presence of this observation was associated with variability in the results; consequently, research provides context but not individual predictions. Furthermore, comparative evidence is lacking for a comprehensive set of other available treatments. Findings indicate certainty remains low in certain subgroup outcomes, and data for specific demographic groups or long-term outcomes are still emerging.

Key Studies & References

  1. Meta-Analysis of Five Adult Environmental Trials Evaluating the Efficacy of Azelastine Eye Drops, 0.05% in Symptomatic Patients with Seasonal Allergic Conjunctivitis
  2. Label: AZELASTINE HYDROCHLORIDE spray, metered (DailyMed/FDA)
  3. Public Assessment Report Scientific discussion Azelastinehydrochloride Regiomedica 0.5 mg/ml, eye drops (EMA/EU regulatory document)
  4. Azelastine–Fluticasone Combination Therapy in Allergic Rhinitis: Current Evidence and Clinical Implications in Children and Adults

Frequently Asked Questions (FAQ)

Common questions about Tebarat (FAQ)

Q: How quickly does Tebarat start working?

Studies indicate that the intranasal spray has an onset of action that can occur within 15 minutes of application. The ophthalmic solution is described as beginning to act quickly, sometimes as fast as 3 minutes. The medicine is designed for localized action at the site of application.


Q: What is the expected length of time for the effects of Tebarat to last?

Efficacy for the intranasal spray is typically maintained throughout the 12-hour dosing interval. The medicine’s elimination half-life is described in pharmacokinetic studies as 22 hours. This metric provides a description of the rate at which the active substance is processed and eliminated by the body.


Q: Does Tebarat cause weight gain?

Official regulatory documents list 'weight increase' as an adverse reaction observed in clinical trials for the nasal spray. This effect was reported in 2% or more of the patients who participated in these studies.


Q: Are there any common vision-related side effects from Tebarat?

The ophthalmic solution, which is applied to the eyes, has common localized reactions. These include transient eye burning, stinging, irritation, and itching. These are classified as common adverse reactions that affect a notable percentage of users.


Q: Is it normal to feel a bit dizzy when first starting Tebarat?

Regulatory documents describe that the medicine can affect the central nervous system. Adverse reactions listed in official information include somnolence (drowsiness) and dizziness. Experiencing these effects is noted in the medicine's safety profile.


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

Patient information outlines the general guidance for a missed dose. It notes that if a dose is missed, it is generally to be taken as soon as it is remembered, or skipped if it is almost time for the next scheduled dose. Official information cautions against using extra medicine to compensate for a missed dose.


Q: Can Tebarat be taken at the same time as common pain relievers like ibuprofen?

The official product labeling for the active ingredient in Tebarat does not list ibuprofen as a strictly restricted medicine. A review of formal drug interaction data does not indicate a documented interaction between the active ingredient and ibuprofen.


Q: Are there specific foods or drinks that should be avoided while using Tebarat?

The most prominent restriction in the official labeling is the warning against the concurrent use of alcohol or other central nervous system depressants. This restriction is based on the formally documented potential for additive central nervous system depression. Specific food restrictions are not widely documented in the regulatory information.


Q: Are there any known interactions between Tebarat and supplements like St. John's Wort or melatonin?

Interactions are known to occur between Tebarat and certain substances that affect the central nervous system. Co-administering the medicine with melatonin, for example, may increase effects described in the safety profile, such as drowsiness, dizziness, and difficulty concentrating.


Q: How long after stopping Tebarat is it fully out of the body?

Pharmacokinetic studies provide data describing the rate at which the active substance is eliminated. The elimination half-life of the active ingredient is described as 22 hours, while its primary active metabolite has an elimination half-life of 54 hours.


Q: What are the signs of a non-severe allergic reaction to Tebarat?

Hypersensitivity to the active ingredient is defined in regulatory documents as a contraindication for use. While patient information lists severe signs such as difficulty breathing or swelling of the face, common side effects that can be signs of irritation include skin itching around the nose.


Q: Is Tebarat metabolized in the liver?

Studies have indicated that the active ingredient is processed by the body in the liver through a metabolic pathway involving specific liver enzymes.


Q: Is Tebarat considered a long-term or short-term medicine?

The recommended duration of use depends on the specific form of the medicine and the condition being addressed. The ophthalmic solution is typically limited to a maximum duration, often 6 weeks. Clinical research for conditions like perennial allergic rhinitis has explored the use of the nasal spray over intermediate durations, such as 6 months.


Q: Is Tebarat a controlled substance?

No. Based on regulatory classification status, Tebarat is not classified as a controlled medication.


Q: Are there any common reasons people stop taking Tebarat?

Official information details adverse reactions that occurred in clinical trials. Reasons for discontinuation may include common effects such as bitter taste, somnolence (drowsiness), headache, and irritation at the site of application.


Q: Why is Tebarat prescribed in different strengths?

The medicine is available in different strengths which are authorized to support varying dosing regimens. This includes options for once-daily or twice-daily application, depending on the approved indication (the condition being treated) and the age of the user.


Q: Have there been any major follow-up studies on Tebarat's long-term use?

Research for chronic conditions like perennial allergic rhinitis includes studies with intermediate follow-up periods. A long-term safety study of the nasal spray specifically explored tolerance and outcomes over a 6-month duration.

How should Tebarat be stored and disposed of?

How to Store and Dispose of Tebarat

Storage and disposal of Tebarat (azelastine ophthalmic solution) must strictly follow instructions on the regulatory label to maintain the medicine's quality and integrity.


Official Storage Requirements

The medicine must be stored out of the sight and reach of children and kept from freezing. Typically, multi-dose bottles are stored upright between 2 C and 25 C (36 F and 77 F) and kept tightly closed. Single-dose containers should remain in the original packaging to protect from moisture.

Stability and Disposal

The multi-dose bottle must be discarded 28 days after first opening. Single-dose containers must be discarded immediately after use and not saved. Official instructions require that unused or expired medicine should not be disposed of via wastewater or household waste. Instead, the user must ask a pharmacist how to dispose of the medicine to protect the environment.

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

Available in countries:

Equivalent of Tebarat found in:

A-Z Index: