Bilastin Teva
Bilastine 20 mg — Second-generation antihistamine for allergic rhinitis and urticaria
Quick Facts About Bilastin Teva
Key Takeaways About Bilastin Teva
- Non-sedating antihistamine: Bilastine causes minimal drowsiness compared to first-generation antihistamines and even some other second-generation options like cetirizine
- Take on an empty stomach: Must be taken 1 hour before or 2 hours after food or fruit juice for optimal absorption — food reduces bioavailability by up to 30%
- Once-daily dosing: One 20 mg tablet per day provides 24-hour symptom relief for both allergic rhinitis and urticaria
- No hepatic metabolism: Bilastine is not significantly metabolized by the liver, resulting in fewer drug interactions than many other antihistamines
- Proven efficacy: Clinical trials demonstrate bilastine 20 mg is as effective as cetirizine 10 mg for allergic rhinitis and desloratadine 5 mg for urticaria, with a superior tolerability profile
What Is Bilastin Teva and What Is It Used For?
Bilastin Teva is a prescription antihistamine containing bilastine 20 mg, used to treat symptoms of allergic rhinitis (hay fever) and chronic spontaneous urticaria (hives) in adults and adolescents aged 12 years and older. It works by selectively blocking histamine H1 receptors, providing 24-hour relief from sneezing, itching, nasal congestion, and skin wheals.
Bilastine belongs to the second-generation class of antihistamines, which are specifically designed to provide effective allergy relief while minimising the sedative side effects associated with older antihistamines such as diphenhydramine and chlorpheniramine. Approved by the European Medicines Agency (EMA) in 2010, bilastine has since become widely available across Europe, Asia, and Latin America as a first-line treatment option for allergic conditions.
The active substance, bilastine, is a selective and potent histamine H1 receptor antagonist. Unlike first-generation antihistamines, it does not significantly cross the blood-brain barrier at therapeutic doses, which explains its low incidence of sedation. It also lacks clinically meaningful anticholinergic activity, meaning it does not cause the dry mouth, blurred vision, or urinary retention commonly associated with older antihistamines.
Bilastin Teva is manufactured by Teva Pharmaceutical Industries, one of the world's largest generic pharmaceutical companies. The formulation is bioequivalent to the originator product and meets the same quality, safety, and efficacy standards required by regulatory authorities.
Indications
Bilastin Teva 20 mg tablets are indicated for:
- Seasonal allergic rhinitis (hay fever): Relief of nasal and ocular symptoms such as sneezing, rhinorrhoea (runny nose), nasal itching, nasal congestion, itchy eyes, watery eyes, and red eyes triggered by pollen or other seasonal allergens
- Perennial allergic rhinitis: Year-round nasal symptoms caused by persistent allergens such as dust mites, pet dander, and mould
- Chronic spontaneous urticaria: Relief of itching (pruritus) and wheals (hives) in patients with chronic spontaneous urticaria, a condition characterised by recurrent episodes of hives lasting more than 6 weeks without an identifiable external trigger
How Does Bilastine Work?
When you encounter an allergen — such as pollen, dust mites, or pet dander — your immune system releases histamine from mast cells and basophils. Histamine binds to H1 receptors on various cells throughout the body, triggering the classic symptoms of allergy: sneezing, itching, swelling of the nasal mucosa, increased mucus production, and skin reactions like hives.
Bilastine works by competitively and reversibly binding to H1 histamine receptors, preventing histamine from activating these receptors. This blocks the downstream cascade of allergic symptoms. In pharmacological studies, bilastine has demonstrated high selectivity for H1 receptors with negligible affinity for muscarinic, adrenergic, serotonergic, or other receptor types, which contributes to its favourable side-effect profile.
The onset of action is typically within 1 hour of taking the tablet, with peak plasma concentrations reached at approximately 1.3 hours. The clinical effect lasts for at least 24 hours, supporting once-daily dosing. The elimination half-life is approximately 14.5 hours.
What Should You Know Before Taking Bilastin Teva?
Before taking Bilastin Teva, inform your doctor about all medical conditions, current medications, and whether you are pregnant or breastfeeding. Bilastine must be taken on an empty stomach and should not be combined with certain drugs that inhibit transport proteins (P-glycoprotein or OATP1A2).
Contraindications
Do not take Bilastin Teva if you:
- Are allergic to bilastine or any of the other ingredients in the tablet (see the "What Does Bilastin Teva Contain?" section below)
- Have a known hypersensitivity to any component of the formulation
There are relatively few absolute contraindications for bilastine compared to many other medications. However, caution is advised in patients with significant renal impairment, as bilastine is primarily excreted unchanged via the kidneys. In patients with moderate to severe renal impairment (creatinine clearance below 60 mL/min), plasma concentrations of bilastine may be increased, and dose adjustment or alternative treatment should be considered under medical supervision.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Bilastin Teva if you:
- Have moderate or severe kidney disease — bilastine is primarily cleared by the kidneys and may accumulate
- Are taking P-glycoprotein inhibitors such as ketoconazole, erythromycin, cyclosporine, ritonavir, or diltiazem, which can increase bilastine blood levels
- Are elderly, as renal function naturally declines with age
- Are about to have an allergy skin test — antihistamines can suppress skin test results and should be stopped at least 7 days before testing
Bilastin Teva must be taken at least 1 hour before or 2 hours after eating food or drinking fruit juice. Food and fruit juice (particularly grapefruit juice) significantly reduce the absorption of bilastine by up to 30%, which can make the medicine less effective. Water is fine to take with the tablet.
Pregnancy and Breastfeeding
There is limited clinical data on the use of bilastine during pregnancy. Animal studies have not shown direct harmful effects on embryonic or foetal development, but the absence of human data means that bilastine should only be used during pregnancy if clearly necessary and only after consultation with a healthcare provider.
It is not known whether bilastine passes into human breast milk. Animal studies have shown excretion in milk. Therefore, a decision must be made whether to discontinue breastfeeding or to discontinue bilastine therapy, taking into account the benefit of the medicine for the mother and the potential risk to the infant. Discuss this with your doctor before taking Bilastin Teva while breastfeeding.
Driving and Operating Machinery
Clinical studies have shown that bilastine 20 mg does not significantly impair driving ability or psychomotor performance. In a standard driving test (the on-the-road driving test by O'Hanlon), bilastine 20 mg showed no significant difference from placebo in standard deviation of lateral position (SDLP), the primary measure of driving impairment. This contrasts with cetirizine 10 mg, which showed measurable impairment in the same study.
However, individual responses may vary. If you experience any drowsiness or dizziness while taking Bilastin Teva, do not drive or operate heavy machinery until these symptoms resolve.
How Does Bilastin Teva Interact with Other Drugs?
Bilastin Teva has a favourable drug interaction profile because it is not significantly metabolised by the liver. However, drugs that inhibit P-glycoprotein or OATP1A2 transport proteins (such as ketoconazole, erythromycin, and cyclosporine) can increase bilastine levels. Grapefruit juice also reduces absorption and should be avoided.
One of the notable pharmacological advantages of bilastine is that it undergoes minimal hepatic metabolism. Unlike many other antihistamines (such as loratadine, which is metabolised by CYP3A4 and CYP2D6), bilastine is not a significant substrate for cytochrome P450 enzymes. This means that the common CYP-mediated drug interactions seen with other antihistamines are largely absent with bilastine.
However, bilastine is a substrate for P-glycoprotein (P-gp) and organic anion transporting polypeptide 1A2 (OATP1A2), which are membrane transport proteins involved in drug absorption and distribution. Co-administration with inhibitors of these transporters can increase plasma levels of bilastine.
Major Interactions
| Drug | Mechanism | Effect | Recommendation |
|---|---|---|---|
| Ketoconazole | P-glycoprotein & CYP3A4 inhibitor | Increases bilastine AUC by ~2-fold | Avoid co-administration or use under medical supervision |
| Erythromycin | P-glycoprotein inhibitor | Increases bilastine AUC by ~2-fold | Avoid co-administration or use under medical supervision |
| Cyclosporine | P-glycoprotein inhibitor | May significantly increase bilastine levels | Avoid co-administration |
| Ritonavir | P-glycoprotein inhibitor | May significantly increase bilastine levels | Avoid co-administration |
| Diltiazem | P-glycoprotein inhibitor | May increase bilastine exposure | Use with caution; monitor for increased side effects |
Minor Interactions
| Substance | Type | Effect | Recommendation |
|---|---|---|---|
| Grapefruit juice | OATP1A2 inhibitor | Reduces bilastine absorption by ~30% | Avoid grapefruit juice during treatment |
| Food in general | Absorption interference | Reduces bilastine bioavailability by up to 30% | Take on empty stomach |
| Alcohol | CNS depressant | No pharmacokinetic interaction, but may enhance any CNS effects | Moderate alcohol use; bilastine 20 mg does not potentiate alcohol effects in clinical studies |
| Other antihistamines | Pharmacodynamic overlap | Additive antihistamine effects | Do not combine multiple antihistamines unless directed by physician |
Importantly, bilastine has been studied in combination with common medications including lorazepam and alcohol. At the recommended dose of 20 mg, bilastine did not potentiate the CNS-depressant effects of either lorazepam or alcohol, further supporting its non-sedating profile.
What Is the Correct Dosage of Bilastin Teva?
The recommended dose of Bilastin Teva is one 20 mg tablet once daily for adults and adolescents aged 12 years and older. The tablet should be taken on an empty stomach, at least 1 hour before or 2 hours after food or fruit juice, and swallowed whole with water.
Adults
Standard Adult Dosage
Dose: 20 mg (one tablet) once daily
Route: Oral
Timing: On an empty stomach, 1 hour before or 2 hours after food/fruit juice
Duration: Continue as long as symptoms persist; for seasonal allergic rhinitis, typically during pollen season; for chronic urticaria, as directed by physician
The 20 mg once-daily dose has been established through extensive clinical trials as the optimal balance between efficacy and tolerability. Higher doses (up to 80 mg) have been studied in clinical research settings and have shown increased efficacy for urticaria, but the 20 mg dose remains the standard approved dose in most markets. Some specialists may consider higher doses (up to 4-fold, i.e. 80 mg daily) for refractory chronic spontaneous urticaria in accordance with international urticaria guidelines (EAACI/GA2LEN/EDF/WAO), but this should only be done under specialist supervision.
Children
Paediatric Dosage
Adolescents (12–17 years): 20 mg (one tablet) once daily — same as adult dose
Children 6–11 years (≥20 kg): 10 mg once daily (orodispersible tablet formulation where available; the 20 mg tablet is not indicated for this age group)
Children under 6 years: Bilastine is not recommended for children under 6 years due to insufficient safety data
For adolescents aged 12 years and older, the dosing regimen is identical to adults. The same precaution of taking the medication on an empty stomach applies equally to paediatric patients. Parents and caregivers should ensure that children follow the fasting requirement for optimal drug absorption.
Elderly
No dose adjustment is generally required for elderly patients solely based on age. However, renal function should be assessed, as it naturally declines with ageing. In elderly patients with moderate to severe renal impairment (creatinine clearance <60 mL/min), bilastine plasma levels may be elevated, and the treating physician should consider dose reduction or alternative therapy. Clinical trials included patients aged 65 years and older and found bilastine to be safe and effective in this population.
Missed Dose
If you forget to take a dose of Bilastin Teva, take it as soon as you remember, provided it is still within the same day. If it is nearly time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.
Overdose
In clinical studies, bilastine has been administered at doses up to 220 mg (11 times the standard dose) without serious adverse events. Symptoms of overdose may include increased drowsiness, headache, dizziness, or dry mouth. There is no specific antidote for bilastine overdose. Treatment is supportive and symptomatic. If you suspect an overdose, contact a poison control centre or seek emergency medical attention immediately.
Always take Bilastin Teva exactly as prescribed by your doctor. Do not exceed the recommended dose. If symptoms persist or worsen, consult your healthcare provider. In case of suspected overdose, contact your local poison control centre or emergency services immediately.
What Are the Side Effects of Bilastin Teva?
Bilastin Teva is generally well-tolerated. The most common side effects are headache and drowsiness, occurring at rates comparable to placebo in clinical trials. Serious side effects are very rare. Bilastine has one of the most favourable safety profiles among second-generation antihistamines.
Like all medicines, Bilastin Teva can cause side effects, although not everybody gets them. The overall incidence of adverse events with bilastine 20 mg in clinical trials was similar to placebo (approximately 12.7% vs 12.8%), indicating an excellent tolerability profile. The following side effects have been reported based on data from clinical trials and post-marketing surveillance:
Common
- Headache
- Drowsiness (somnolence)
Uncommon
- Dizziness
- Fatigue
- Dry mouth
- Abdominal pain
- Nausea
- Upper respiratory tract infection
- Increased appetite
- Nasal dryness or discomfort
Rare
- Tachycardia (rapid heartbeat)
- Palpitations
- Weight gain
- Vertigo
- Insomnia
- Anxiety
- ECG abnormalities (QTc prolongation — not clinically significant at 20 mg)
Very Rare / Post-Marketing
- Allergic reactions (rash, urticaria, angioedema)
- Dyspnoea (shortness of breath)
- Pruritus (itching)
It is important to note that in head-to-head clinical trials comparing bilastine 20 mg with cetirizine 10 mg, bilastine was associated with significantly less somnolence (5.8% vs 7.5%). Similarly, when compared against placebo, the incidence of somnolence with bilastine 20 mg was not statistically different, which is a key differentiator from cetirizine and some other second-generation antihistamines.
Cardiac Safety
Bilastine has been extensively studied for cardiac safety. At the therapeutic dose of 20 mg, it has no clinically significant effect on the QT/QTc interval. Even at supratherapeutic doses of up to 100 mg (five times the standard dose), no meaningful QTc prolongation was observed in a thorough QT study. This distinguishes bilastine from some older antihistamines (e.g. terfenadine, astemizole) that were withdrawn from the market due to cardiac arrhythmia risk.
When to Seek Medical Attention
Stop taking Bilastin Teva and seek immediate medical attention if you experience:
- Signs of a severe allergic reaction: swelling of the face, lips, tongue, or throat; difficulty breathing or swallowing; severe rash or hives
- Irregular or very rapid heartbeat
- Any symptoms that concern you or seem unusual
If you experience any side effects, including any not listed above, talk to your doctor or pharmacist. You can also report side effects directly to your national pharmacovigilance authority to help gather more information about the safety of this medicine.
How Should You Store Bilastin Teva?
Store Bilastin Teva at room temperature below 25°C (77°F), in the original packaging to protect from moisture. Keep out of the sight and reach of children. Do not use after the expiry date printed on the carton and blister pack.
Proper storage of medication is essential to maintain its effectiveness and safety. Follow these guidelines for storing Bilastin Teva:
- Temperature: Store below 25°C (77°F). Do not refrigerate or freeze.
- Moisture protection: Keep the tablets in the original blister packaging until ready to take them. Do not transfer to a pill organiser for extended periods as this exposes the tablets to moisture.
- Light: No special precautions for light are required, but storing in the original carton provides additional protection.
- Children: Keep out of the sight and reach of children. The packaging is not child-resistant.
- Expiry date: Do not use this medicine after the expiry date (EXP) stated on the blister and carton. The expiry date refers to the last day of that month.
Do not dispose of medicines via household waste or wastewater. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment and prevent accidental ingestion by others.
What Does Bilastin Teva Contain?
Each Bilastin Teva 20 mg tablet contains bilastine as the active substance, along with inactive ingredients including microcrystalline cellulose, sodium starch glycolate, colloidal anhydrous silica, and magnesium stearate.
Active Ingredient
- Bilastine 20 mg — the active pharmaceutical ingredient responsible for the therapeutic effect
Inactive Ingredients (Excipients)
The tablet also contains the following excipients that are necessary for manufacturing and stability:
- Microcrystalline cellulose — serves as a filler and binder
- Sodium starch glycolate — acts as a disintegrant to help the tablet break down in the stomach
- Colloidal anhydrous silica — used as a flow agent during manufacturing
- Magnesium stearate — serves as a lubricant to prevent the tablet from sticking to manufacturing equipment
Bilastin Teva tablets do not contain lactose, gluten, or any animal-derived ingredients. Patients with known allergies or intolerances to any of the listed excipients should consult their pharmacist or physician before taking this medication.
Appearance
Bilastin Teva 20 mg tablets are white to off-white, round, biconvex, uncoated tablets. They are supplied in aluminium/aluminium blister packs, available in pack sizes of 10, 20, 30, 40, and 50 tablets. Not all pack sizes may be marketed in all countries.
Frequently Asked Questions About Bilastin Teva
Medical References
All medical claims in this article are based on peer-reviewed research and international clinical guidelines:
- European Medicines Agency (EMA). "Bilastine – Summary of Product Characteristics." EMA/CHMP/681040/2010. European regulatory approval and prescribing information for bilastine.
- Kuna P, et al. (2009). "Efficacy and safety of bilastine 20 mg compared with cetirizine 10 mg and placebo for the symptomatic treatment of seasonal allergic rhinitis." Ann Allergy Asthma Immunol. 103(2):137-145. Pivotal randomised controlled trial comparing bilastine to cetirizine in seasonal allergic rhinitis.
- Zuberbier T, et al. (2022). "The international EAACI/GA2LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria." Allergy. 77(3):734-766. International guidelines recommending second-generation antihistamines as first-line therapy for urticaria.
- Corcostegui R, et al. (2006). "Pharmacological characterization of bilastine, a novel potent and selective histamine H1 receptor antagonist." Br J Pharmacol. 140(4):672-680. Preclinical pharmacology study establishing bilastine's receptor selectivity profile.
- Graff C, et al. (2012). "The effect of bilastine on cardiac repolarization: a randomized, placebo- and active-controlled crossover study." Clin Drug Investig. 32(5):339-351. Thorough QT study demonstrating cardiac safety of bilastine at therapeutic and supratherapeutic doses.
- Bousquet J, et al. (2020). "ARIA 2019: Care pathways for allergic rhinitis." Allergy. 75(11):2858-2890. International ARIA guidelines for allergic rhinitis treatment including second-generation antihistamines.
- Garcia-Gea C, et al. (2014). "Bilastine, a new antihistamine, does not impair driving performance even at high doses." Hum Psychopharmacol. 29(2):136-145. Driving performance study confirming non-sedating properties of bilastine.
Evidence grading: This article uses the GRADE framework (Grading of Recommendations Assessment, Development and Evaluation) for evidence-based medicine. Evidence level 1A represents the highest quality of evidence, based on systematic reviews of randomised controlled trials.
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