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Bilaxten: Fast-Acting, Long-Lasting Relief from Allergies

Bilaxten is a long-acting, antihistamine. It is used to treat the symptoms of allergic rhinitis (seasonal or perennial) and urticaria (hives). Bilaxten works by blocking histamine, a chemical that is released by the body when it comes into contact with an allergen. Histamine causes the symptoms of allergic rhinitis and urticaria, such as sneezing, runny nose, itchy eyes, and hives.

Bilastine.

Description

Each tablet also contains the following excipients: Microcrystalline cellulose, sodium starch glycolate (type A) (derived from potato), anhydrous colloidal silica and magnesium stearate.
The score line in Bilaxten tablet is intended only to facilitate breaking for ease of swallowing and not to divide into equal doses.

BENEFITS OF BILAXTEN TABLET

In Treatment of Allergic conditions

Bilaxten Tablet is used to treat many different inflammatory and allergic conditions. It works by lowering your immune system’s response to these conditions and prevents the release of substances in the body that cause inflammation. It helps relieve symptoms such as swelling, pain, itching, and other allergic-type reactions. If you are not sure why you are being given this medicine, ask your doctor.

This medicine is given orally (by mouth). You should always take it as it has been prescribed for you. Do not stop taking it without your doctor’s advice. This can cause unpleasant withdrawal symptoms. Because this medicine weakens your immune system, you should avoid being near people who are ill or have infections.

Indications/Uses

Symptomatic treatment of seasonal and perennial allergic rhino-conjunctivitis and urticaria.

Dosage/Direction for Use

Adults and Adolescents ≥12 years: Allergic Rhino-conjunctivitis (SAR and PAR) and Urticaria: 20 mg (1 tablet) once daily.
Elderly: No dosage adjustments are required in elderly patients (see Pharmacodynamics and Pharmacokinetics under Actions). There is little experience in patients >65 years.
Renal Impairment: No dosage adjustment is required in patients with renal impairment (see Pharmacokinetics under Actions).
Hepatic Impairment: There is no clinical experience in patients with hepatic impairment. Since bilastine is not metabolized and renal clearance is its major elimination route, hepatic impairment is not expected to increase systemic exposure above the safety margin. Therefore, no dosage adjustment is required in patients with hepatic impairment (see Pharmacokinetics under Actions).

Duration of Treatment: For allergic rhinitis the treatment should be limited to the period of exposure to allergens. For seasonal allergic rhinitis, treatment could be discontinued after the symptoms have resolved and reinitiated upon their reappearance. In perennial allergic rhinitis continued treatment may be proposed to the patients during the allergen exposure periods. For urticaria the duration of treatment depends on the type, duration and course of the complaints.

Administration: The tablet should be taken by oral route 1 hr before or 2 hrs after intake of food or fruit juice. It is recommended to take the daily dose in 1 single intake.

Overdosage

Information regarding acute overdose is limited to experience from clinical trials conducted during the development of bilastine. After administration of bilastine at doses 10-11 times the therapeutic dose [220 mg (single dose); or 200 mg/day for 7 days] to healthy volunteers, frequency of treatment emergent adverse events was 2 times higher than with placebo. The adverse reactions most frequently reported were dizziness, headache and nausea. No serious adverse events and no significant prolongation in the QTc interval were reported.

Critical evaluation of bilastine’s multiple dose (100 mg x 4 days) effect on ventricular repolarization by a “thorough QT/QTc cross-over study” involving 30 healthy volunteers did not show significant QTc prolongation.
In the event of overdose, symptomatic and supportive treatment is recommended.
There is no known specific antidote to bilastine.

Contraindications

Hypersensitivity to bilastine or to any of the excipients of Bilaxten.

Precautions

In patients with moderate or severe renal impairment, co-administration of bilastine with P-gp inhibitors eg, ketoconazole, erythromycin, cyclosporine, ritonavir or diltiazem, may increase plasmatic levels of bilastine and therefore increase the risk of adverse effects of bilastine. Therefore, co-administration of bilastine and P-gp inhibitors should be avoided in patients with moderate or severe renal impairment.

Effects on the Ability to Drive or Operate Machinery: A study performed to assess the effects of bilastine on the ability to drive demonstrated that treatment with 20 mg did not affect the driving performance. However, patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive or use machines.

Impairment of Fertility: There are no or limited amount of clinical data. A study in rats did not indicate any negative effect on fertility (see Toxicology: Preclinical Safety Data under Actions).

Use in pregnancy & lactation: There are no or limited amount of data from the use of bilastine in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, parturition or postnatal development (see Toxicology: Preclinical Safety Data under Actions). As a precautionary measure, it is preferable to avoid the use of Bilaxten during pregnancy.

It is unknown whether bilastine is excreted in human breast milk. The excretion of bilastine in milk has not been studied in animals. A decision on whether to continue/discontinue breastfeeding or to continue/discontinue therapy with Bilaxten should be made taking into account the benefit of breastfeeding to the child and the benefit of bilastine therapy to the mother.

Use in children: The safety and efficacy of bilastine in children <12 years have not been established.

Use In Pregnancy & Lactation

There are no or limited amount of data from the use of bilastine in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, parturition or postnatal development (see Toxicology: Preclinical Safety Data under Actions). As a precautionary measure, it is preferable to avoid the use of Bilaxten during pregnancy.
It is unknown whether bilastine is excreted in human breast milk. The excretion of bilastine in milk has not been studied in animals. A decision on whether to continue/discontinue breastfeeding or to continue/discontinue therapy with Bilaxten should be made taking into account the benefit of breastfeeding to the child and the benefit of bilastine therapy to the mother.

Adverse Reactions

The number of adverse events experienced by patients suffering from allergic rhino-conjunctivitis or chronic idiopathic urticaria treated with bilastine 20 mg in clinical trials was comparable with patients receiving placebo (12.7% vs 12.8%).
The adverse drug reactions (ADRs) most commonly reported by patients receiving bilastine 20 mg during phase II and III clinical trials were headache, somnolence, dizziness and fatigue. These adverse events occurred with a comparable frequency in patients receiving placebo.

ADRs at least possibly related to bilastine and reported in >0.1% of the patients receiving bilastine 20 mg during the clinical development are presented as follows. (See table.) Frequencies are assigned as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data); rare, very rare and reactions with unknown frequency have not been included in the table.

Drug Interactions

Interaction with Food: Food significantly reduces the oral bioavailability of bilastine by 30%.
Interaction with Grapefruit Juice: Concomitant intake of bilastine 20 mg and grapefruit juice decreased bilastine bioavailability by 30%. This effect may also apply to other fruit juices. The degree of bioavailability decrease may vary between producers and fruits. The mechanism for this interaction is an inhibition of OATP1A2, an uptake transporter for which bilastine is a substrate (see Pharmacokinetics under Actions). Medicinal products that are substrates or inhibitors of OATP1A2 eg, ritonavir or rifampicin, may likewise have the potential to decrease plasma concentrations of bilastine.

Interaction with Ketoconazole or Erythromycin: Concomitant intake of bilastine and ketoconazole or erythromycin increased bilastine AUC 2-fold and C_max 2-3 fold. These changes can be explained by interaction with intestinal efflux transporters, since bilastine is substrate for P-gp and not metabolized (see Pharmacokinetics under Actions).
These changes do not appear to affect the safety profile of bilastine and ketoconazole or erythromycin, respectively.
Other medicinal products that are substrates or inhibitors of P-gp eg, cyclosporine, may likewise have the potential to increase plasma concentrations of bilastine.

Interaction with Diltiazem: Concomitant intake of bilastine 20 mg and diltiazem 60 mg increased C_max of bilastine by 50%. This effect can be explained by interaction with intestinal efflux transporters and does not appear to affect the safety profile of bilastine.

Interaction with Alcohol: The psychomotor performance after concomitant intake of alcohol and bilastine 20 mg was similar to that observed after intake of alcohol and placebo.

Interaction with Lorazepam: Concomitant intake of bilastine 20 mg and lorazepam 3 mg for 8 days did not potentiate the depressant CNS effects of lorazepam.
Incompatibilities: Not applicable.

Caution For Usage

Instructions for Use and Handling: No special requirements. Any unused product or waste material should be disposed of in accordance with local requirements.

Conclusion

Bilaxten is an antihistamine that offers several advantages over other second-generation antihistamines. It has a faster onset of action, a longer duration of action, and a lower risk of causing drowsiness. Bilaxten is also effective in relieving the symptoms of both seasonal and perennial allergic rhinitis, as well as urticaria.

In clinical trials, bilaxten has been shown to be as effective as other second-generation antihistamines, such as cetirizine and desloratadine, in relieving the symptoms of allergic rhinitis and urticaria. However, bilaxten has a faster onset of action and a longer duration of action than these other antihistamines. This means that bilaxten can start working sooner and last longer, providing relief from allergy symptoms for a longer period of time.

Bilaxten is also less likely to cause drowsiness than other second-generation antihistamines. This is because bilaxten does not cross the blood-brain barrier as easily as other antihistamines. This makes bilaxten a good choice for people who need to be alert during the day, such as students, drivers, and people who operate machinery.

Bilaxten is a good option for people who are looking for a safe and effective treatment for allergic rhinitis or urticaria.

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Frequent Asked Questions

What is Bilaxten used for?

Bilaxten is used to treat the symptoms of allergic rhinitis (seasonal or perennial) and urticaria (hives).

How does Bilaxten work?

Bilaxten works by blocking histamine, a chemical that is released by the body when it comes into contact with an allergen. Histamine causes the symptoms of allergic rhinitis and urticaria, such as sneezing, runny nose, itchy eyes, and hives.

Is Bilaxten safe?

Bilaxten is generally safe and well-tolerated. The most common side effects are mild and include headache, fatigue, and dizziness. Bilaxten is non-drowsy, so it is less likely to cause drowsiness than first-generation antihistamines.

What is the dosage of Bilaxten?

The recommended dose of Bilaxten for adults and children over 12 years of age is 20 mg once a day.

Can I take Bilaxten with other medications?

Bilaxten can be taken with most other medications, but it is important to talk to your doctor before taking any new medications. Bilaxten should not be taken with ketoconazole, erythromycin, ritonavir, cyclosporin, or diltiazem, as these medications can increase the plasma concentration of Bilaxten and increase the risk of side effects.

Can I take Bilaxten while pregnant or breastfeeding?

There is limited data on the safety of Bilaxten in pregnant and breastfeeding women. Bilaxten should only be used during pregnancy or breastfeeding if the potential benefits outweigh the potential risks.

Africa Digital Clinic