Nixar pills 20mg, 30pcs

Composition

Active ingredient:

Bilastine – 20.00 mg; Excipients:

microcrystalline cellulose – 103.00 mg,

sodium carboxy-methyl starch (type A) – 1.00 mg,

colloidal silicon dioxide-0.50 mg,

magnesium stearate-0.50 mg.

Description:

Oval, biconvex tablets of white color, with a one-sided risk for division.

Pharmacological action

anti-allergic agent-H1-histamine receptor blocker

Pharmacodynamics : Bilastine is a long-acting antihistamine that selectively blocks peripheral H1 receptors. A significant therapeutic effect is observed one hour after taking the drug, the antihistamine effect persists for 24 hours. There may be a slight penetration of Bilastinee through the blood-brain barrier, but Bilastinee does not have a significant effect on the central nervous system and does not cause sedation.

It has no anticholinergic effect. There is no prolongation of the QT interval on the ECG.

Pharmacokinetics:

Suction. After oral use, Bilastine is rapidly absorbed from the gastrointestinal tract. The time to reach the maximum concentration in blood plasma (TMAX) is 1.3 hours. The bioavailability of Bilastine when taken orally is 61%. Simultaneous food intake reduces the bioavailability of Bilastine by 30%. Accumulation of the drug is not observed. The relationship with plasma proteins is 84-90%.

Metabolism and elimination. Bilastine is slightly metabolized, and after a single dose, up to 95% of the total dose of Bilastine is excreted unchanged by the kidneys (28.3%) and bile (66.5%). The elimination half-life (T 1/2) averages 14.5 hours.

Moderate renal insufficiency (glomerular filtration rate (GFR) 30-50 ml/min/1.73 m2) and severe renal insufficiency (GFR Changes in pharmacokinetic parameters do not affect the safety profile of Bilastine, since the concentration of Bilastine in blood plasma in patients with renal insufficiency remains within acceptable values.

In hepatic insufficiency, clinically significant changes in the pharmacokinetic parameters of Bilastinee do not occur, since Bilastinee is slightly metabolized in the liver.

The pharmacokinetic parameters of Bilastine in elderly patients are similar to those in young patients.

Indications

-Allergic (seasonal and year-round) rhinoconjunctivitis: elimination or relief of symptoms (sneezing, nasal congestion, itching of the nasal mucosa, rhinorrhea, burning and itchy eyes, redness of the eyes, lacrimation);

– urticaria: elimination or reduction of skin itching, rash.

Contraindications

-Hypersensitivity to Bilastine or auxiliary components of the drug; – age up to 12 years (efficacy and safety have not been established);- pregnancy and lactation period.

Side effects

Possible side effects are listed below by descending case frequency: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, < 1/1000), very rare (

Disorders of the gastrointestinal tract often: dryness of the oral mucosa, diarrhea, dyspepsia, gastritis, abdominal pain, pain in the upper abdomen, stomach discomfort, nausea.

Skin and subcutaneous tissue disorders often: pruritus of the skin.

Nervous system disorders: Often: drowsiness, headache; Infrequently: dizziness.

Mental disorders often: anxiety, insomnia.

Metabolic disorders frequently: increased appetite, increased body weight.

Hearing disorders and labyrinth disorders often: tinnitus, vertigo.

Disorders of the respiratory system, thoracic organs and mediastinum often: shortness of breath, dryness of the nasal mucosa, unpleasant sensations in the nose.

Disorders of the cardiovascular system often: blockage of the right bundle branch, sinus arrhythmia, prolongation of the QT interval on the electrocardiogram, other changes on the electrocardiogram.

Infectious and parasitic diseases often: herpetic lesions of the oral cavity. Other services: Infrequently: thirst, increased fatigue, asthenia, fever, increased concentration of triglycerides in blood plasma, increased concentration of creatinine in blood plasma, increased activity of “liver” enzymes (aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase).

Interaction

When Bilastine was co-administered with ketoconazole or erythromycin, the area under the concentration-time curve (AUC) of Bilastine increased by 2 times, and the maximum concentration (Cmax) – by 2-3 times.

When Bilastine 20 mg and diltiazem 60 mg were administered concomitantly, the Cmax of Bilastine increased by 50%. Such effects can be explained by the interaction at the level of transporter proteins (including P-glycoprotein), which are responsible for the elimination of drugs from intestinal cells, the substrate of which is Bilastine. When Bilastine is co-administered with other drugs that are substrates or inhibitors of P-glycoprotein (for example, cyclosporine), the concentration of Bilastine in blood plasma may increase.

Grapefruit and other fruit juices reduce the bioavailability of Bilastine by 30%. This interaction is due to the ability of fruits to inhibit the activity of the organic anion carrier protein OATP1A2, for which Bilastine is a substrate. Drugs that are substrates or inhibitors of OATP1 and 2 (for example, ritonavir or rifampicin) can reduce the concentration of Bilastine in blood plasma.

Bilastine does not enhance the effect of ethanol on the central nervous system.

With the simultaneous use of Bilastinee and lorazepam, an increase in the suppressive effect of lorazepam on the central nervous system was not detected.

How to take, course of use and dosage

Inside.

If the doctor does not prescribe otherwise, the following doses of Nixar are recommended to relieve the symptoms of allergic rhinoconjunctivitis and urticaria:

Adults and children over 12 years of age: 1 tablet of Nixar, which corresponds to 20 mg of Bilastine, once a day.

The maximum daily dose of Bilastine is 20 mg, since an increase in the dose does not lead to an increase in the therapeutic effect. The tablet is taken one hour before a meal or 2 hours after a meal (or fruit juice).

In allergic rhinoconjunctivitis, the drug is used during the entire period of contact with allergens.

With urticaria, treatment is continued until the symptoms disappear or ease.

In patients with impaired liver and kidney function, no dose adjustment is required.

No dose adjustment is required in elderly patients. Experience with the use of Nixar® in persons over 65 years of age is insignificant.

Overdose

Symptoms: when using Bilastine at a dose exceeding the recommended 10-11 times, side effects occurred 2 times more often than when using placebo. The most common symptoms were dizziness, headache, and nausea. There were no serious side effects, including significant prolongation of the QT interval.

Treatment: symptomatic and supportive therapy. There is no specific antidote.

Special instructions

In patients with moderate renal insufficiency (GFR 30-50 ml/min/1.73 m2) and severe renal insufficiency (GFR In this regard, in patients with moderate and severe renal insufficiency, caution should be exercised when using Bilastinee concomitantly with P-glycoprotein inhibitors (ketoconazole, erythromycin, cyclosporine, ritonavir, diltiazem, etc. ).

Influence on the ability to drive vehicles and fur. :

In a study conducted to evaluate the effect of Bilastine at a dose of 20 mg on the ability to drive vehicles, no negative effects of the drug were found. However, patients should be warned that in very rare cases, dizziness and drowsiness may occur, which in turn may affect the ability to drive vehicles or perform other activities that require increased concentration of attention. If the described adverse events occur, you should refrain from performing these types of activities.

Active ingredient

Bilastine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

Children over 12 years old, For adults

Indications

Allergic Rhinitis, Allergic Conjunctivitis, Allergy