Nalorius - instructions for use, doses, side effects, contraindications

Excipients: calcium hydrogen phosphate dihydrate 145.4 mg, microcrystalline cellulose 14.8 mg, hypromellose (hydroxypropylmethylcellulose) 3.7 mg, pregelatinized starch 5.55 mg, croscarmellose sodium 1.85 mg, silicon dioxide colloid (aerosil) 1.85 mg, magnesium stearate 1.85 mg;

composition of the shell: opahedra II blue (lactose monohydrate 36.0%, hypromellose (E464) 28.0%, titanium dioxide (E171) 23.0%, polyethylene glycol (macrogol) (E1521) 10.0%, indigocarmine (E132) 2.5% , brilliant blue (E133) 0.380%, iron oxide yellow (E172) 0.120%) 4.967 mg emulsion of simethicone 0.033 mg.

Description:Round, biconvex tablets, film-coated, blue. Insignificant roughness of the surface is permissible. Color of tablets on a break - white or white with a yellowish shade.

Pharmacotherapeutic group:Antiallergic agent - H1-histamine receptor blocker

ATX: & nbsp

R.06.A.X Other antihistamines for systemic use

R.06.A.X.27 Desloratadine

Pharmacodynamics:

Antihistamine is a long-acting drug. It is the primary active metabolite of loratadine.Inhibits the cascade of reactions allergic inflammation, including - the release of proinflammatory cytokines, including interleukin-4, interleukin-13, interleukin-6, interleukin-8, the release of proinflammatory chemokines (RANTES), the production of superoxide anion by activated polymorphonuclear neutrophils adhesion and chemotaxis eosinophils, selection adhesion molecules such as P-selectin, IgE-mediated release of histamine, prostaglandin D2 and leukotriene C4. Thus, it prevents development and facilitates the course of allergic reactions, has antipruritic and antiexcudative action, reduces permeability of capillaries, prevents the development of edema of tissues, spasm of smooth muscles.

The drug has no effect on the central nervous system, has practically no sedative effect (does not cause drowsiness) and does not affect the rate of psychomotor reactions. In klinikofarmakologicheskih studies of desloratadine in recommended therapeutic dose were observed lengthening QT interval on the electrocardiogram. The effect of desloratadine begins within 30 minutes after ingestion and lasts for 24 hours.

Pharmacokinetics:

Desloratadine is well absorbed in the gastrointestinal tract. It is determined in the blood plasma 30 minutes after ingestion. The maximum concentration is achieved on average 3 hours after administration. It does not penetrate the blood-brain barrier, it penetrates the placental barrier and into breast milk. The connection with plasma proteins is 83-87%. When used in adults and adolescents for 14 days at a dose of 5 mg to 20 mg once a day, there is no clinically significant cumulation of the drug. Simultaneous intake of food or grapefruit juice does not affect the distribution of desloratadine when administered at a dose of 7.5 mg 1 time per day. Desloratadine is not an inhibitor of isoenzymes CYP3A4 and CYP2D6 and is not a substrate or inhibitor of P-glycoprotein. Intensively metabolized in the liver by hydroxylation to form 3-OH-desloratadine, combined with glucuronide. Only a small part of the dose taken internally is excreted by the kidneys (less than 2%) and through the intestine (less than 7%) unchanged. Half-life is an average of 27 hours.

Indications:

- Allergic rhinitis (elimination or relief of sneezing, nasal congestion, mucus discharge from the nose, itching of the nose, itching of the palate, itching and redness of the eyes, lachrymation);

- urticaria (reduction or elimination of itching, rash).

Contraindications:

- Hypersensitivity to any component of the drug or loratadine;

- pregnancy and lactation (breastfeeding);

- lactose intolerance, lactase deficiency and glucose-galactose malabsorption syndrome;

- children under 12 years.

Carefully:

Severe kidney failure.

Pregnancy and lactation:

The use of the drug in pregnancy is contraindicated in connection with the lack of clinical data on the safety of desloratadine during pregnancy.

The active substance is excreted in breast milk, so the use of the drug NALORIUS® during breastfeeding is contraindicated.

Dosing and Administration:

For oral administration. The tablet should be swallowed whole and washed down with water. The drug should be taken regularly at the same time of the day, regardless of the time of ingestion.

Adults and teenagers from 12 years old - 1 tablet (5 mg) once a day.

In seasonal (intermittent) allergic rhinitis (if symptoms last less than 4 days per week or less than 4 weeks per year), it is necessary to evaluate the course of the disease.With the disappearance of symptoms, the drug should be discontinued, if the symptoms reappear, the drug should be resumed. With year-round (persistent) allergic rhinitis (in the presence of symptoms lasting more than 4 days a week or more than 4 weeks per year), the drug should be taken during the entire exposure period of the allergen.

Side effects:

The most common side effects (≥1 / 100 to ≤1 / 10), whose frequency was slightly higher than when taking placebo ("dummy"): increased fatigue (1.2%), dry mouth (0.8% ) and headache (0.6%).

In children aged 12-17 years, according to the results of clinical studies, the most common side effect was headache (5.9%), the frequency of which was not higher than with placebo (6.9%). The information on the side effects is presented by the results of clinical studies and post-registration period observations.

According to the World Health Organization (WHO), side effects are classified according to their frequency of development as follows: very often (≥1/10), often (from ≥1 / 100 to <1/10), infrequently (from ≥1 / 1000 up to <1/100),rarely (from ≥1 / 10000 to <1/1000), very rarely (<1/10000); frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

From the side of the psyche: very rarely-hallucinations.

From the nervous system: often - headache; very rarely - dizziness, drowsiness, insomnia, psychomotor hyperactivity, convulsions.

From the liver and biliary tract: very rarely - increased activity of liver enzymes, increased concentrations of bilirubin, hepatitis; frequency is unknown - jaundice.

From the digestive system: often - dry mouth; very rarely - abdominal pain, nausea, vomiting, indigestion, diarrhea.

From the side of the cardiovascular system: very rarely - tachycardia, palpitations; frequency unknown - QT interval elongation.

From the side of the musculoskeletal system: very rarely - myalgia.

From the skin and subcutaneous tissues: frequency unknown - photosensitivity.

General disorders: often - increased fatigue; very rarely - anaphylaxis, angioedema, dyspnea, itching, rash, including urticaria; frequency unknown - asthenia.

Post-registration period.

Children: frequency unknown - prolongation of QT interval, arrhythmia, bradycardia. If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

Symptoms

Taking a dose that exceeds the recommended dose by 5 times did not lead to any symptoms. In clinical trials, the daily use of desloratadine in adults and adolescents at doses up to 20 mg for 14 days was not accompanied by statistically or clinically significant changes in the cardiovascular system. In a clinical pharmacological study, the use of desloratadine at a dose of 45 mg per day (9 times as high as recommended) for 10 days did not cause lengthening of the interval QT and was not accompanied by the appearance of serious side effects.

Treatment

If you ingest large amounts of the drug, you should immediately consult a doctor. Recommended gastric lavage, reception of activated charcoal; if necessary, symptomatic therapy. Desloratadine is not excreted in hemodialysis, the effectiveness of peritoneal dialysis is not established.

Interaction:

There were no clinically significant interactions in studies when combined with azithromycin, ketoconazole, erythromycin, fluoxetine and cimetidine. Simultaneous intake of food or grapefruit juice does not affect the effectiveness of the drug. Desloratadine does not enhance the effect of alcohol on the central nervous system. However, during the post-registration use cases of alcohol and alcohol intolerance were reported. therefore desloratadine Alcohol should be used with caution.

Special instructions:

Caution is prescribed NALORIUS® in severe renal failure.

Effect on the ability to drive transp. cf. and fur:

With the development of unwanted reactions from the central nervous system, such as drowsiness, dizziness, hallucinations, it is not recommended to perform actions requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets, film-coated, 5 mg.

Packaging:

For 7 or 10 tablets in a contour mesh package.

For 1, 2, 3 or 5 contour squares with instructions for use in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

4 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-002472

Date of registration:22.05.2014 / 23.11.2017

Expiration Date:22.05.2019

The owner of the registration certificate:NANOLEC, LTD. NANOLEC, LTD. Russia

Manufacturer: & nbsp

NANOLEC, LTD. Russia

Representation: & nbspNANOLEC, LTD.NANOLEC, LTD.

Information update date: & nbsp28.05.2018

Illustrated instructions

Instructions

Nalorius® (Nalorius®)