Instructions for Hitax orodispersible tablets 5 mg blister No. 10
Composition
active ingredient: desloratadine;
1 orodispersible tablet contains 5 mg of desloratadine;
excipients: polacrilin potassium; citric acid, monohydrate; purified water; red iron oxide (E 172); magnesium stearate; croscarmellose sodium, flavoring, aspartame (E 951), microcrystalline cellulose, mannitol (E 421).
Dosage form
Orodispersible tablets.
Main physicochemical properties: round, flat, brick-red tablets, with a bevel and embossed "5" on one side.
Pharmacotherapeutic group
Antihistamines for systemic use.
ATX code R06A X27.
Pharmacological properties
Pharmacodynamics
Desloratadine is a non-sedating, long-acting antihistamine with selective peripheral H1-receptor antagonist activity. After oral administration, desloratadine selectively blocks peripheral histamine H1-receptors. In in vitro studies, desloratadine has demonstrated antiallergic properties on endothelial cells. This was demonstrated by inhibition of the release of pro-inflammatory cytokines, such as IL-4, IL-6, IL-8, and IL-13, from human mast cells/basophils, as well as inhibition of the expression of adhesion molecules, such as P-selectin. The clinical significance of these observations remains to be confirmed.
Studies have shown that, in addition to antihistamine activity, Hitaxa has anti-allergic and anti-inflammatory effects.
Desloratadine does not penetrate the central nervous system and does not affect psychomotor function.
In patients with allergic rhinitis, Hitaxa effectively relieved symptoms such as sneezing, nasal discharge and itching, as well as eye irritation, tearing and redness, and itching of the palate. Hitaxa effectively controlled symptoms for 24 hours.
Pharmacokinetics
Absorption.
Desloratadine plasma concentrations can be determined 30 minutes after administration.
Desloratadine is well absorbed, with peak plasma concentrations occurring after approximately 3 hours.
Breeding.
The elimination half-life is approximately 27 hours. The degree of accumulation of desloratadine is consistent with its elimination half-life (approximately 27 hours) and the frequency of once-daily dosing.
Linearity and nonlinearity.
The bioavailability of desloratadine was dose proportional over the range of 5 mg to 20 mg. Desloratadine is moderately bound to plasma proteins (83–87%). When desloratadine was administered at doses of 5 to 20 mg once daily for 14 days, there was no evidence of clinically significant accumulation.
Food (a high-fat, high-calorie breakfast) does not affect the pharmacokinetics of desloratadine. Grapefruit juice has also been shown to have no effect on the pharmacokinetics of desloratadine.
Indication
Elimination of symptoms associated with allergic rhinitis and urticaria.
Contraindication
Hypersensitivity to the active substance, to any auxiliary component of the drug or to loratadine.
Interaction with other medicinal products and other types of interactions
No clinically significant interactions were observed when desloratadine tablets were co-administered with erythromycin or ketoconazole.
Desloratadine, taken with alcohol, did not enhance the negative effects of ethanol on psychomotor function.
Application features
The drug Hitaxa should be used with caution and under the supervision of a physician in case of severe renal failure.
The medicine contains aspartame, so it may be harmful for people with phenylketonuria.
It should be used with caution in patients with a medical or family history of seizures, and especially in young children, who are more likely to develop new seizures while receiving desloratadine. Healthcare professionals may consider discontinuing desloratadine in patients who experience seizures during treatment.
Ability to influence reaction speed when driving vehicles or other mechanisms
No impairment of performance was observed in patients receiving desloratadine. However, patients should be informed that very rarely, somnolence may occur in some individuals, which may affect the ability to drive and use machines.
Use during pregnancy or breastfeeding
The safety of the drug during pregnancy has not been established, therefore it is not recommended to use Hitaxa during pregnancy.
Desloratadine passes into breast milk, so women who are breastfeeding should not take Hitax.
Method of administration and doses
Treatment of intermittent allergic rhinitis (presence of symptoms less than 4 days a week or less than 4 weeks) should be carried out taking into account the anamnesis: stop after the disappearance of symptoms and resume after their reappearance. In persistent allergic rhinitis (presence of symptoms more than 4 days a week or more than 4 weeks), treatment should be continued throughout the entire period of contact with the allergen.
Method of application.
Immediately before taking, carefully open the blister and remove the orodispersible tablet without crushing it, so that it does not crumble. Place the tablet in your mouth, where it will immediately disintegrate. Water or other liquid is not required to swallow the tablet. The dose should be taken immediately after opening the blister.
Children
In this dosage form, the drug is intended for use in children aged 12 years and older.
Overdose
In case of overdose, standard measures are indicated to remove unabsorbed active substance. Symptomatic and supportive treatment is recommended. In studies with multiple doses in adults and adolescents, who were given up to 45 mg of desloratadine (9 times the therapeutic dose), no clinically significant effects were observed.
Desloratadine is not removed by hemodialysis; it is not known whether it is removed by peritoneal dialysis.
Adverse reactions
There is a risk of psychomotor hyperactivity (abnormal behavior) associated with the use of desloratadine (which may manifest as anger and aggression, as well as agitation).
The frequency of adverse reactions is classified as follows: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000) and frequency unknown.
Psychiatric disorders: very rare: hallucinations; frequency unknown: abnormal behavior, aggression;
Nervous system disorders: common: headache; very rare: dizziness, drowsiness, insomnia, psychomotor agitation, convulsions.
Cardiac disorders: very rare: tachycardia, palpitations; frequency unknown: QT prolongation, supraventricular tachyarrhythmia
From the digestive tract: often: dry mouth; very rarely: abdominal pain, nausea, vomiting, dyspepsia, diarrhea.
Hepatobiliary system: very rare: increased liver enzymes, increased bilirubin, hepatitis; frequency unknown: jaundice.
Musculoskeletal and connective tissue disorders: very rare: myalgia.
Skin and subcutaneous tissue disorders: frequency unknown: photosensitivity.
General disorders: common: fatigue; very rare: hypersensitivity reactions (anaphylaxis, angioedema, dyspnoea, pruritus, rash and urticaria), frequency unknown: asthenia.
Metabolism and digestive disorders: increased appetite.
Research: weight gain.
Expiration date
3 years.
Storage conditions
No special storage conditions are required.
Packaging
10 tablets in a blister, 1 blister in a cardboard box.
Vacation category
Without a prescription.
Producer
Genepharm S.A.
Location of the manufacturer and its business address
18 km Marathonos Ave, Pallini Attiki, 15351, Greece.
