Description
Release form
Film-coated tablets.
Packing
14 pcs.
Pharmacological action of
Suprastinex – a blocker of histamine H1 receptors. Levocetirizine is the enantiomer of cetirizine, a competitive histamine antagonist. It blocks H1-histamine receptors, the affinity for which is 2 times higher than that of cetirizine. It has an effect on the histamine-dependent stage of allergic reactions, reduces eosinophil migration, reduces vascular permeability, and limits the release of inflammatory mediators. It prevents the development and facilitates the course of allergic reactions, has an antiexudative, antipruritic effect. Virtually no anticholinergic and antiserotonergic effects. In therapeutic doses, it has practically no sedative effect.
Indications
Symptomatic treatment:
– Year-round and seasonal allergic rhinitis and conjunctivitis (pruritus, sneezing, rhinorrhea, lacrimation, conjunctival hyperemia).
– Hay fever (hay fever).
– Urticaria, including chronic idiopathic urticaria.
– Quincke’s edema.
– Allergic dermatoses, accompanied by itching and rashes.
Contraindications
– Severe renal failure (CC less than 10 ml / min).
– Children under 6 years of age (for this dosage form).
– Pregnancy.
– Lactation.
– Lactose intolerance, hereditary lapp lactase deficiency lapp (lactase deficiency in some peoples of the North) or glucose-galactose malabsorption syndrome (due to the content of lactose in the tablets).
– Hypersensitivity to the active (including piperazine derivatives) or any auxiliary component of the drug.
Caution should be used in: – Chronic renal failure.
– Elderly patients (possibly reduced glomerular filtration).
Pregnancy and lactation
Research, conducted on animals, did not reveal a direct or indirect harmful effect on pregnancy, development of the embryo or fetus, childbirth or postnatal development. There have been no controlled clinical trials on the safety of the drug in pregnant women, so the drug should not be prescribed during pregnancy.
Levocetirizine is excreted in breast milk, so if it is necessary to use it during lactation, breastfeeding should be discontinued while taking the drug.
Special instructions
Influence on the ability to drive vehicles and operate machinery: during treatment it is recommended to refrain from engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.
Composition of
In 1 film-coated tablet contains: levocetirizine dihydrochloride 5 mg, which corresponds to the content of levocetirizine 4.21 mg.
Excipients: microcrystalline silicon cellulose (microcrystalline cellulose, colloidal silicon dioxide anhydrous), lactose monohydrate (37.9 mg), low-substituted hyprolose (L-HPC11), magnesium stearate.
Shell composition: Opadry II 33G28523 white (hypromellose 2910, titanium dioxide, lactose monohydrate (1.05 mg), macrogol 3350, triacetin).
Dosage and administration of
The drug should be taken with food or on an empty stomach, washed down with a small amount of water, do not chew tablets. The daily dose is recommended to be taken in 1 dose. Recommended dose for adults and children over 6 years of age, elderly patients: (subject to normal renal function) – 5 mg (1 tablet) / day. The duration of administration depends on the disease. The course of treatment of hay fever on average is 1-6 weeks.
Side effects of
Metabolism: very rarely – weight gain.
From the side of the central nervous system: often – drowsiness, headache, increased fatigue infrequently – asthenia rarely – migraine, dizziness.
From the respiratory system: very rarely – dyspnea.
From the digestive system: often – dry mouth is rare – abdominal pain is very rare – nausea, dyspepsia, changes in functional liver tests.
Allergic reactions: very rarely – anaphylaxis, angioedema, pruritus, rash, urticaria.
Drug Interactions
Studies of the interaction of levocetirizine have shown no clinically significant interaction with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide and diazepam. Joint use with macrolides or ketoconazole did not cause significant changes on the ECG.
Theophylline (400 mg /) reduces the total clearance of levocetirizine by 16%. The pharmacokinetics of theophylline does not change.
Levocetirizine does not enhance the effects of ethanol, however, in sensitive patients, concomitant use of levocetirizine with ethanol or other central nervous system depressants may have an effect on the central nervous system.
overdose
Symptoms: overdoses in adults are drowsy, in children – excitement, anxiety, which are replaced by drowsiness.
Treatment: There is no specific antidote. Symptomatic and supportive therapy, gastric lavage is recommended. Hemodialysis is ineffective.
Storage conditions
Do not store above 25 ° C.
Active ingredient
Levocetirizine
Pharmacy conditions
without prescription
lekarstvennaja tablet form
Indications
Indications
Pollinosis, Quincke’s Edema, Neurodermatitis, Urticaria, Itchy skin, Allergic rhinitis, Dermatosis, Allergic conjunctivitis, Allergy