Suprastinex, drops for oral use 5mg/ml 20ml

Composition

>1 ml of drops contains: levocetirizine dihydrochloride 5 mg. Auxiliary substances: glycerol 85%, propylene glycol, sodium saccharinate, sodium acetate trihydrate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, ice acetic acid, purified water.

Pharmacological action

Suprastinex is a histamine H1-receptor blocker. Levocetirizine is an enantiomer of cetirizine and a competitive histamine antagonist. Blocks H1-histamine receptors, the affinity for which is 2 times higher than that of cetirizine. It affects the histamine-dependent stage of allergic reactions, reduces the migration of eosinophils, reduces vascular permeability, and limits the release of inflammatory mediators. Prevents the development and eases the course of allergic reactions, has an anti-exudative, antipruritic effect. Practically does not have anticholinergic and antiserotonergic effects. In therapeutic doses, it has practically no sedative effect.

Indications

Symptomatic treatment:  – Year-round and seasonal allergic rhinitis and conjunctivitis (itching, sneezing, rhinorrhea, lacrimation, conjunctival hyperemia). – Hay fever (hay fever). – Urticaria, including chronic idiopathic urticaria. – Angioedema. – Allergic dermatoses, accompanied by itching and rashes.

Use during pregnancy and lactation

Animal studies have shown no direct or indirect adverse effects on pregnancy, embryo or fetal development, delivery, or postnatal development. No controlled clinical studies have been conducted 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.

Recommendations for use

The drug should be taken orally with a meal or on an empty stomach. Drops should be taken orally immediately after dilution. The daily dose is recommended to be taken in 1 dose. The recommended dose for adults and children over 6 years of age, elderly patients (assuming normal renal function) is 5 mg-1 ml of drops or 20 drops from a dropper per day. For children aged 2 to 6 years, the drug is prescribed in the form of drops. The daily recommended dose is 2.5 mg in 2 divided doses in equal doses of 1.25 mg (2 times 0.25 ml drops = 2 x 5 drops from the dropper). The duration of admission depends on the disease. The average course of treatment for pollinosis is 1-6 weeks. For chronic diseases (year-round rhinitis, chronic idiopathic urticaria), the course of treatment may be extended. There is a clinical experience of using the drug for up to 18 months.

Contraindications

: Severe renal insufficiency (creatinine clearance less than 10 ml / min). – Children under 6 years of age (for this dosage form). – Pregnancy. – Lactation period. – Lactose intolerance, hereditary lactase deficiency lapp (lactase deficiency in some peoples of the North) or glucose-galactose malabsorption syndrome (due to the content of lactose in tablets). – Hypersensitivity to the active (including piperazine derivatives) or any auxiliary component of the drug. Use with caution in patients with: – Chronic renal failure. – Elderly patients (glomerular filtration rate may decrease).

Side effects

From the side of metabolism:  very rarely – weight gain. From the central nervous system:  often-drowsiness, headache, increased fatigue; infrequently-asthenia; rarely-migraine, dizziness. Respiratory system disorders:  very rarely – dyspnoea. From the digestive system:  often – dry mouth; infrequently-abdominal pain; very rarely-nausea, dyspepsia, changes in liver function tests. Allergic reactions:  very rarely – anaphylaxis, angioedema, pruritus, rash, urticaria.

Interaction

Interaction studies of levocetirizine have shown no clinically significant interaction with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide, and diazepam. Concomitant use with macrolides or ketoconazole did not cause significant ECG changes. Theophylline (400 mg/ day) reduces the total clearance of levocetirizine by 16%. In this case, the pharmacokinetics of theophylline do not change. Levocetirizine does not enhance the effects of ethanol, but in sensitive patients, concomitant use of levocetirizine with ethanol or other CNS depressants may have an effect on the central nervous system.

Overdose

Symptoms:  overdoses in adults are manifested by drowsiness, in children – agitation, anxiety, which are replaced by drowsiness. Treatment:  there is no specific antidote. Symptomatic and supportive therapy, gastric lavage is recommended. Hemodialysis is ineffective.

Special instructions

Influence on the ability to drive motor vehicles and manage mechanisms:  during the treatment period, it is recommended to refrain from engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Drops for oral use.

Storage conditions

At a temperature not exceeding 25 °C (do not freeze)

Shelf life

4 years

Active ingredient

Levocetirizine

Dosage form

Drops for oral use

Description

For adults, Children over 2 years of age

Indications

Urticaria, Allergy, Allergic Conjunctivitis, Allergic Rhinitis, Pollinosis, Dermatosis, Neurodermatitis