Description
Release form
Tablets, film-coated.
Packing
In a blister pack of 10 tablets. In a pack of cardboard 1 blister.
Pharmacological action
GLENCET – Levocetirizine – enantiomer of cetirizine, a competitive histamine antagonist:
– blocks the H1-histamine receptors
– affinity for which is 2 times higher than that of cetirizine
– affects the histamine-dependent stage of allergic reactions
– reduces the migration of eosinophils
– vascular permeability, reduces inflammation, and reduces inflammation allergic reactions
– has an antiexudative, antipruritic effect
– practically has no anticholinergic and antiserotonin effect.
In therapeutic doses, sedation is very mild. The action begins 12 minutes after taking a single dose in 50% of patients, after 1 h – in 95% of patients and lasts for 24 hours.
Indications
– symptomatic treatment of urticaria, incl. chronic idiopathic urticaria
– Quincke’s edema
– other allergic dermatoses, accompanied by itching and rashes.
Contraindications
Hypersensitivity (including to piperazine derivatives), severe chronic renal failure (CRF, CC less than 10 ml / min), pregnancy, lactation, children under 6 years of age.
Galactose intolerance, lactase deficiency and glucose-galactose malabsorption.
Precautions:
Chronic renal failure (dosage adjustment required), advanced age (possibly reduced glomerular filtration).
Special instructions
Caution is required while drinking with alcohol (see Interactions with Other Medicines).
Effect on the ability to drive vehicles and control mechanisms
With an objective assessment, the effect of the drug on the ability to drive vehicles and control mechanisms when taken at the recommended dose was not reliably noted.
Nevertheless, during the period of taking the drug, it is advisable to refrain from engaging in potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions.
Ingredients
Core:
Active ingredient:
Levocetirizine dihydrochloride – 5 mg Excipients:
Lactose monohydrate (Tablet 100)
Microcrystalline crystalline (sulphate)
Opadry white (Opadry white Y-1-7000) [hypromellose-5cP, titanium dioxide, macrogol-400 (polyethylene oxide-400)]
Dosage and administration
Inside, with food or on an empty stomach, with a little water, without chewing.
Recommended dose for adults and children over 6 years of age, elderly patients (subject to normal renal function) – 5 mg (1 tablet) once a day.
In patients with chronic renal failure, the dose is halved (1 tablet every other day) with CC from 30 to 49 ml / min and 3 times (1 tablet in 3 days) with CC from 10 to 29 ml / min.
Dosage adjustment is not required for patients with hepatic insufficiency.
The course of treatment for chronic diseases is up to 18 months.
Side effects
Possible side effects are listed below on the body systems and frequency of occurrence: often (> 1/10), infrequently (? 1/100,? 1/10), rarely (? 1/1000,? 1/100), very rarely (? 1/10000,? 1/1000).
From the central nervous system
Infrequently: headache, fatigue, drowsiness.
Rarely: asthenia.
Very rarely: aggression, agitation, hallucinations, depression, convulsions. On the part of the sensory organs:
Very rarely: visual impairment.
From the digestive system:
Infrequently: dry oral mucosa.
Rarely: abdominal pain.
Very rare: nausea, diarrhea, hepatitis.
From the cardiovascular system:
Very rarely: tachycardia.
From the respiratory system: Very rarely: dyspnea.
From the musculoskeletal system:
Very rarely: myalgia. Metabolism:
Very rare: weight gain.
Laboratory findings:
Very rare: changes in liver function tests.
Allergic reactions:
Very rare: itching, rash, urticaria, angioedema, anaphylaxis
Drug interaction
Theophylline (400 mg / day) reduces the total clearance of levocetirizine by 16%, while theophylline kinetics does not change.
Joint use with macrolides or ketoconazole did not cause significant changes on the ECG.
May enhance the effects of drugs that inhibit the central nervous system and ethanol.
Overdose
Symptoms: drowsiness, anxiety in children, irritability.
Treatment: gastric lavage, activated charcoal, symptomatic therapy.
There is no specific antidote.
Hemodialysis is ineffective.
Storage conditions
In a dry, dark place at a temperature not exceeding 30 ° C.
Keep out of the reach and sight of children.
Shelf life
3 years.
Active ingredient
levocetirizine
pharmacy conditions17
Prescription
dosage form
tablets
Prescription
for
Prescribing for children over 6 years old, for adults
Glenmark Farmasʹûtikalz Ltd, India
