La-Son tablets film-coated

Valsts: Armēnija

Valoda: angļu

Klimata pārmaiņas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktīvā sastāvdaļa:

hydroxyzine (hydroxyzine hydrochloride)

Pieejams no:

Arpimed LLC

ATĶ kods:

N05BB01

SNN (starptautisko nepatentēto nosaukumu):

hydroxyzine (hydroxyzine hydrochloride)

Deva:

25mg

Zāļu forma:

tablets film-coated

Vienības iepakojumā:

(20/2x10/) in blister

Receptes veids:

Prescription

Autorizācija statuss:

Registered

Autorizācija datums:

2018-07-17

Produkta apraksts

SUMMARY PRODUCT CHARACTERISTIC
LA-SON
25 MG FILM-COATED TABLETS
1.1.TRADE NAME - La-Son
1.2. INTERNATIONAL NON-PROPERTY NAME– Hydroxyzine
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
_ACTIVE INGREDIENT:_Hydroxyzine hydrochloride – 25mg;
_For a full list of excipients, see section 6.1. _
_ _
3. PHARMACEUTICAL FORM
White biconvexoval scored film-coated tablets.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
La-Son is indicated to assist in the management of anxiety in adults.
La-Son is indicated for the management of pruritus associated with
acute and chronic urticaria,
including cholinergic and physical types, and atopic and contact
dermatitis in adults and children.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
La-Son should be used at the lowest effective dose and for the
shortest possible duration.
In adults and children over 40 kg in weight, the maximum daily dose is
100 mg per day.
_Anxiety _
_ADULTS_50-100mg daily in divided doses_ _
_Pruritus _
_ADULTS_Starting dose of 25mg at night increasing as necessary to 25mg
three or four times daily._ _
_ELDERLY _
In the elderly, the maximum daily dose is 50 mg per day (see section
4.4). A reduced dose is advised.
This is due to a possible increase in the volume of distribution,
prolonged action and the possible effect
of age-related changes on pharmacologic functions; including hepatic
metabolism and renal excretion
(see Section 5.2 'Pharmacokinetic properties')
_PAEDIATRIC POPULATION _
In children up to 40 kg in weight, the maximum daily dose is 2
mg/kg/day.
From 6 months to 6 years, 5-15mg daily in divided doses adjusted
depending on the child's weight.
In children and adolescents, over 40 kg in weight the maximum daily
dose is 100mg per day.
For children over 6 years, starting at 15-25mg and increasing to
50-100mg daily in divided doses
adjusted according to the child's weight.
As with all medications, the dosage should be adjusted according to
the patient's response to therapy.
_HEPATIC IMPAIRMENT _
The total daily dose sh