Levomepromazine tablets coated

Land: Armenien

Språk: engelska

Källa: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Produktens egenskaper Produktens egenskaper (SPC)
12-04-2022

Aktiva substanser:

levomepromazine (levomepromazine maleate)

Tillgänglig från:

Arpimed LLC

ATC-kod:

N05AA02

INN (International namn):

levomepromazine (levomepromazine maleate)

Dos:

25mg

Läkemedelsform:

tablets coated

Enheter i paketet:

(50/5x10/) in blister

Receptbelagda typ:

Prescription

Bemyndigande status:

Registered

Tillstånd datum:

2022-04-12

Produktens egenskaper

                                SUMMARY OF PRODUCT CHARACTERISTICS
LEVOMEPROMAZINE
25 MG COATED TABLETS
1. NAME OF THE MEDICINAL PRODUCT –
Levomepromazine 25mg coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 25 mg levomepromazine maleate
For excipients, see 6.1.
3. PHARMACEUTICAL FORM
White, oval, biconvex coated tablets with scored on one side,
odorless.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Levomepromazine is a neuroleptic with indications in psychiatry and
general medicine,
particularly in terminal illness. Clinically it is more sedative and
more potent than
chlorpromazine in the management of psychotic conditions and in the
relief of severe chronic
pain.
Psychiatry
As an alternative to chlorpromazine in schizophrenia especially when
it is desirable to reduce
psychomotor activity.
General medicine – Terminal illness
Adjunct therapy in the relief of pain and the accompanying distress.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dosage varies with the condition under treatment and the individual
response of the patient.
1. Terminal illness
Levomepromazine coated tablets 25mg may be substituted for the
injection if oral therapy is
more convenient, the dosage being 12.5mg to 50mg every 4 to 8 hours.
Elderly
No specific dosage recommendations.
2. Psychiatric conditions
Adults
Ambulant patients: initially the total daily oral dose should not
exceed 25mg to 50mg usually
divided into 3 doses; a larger portion of the dosage may be taken at
bedtime to minimise diurnal
sedation. The dosage is then gradually increased to the most effective
level compatible with
sedation and other side effects.
Bed patients: initially the total daily oral dosage may be 100mg to
200mg, usually divided into 3
doses, gradually increased to 1g daily if necessary. When the patient
is stable attempts should be
made to reduce the dosage to an adequate maintenance level.
Children
Children are very susceptible to the hypotensive and soporific effects
of levomepromazine. It is
advised that a total daily oral dosage of 1½ tabl
                                
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