Trittico

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

trazodone

Available from:

Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Via Vecchiaa Del Pinocchio

INN (International Name):

trazodone

Dosage:

150mg

Pharmaceutical form:

tablets prolonged-release

Prescription type:

Prescription

Summary of Product characteristics

ENGLISH VERSION of IT-SPC DEC 2010 (post work-sharing)
SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Trittico 75 mg prolonged-release tablets
Trittico 150 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
_Trittico 75 mg prolonged-release tablets _
_ _
Each tablet contains_: _
_ _
_ _75 mg trazodone hydrochloride corresponding to 68.3 mg trazodone _
_
_ _
_ _
_Trittico 150 mg prolonged-release tablets _
Each tablet contains_ _
_ _
150 mg trazodone hydrochloride corresponding to 136.6 mg trazodone
For complete list of excipients see section 6.1._ _
3.
PHARMACEUTICAL FORM
Scored prolonged-release tablets dividable in 3 parts.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS:
Depressive disorders with or without anxiety
4.2
POSOLOGY AND METHOD OF ADMINISTRATION:
The use of the drug is restricted to adult patients.
Therapy should begin with an evening administration and with
increasing daily doses. The
drug should be administered for therapeutic cycles of at least one
month.
Decrease of the side-effects (increase of the resorption and decrease
of the peak plasma
concentration) can be reached by taking trazodone hydrochloride after
a meal.
The scored tablets can be divided into three parts in order to permit
a gradual dose increase
depending on the severity of the disease, weight, age and general
condition of the patient.
_Adults: _
75-150 mg/day to be administered in a single dose in the evening
before bedtime.
The dose can be increased up to 300 mg/day divided in two
administrations.
In hospitalized patients the dose can be further increased up to 600
mg/day in repeated
doses.
_Elderly _
For very elderly, or frail patients, the recommended initial dose is
reduced to 100 mg a day,
administered in divided doses or as a single night time dose. This may
be incrementally
increased, as described under Adults, under supervision, according to
tolerance and efficacy.
In general, single doses above 100 mg should be avoided in these
patients. . It is unlikely
that doses h