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DEPRAX®
100 mg
Trazodone
Broad-spectrum antidepressant
Deprax®
is comprised of trazodone hydrochloride, a molecule with a potent antidepressant
action, which differs from the usual antidepressants in its biochemical
structure and its mechanism of action.
According to biochemical and neurophysiological data, the site of action
of Deprax® is the diencephalic structures that control and organise
the emotional and affection sphere, and whose primitive or secondary alteration
represents a common pathogenic stage of depression and its somatic equivalences.
COMPOSITION
Each tablet contains:
Trazodone (INN) HCl.................................100 mg
Excipients: microcrystalline cellulose, calcium hydrogen phosphate dihydrate,
sodium croscarmellose, povidone, cochineal red A (E-124), sunset yellow
S (E-110), magnesium stearate, Eudragit E 12.5%, micronised talc.
THERAPEUTIC
INDICATIONS
Psychiatric: Organic, endogenous, psychogenic, symptomatic and
involutional depressions. Mixed stages of depression with anxiety. Atypical
or masked depressions (psychosomatic disorders).
Neurological: Tremors, dyskinesias.
Geriatric: Emotional-affective and behavioural disorders: irritability,
aggressiveness, emotional lability, tendency towards isolation, reduction
in sleep time.
Surgical: Pre-anaesthetic, pre-endoscopic and postoperative medication.
POSOLOGY
Dosage will be adapted to the needs and to the response of each patient,
beginning at low doses that may be increased progressively to suitable
levels, beginning preferably at night.
In moderate exogenous symptomatic and psychogenic depressions, 150 to
300 mg/day.
In severe endogenous and psychogenic depressions, 300 to 600 mg/day. The
maximum ambulatory dose should not be more than 400 mg/day, with the dose
of up to 600 mg/day reserved for hospitalised patients.
In organic and involutional depressions, neurological indications and
psychosomatic disorders, 75 to 150 mg/day.
In geriatrics, 50 to 75 mg/day.
INSTRUCTIONS
FOR USE
To be taken preferably after meals.
In the event of uneven fractionated doses the highest dose should be given
at night.
CONTRAINDICATIONS
AND PRECAUTIONS
Proceed with caution in cases of decompensated heart failure and hypotension.
During the first week of treatment it may affect the capacity to drive
vehicles or use precision machinery.
Do not use during the first three months of pregnancy.
INCOMPATIBILITIES
There are no incompatibilities. Nevertheless, the patient should be monitored
if the treatment is combined with other psychopharmaceuticals, as well
in treatments with antihypertensives.
WARNINGS
Warning on excipients: This medicine contains cochineal red A (E-124)
and sunset yellow S (E-110) as excipients. They may cause allergic-type
reactions, including asthma, particularly in patients allergic to acetyl
salicylic acid.
UNDESIRABLE
EFFECTS
In some cases, drowsiness, asthenia, hypotension, headache, vertigo, mild
excitation, dryness of mouth, psychomotor and gastrointestinal disorders
may appear. Generally speaking, these effects are transient and do not
require interruption of the treatment.
As occurs with other drugs with alpha-adrenolytic activity, rare cases
of priapism associated with treatment with trazodone have been reported.
In this case the patient should stop the treatment rapidly.
OVERDOSE
In case of overdose, symptomatic treatment with analeptics, gastric lavage
and forced diuresis should be initiated.
In case of overdose or accidental intake, call the Toxicology Information
Service on 91 562 04 20.
PRESENTATION
Boxes with 30 and 60 tablets of 100 mg.
Clinical container: box with 1,000 tablets of 100 mg.
Other
presentations
Tablets
Box with 30 tablets of 50 mg.
Solution
for injection
Box with 10 ampoules of 50 mg.
Clinical container: box with 100 ampoules of 50 mg.
BY
PRESCRIPTION ONLY
Keep
medicines out of the reach of children.
Farma-Lepori,
S.A.
C. Osi, 7- 08034 Barcelona
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