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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