Medicinal Products

PAROXETINE BGR 20 mg

Deroxat Generic Drug
Therapeutic Class: Neurology-Psychiatry
active ingredients: Paroxetine
laboratory: Glaxosmithkline

Divisible coated tablet
Box of 14
All forms

Indication

- Major depressive episodes (that is, characterized).
- Prevention of panic attacks with or without agoraphobia.
- Obsessive compulsive disorders.
- Social anxiety disorder characterized by "social phobias" when it significantly disrupts professional or social activities.
- Generalized anxiety, evolving for at least 6 months.

Dosage PAROXETINE BGR 20 mg Breakable film-coated tablet Box of 14

- Major depressive episodes:
The recommended starting dose is 20 mg daily. Depending on the therapeutic response, evaluated after 3 weeks of treatment, this dose may be increased in increments of 10 mg up to a maximum of 50 mg per day. These increases should be made at intervals of at least one week.
Duration of treatment : Antidepressant treatment is symptomatic. The treatment of an episode is several months (usually about 6 months) to prevent the risk of relapse of the depressive episode.
- Prevention of panic attacks with or without agoraphobia:
The recommended dosage is 40 mg daily. Treatment should be started at a low dose, 10 mg daily. The dose will be increased in increments of 10 mg per week depending on the therapeutic response, up to a maximum of 60 mg per day. These increases should be made at intervals of at least one week.
- Obsessive-compulsive disorders:
The recommended dosage is 40 mg daily.
The recommended starting dose is 20 mg daily. Depending on the therapeutic response, the dosage may be increased in increments of 10 mg to a maximum of 60 mg per day. These increases should be made at intervals of at least one week.
- Social anxiety disorder characterized by "social phobias" when it significantly disrupts professional or social activities:
The recommended starting dose is 20 mg daily. Depending on the therapeutic response, evaluated after 2 weeks of treatment, this dose may be increased in increments of 10 mg up to a maximum of 50 mg per day. These increases should be made at intervals of at least one week.
Duration of treatment : The efficacy of paroxetine in this indication has been demonstrated in placebo-controlled trials over a period of 3 months.
Long-term efficacy has not been demonstrated.
The place of this treatment with respect to cognitive-behavioral therapies (CBT) has not been studied.
The overall care of the patient remains a fundamental element for the success of the treatment.
- Generalized anxiety
The recommended starting dose is 20 mg daily. Depending on the therapeutic response, evaluated after 3 weeks of treatment, this dose may be increased in increments of 10 mg up to a maximum of 50 mg per day. These increases should be made at intervals of at least one week.
Duration of treatment : The efficacy of paroxetine in generalized anxiety has been demonstrated in placebo-controlled trials for up to 8 months. The treatment of generalized anxiety generally requires a continuous medication prescription of several months; a regular reassessment of the diagnosis is necessary.
For all indications :
- In cases of hepatic or renal insufficiency:
In patients with renal impairment (creatinine clearance <30 ml / min) and in patients with severe hepatic impairment, an increase in paroxetine plasma concentrations may occur. It is therefore recommended to limit the use of the lowest doses to the proposed therapeutic range.
- In the elderly subject:
Do not exceed 40 mg daily.
- In children and adolescents:
The efficacy of paroxetine has not been demonstrated in children and adolescents under 18 years of age.
Controlled clinical studies in depression have not demonstrated the efficacy of paroxetine in children and adolescents with major depressive episodes (see section 4.8).
- Administration mode :
The tablets are administered in a single daily dose, in the morning during breakfast. They must be swallowed rather than chewed. The breakable tablet makes it possible to adapt the dosage in the therapeutic range.
- Methods of stopping treatment:
Stopping a prolonged treatment should be done gradually over several weeks.

Against indications

CONTRAINDICATED:
This medicine MUST NEVER be prescribed in the following cases:
- Hypersensitivity to paroxetine.
- Children under 15 years old.
- Association with non-selective MAOIs (see interactions).
- Association with MAOI A (moclobemide, toloxatone). However, in exceptional cases, association may be essential (see warnings and interactions).
NOT RECOMMENDED :
This medicine should NOT be prescribed in the following cases:
- Breast-feeding: Although paroxetine passes into breast milk, treatment with paroxetine is not recommended during breastfeeding.
- Although no clear interaction has been demonstrated with alcohol, consumption is discouraged, as with any psychotropic medication.

Side effects Paroxetine Bgr

The most common side effects are especially noted during the first, or even the first two weeks of treatment. Most fade afterwards, along with the improvement of the depressive episode.
Have been found, as monotherapy or in combination with other psychotropic drugs, disorders:
- digestive : nausea, vomiting, constipation, diarrhea;
- neuropsychic : somnolence, asthenia, insomnia, dizziness, trembling; rarely develops or worsens extrapyramidal symptoms including orofacial dyskinesia (usually with inducing drugs), confusion (especially in elderly patients), seizures.
Very rarely and in combination, serotonin syndrome (see interactions);
Hepatic : very rare cases of elevated liver enzymes have been reported as well as exceptional hepatitis, sometimes associated with jaundice and / or hepatocellular insufficiency.
In case of abnormal liver function, discontinuation of treatment is required;
- cases of hyponatremia, some severe, have been reported. This hyponatremia is reversible upon discontinuation of treatment and may be revealed by a confusional syndrome, or even convulsions. Most cases have been described in elderly patients or taking diuretics or hypovolemic drugs.
Some cases may be associated with an inappropriate syndrome of secretion of antidiuretic hormone;
- disorders of libido and ejaculation (which can be frequent if paroxetine is prescribed for the treatment of a social anxiety disorder characterized by "social phobias"), galactorrhea and other symptoms suggestive of hyperprolactinemia and rare cases urinary retention;
- rare cases of maculopapular rashes, urticaria, exceptionally angioedema;
- rare cases of bruising, gynecological haemorrhage, gastrointestinal bleeding or other mucocutaneous bleeding;
- rare cases of elevation or decrease in blood pressure regressing when treatment is stopped;
- various : sweating, dry mouth. Some visual disturbances have been reported including mydriasis and much more rarely aggravations of acute glaucoma. Rare weight gains, sometimes significant, have been reported.
Sudden discontinuation of treatment may result in symptoms such as dizziness, sensory disturbances, sleep disturbances, restlessness and anxiety, asthenia, digestive disorders and sweating within one week. These signs may persist for 1 to 2 weeks.
In addition, certain undesirable effects are linked to the very nature of the depressive illness:
- removal of psychomotor inhibition, with suicidal risk,
- reversal of mood with the appearance of manic episodes,
- reactivation of delirium in psychotic subjects.
In clinical trials conducted in children and adolescents, the reported adverse effects are identical to those seen in adults. However, the following adverse reactions were at least twice as frequent in the paroxetine group compared to placebo (and> 2% frequency): decreased appetite, tremor, sweating, hyperkinesia, hostility, agitation, emotional lability including crying, mood swings, self-aggression, suicidal thoughts, and attempted suicide. These last two effects have been observed mainly in adolescents suffering from major depressive episode.
In studies including a regimen of gradual decrease in dosage, symptoms twice as frequent in the paroxetine group compared to placebo (and frequency> = 2%) were: nervousness, dizziness, nausea, emotional lability (including crying, fluctuations mood, self-aggression, suicidal thoughts and attempted suicide) and abdominal pain.

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