Medicinal Products

PAROXETINE IVAX 20 mg

Deroxat Generic Drug
Therapeutic Class: Neurology-Psychiatry
active ingredients: Paroxetine
laboratory: IVAX PHARMACEUTICALS SAS

Divisible coated tablet
Box of 14
All forms

Indication

Treatment of :
- Major depressive episode.
- Obsessive Compulsive Disorders.
- Panic disorder with or without agoraphobia.
- Social Anxiety Disorder / Social Phobia.
- Generalized anxiety disorder.
- State of post-traumatic stress.

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

- It is recommended to administer paroxetine once daily in the morning during breakfast.
- The tablets should be swallowed rather than chewed.
MAJOR DEPRESSIVE EPISODE :
- The recommended dosage is 20 mg daily.
- In general, improvement of the patient begins after one week of treatment but may not become apparent until the second week.
- As with all antidepressant medications, the dosage should be reviewed and adjusted if necessary within 3 to 4 weeks of starting treatment and thereafter if clinically justified.
- In some patients with insufficient response at 20 mg, the dosage may be increased gradually in 10 mg increments depending on the therapeutic response, up to a maximum of 50 mg per day.
- Patients with depression should be treated for a sufficient period of at least 6 months to ensure the disappearance of symptoms.
OBSESSIVE DISORDERS COMPULSIVE :
- The recommended dosage is 40 mg daily. Treatment will be started at a dose of 20 mg per day, which may be increased gradually in 10 mg increments to the recommended dose.
- In case of insufficient response after several weeks of treatment at the recommended dose, some patients may benefit from a gradual increase in dose, up to a maximum of 60 mg per day.
- Patients with obsessive-compulsive disorder should be treated for a sufficient period of time to ensure the disappearance of symptoms. This period may last several months or even longer (see section on pharmacodynamic properties).
PANIC DISORDER :
- The recommended dosage is 40 mg daily. The treatment will be started at the dose of 10 mg per day, which may be increased gradually in 10 mg increments depending on the therapeutic response up to the recommended dose.
- A low initial dose is recommended to minimize potential worsening of symptoms of panic disorder, which may occur at the beginning of treatment. In case of insufficient response after several weeks of treatment at the recommended dose, some patients may benefit from a gradual increase in dose, up to a maximum of 60 mg per day.
- Patients with panic disorder should be treated for a sufficient period of time to ensure the disappearance of symptoms. This period may last several months or even longer (see section on pharmacodynamic properties).
SOCIAL ANXIETY DISORDER / SOCIAL PHOBY :
- The recommended dosage is 20 mg daily. In case of insufficient response after several weeks of treatment at the recommended dose, some patients may benefit from a gradual increase in dose in 10 mg increments up to a maximum of 50 mg per day.
- Long-term use should be regularly evaluated (see section on pharmacodynamic properties).
GENERALIZED ANXIETY DISORDER :
- The recommended dosage is 20 mg daily. In case of insufficient response after several weeks of treatment at the recommended dose, some patients may benefit from a gradual increase in dose in 10 mg increments up to a maximum of 50 mg per day.
- Long-term use should be regularly evaluated (see section on pharmacodynamic properties).
STATE OF POST-TRAUMATIC STRESS :
The recommended dosage is 20 mg daily. In the event of an inadequate response after several weeks of treatment at the recommended dose, some patients may benefit from a gradual dose increase in 10 mg increments per week, up to a maximum of 50 mg per day. Long-term use should be regularly evaluated (see section on pharmacodynamic properties).
GENERAL INFORMATION :
WEANING SYMPTOMS OBSERVED DURING THE STOPPING OF PAROXETINE:
- Abrupt discontinuation of treatment should be avoided (see sections cautionary and precautions for use and adverse effects).
- The pattern used in the clinical trials included a gradual discontinuation of treatment with a decrease in the daily dose in increments of 10 mg per week.
- The occurrence of uncomfortable symptoms during the dose reduction or at the end of treatment may necessitate the resumption of the previously prescribed dose. The doctor can then continue to decrease the dose at a more gradual rate.
SPECIAL POPULATIONS:
- Elderly people:
An increase in plasma concentrations is observed in the elderly, but they remain within the limits of those observed in younger patients. The initial dosage is the same as in adults. A dose increase may be useful in some patients, but the maximum dose should not exceed 40 mg per day.
- Children and adolescents (7-17 years):
Paroxetine is not recommended in children and adolescents, as controlled clinical studies have shown that paroxetine is associated with an increased risk of suicidal behavior and hostility. In addition, the efficacy of paroxetine has not been sufficiently demonstrated in these trials (see sections cautionary and precautions for use and adverse effects).
- Children under 7 years old:
The use of paroxetine has not been studied in children under 7 years of age. Paroxetine is not recommended until its effectiveness and safety of use has been demonstrated in this age group.
- Hepatic or renal insufficiency:
Increased plasma concentrations of paroxetine are observed in patients with severe renal impairment (creatinine clearance <30 ml / min) and in patients with hepatic impairment. The lowest recommended dosage should not be exceeded in these patients.

Against indications

CONTRAINDICATED:
- Known hypersensitivity to paroxetine or to any of the excipients.
- Paroxetine is contraindicated in combination with Monoamine Oxidase Inhibitors (MAOIs).
Treatment with paroxetine may be initiated:
. 2 weeks after stopping treatment with a non-selective MAOI, or
. at least 24 hours after stopping a selective MAOI (eg moclobemide).
Observe a delay of at least one week between stopping paroxetine and the start of treatment with an MAOI.
- Paroxetine should not be used in combination with thioridazine. Like other CYP450 2D6 inhibitors, it is likely to increase plasma concentrations of thioridazine (see section interactions). Administration of thioridazine alone may lead to prolongation of the QTc interval associated with serious ventricular arrhythmias such as torsades de pointes, and sudden death.
- Paroxetine should not be used in combination with serotonin precursors (such as L-tryptophan, oxitriptan) because of the risk of serotonin syndrome (see section on interactions: triptans, tramadol, linezolid, SSRI, lithium and preparations with St. John's wort - Hypericum perforatum ).
- Paroxetine should not be associated with pimozide (see section interactions).
NOT RECOMMENDED :
- Use in children and adolescents under 18 years: the use of Paroxetine Ivax is not recommended for children and adolescents under 18 years.
- Pregnancy: some epidemiological studies suggest a slight increase in the risk of cardiovascular malformation (intertropicular communication in particular and interauricular) in children of mothers treated with paroxetine during the first trimester of pregnancy. The mechanism is not known. These data suggest that the risk of having a child with a cardiovascular malformation is less than 2% for a mother exposed to paroxetine, while the expected rate of this type of abnormality is about 1% in the general population. The available data do not suggest an increase in the rate of all congenital malformations. Paroxetine will only be used during pregnancy if it is strictly necessary. The doctor will have to evaluate the interest of an alternative treatment in a pregnant woman or considering to be it. Abrupt discontinuation of treatment should be avoided during pregnancy (see "Withdrawal symptoms observed during discontinuation of paroxetine" section titration and method of administration).
- Breast-feeding: Small amounts of paroxetine are excreted in breast milk. In published studies, serum concentrations of breastfed infants were undetectable (<2 ng / ml) or very low (<4 ng / ml). No evidence of drug effect was observed in these infants. Nevertheless, treatment with paroxetine is not recommended during breastfeeding, unless the expected benefits to the mother do not justify the potential risks to the infant.
- As with other psychotropic treatments, alcoholic beverages are discouraged during treatment.
- It is not recommended to use paroxetine in combination with metoprolol when administered in heart failure because of a narrow therapeutic index of metoprolol in this indication.

Adverse effects Paroxetine Ivax

- Some of the side effects listed below may decrease in intensity and frequency with continued treatment and usually do not require treatment discontinuation.
- The undesirable effects are listed below by organ system and frequency.
- The frequencies are defined as follows: very frequent (> = 1/10), frequent (> = 1/100, = 1/1000, = 1/10000, <1/1000) and very rare (<1/10000), including isolated observations.
- Hematological and lymphatic system disorders:
. Uncommon : abnormal bleeding, mainly cutaneous and mucous (especially bruising).
. Very rare : thrombocytopenia.
- Immune system disorders:
Very rare : allergic reactions (including urticaria and angioedema).
- Endocrine disorders:
Very rare : syndrome of inappropriate secretion of antidiuretic hormone (SIADH).
- Metabolism and nutrition disorders:
. Frequent : decreased appetite.
. Rare : hyponatremia. Most cases have been described in elderly patients and are sometimes due to an inappropriate syndrome of secretion of antidiuretic hormone (SIADH).
- Psychiatric disorders:
. Frequent : drowsiness, insomnia, agitation.
. Uncommon : confusion, hallucinations.
. Rare : manic reactions, anxiety, depersonalization, panic attacks, akathisia (see section on warnings and precautions for use).
. These symptoms may also be due to the underlying pathology.
- Nervous system disorders:
. Frequent : dizziness, trembling.
. Uncommon : extrapyramidal syndromes.
. Rare : convulsions.
. Very rare : serotonin syndrome (symptoms may include agitation, confusion, hypersudation, hallucinations, hyperreflexia, myoclonus, chills, tachycardia and tremors).
. Extrapyramidal syndromes including orofacial dyskinesia have been reported in patients with sometimes underlying abnormal movements or in patients treated with neuroleptics.
- Eye disorders:
. Common : blurred vision
. Very rare : acute glaucoma.
- Cardiac disorders:
. Uncommon : sinus tachycardia.
. Rare : bradycardia.
- Vascular disorders:
. Uncommon : transient elevations or decreases in blood pressure.
. There have been reports of transient elevations or decreases in blood pressure following paroxetine treatment, usually in patients with pre-existing hypertension or anxiety.
- Respiratory, thoracic and mediastinal disorders:
Frequent : yawning
- Gastrointestinal disorders:
. Very common : nausea.
. Frequent : constipation, diarrhea, dry mouth.
. Very rare : gastrointestinal bleeding.
- Hepatobiliary disorders:
. Rare : elevation of liver enzymes.
. Very rare : liver problems (such as hepatitis, sometimes associated with jaundice and / or hepatocellular insufficiency).
. Cases of hepatic enzyme elevation have been reported. Very rarely, cases of hepatitis, sometimes associated with jaundice and / or hepatocellular insufficiency, have been reported after the marketing of paroxetine. In case of prolonged elevation of liver function tests, discontinuation of treatment should be considered.
- Skin and subcutaneous tissue disorders:
. Frequent : sweating.
. Uncommon : rash, pruritus.
. Very rare : photosensitization reactions.
- Renal and urinary disorders:
Uncommon : urinary retention.
- Disorders of the reproductive organs and the breast:
. Very common : sexual dysfunction.
. Rare : hyperprolactinemia / galactorrhea.
. Very rare : priapism.
- Musculoskeletal problems :
Rare : arthralgia, myalgia.
- General disorders:
. Frequent : asthenia, weight gain.
. Very rare : peripheral edema.
WASTE SYMPTOMS AT STOPPING TREATMENT :
- Frequent : dizziness, sensory disturbances, sleep disorders, anxiety, headache.
- Uncommon : agitation, nausea, tremor, confusion, sweating, emotional instability, visual disturbances, palpitations, diarrhea, irritability.
- Stopping treatment with paroxetine, especially when it is brutal, frequently leads to withdrawal symptoms.
- Have been observed: dizziness, sensory disturbances (including paresthesia and sensations like electric shocks), sleep disorders (including intense dreams), agitation or anxiety, nausea, tremors, confusion, sweating, headache, diarrhea, palpitations, instability emotional, irritability and visual disturbances.
- Generally, these effects are of mild to moderate intensity, and spontaneously resolving; however, in some patients they may be severe and / or prolonged.
- It is therefore recommended to gradually reduce the doses of paroxetine when the treatment is no longer necessary (see sections dosage and method of administration and warnings and precautions for use).
ADVERSE EFFECTS DURING PEDIATRIC CLINICAL TRIALS :
- In short-term (up to 10-12 weeks) clinical trials in children and adolescents, the following adverse events have been observed in patients treated with paroxetine, with> 2% frequency and at least twice that observed in the placebo group: increased suicidal behavior (including suicide attempts and suicidal thoughts), self-aggression behaviors and increased hostility. Suicidal thoughts and suicide attempts were mainly observed in clinical trials in adolescents with major depressive episodes. The increase in hostility has been observed among children with obsessive-compulsive disorders, especially among children under 12 years of age. Other adverse events observed more frequently in the paroxetine group compared to the placebo group were: decreased appetite, tremor, hypersudation, hyperkinesia, agitation, emotional lability (including crying and mood swings).
- In studies with a progressive treatment discontinuation schedule, symptoms reported during the dose reduction or discontinuation phase, with a frequency> = 2% and at least twice that observed in the group placebo were: emotional lability (including crying, mood swings, self-aggression, suicidal thoughts and suicide attempt), nervousness, dizziness, nausea, and abdominal pain (see section on warnings and precautions for use).

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