deroxat 20 mg (Paroxetine) Uses, Dosage, Side Effects, Precautions & Warnings

deroxat 20 mg (Paroxetine) Uses, Dosage, Side Effects, Precautions & Warnings
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deroxat 20 mg Generic drug of the therapeutic class: Neurologypsychiatry
active ingredients: Paroxetine

Important to know about Deroxat ?

The anxiety disorders in which DEROXAT can be prescribed are as follows:

  • obsessive-compulsive disorders (repetitive, obsessive thoughts with uncontrollable behavior),
  • panic disorder (panic attacks, including those caused by fear of public places, agoraphobia),
  • social anxiety disorder (fear or rejection of situations where you must be in society),
  • post-traumatic stress disorder (anxiety caused by a traumatic event),
  • generalized anxiety.

DEROXAT belongs to the class of drugs called Selective Serotonin Reuptake Inhibitors (SSRIs).

People with depression or anxiety have decreased levels of serotonin (substance in the brain).

The mechanism of action of DEROXAT and other SSRIs is not fully known, but they would increase serotonin levels in the brain.

Treating your depression or anxiety disorder well is important to help you feel better.

Deroxat Uses and indication

Treatment of :

  • Major depressive episode.
  • Obsessive-compulsive disorders.
  • Panic disorder, with or without agoraphobia.
  • Social anxiety disorder / social phobia.
  • Generalized anxiety disorder.
  • Post-traumatic stress disorder

Deroxat Dosage :

It is recommended to take 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 an 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.

COMPULSIVE OBSESSIVE DISORDERS

  • 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 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 panic disorder symptoms that 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 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 5.1 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 5.1 Pharmacodynamic properties ).

STATE OF POST-TRAUMATIC STRESS

  • 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 per week, up to a maximum of 50 mg per day.
  • Long-term use should be regularly evaluated (see section 5.1 Pharmacodynamic properties ).

GENERAL INFORMATIONS

WEANING SYMPTOMS OBSERVED DURING THE STOPPING OF PAROXETINE

  • Abrupt discontinuation of treatment should be avoided (see Warnings and Precautions and Adverse Reactions sections ).
  • The pattern used in the clinical trials included a gradual discontinuation of treatment with a decrease in the daily dose 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

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 old)

  • 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 Warnings and precautions for use and undesirable 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.

How it works Deroxat

Pharmacotherapeutic group: antidepressant – Selective serotonin reuptake inhibitor, ATC code: N06 AB 05

Action mechanism

Paroxetine is a potent and selective inhibitor of the reuptake of 5-hydroxytryptamine (5HT, serotonin). Its antidepressant action and its efficacy in the treatment of Obsessive Compulsive Disorders, Social Anxiety / Social Phobia disorder, Generalized Anxiety Disorder, Posttraumatic Stress Disorder and Panic Disorder appear to be due to its specific inhibition of recapture serotonin in brain neurons.

Paroxetine is not chemically related to tricyclic antidepressants, tetracyclics and other available antidepressants.

Paroxetine has a low affinity for cholinergic muscarinic receptors and animal studies have shown only weak anticholinergic activity.

In relation to this selective action, in vitro studies have shown that, unlike most tricyclic antidepressants, paroxetine has little affinity for alpha 1, alpha 2, and beta adrenergic, dopaminergic (D2), related 5HT1 receptors , 5-HT2 and histaminergic (H1). This lack of interaction with postsynaptic receptors in vitro is corroborated by in vivo studies demonstrating the absence of depressant effect on the central nervous system as well as hypotensive properties.

Pharmacodynamic effects 

  • Paroxetine does not alter the psychomotor functions and does not potentiate the depressant effects of ethanol.
  • As with other SSRIs, paroxetine causes symptoms of over-stimulation of serotonin receptors when administered to animals that have previously received monoamine oxidase inhibitors (MAOIs) or tryptophan.
  • Behavioral and electroencephalographic (EEG) studies show that paroxetine is weakly activating at doses generally greater than those resulting in the inhibition of serotonin reuptake. These activating properties are not amphetaminic in nature.
  • Animal studies indicate that paroxetine is well tolerated at the cardiovascular level. In healthy volunteers, paroxetine does not result in clinically significant changes in blood pressure, heart rate, and electrocardiogram.
  • In contrast to antidepressants that inhibit norepinephrine reuptake, studies indicate that paroxetine has a low propensity to inhibit the antihypertensive effects of guanethidine.
  • In the treatment of depressive disorders, paroxetine shows comparable efficacy to antidépresse u rs standards.
  • Paroxetine may be of therapeutic interest in patients who do not respond to standard therapies.
  • Morning intake of paroxetine has no detrimental effect on the quality or duration of sleep.
  • In addition, patients are likely to improve their sleep when they respond to treatment with paroxetine.

Suicidality analysis in adults

A specific analysis of studies comparing paroxetine with placebo in adults with psychiatric disorders showed a higher frequency of suicidal behavior in paroxetine-treated young adults (aged 18 to 24) than in those receiving placebo (2). , 19% vs. 0.92%). No such differences were observed in the older age groups. In adults with a major depressive episode (all ages), an increase in the frequency of suicidal behavior was observed in patients treated with paroxetine, compared to those receiving placebo (0.32% vs. 0.05%) ; all the events observed were suicide attempts. However, the majority of attempts seen with paroxetine (8 of 11) involved younger adults (see also sectionWarnings and precautions for use ).

Dose response

In fixed-dose studies, the dose-response curve is flattened, suggesting no benefit in using doses higher than the recommended doses in terms of efficacy. However, some clinical data suggest that increasing doses may be beneficial in some patients.

Long-term efficiency

  • The long-term efficacy of paroxetine in depression was demonstrated in a 52-week efficacy-maintenance study (following a “relapse prevention” pattern): 12% of patients receiving paroxetine (20- 40 mg daily) relapsed versus 28% of patients in the placebo arm.
  • The long-term efficacy of paroxetine in obsessive-compulsive disorder has been demonstrated in three 24-week, “relapse-prevention” efficacy studies. One of the 3 studies showed a significant difference between the proportion of relapses on paroxetine (38%) and placebo (59%).
  • The long-term efficacy of paroxetine in the treatment of panic disorder has been demonstrated in a 24-week, “relapse-prevention” efficacy study: 5% of patients on paroxetine (10-40 mg) relapsed versus 30% of patients on placebo. This was confirmed in a 36-week efficacy maintenance study.
  • The long-term efficacy of paroxetine in the treatment of Social Anxiety Disorder, Generalized Anxiety Disorder and Posttraumatic Stress Disorder has not been sufficiently demonstrated.

Adverse effects in 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 ³2% and at least twice that observed in the placebo group: increased suicidal behavior (including suicide attempts and suicidal thoughts), self-aggressive behavior 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 in children with obsessive-compulsive disorders, especially among children under 12 years of age. Other adverse events observed more frequently in the paroxetine group compared with the placebo group were: decreased appetite, tremor, hypersudation, hyperkinesia, agitation, emotional lability (including crying and fluctuations in

In studies with progressive treatment discontinuation, symptoms reported during the dose reduction or discontinuation phase, with ³2 % frequency and at least twice that observed in the placebo group were : emotional lability (including crying, mood swings, self-aggression, suicidal thoughts and suicide attempts), nervousness, dizziness, nausea and abdominal pain (see Warnings and Precautions section ).

In five parallel group studies with a duration of treatment ranging from 8 weeks to 8 months, adverse events related to bleeding mainly affecting the skin and mucous membranes were observed in patients treated with paroxetine, at a 1.74%, while their frequency in the placebo group was 0.74%.

deroxat side effects

Description of adverse effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Adverse effects occur more often in the first few weeks of taking DEROXAT 20 mg film-coated tablets.

If any of the following side effects occur, contact your doctor immediately or go to the emergency room.

Uncommon side effects (less than 1 in 100 people):

  • · Abnormal bleeding (including vomiting of blood, blood in the stool, or “blues”),
  • · Difficulty or impossibility to last.

Rare side effects (less than 1 in 1,000 people):

  • · Seizures,
  • · Restlessness, impatience of the legs, inability to sit or stand still. Increasing the dose of DEROXAT 20 mg film-coated tablets may aggravate these sensations.
  • · Tiredness, weakness, confusion, pain, muscle stiffness or involuntary movements of muscles(may be related to low blood sodium levels).

Very rare side effects (less than 1 in 10,000 people):

· Allergic reactions to DEROXAT 20 mg film-coated tablets that may be severe : if you developredness or blistering of the skin, swelling of the eyelids, face, lips, mouth or tongue, rash dermal or urticaria anywhere on the body, itching, difficulty breathing (shortness of breath) or swallowing and a feeling of weakness or numbness leading to discomfort or loss of consciousness, contact your doctor immediately or go to the emergency room.

· If you have any or all of the following symptoms , you may have serotonin syndrome or neuroleptic malignant syndrome : symptoms include feeling of great agitation or confusion, confusion, agitation, feeling hot, excessive sweating, tremors, chills, hallucinations (strange sounds or visions), muscle rigidity, myoclonus (sudden jerking of muscles), or rapid heartbeat. The severity of these symptoms can worsen leading to a loss of consciousness. If you feel this contact your doctor .

· Acute glaucoma.

If you have eye pain and your vision becomes cloudy, contact your doctor .

Frequency unknown

· Suicidal cases or suicidal behaviors have been reported during treatment with DEROXAT 20 mg film-coated tablets or soon after discontinuation (see section 2. “What information should you know before taking DEROXAT 20 mg film-coated tablets? “).

· Cases of aggression have been observed during treatment with DEROXAT. If you experience these side effects, contact your doctor.

Other possible side effects during treatment

Very common side effects (more than 1 in 10 people):

  • · Nausea Taking your medicine in the morning during breakfast reduces the risk of this effect occurring
  • · Sexual disorders. For example, lack of orgasm, and in humans, abnormal erection and ejaculation

Common side effects (less than 1 in 10 people):

  • · Increase in the amount of cholesterol in the blood
  • · Lack of appetite
  • · Sleep disorders: insomnia or drowsiness
  • · Abnormal dreams (including nightmares)
  • · Feeling dizzy or trembling
  • · Headaches
  • · Difficulty concentrating
  • · Agitation
  • · Feeling weak
  • · Blurred vision
  • · Yawns
  • · Dry mouth
  • · Diarrhea or constipation
  • · Vomiting
  • · Weight gain
  • · Sweats

Uncommon side effects (less than 1 in 100 people):

  • · Transient increase in blood pressure, or transient decrease in fast transition from sitting to standing with dizziness or weakness
  • · Faster heartbeat
  • · Lack of movement, rigidity, tremors or abnormal movements of the mouth and tongue
  • · Dilated pupils
  • · Rash
  • · Itching
  • · Mental confusion
  • · Hallucinations (visions or strange sounds)
  • · Unintentional and uncontrollable emission of urine (urinary incontinence) or impossibility to cure (urinary retention)
  • · If you have diabetes, you may notice an imbalance in the level of sugar in your blood while taking DEROXAT 20 mg film-coated tablets. Talk to your doctor about adjusting the dose of insulin or diabetes medications.

Rare side effects (less than 1 in 1,000 people):

  • · Mania (excitement, euphoria,)
  • · Anxiety
  • · Sensation BE detached from yourself (depersonalisation)
  • · Panic attacks
  • · Irresistible desire to move the legs (restless leg syndrome)
  • · Slow heartbeat
  • · Elevation of liver function values
  • · Abnormal milk flow in men and women
  • · Pain in the joints or muscles
  • · Increase in the blood of the hormone called prolactin
  • · Menstrual disturbances (including heavy or irregular periods, bleeding outside the rules, and lack or delay of rules)

Very rare side effects (less than 1 in 10,000 people):

  • · Skin rash, possibly accompanied by blisters, and resembling small targets (dark central spots bordered by a lighter area, and surrounded by a dark ring) called erythema multiforme
  • · Generalized rash with blistering and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
  • · Extensive skin rash accompanied by blistering and peeling of the skin over a large part of the body (toxic epidermal necrolysis or Lyell syndrome)
  • · Liver injury which may cause jaundice in the skin and eyes
  • · Syndrome of inappropriate secretion of anti-diuretic hormone (SIADH) which is a condition in which the body has an excess of water and a decrease in the concentration of sodium (salt), due to inappropriate chemical signals. Patients with SIADH may be severely ill, or may have no symptoms
  • · Intolerance to the sun (photosensitization)
  • · Retention of water that can cause an edema of the arms and legs
  • · Persistent and painful erection of the penis
  • · Decrease in the number of platelets in the blood
  • Some patients have reported buzzing, whistling or ringing in the ears during treatment with DEROXAT 20 mg film-coated tablets.
  • An increased risk of bone fractures has been observed in patients who use this type of medication.

Deroxat Interactions

Serotoninergic drugs

As with other SSRIs, the combination of paroxetine with serotonergic drugs may increase the effects of serotonin (serotonin syndrome: see Warnings and precautions for use ).

Special attention and close clinical monitoring is recommended when these serotoninergic drugs (including L-tryptophan, triptans, tramadol, linezolid, methylthioninium chloride (methylene blue), SSRIs, lithium, pethidine and St. John’s Wort preparations – Hypericum perforatum ) are associated with paroxetine. Caution is also advised with fentanyl, used in general anesthesia or as a treatment for chronic pain. The combined use of paroxetine and MAOIs is contraindicated due to the risk of serotonin syndrome (see section 4.3 ).

pimozide

An increase in pimozide concentrations of approximately 2.5 fold on average was demonstrated in an interaction study between a low dose of pimozide (2 mg) and a paroxetine dose of 60 mg. This may be due to the known inhibitory properties of paroxetine on CYP2D6. Since pimozide has a narrow therapeutic index and may cause prolongation of the QT interval, the combination of paroxetine and pimozide is contraindicated (see section 4.3 ).

Metabolism enzymes

  • The metabolism and pharmacokinetics of paroxetine can be modified by the inhibition or induction of metabolizing enzymes.
  • When paroxetine is to be combined with a known enzyme inhibitor, the lowest recommended doses will be used.
  • No dose adjustment is necessary when paroxetine is co-administered with enzyme inducers (eg carbamazepine, rifampicin, phenobarbital, phenytoin) or with a combination of fosamprenavir / ritonavir. Any dose adjustment of paroxetine (either after initiation of therapy or upon discontinuation of an enzyme inducer) will be based on the observed clinical effect (safety and efficacy).

Myorelaxants

SSRIs may decrease plasma cholinesterase activity inducing prolongation of neuromuscular inhibition of mivacurium and suxamethonium.

Fosamprenavir / ritonavir combination

Co-administration of fosamprenavir / ritonavir at a dosage of 700/100 mg twice daily with 20 mg paroxetine daily in healthy volunteers for 10 days resulted in a significant decrease in plasma paroxetine about 55%. In this co-administration with paroxetine, plasma concentrations of fosamprenavir / ritonavir were similar to baseline values ​​from other studies, indicating that paroxetine had no significant effect on the metabolism of fosamprenavir / ritonavir. There are no data available on the long-term effects of co-administration of paroxetine and a combination of fosamprenavir / ritonavir beyond 10 days.

Procyclidine

Daily administration of paroxetine significantly increases the plasma concentrations of procyclidine. If anti-cholinergic effects are observed, the dose of procyclidine should be reduced.

Anticonvulsants

Carbamazepine, phenytoin, sodium valproate. Concomitant administration does not appear to influence the pharmacokinetic / dynamic profile in epileptic patients.

Inhibition of CYP2D6 by paroxetine

Like other antidepressants, including other SSRIs, paroxetine inhibits hepatic cytochrome P450 CYP2D6 isoenzyme. Inhibition of this isoenzyme may lead to increased plasma concentrations of the associated drugs metabolized by it.

These medications include certain tricyclic antidepressants (clomipramine, nortriptyline and desipramine), phenothiazine-type neuroleptics (eg perphenazine and thioridazine, see section 4.3 ), risperidone, atomoxetine, some type 1c antiarrhythmics (eg propafenone and flecainide) and metoprolol. 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.

The pharmacokinetic interaction between CYP2D6 inhibitors and tamoxifen, showing a 65-75% decrease in plasma concentrations of endoxifen, one of the most active forms of tamoxifen, has been reported in the literature. A decrease in the efficacy of tamoxifen has been reported in some studies when concomitant use of certain SSRI antidepressants. Since tamoxifen can not be excluded, the combination of a strong CYP2D6 inhibitor (including paroxetine) with tamoxifen should be avoided as far as possible (see Warnings and Precautions ). .

Alcohol

As with other psychotropic treatments, alcoholic beverages are discouraged during treatment.

Oral anticoagulants

A pharmacodynamic interaction may occur between paroxetine and oral anticoagulants. Concomitant administration of paroxetine with these medicinal products may lead to an increase in anticoagulant activity and haemorrhagic risk. Paroxetine should therefore be used with caution in patients receiving oral anticoagulants (see Warnings and Precautions ).

Non-steroidal anti-inflammatory drugs and acetylsalicylic acid, other antiplatelet agents

  • A pharmacodynamic interaction may occur between paroxetine and NSAIDs / acetylsalicylic acid. Concomitant use of these drugs may increase the risk of bleeding (see Warnings and Precautions section ).
  • Caution is advised in patients treated with SSRIs in combination with oral anticoagulants, drugs that affect platelet function or may increase the risk of bleeding (eg, atypical antipsychotics such as clozapine, phenothiazines, most tricyclic antidepressants, aspirin, NSAIDs and COX-2 inhibitors) as well as in patients with a history of hemostasis abnormalities or conditions that predispose them to bleeding.

pravastatin

An interaction between paroxetine and pravastatin has been observed in studies suggesting that concomitant administration of paroxetine and pravastatin may lead to an increase in blood glucose. Dosage adjustment of oral hypoglycemic agents and / or insulin may be required in diabetic patients receiving paroxetine and pravastatin (see Warnings and Precautions ).

Deroxat Warnings and Precautions

Treatment with paroxetine should be initiated with caution 2 weeks after discontinuation of irreversible MAOI or 24 hours after discontinuation of reversible MAOI. The dose of paroxetine should be increased gradually until an optimal therapeutic response is obtained (see sections 4.3 and 4.5).

Pediatric population

The use of DEROXAT is not recommended for children and adolescents under 18 years of age. Suicidal (suicide attempts and suicidal ideation) and hostile (predominantly aggression, anti-doping behavior and anger) behaviors were more frequently observed in clinical studies in children and adolescents treated with antidepressants compared to those treated with placebo. If, in case of clinical need, the decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms. In addition, no long-term safety data are available for children and adolescents on growth, maturation and cognitive and behavioral development.

Suicide / suicidal ideation or clinical worsening

Depression is associated with increased risk of suicidal thoughts, self-aggression and suicide (suicidal behavior). This risk persists until significant remission occurs.

Since clinical improvement may not occur for several weeks, patients should be closely monitored until this improvement is achieved. Clinical experience shows that suicidal risk may increase in the early stages of recovery.

Other psychiatric conditions in which paroxetine is prescribed may also be associated with an increased risk of suicidal behavior. In addition, these disorders may be associated with a major depressive episode. The same precautions for use as those for patients with major depressive episodes should therefore be applied to patients with other psychiatric disorders.

Patients with a history of suicidal behavior or those who express significant suicidal ideation before starting treatment have a higher risk of developing suicidal or suicidal behaviors, and should be closely monitored during treatment.

A meta-analysis of placebo-controlled clinical trials on the use of antidepressants in adults with psychiatric disorders showed an increased risk of suicidal behavior in patients under 25 years of age treated with antidepressants compared to those receiving placebo (see also section 5.1).

Close monitoring of patients, particularly those at high risk, should accompany drug therapy, especially at the start of treatment and during dose changes.

Patients (and those around them) should be advised of the need to monitor the occurrence of clinical worsening, the appearance of suicidal ideation / behavior, and any abnormal changes in behavior, and to seek immediate medical attention if these symptoms occur.

Akathisie / psychomotor agitation

The use of paroxetine has been associated with the onset of Akathisia, characterized by an inner feeling of impotence and psychomotor agitation, such as an inability to sit or stand quietly, usually associated with a feeling of helplessness. These symptoms occur rather in the first weeks of treatment. In patients developing these symptoms, an increase in dosage may be detrimental.

Serotonin Syndrome / Neuroleptic Malignant Syndrome

In rare cases, serotonin syndrome or a suggestive neuroleptic malignant syndrome may occur during treatment with paroxetine, particularly when combined with serotonergic drugs and / or neuroleptics. Since these syndromes may be life-threatening, treatment with paroxetine should be discontinued if such effects occur (characterized by a set of symptoms such as hyperthermia, rigidity, myoclonus, autonomic dysfunction with possible rapid fluctuations in vital constants, changes in psychic state including confusion, irritability, extreme agitation evolving into delirium and coma).

Symptomatic treatment should be instituted.

Paroxetine should not be used in combination with serotonin precursors (such as L-tryptophan, loxitriptan) because of the risk of serotonin syndrome (see sections 4.3 and 4.5).

Mania

As with all antidepressants, paroxetine should be used with caution in patients with a history of manic episodes. In case of a manic turn, treatment with paroxetine should be discontinued.

Renal / hepatic insufficiency

Special care is recommended in patients with severe renal impairment or hepatic impairment (see section 4.2).

Diabetes

  • Treatment with Selective Serotonin Reuptake Inhibitors (SSRIs) can lead to imbalance of glycemic control in diabetic patients. Adjustment of doses of insulin and / or oral hypoglycemic agent may be necessary. In addition, studies suggest that an increase in blood glucose may occur during the concomitant administration of paroxetine and pravastine (see section 4.5).

Epilepsy

  • Like other antidepressants, paroxetine should be used with caution in patients with epilepsy.

convulsions

  • The overall incidence of seizures is less than 0.1% in patients treated with paroxetine. The occurrence of seizures necessitates the cessation of treatment.

Electroconvulsive therapy (ECT)

  • There is limited clinical data on the concomitant administration of paroxetine and electroconvulsive therapy.

Glaucoma

  • Like other SSRIs, paroxetine may cause mydriasis and should be used with caution in patients with narrow-angle glaucoma or a history of glaucoma.

Heart diseases

  • Use precautions should be observed in patients with cardiac disorders.

hyponatremia

  • Hyponatremia has been reported rarely, mainly in the elderly.
  • Special attention should also be given to patients at risk of hyponatremia associated with concomitant treatment or cirrhosis.
  • Hyponatremia is usually reversible when paroxetine is discontinued.

hemorrhage

Skin bleeds such as bruises and purpuras have been reported with SSRIs. Other haemorrhagic manifestations, such as gastrointestinal and gynecological haemorrhages, have been reported.

The risk of non-menstrual bleeding may be increased in elderly patients.

Caution is advised in patients treated concurrently with SSRIs and oral anticoagulants, drugs that affect platelet function, or other drugs that may increase the risk of bleeding (eg, atypical antipsychotics such as clozapine, phenothiazines, most tricyclic antidepressants, aspirin, NSAIDs and COX-2 inhibitors) as well as in patients with a history of hemostasis abnormalities or conditions that predispose them to bleeding (see section 4.8). ).

Interaction with tamoxifen

  • Paroxetine, a potent inhibitor of CYP2D6, may result in decreased concentrations of endoxifen, one of the most important active metabolites of tamoxifen. Therefore, paroxetine should be avoided as much as possible during treatment with tamoxifen (see section 4.5).
  • Withdrawal symptoms after discontinuation of paroxetine
  • Withdrawal symptoms at the end of treatment are common, especially if discontinuation is abrupt (see section 4.8).
  • In clinical trials, adverse events were observed at the end of treatment in 30% of patients treated with paroxetine versus 20% of patients receiving placebo.
  • The occurrence of withdrawal symptoms is not synonymous with addiction or dependence.
  • The risk of withdrawal symptoms may be a function of several factors including duration of treatment, dosage, and rate of dose reduction.

Have been reported: dizziness, sensory disturbances (including paresthesia, and sensations like electric shock and tinnitus), sleep disorders (including intense dreams), agitation or anxiety, nausea, tremor, confusion, sweating, headache, diarrhea, palpitations emotional instability, irritability and visual disturbances. Generally, these symptoms are of mild to moderate intensity but they may be more severe in some patients.

They usually occur in the first few days after treatment has stopped, but very few cases have been reported in patients who accidentally skipped a dose. Generally, these symptoms are spontaneously resolving in two weeks, although in some people they may be prolonged (two to three months or more). It is therefore advisable to gradually reduce the dose of paroxetine over a period of several weeks or months, according to the needs of patients (see “Withdrawal symptoms observed during paroxetine discontinuation”, section 4.2).

Drive and use machines with deroxat

  • Clinical experience has shown that treatment with paroxetine does not result in impaired cognitive or psychomotor function.
  •  Nevertheless, as with any psychoactive drug, drivers of vehicles and machine users should be cautioned about their ability to drive or use machines.
  • Although paroxetine does not increase the mental and motor impairments caused by alcohol, the concomitant use of paroxetine and alcohol is not recommended.

Deroxat and PREGNANCY / BREAST FEEDING / FERTILITY:

Pregnancy 

Some epidemiological studies suggest an increased risk of congenital malformations, especially cardiovascular (interventricular and interauricular communication) in children of mothers treated with paroxetine during the 1

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.

Paroxetine will only be used during pregnancy if it is strictly necessary. The doctor should evaluate the interest of an alternative treatment in a pregnant woman or considering to be. Abrupt discontinuation of treatment should be avoided during pregnancy ( see Posology and method of administration  : Withdrawal symptoms observed when paroxetine was discontinued).

Monitoring of the newborn must be done if the use of paroxetine continued until the end of pregnancy, especially 3 th  quarter.

The following symptoms may occur in the newborn after administration of paroxetine in the mother during the 3 th  trimester of pregnancy: respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia hypertonia, hyperreflexia, tremors, nervousness, irritability, lethargy, permanent crying, drowsiness and sleep disorders. These symptoms may be due to either serotonergic effects or withdrawal symptoms. In most cases, these symptoms occur immediately or almost immediately after delivery (less than 24 hours).

Epidemiological evidence suggests that the use of SSRIs during pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary arterial hypertension (PAH) in the neonate. The risk observed was approximately five cases per 1000 pregnancies. In the general population, the risk of HTAPP in the newborn is one to two cases per 1000 pregnancies.

Studies in animals have shown reproductive toxicity, but do not indicate direct deleterious effects on pregnancy, embryo-fetal development, childbirth or postnatal development ( see Preclinical Safety ).

deroxat – Breastfeeding:

Small amounts of paroxetine are excreted in breast milk.In published studies, serum concentrations of breastfed infants were undetectable (<2 nanograms / ml) or very low (<4 nanograms / ml). No evidence of drug effect was observed in these infants.

No effect is expected, breastfeeding is possible.

Fertility:

Animal data have shown that paroxetine may affect sperm quality ( see Preclinical Safety ). In vitro data obtained with human material suggest a change in sperm quality; however, cases reported in humans treated with certain SSRIs (including paroxetine) have shown that this effect on sperm quality seems to be reversible. The impact on human fertility has not been observed so far.

What should I do if I miss a dose?

If you forget to take DEROXAT 20 mg film-coated tablets:

  1. If you realize it before bed, take the dose of DEROXAT.
  2. If you realize it during the night, take only the next dose of DEROXAT the next morning at the usual time.
  3. After 2 weeks, most people start to feel better. If this is not your case, consult your doctor who may increase the dose. Do not stop your treatment without medical advice.
  4. The medicine should be taken until the doctor tells you to stop it. The doctor can tell you to continue treatment for several months, even if you feel better, to help prevent recurrence of symptoms
  5. Continue to follow the instructions of your doctor.

What happens if I overdose from Deroxat ?

If you take more DEROXAT 20 mg film-coated tablets than you should:

Tell your doctor or health professional as soon as possible if you have taken too much. The possible side effects in case of overdose are those listed in section 4. “What are the possible side effects?” or the following: fever, involuntary contraction of muscles.

What is  Forms and Composition Deroxat ?

FORMS and PRESENTATIONS

* 20 mg scored film-coated tablet (oval, biconvex, debossed “20” on one side and scored on the other side, white):  Box of 14, under a blister, with childproof lock.

Hospital model: Box of 50, under plate, with child safety.

*  The tablet can be divided into equal doses if necessary. Oral suspension 20 mg / 10 ml (slightly viscous, with orange odor, free from foreign particles, bright orange):   150 ml bottle with measuring cup (graduated to 5 ml, 10 ml, 15 ml and 20 ml) and child safety closure.

 

COMPOSITION
Compressed :p cp
Paroxetine (INN) hydrochloride hemihydrate expressed as paroxetine20 mg
  • Excipients: calcium hydrogen phosphate dihydrate (E 341), sodium carboxymethyl starch (type A), magnesium stearate (E 470b). Film coating :hypromellose (E 464), titanium dioxide (E 171), macrogol 400, polysorbate 80 (E 433).
Oral suspension:p 10 ml
Paroxetine (INN) hydrochloride hemihydrate expressed as paroxetine20 mg
  • Excipients: polacrilin potassium, dispersible cellulose (E 460), propylene glycol, glycerol (E 422), sorbitol (E 420), methyl parahydroxybenzoates (E 218) and propyl (E 216), sodium citrate dihydrate (E 331), citric acid anhydrous (E 330), saccharin sodium (E 954), yellowish orange color S (E 110), simeticone emulsion, purified water. Aromas: natural orange, natural lemon.
  • Excipients with known effect: sorbitol: 4 g / 10 ml; orange-yellow S (E 110): 0.9 mg / 10 ml; methyl parahydroxybenzoate: 20 mg / 10 ml; propyl parahydroxybenzoate: 6 mg / 10 ml.

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

  • Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

  • General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

  • For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

  • It treats possible side effects and drug interactions that require attention and its effect on continuous use.
  • The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

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