Medicinal Products

PAROXETINE RANBAXY 20 mg

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

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 RANBAXY 20 mg film-coated tablet scored box of 14

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.

Against indications

Known hypersensitivity to paroxetine or any of the excipients.

Paroxetine is contraindicated in combination with Monoamine Oxidase Inhibitors (MAOIs). In exceptional circumstances, linezolid (a reversible non-selective MAOI antibiotic) may be used in combination with paroxetine provided that it is able to provide close monitoring to detect symptoms suggestive of serotonin syndrome and follow-up. blood pressure (see section Interactions with other medicinal products and other forms of interaction ).

Treatment with paroxetine may be initiated:

· 2 weeks after stopping treatment with an irreversible MAOI, or,

· At least 24 hours after stopping a reversible MAOI (eg moclobemide, linezolid, methylthioninium chloride (methylene blue, preoperative marking agent that is a reversible non-selective MAOI).

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 the plasma concentrations of thioridazine (see section 4.5 ). Administration of thioridazine alone may lead to prolongation of the QTc interval associated with severe ventricular arrhythmias such as torsades de pointes, and sudden death.

Paroxetine should not be used in combination with pimozide (see section 4.5, Interactions with other medicinal products and other forms of interaction ).

Paroxetine Ranbaxy side effects

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, <1/10), infrequent (≥ 1/1000, <1/100), rare (≥ 1/10000, <1/1000) and very rare (<1/10000), including isolated observations.

Hematologic and lymphatic system disorders

· Uncommon: abnormal bleeding, mainly mucocutaneous (especially bruising).

· Very rare: thrombocytopenia.

Immune system disorders

· Very rare: allergic reactions (including urticaria and Quincke's edema).

Endocrine disorders

· Very rare: syndrome of inappropriate secretion of the anti-diuretic hormone (SIADH).

Metabolism and nutrition disorders

· Common: increased cholesterol levels, 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, abnormal dreams (including nightmares).

· Uncommon: confusion, hallucinations.

· Rare: manic reactions, anxiety, depersonalization, panic attacks, akathisia (see Warnings and Precautions section ).

· Not known: Suicidal ideation and behavior

Cases of suicidal ideation and behavior have been reported during or shortly after discontinuation of paroxetine (see Warnings and Precautions ).

These symptoms may also be due to the underlying pathology.

Nervous system disorders

· Frequent: dizziness, trembling, headache, difficulty concentrating.

· Uncommon: extrapyramidal syndromes.

· Rare: convulsions, restless legs syndrome.

· Very rare: serotonin syndrome (symptoms may include agitation, confusion, sweating, hallucinations, hyperreflexia, myoclonus, chills, tachycardia and tremors).

Extra-pyramidal syndromes including oral-facial dyskinesias have been reported in patients with sometimes underlying abnormal movements or in patients treated with neuroleptics.

Eye disorders

· Common: blurred vision

· Uncommon: mydriasis (see Warnings and Precautions ) section.

· Very rare: acute glaucoma.

Ear and labyrinth disorders

· Not known: tinnitus.

Cardiac disorders

· Uncommon: sinus tachycardia.

· Rare: bradycardia.

Vascular disorders

· Uncommon: transient elevations or decreases in blood pressure, orthostatic hypotension.

Cases of transient elevations or decreases in blood pressure have been reported following paroxetine treatment, usually in patients with pre-existing hypertension or anxiety.

Respiratory, thoracic and mediastinal disorders

· Common: yawning

Gastrointestinal disorders

· Very common: nausea.

· Common: constipation, diarrhea, vomiting, dry mouth.

· Very rare: gastrointestinal bleeding.

Hepatobiliary disorders

· Rare: Elevated 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: serious skin reactions (including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis or Lyell's syndrome), photosensitization reactions.

Renal and urinary disorders

· Uncommon: urinary retention, urinary incontinence.

Disorders of the reproductive organs and breast

· Very common: sexual dysfunction.

· Rare: hyperprolactinemia / galactorrhea.

· Very rare: priapism.

Musculoskeletal and systemic disorders

· Rare: arthralgia, myalgia.

Epidemiological studies, conducted primarily in patients 50 years of age and older, indicate an increased risk of fractures in patients taking SSRIs and tricyclic antidepressants. The mechanism leading to this risk is not known.

General disorders and administration site conditions

· Frequent: asthenia, weight gain.

· Very rare: peripheral edema.

WASTE SYMPTOMS AT STOPPING TREATMENT

· Frequent: dizziness, sensory disturbances, sleep disorders, anxiety, headache.

· Uncommon: agitation, nausea, tremors, confusion, sweating, emotional instability, visual disturbances, palpitations, diarrhea, irritability.

Stopping treatment with paroxetine, especially when it is brutal, frequently leads to withdrawal symptoms.

Dizziness, sensory disturbances (including paresthesia and sensations like electric shocks and tinnitus), sleep disturbances (including intense dreams), agitation or anxiety, nausea, tremors, confusion, sweating, headache, diarrhea, palpitations, have been observed. emotional instability, 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 Posology and method of administration and Warnings and precautions for use ).

ADVERSE EFFECTS DURING PEDIATRIC CLINICAL TRIALS

The following adverse events have been observed: increased suicidal behavior (including suicidal attempts and suicidal thoughts), self-aggressive behavior and increased hostility. Suicidal thoughts and suicide attempts have mainly been observed in clinical studies of adolescents with major depressive disorder. Increased hostility occurred particularly in children with obsessive-compulsive disorder and mainly in children under 12 years of age.

Other events observed: decreased appetite, tremor, excessive sweating, hyperkinesia, agitation, emotional lability (including crying and fluctuating mood), adverse events related to bleeding, mainly in the skin and mucous membranes.

The events observed after stopping / decreasing paroxetine are : emotional lability (including crying, mood changes, self-aggression, suicidal thoughts and suicide attempts), nervousness, dizziness, nausea, and pain abdominal (see Warnings and Precautions ) section.

See section 5.1 Pharmacodynamic properties for further information on pediatric clinical studies.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Healthcare professionals must declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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