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APEXIDONE: antipsychotics, mood stabilizers –

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APEXIDONE is an atypical antipsychotic agent indicated for treatment of Schizophrenia,Bipolar Disorder and Irritability associated with Autistic Disorder.

Classification and Availability

  • Active Content: Risperidone (riss-per-i-done).
  • Therapeutic Class: antipsychotics, mood stabilizers.
  • Pregnancy Category: C, that means there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of Risperidone in pregnant women despite potential risks.

    • أبيكسيدون أقراص

    What is APEXIDONE?

    APEXIDONE belongs to a group of medicines called “anti-psychotics”. APEXIDONE is used to treat the following:

  • Schizophrenia, where you may see, hear or feel things that are not there, believe things that are not true or feel unusually suspicious, or confused.
  • Mania, where you may feel very excited, elated, agitated, enthusiastic or hyperactive. Mania occurs in an illness called “bipolar disorder”
  • Short-term treatment (up to 6 weeks) of long-term aggression in people with Alzheimer’s dementia, who harm themselves or others.
  • Short-term treatment (up to 6 weeks) of long-term, aggression in intellectually disabled children (at least 5 years of age) and adolescents with conduct disorder. 

    • APEXIDONE can help alleviate the symptoms of your disease and stop your symptoms from coming back. 

    APEXIDONE-An alternative to the brand Risperdal

    Indications

  • Schizophrenia in adults and adolescents age 13-17 yr.
  • Short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder (oral only) in adults, and children and adolescents aged 10-17 yr.
  • Maintenance treatment of Bipolar I Disorder (IM only) in adults only, can be used with lithium or valproate (adults only). 
  • Irritability associated with autistic disorder in children.
  • Treatment of Tourette’s syndrome.
  • Psychosis/agitation related to Alzheimer’s dementia.
  • Post-traumatic stress disorder (PTSD) 

    • APEXIDONE may act by antagonizing dopamine and serotonin in the CNS. This medicine decreases symptoms of psychoses, bipolar mania, or autism.

    APEXIDONE Desired Outcomes

  • Decline in excited, manic behavior.
  • Decline in positive symptoms (delusions, hallucinations) of schizophrenia.
  • Decline in aggression toward others, deliberate self—injury, temper tantrums, and mood changes in children with autism. 
  • Decline in negative symptoms (social withdrawal, flat, blunted effects) of schizo-phrenia.
  • Decline in autism symptoms.

    • Adverse Reactions/Side Effects

    Common Central nervous system Side Effects

  • Sedation (children 12% to 63%; adults 5% to 11%).
  • Parkinsonism (children: 28% to 62%; adults 8% to 25%).
  • Somnolence (adults 5% to 41%; children 4% to 11%).
  • Insomnia (32%).
  • Fatigue (children 18% to 31%; adults 1% to 9%).
  • Headache (12% to 21%).
  • Anxiety (58% to 16%).
  • Dizziness (3% to 16%).
  • Fever (children 16%; adults 1% to 2%).
  • Akathisia (5% to 11%).

    • Other Central Nervous System Adverse Reactions: NEUROLEPTIC MALIGNANT SYNDROME, SUICIDAL THOUGHTS, aggressive behavior, dizziness, extrapyramidal reactions, increased dreams, increase sleep duration, impaired temperature regulation, nervousness, tardive dyskinesia. 

    Common Gastrointestinal Side Effects

  • Appetite increased (children 4% to 44%; adults 4%).
  • Weight gain (>7 kg increase from baseline: children 8% to 33%; adults 4% to 21%).
  • Vomiting (children 10% to 20%; adults <4%).
  • Constipation (5% to 17%).
  • Nausea (5% to 16%).
  • Abdominal pain (children 6% to 16%; adults <4%).
  • Drooling (children 12%; adults <4%).

    • Common Genitourinary Side Effects

  • Urinary incontinence (children 5% to 22%; adults <4%).
  • Enuresis (children 16%; adults <1%).
  •  Decreased libido.
  • Dysmenorrhea/menorrhagia.
  • Difficulty urinating.
  • Polyuria.
  • Priapism.

    • Common Neuromuscular & skeletal Side Effects

  • Tremor (adults 4%; children <11%).
  • Arthralgia.
  • Back pain.

    • Common Respiratory Side Effects

  • Nasopharyngitis (children 19%; adults 54%)- i.e. increase infection and inflammation liability in nose and pharynx.
  • Cough (children 517%; adults 54%).
  • Rhinorrhea (children 12%; adults <4%)- i.e. increase in nasal discharge.
  • Dyspnea- i.e. difficulty in breathing

    • Cardio-Vascular Side Effects

  • Arrhythmias- i.e. irregular heart beats.
  • Orthostatic hypotension- i.e. feeling faint upon sudden change in position.
  • Tachycardia- i.e. increase heart rate..

    • Dermatological Side Effects

  • Itching/skin rash.
  • Dry skin.
  • Increased pigmentation.
  • Sweating.
  • Photosensitivity.
  • Seborrhea, i.e. increases fatty discharge from the scalp and other skin area, which may worsen acne or dandruff.

    • Common Endocrine Side Effects

  • Dyslipidemia, i.e.abnormal amount of lipids (e.g. triglycerides, cholesterol and/or fat phospholipids) in the blood.
  • Galactorrhea, i.e. increase in breast size, and milky discharge from breasts
  • Hypergly-cemia, i.e. increase blood sugar level.

    • Common Blood Side Effects

  • AGRANULOCYTOSIS.
  • Leukopenia.
  • Neutropenia.

    • These Blood side effects may decrease your body ability to fight infections.

    Drug-Drug Interactions

  • Risperidone may decrease the antiparkinsonian effects of levodopa or other dopamine agonists. 
  • Carbamazepine, phenytoin, rifampin, phenobarbital, and other enzyme inducers increase metabolism and may decrease Risperidone effectiveness; dose adjustments may be necessary.
  • Fluoxetine and paroxetine may increase Risperidone blood levels and may increase its effects; dose adjustments may be necessary.
  • Clozapine decreases Risperidone metabolism and may increase the effects of risperidone.

    • Apexidone Patient Information Leaflet

    APEXIDONE- FAQ

    Is APEXIDONE a good sleep aid? APEXIDONE is not approved as sleeping pills. Risperidone, the active ingredient, has been officially approved for schizophrenia, bipolar disorder and major depression only. Risperidone is sedating and makes people drowsy.

    Is APEXIDONE good for anxiety? Studies suggested that the antipsychotic drug, like APEXIDONE, may help battle major depression and generalized anxiety disorder. APEXIDONE is already approved to treat schizophrenia and bipolar disorder (formerly called manic-depressive illness).

    Does APEXIDONE work immediately? Sedative effects happen almost immediately; however, it may take up to two to three weeks to see some improvement in other symptoms and up to six weeks for the full effects to be seen.

    Is APEXIDONE a mood stabilizer? APEXIDONE is effective mood stabilizers, clinically used to treat mania and depression, while preventing recurrence and improving quality of life.

    Is APEXIDONE physically addictive? Risperidone(APEXIDONE) is an atypical or second-generation antipsychotic agent and has been a subject of a series of case reports and suggested to have the potential for misuse or abuse. However, it is not a controlled substance and is not generally considered addictive.

    أبيكسيدون- معلومات باللغة العربية

    Tags and Categories: #Risperidone, #N05AX08, #PSYCHIATRIC, #ANTIPSYCHOTICS


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