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Sedatives

Olanstad 10

 

Pack size:

Blister of 10 tablets. Box 3 blisters.

 

Composition:

Each film-coated tablet contains olanzapine 10 mg.

 

Shelf-life:          

24 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Do not store above 30oC.

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Management of schizophrenia. 
  • Treatment of moderate to severe mania associated with bipolar disorder.
     
  • Administered orally without regard to meals.

  • Adults
    Schizophrenia:
    The starting dose is 5 to 10 mg daily and it is recommened that dosage adjustments beyond 10 mg daily are made at intervals of not less than one week; the daily dosage should be adjusted in steps of 5 mg.
    Manic episode:
    The treatment of acute manic episodes:
    Monotherapy: 10 mg or 15 mg daily.
    Combination therapy: 10 mg.
    The daily dosage may be adjunct of 5 mg if necessary, at intervals of not less than 24 hours to a dose of between 5 to 20 mg daily.
    If a response is achieved, therapy may continue at the same dosage to prevent recurrence.
    Prevention of recurrence in patients whose manic episodes have responded previously to olanzapine: The recommended starting dose is 10 mg daily.

  • Hepatic or renal impairment:
    A starting dose of 5 mg daily of olanzapine  orally may be necessary for patients with renal impairmet; patients with moderate hepatic insufficiency the starting dose should be 5 mg daily, and only increased with caution.

  • Gender:
    The starting dose and dose range need not be routinely altered for female patients relative to male patients.

  • Smokers:
    The starting dose and dose range need not be routinely altered for nonsmokers relative to smokers.

  • When more than one factor is present which might result in slower metabolism (female gender, geriatric age, non-smoking status), consideration should be given to decreasing the starting dose.
    Dose escalation, when indicated, should be conservative in such patients.

  • Children and adolescents:
    Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.

  • Elderly:
    A lower starting dose (5 mg/day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant.


Or as prescribed by physician.

 

  • Known hypersensitivity to any ingredients of the drug.
  • Patients with known risk for narrow - angle glaucoma.

     

Very common

  • Weight gain.
  • Somnolence.
  • Orthostatic hypotension.
  • Elevated plasma prolactin levels.

Common

  • Eosinophilia, leukopenia, neutropenia.
  • Elevated cholesterol levels, elevated glucose levels, elevated triglyceride levels, glucosuria, increased appetite.
  • Dizziness, akathisia, Parkinsonism, dyskinesia.
  • Mild, transient anticholinergic effects including constipation and dry mouth.
  • Transient, asymptomatic elevations of hepatic aminotransferases (ALT, AST), especially in early treatment.
  • Rash.
  • Arthralgia.
  • Erectile dysfunction in males, decreased libido in males and females.
  • Asthenia, fatigue, oedema, pyrexia.
  • Increased alkaline phosphatase, high creatine phosphokinase, high gamma glutamyltransferase, high uric acid.

Uncommon

  • Hypersensitivity.
  • Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases.
  • Seizures where in most cases a history of seizures or risk factors for seizures were reported, dystonia (including oculogyration), tardive dyskinesia, amnesia, dysarthria.
  • Bradycardia, QTc prolongation.
  • Thromboembolism (including pulmonary embolism and deep vein thrombosis).
  • Epistaxis.
  • Abdominal distension.
  • Photosensitivity reaction, alopecia.
  • Urinary incontinence, urinary retention, urinary hesitation.
  • Amenorrhea, breast enlargement, galactorrhea in females, gynaecomastia/breast enlargement in males.
  • Increased total bilirubin.

Rare

  • Thrombocytopenia.
  • Hypothermia.
  • Neuroleptic malignant syndrome, discontinuation symptoms.
  • Ventricular tachycardia/fibrillation, sudden death.
  • Pancreatitis.
  • Hepatitis (including hepatocellular, cholestatic or mixed liver injury).
  • Rhabdomyolysis.
  • Priapism.

Not known

  • Pregnancy, puerperium and perinatal conditions: Drug withdrawal syndrome neonatal.

     

  • Olanstad contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
  • Anticholinergic activity: While olanzapine demonstrated anticholinergic activity in vitro experience during the clinical trials revealed a low incidence of related events. However, as clinical experience with olanzapine in patients with concomitant illness is limited, caution is advised when prescribing for patients with prostatic hypertrophy, or paralytic ileus and related conditions.
  • General CNS activity: Given the primary CNS effects of olanzapine, caution should be used when it is taken in combination with other centrally acting medicines and alcohol. As it exhibits in vitro dopamine antagonism, olanzapine may antagonise the effects of direct and indirect dopamine agonists.
  • Dementia-related psychosis and/or behavioural disturbances: Olanzapine is not recommended for use in this particular group of patients because of an increase in mortality and the risk of cerebrovascular accident.
  • Parkinson's disease: The use of olanzapine in the treatment of dopamine agonist associated psychosis in patients with Parkinson's disease is not recommended. In clinical trials, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo, and olanzapine was not more effective than placebo in the treatment of psychotic symptoms.
  • Neuroleptic malignant syndrome (NMS): is a potentially life-threatening condition associated with antipsychotic medicinal product. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia), additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis) and acute renal failure. If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, all antipsychotic medicines, including olanzapine must be discontinued.
  • Hyperglycaemia and diabetes: Hyperglycaemia and/or development or exacerbation of diabetes, occasionally associated with ketoacidosis or coma, has been reported rarely, including some fatal cases. In some cases, a prior increase in body weight has been reported, which may be a predisposing factor. Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines. Patients treated with any antipsychotic agents, including olanzapine, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control. Weight should be monitored regularly.
  • Lipid alterations: Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebo-controlled clinical trials. Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders. Patients treated with any antipsychotic agents, including olanzapine, should be monitored regularly for lipids in accordance with utilised antipsychotic guidelines.
  • Agranulocytosis: Caution should be exercised in patients with low leucocyte and/or neutrophil counts for any reason, in patients receiving medicines known to cause neutropenia, in patients with a history of drug-induced bone marrow depression/toxicity, in patients with bone marrow depression caused by concomitant illness, radiation therapy or chemotherapy and in patients with hypereosinophilic conditions or with myeloproliferative disease. Neutropenia has been reported commonly when olanzapine and valproate are used concomitantly and in patients with hypereosinophilic conditions or with myeloproliferative disease.
  • Discontinuation of treatment: Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported very rarely when olanzapine is stopped abruptly.
  • QT interval: Caution should be exercised when olanzapine is prescribed with medicines known to increase QTc interval, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia.
  • Thromboembolism: Very rarely, a causal relationship between the occurrence of venous thromboembolism and treatment with olanzapine has not been established. However, since patients with schizophrenia often present with acquired risk factors for venous thromboembolism e.g., immobilisation of patients, should be identified and preventive measures undertaken.
  • Tardive dyskinesia: The risk of tardive dyskinesia increases with long-term exposure, and therefore if signs or symptoms of tardive dyskinesia appear in a patient on olanzapine, a dose reduction or discontinuation should be considered.
  • Seizures: Olanzapine should be used cautiously in patients who have a history of seizures or are subject to factors which may lower the seizure threshold. Seizures have been reported to occur rarely in patients when treated with olanzapine. In most of these cases, a history of seizures or risk factors for seizures were reported.
  • Hemodynamic effects: Olanzapine may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients, syncope, especially during the initial dose-titration period, probably reflecting its a1 - adrenergic antagonistic properties.
  • Sudden cardiac death: In postmarketing reports with olanzapine, the event of sudden cardiac death has been reported in patients with olanzapine. In a retrospective observational cohort study, the risk of presumed sudden cardiac death in patients treated with olanzapine was approximately twice the risk in patients not using antipsychotics. In the study, the risk of olanzapine was comparable to the risk of atypical antipsychotics included in a pooled analysis.
  • Transaminase elevations: Caution should be exercised in patients with signs and symptoms of hepatic impairment, in patients with pre-existing conditions associated with limited hepatic functional reserve, and in patients who are being treated with potentially hepatotoxic drugs. Periodic assessment of transaminases is recommended in patients with significant hepatic disease.
  • Body temperature regulation: Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic agents. Appropriate care is advised when prescribing olanzapine for patients who will be experiencing conditions which may contribute to an elevation in core body temperature, e.g., exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity, or being subject to dehydration.
  • Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality in patients with advanced Alzheimer's disease. Olanzapine and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia.
  • Suicide: The possibility of a suicide attempt is inherent in schizophrenia and in bipolar disorder, and close supervision of high-risk patients should accompany drug therapy.
  • Lactation: Patients should be advised not to breast-feed an infant if they are taking olanzapine.
  • No studies on the effects on the ability to drive and use machines have been performed. Because olanzapine may cause somnolence and dizziness, patients should be cautioned about operating machinery, including motor vehicles.

 

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