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Olanstad 10
Rx

Olanstad 10 contains olanzapine is a thienobenzodiazepine atypical antipsychotic. It has affinity for serotonin, muscarinic, histamine (H1) and adrenergic (a1) receptors as well as various dopamine receptors.

Pack size Box of 30 tablets
Shelf-life 36 months
Composition Olanzapine
Dosage forms and strengths Film-coated tablet: 10 mg
Product code :

PRESCRIBING INFORMATION

Indications

  • Management of schizophrenia and for the treatment of moderate to severe mania associated with bipolar disorder.

Dosage

Adults

  • Schizophrenia:
    Start with 5 – 10 mg daily and the daily dosage should be adjusted in steps of 5 mg at intervals of not less than one week up to 10 mg daily.
  • Manic episode:
    The treatment of acute manic episodes: 10 mg or 15 mg daily (in monotherapy) or 10 mg (in combination therapy). The daily dosage may be adjunct of 5 mg/day if necessary, to a dose of between 5 to 20 mg daily. If a response is achieved, continue at the same dosage to prevent recurrence.
    Prevention of recurrence in patients whose manic episodes have responded previously to olanzapine: Start with 10 mg daily.
  • Moderate hepatic or renal impairment: A starting dose of 5 mg daily, only increased with caution.
  • When more than one factor is present which might result in slower metabolism (female, geriatric age, non-smoking): Consideration should be given to decreasing the starting dose and dose escalation should be conservative.

Children and adolescents < 18 years old

  • Olanzapine is not recommended for use.

Elderly >= 65 years old when clinical factors warrant

  • A lower starting dose (5 mg/day) should be considered.

Usage

  • Olanstad 10 is administered orally without regard to meals.
  • Known hypersensitivity to any ingredients in the formulation.
  • 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.

Olanstad 10 is not recommended for use in patients:

  • Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose – galactose malabsorption.
  • Dementia-related psychosis and/or behavioural disturbances patients.
  • Parkinson’s disease.
  • Develops signs/symptoms indicative of neuroleptic malignant syndrome (NMS); presents with unexplained high fever: Discontinue the drug.
  • Tardive dyskinesia: A dose reduction or discontinuation.

Caution is advised when prescribing Olanstad 10 for patients:

  • Prostatic hypertrophy, or paralytic ileus and related conditions.
  • Combination with other centrally acting medicines and alcohol.
  • Diabetes mellitus/dyslipidemic or patients with risk factors.
  • Low leucocyte and/or neutrophil counts; receiving medicines known to cause neutropenia; history of drug-induced bone marrow depression/toxicity; bone marrow depression caused by concomitant illness, radiation therapy or chemotherapy; hypereosinophilic or myeloproliferative disease.
  • Have a history of seizures or are subject to factors which may lower the seizure threshold.
  • Hepatic impairment; pre-existing conditions associated with limited hepatic functional reserve; being treated with potentially hepatotoxic drugs.
  • Experiencing conditions which may contribute to an elevation in core body temperature.
  • At risk for aspiration pneumonia.
  • Elderly; in patients with congenital long QT syndrome; congestive heart failure; heart hypertrophy; hypokalaemia or hypomagnesaemia.

Risk of sudden cardiac death.

Olanstad 10 should be used in pregnancy only if the benefit justifies the risk. Patients should be advised not to breast-feed an infant.

Patients should be aware of how they react to drug before driving or operating machinery.