Olanzapine oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of olanzapine.
Drugs List
Therapeutic Indications
Uses
Bipolar disorder: prevention of recurrence
Moderate to severe manic episodes - combination treatment
Moderate to severe manic episodes - monotherapy
Schizophrenia
Dosage
Adults
Schizophrenia
Initial dose: 10mg daily.
Manic Episode
Initial dose in monotherapy: 15mg as a single daily dose.
Initial dose in combination therapy: 10mg daily.
Preventing Recurrence in Bipolar Disorder
Initial dose: 10mg daily.
Patients receiving olanzapine for treatment of manic episode, should continue therapy for preventing recurrence in Bipolar Disorder at the same dose. If a new manic, mixed or depressive episode occurs, olanzapine treatment should be continued (with dose optimisation as needed), with supplementary therapy to treat mood symptoms, as clinically indicated.
Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5mg to 20mg daily. Only after clinical reassessment should an increase to a dose greater than the recommended starting dose be considered, increases should not occur at less than 24 hours.
Elderly
A lower starting dose of 5mg per day should be considered for those aged 65 years and over when clinical factors warrant.
Children
Schizophrenia or Combination therapy for mania (unlicensed)
Children aged 12 to 18 years
Initial dose: 5mg to 10mg daily adjusted according to response.
Maintenance dose: 5mg to 20mg daily. Doses greater than 10mg daily should only be given after reassessment.
Maximum dose: 20mg daily.
Monotherapy for mania (unlicensed)
Children aged 12 to 18 years
Initial dose: 15mg daily adjusted according to response.
Maintenance dose: 5mg to 20mg daily. Doses greater than 15mg daily should only be given after reassessment.
Maximum dose: 20mg daily.
Patients with Renal Impairment
A lower starting dose of 5mg per day should be considered for patients with renal impairment.
Patients with Hepatic Impairment
In cases of moderate hepatic insufficiency (cirrhosis, Child-Pugh Class A or B), the starting dose should be 5mg and only increased with caution.
Additional Dosage Information
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.
Contraindications
Children under 12 years
Predisposition to narrow angle glaucoma
Breastfeeding
Long QT syndrome
Torsade de pointes
Precautions and Warnings
Children aged 12 to 18 years
Family history of long QT syndrome
Patients over 65 years
Predisposition to diabetes mellitus
Predisposition to seizures
Predisposition to venous thromboembolism
Tobacco smoking
Benign prostatic hyperplasia
Cardiac hypertrophy
Congestive cardiac failure
Dementia
Diabetes mellitus
Disorder of lipid metabolism
Electrolyte imbalance
Elevated serum transaminases
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of myelosuppression
History of seizures
History of torsade de pointes
Hypereosinophilic disorder
Hyperglycaemia
Lactose intolerance
Leucopenia
Myeloproliferative disorder
Myelosuppression
Neutropenia
Paralytic ileus
Parkinson's disease
Phenylketonuria
Pregnancy
Renal impairment
Consider preventative measures in patients at risk of thromboembolism
Correct electrolyte disorders before treatment
Reduce dose in patients with renal impairment
Some formulations contain aspartame - caution in phenylketonuria
Advise ability to drive/operate machinery may be affected by side effects
Some formulations contain hydroxybenzoate
Some formulations contain lactose
Monitor blood pressure in elderly
Monitor ECG in patients at risk of QT prolongation
Monitor patient initially- response may take 2 or more weeks
Monitor patient's weight
Monitor patients with existing or tendency towards diabetes mellitus
Monitor periodically for signs or symptoms of hyperglycaemia
Monitor serum electrolytes
Monitor serum lipids
Consider discontinuation if signs of tardive dyskinesia occur
Discontinue if hepatitis develops
Discontinue in patients with unexplained high fever
May cause postural hypotension especially in elderly
To discontinue, reduce dose gradually
Advise patient to seek advice at first indications of pregnancy
Discontinue if patient develops neuroleptic malignant syndrome
Dose adjustment required if patient starts/stops smoking during therapy
Slower metabolisers with 2+ factors(female,elderly,non-smoke):modify dosing
Advise that effects are potentiated by CNS depressants (including alcohol)
Clinical monitoring of physical health is required, the manufacturer states this must include blood glucose measurement at baseline, after 12 weeks then annually, weight at baseline, after 4, 8 and 12 weeks then quarterly and lipid levels at baseline, after 12 weeks then every 5 year. Additional and/or more frequent monitoring may be recommended in other resources. The risk of hyperglycaemia and diabetes may be higher in patients with a prior increase in body weight.
Caution is advised in patients with increased ALT or AST, signs of hepatic impairment, those with limited hepatic reserve or those with concomitant hepatotoxic medicines. Consider dose reduction if elevated ALT and/or AST occurs.
Pregnancy and Lactation
Pregnancy
Use olanzapine with caution during pregnancy.
The manufacturer advises to only use olanzapine in pregnancy if the benefit justifies the potential risk to the foetus. There are no adequate studies in pregnant women.
New born infants exposed to olanzapine during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms. There has been reports of agitation, hypertonia, tremor, somnolence, respiratory distress or feeding disorder, therefore newborns should be monitored carefully.
Lactation
Olanzapine is contraindicated during breastfeeding.
The manufacturers advise not to breastfeed whilst taking olanzapine. Available data suggests olanzapine is expressed into breast milk and indicate possible adverse effects on the developing nervous system. Whilst some sources indicate that available reports demonstrate no significant adverse effects in humans, others do not advise long term use of olanzapine during breastfeeding. Overall data is currently limited.
Counselling
Advise patients not to drive or operate machinery if affected by somnolence or dizziness.
Advise patients that they should notify their physician if they become pregnant or intend to become pregnant during treatment with olanzapine.
Advise patients that olanzapine orodispersible tablet should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed. Removal of the intact orodispersible tablet from the mouth is difficult.
Advise patient the orodispersible tablet should be taken immediately on opening the blister. Alternatively, it may be dispersed in a full glass of water or other suitable beverage (orange juice, apple juice, milk or coffee) immediately before administration.
Side Effects
Abdominal distension
Akathisia
Alopecia
Amenorrhoea
Amnesia
Anticholinergic effects
Arthralgia
Asthenia
Blood lipid changes
Bradycardia
Breast enlargement
Cerebrovascular disorders
Coma
Constipation
Creatine phosphokinase increased
Deep vein thrombosis (DVT)
Dizziness
Drug rash with eosinophilia and systemic symptoms (DRESS)
Dry mouth
Dysarthria
Dyskinesia
Dystonia
Eosinophilia
Epistaxis
Erectile dysfunction
Erythema
Exacerbation of diabetes
Falls
Fatigue
Gait abnormality
Galactorrhoea
Gamma glutamyl transferase (GGT) increased
Glucosuria
Gynaecomastia
Hallucinations
Hepatitis
Hyperglycaemia
Hypotension
Hypothermia
Increase in alkaline phosphatase
Increase in serum glucose
Increase in total cholesterol
Increase of liver transaminases
Increased appetite
Increased prolactin
Increased uric acid level
Ketoacidosis
Lethargy
Leucopenia
Neuroleptic malignant syndrome
Neutropenia
Oculogyric crisis
Oedema
Orthostatic hypotension
Pancreatitis
Parkinsonism
Photosensitivity
Pneumonia
Priapism
Prolongation of QT interval
Pulmonary embolism
Pyrexia
Rash
Reduced libido
Restless legs
Rhabdomyolysis
Rise in body temperature
Seizures
Serum bilirubin increased
Somnolence
Speech disturbances
Stuttering
Sudden death reported
Tardive dyskinesia
Thrombocytopenia
Thromboembolism
Tremor
Urinary hesitancy
Urinary incontinence
Urinary retention
Urticaria
Ventricular fibrillation
Ventricular tachycardia
Weight gain
Withdrawal symptoms
Worsening of Parkinson's disease
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: April 2019
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Zalasta 2.5mg tablets. Consilient Health Ltd. Revised October 2014.
Summary of Product Characteristics: Zalasta 5mg tablets. Consilient Health Ltd. Revised October 2014.
Summary of Product Characteristics: Zalasta 7.5mg tablets. Consilient Health Ltd. Revised October 2014.
Summary of Product Characteristics: Zalasta 10mg tablets. Consilient Health Ltd. Revised October 2014.
Summary of Product Characteristics: Zalasta 15mg tablets. Consilient Health Ltd. Revised October 2014.
Summary of Product Characteristics: Zalasta 20mg tablets. Consilient Health Ltd. Revised October 2014.
Summary of Product Characteristics: Zyprexa 2.5mg, 5mg, 7.5mg, 10mg, 15mg and 20mg coated tablets. Eli Lilly & Co Ltd. Revised November 2018.
Summary of Product Characteristics: Zyprexa 5mg, 10mg, 15mg and 20mg orodispersible tablets. Eli Lilly & Co Ltd. Revised November 2018.
Summary of Product Characteristics: Olanzapine 5mg orodispersible tablets. Dr. Reddy's Laboratories (UK) Ltd. Revised February 2017.
Summary of Product Characteristics: Olanzapine 10mg orodispersible tablets. Dr. Reddy's Laboratories (UK) Ltd. Revised February 2017.
Summary of Product Characteristics: Olanzapine 15mg orodispersible tablets. Dr. Reddy's Laboratories (UK) Ltd. Revised February 2017.
Summary of Product Characteristics: Olanzapine 20mg orodispersible tablets. Dr. Reddy's Laboratories (UK) Ltd. Revised February 2017.
Summary of Product Characteristics: Olanzapine 7.5mg orodispersible tablets. Torrent Pharma (UK) Ltd. Revised April 2018.
Summary of Product Characteristics: Olanzapine 2.5mg orodispersible tablets. Torrent Pharma (UK) Ltd. Revised April 2018.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 05 April 2019
Specialist Pharmacy Service (SPS)
Available at: https://www.sps.nhs.uk/
What are the clinically significant drug interactions with tobacco smoking? Last revised: July 2020
Last accessed: 07 December 2020
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.