Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
ZYPREXA powder for solution for injection is indicated for the rapid control of agitation and disturbed behaviours in patients with schizophrenia or manic episode, when oral therapy is not appropriate. Treatment with ZYPREXA powder for solution for injection should be discontinued and the use of oral olanzapine should be initiated as soon as clinically appropriate.
For intramuscular use. Do not administer intravenously or subcutaneously. ZYPREXA powder for solution for injection is intended for short term use only, for up to a maximum of three consecutive days.
The maximum daily dose of olanzapine (including all formulations of olanzapine) is 20 mg.
The recommended initial dose for olanzapine injection is 10 mg, administered as a single intramuscular injection. A lower dose (5 mg or 7.5 mg) may be given, on the basis of individual clinical status, which should also include consideration of medicinal products already administered either for maintenance or acute treatment (see section 4.4). A second injection, 5-10 mg, may be administered 2 hours after the first injection on the basis of individual clinical status. Not more than three injections should be given in any 24 hour period and the maximum daily dose of olanzapine of 20 mg (including all formulations) should not be exceeded.
ZYPREXA powder for solution for injection should be reconstituted in accordance with the recommendation in section 6.6.
For further information on continued treatment with oral olanzapine (5 to 20 mg daily), see the Summary of Product Characteristics for ZYPREXA coated tablets or ZYPREXA VELOTAB orodispersible tablets.
The recommended starting dose in elderly patients (>60 years) is 2.5-5 mg. Depending on the patient’s clinical status (see section 4.4), a second injection, 2.5-5 mg, may be administered 2 hours after the first injection. Not more than 3 injections should be given in any 24 hour period and the maximum daily dose of 20 mg (including all formulations) of olanzapine should not be exceeded.
A lower starting dose (5 mg) should be considered for such patients. In cases of moderate hepatic insufficiency (cirrhosis, Child-Pugh Class A or B), the starting dose should be 5 mg and only increased with caution.
The dose and dose range need not be routinely altered for non-smokers relative to smokers. The metabolism of olanzapine may be induced by smoking. Clinical monitoring is recommended and an increase of olanzapine dose may be considered if necessary (see section 4.5).
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 dose. Additional injections, when indicated, should be conservative in such patients (See sections 4.5 and 5.2).
There is no experience in children. ZYPREXA powder for solution for injection is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Very common symptoms in overdose (>10% incidence) include tachycardia, agitation/aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
Other medically significant sequelae of overdose include delirium, convulsion, coma, possible neuroleptic malignant syndrome, respiratory depression, aspiration, hypertension or hypotension, cardiac arrhythmias (<2% of overdose cases) and cardiopulmonary arrest. Fatal outcomes have been reported for acute overdoses as low as 450 mg but survival has also been reported following acute overdose of approximately 2 g of oral olanzapine.
There is no specific antidote for olanzapine.
Symptomatic treatment and monitoring of vital organ function should be instituted according to clinical presentation, including treatment of hypotension and circulatory collapse and support of respiratory function. Do not use epinephrine, dopamine, or other sympathomimetic agents with beta-agonist activity since beta stimulation may worsen hypotension. Cardiovascular monitoring is necessary to detect possible arrhythmias. Close medical supervision and monitoring should continue until the patient recovers.
Powder: 3 years.
Solution (after reconstitution): 1 hour. Do not freeze.
Do not store above 25°C. Store in the original package in order to protect from light. For storage conditions of the reconstituted medicinal product, see section 6.3.
Type I, 5 ml glass vial.
One carton contains 1 or 10 vial(s).
Not all pack sizes may be marketed.
Reconstitute ZYPREXA only with water for injections using standard aseptic techniques for reconstitution of parenteral products. No other solutions should be used for reconstitution (see section 6.2).
1. Withdraw 2.1 ml of water for injection into a sterile syringe. Inject into a vial of ZYPREXA.
2. Rotate the vial until the contents have completely dissolved, giving a yellow coloured solution. The vial contains 11.0 mg olanzapine as a solution of 5 mg/ml (1 mg olanzapine is retained in the vial and syringe, thus allowing delivery of 10 mg olanzapine).
3. The following table provides injection volumes for delivering various doses of olanzapine:
| Dose (mg) | Volume of injection (ml) |
|---|---|
| 10 | 2.0 |
| 7.5 | 1.5 |
| 5 | 1.0 |
| 2.5 | 0.5 |
4. Administer the solution intramuscularly. Do not administer intravenously or subcutaneously.
5. Discard the syringe and any unused solution in accordance with appropriate clinical procedures.
6. Use the solution immediately within 1 hour of reconstitution.
Parenteral medicines should be inspected visually for particulate matter prior to administration.
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