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Adults
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.
Paediatric population
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.
Elderly
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.
Renal and/or hepatic impairment
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.
Gender
The dose and dose range need not be routinely altered for female patients relative to male patients.
Smokers
The dose and dose range need not be routinely altered for non-smokers 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 dose. Additional injections, when indicated, should be conservative in such patients.
(See sections 4.5 and 5.2.)
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