Olandus 5/Olandus 10: Schizophrenia, combination therapy for mania, preventing recurrence in bipolar disorder: ADULT over 18 years: 10 mg daily adjusted to usual range of 5-20 mg daily; doses greater than 10 mg daily adjusted to usual range of 5-20 mg daily; doses greater than 10 mg daily only after reassessment; max. 30 mg daily. Monotherapy for mania: ADULT over 18 years: 15mg daily adjusted to usual range of 5-20 mg daily doses greater than 15 mg only after reassessment max. 20 mg daily.
Olandus ODT 15: Olanzapine orally disintegrating tablets should be placed in the mouth and allowed to completely dissolve before swallowing the saliva. A glass of water may be taken following administration to assist with swallowing the saliva. Alternatively, the Olanzapine ODT may be dispersed in a full glass of water immediately before administration.
Schizophrenia and Related Disorders: The recommended starting dose for Olanzapine orally disintegrating tablets is 5-10 mg/day, administered as a single daily dose without regard to meals. Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5-20 mg daily. An increase to a dose greater than the routine therapeutic dose of 10 mg/day is recommended only after appropriate clinical reassessment.
Acute Mania Associated with Bipolar Disorder: The recommended starting dose for Olanzapine orally disintegrating tablets is 10 or 15 mg administered once a day as monotherapy or 10 mg administered once daily in combination therapy with lithium or valproate. It may be given without regard to meals. Dosage adjustments, if indicated, should generally occur at intervals of not less than 24 hours. When dosage adjustments are necessary, dose increments/decrements of 5 mg daily are recommended. Antimanic efficacy was demonstrated in a dose range of 5 mg to 20 mg/day in clinical trials. The safety of doses above 20 mg/day has not been evaluated in clinical trials.
Preventing Recurrence in Bipolar Disorder: Patients who have been receiving Olanzapine for the treatment of acute mania should initially continue therapy for preventing recurrence in bipolar disorder at the same dose. For patients already in remission, the suggested starting dose for Olanzapine orally disintegrating tablets is 10 mg once a day. Subsequent daily dosage should be adjusted on the basis of clinical status within a range of 5 mg to 20 mg per day. Olanzapine ODT may be given without regard to meals, as its absorption is not affected by food.
Children: The safety and efficacy of Olanzapine have not been established in patients under 18 years of age.
Elderly patients: A low starting dose of 5 mg/day should be considered for those patients 65 and over when clinical factors warrant.
Patients with hepatic and/or renal impairment: Small single-dose clinical pharmacology studies did not reveal any major alterations in Olanzapine pharmacokinetics in subjects with renal or hepatic impairment. However, as clinical experience is limited in these patients, a lower starting dose (5 mg/day) should be considered. Further dose adjustments, when indicated, should be conservative in these patients.
Female compared with male patients: The starting dose and dose range need not be routinely altered for female patients relative to male patients.
Non-smoking patients compared with smoking patients: The starting dose and dose range need not be routinely altered for non-smoking patients relative to smoking patients.
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.