Olanzapine embonate

The page is Olanzapine embonate, brand ZypAdhera, atypical depot antipsychotic, deep IM gluteal, psychiatry — and the recovered source is the UK SPC for ZYPADHERA 210 mg powder and solvent for prolonged release suspension for injection, i.e. the page's own named brand, its depot formulation and its route. The SPC's own §4.8 confirms the salt, referring to 'Adverse reactions seen with olanzapine pamoate' and to 'the slow dissolution of the olanzapine pamoate salt'. Indication, route and population all match, so the §4.2 dose has been extracted. MANDATORY 3-HOUR OBSERVATION (§4.2, verbatim): 'After each injection, patients should be observed in a health care facility by appropriately qualified personnel for at least 3 hours for signs and symptoms consistent with olanzapine overdose. Immediately prior to leaving the health care facility, it should be confirmed that the patient is alert, oriented, and absent of any signs and symptoms of overdose... The 3-hour observation period should be extended as clinically appropriate for patients who exhibit any signs or symptoms consistent with olanzapine overdose.' PRODUCT CONFUSION WARNING (§4.2, first line, verbatim): 'ZYPADHERA 210 mg, 300 mg or 405 mg powder and solvent for prolonged release suspension for injection must not be confused with olanzapine 10 mg powder for solution for injection.' NOT FOR ACUTE USE (§4.4, verbatim): 'ZYPADHERA should not be used to treat patients with schizophrenia who are in an acutely agitated or severely psychotic state such that immediate symptom control is warranted.' ELDERLY (§4.2, verbatim): 'ZYPADHERA has not been systematically studied in elderly patients (> 65 years). ZYPADHERA is not recommended for treatment in the elderly population unless a well-tolerated and effective dose regimen using oral olanzapine has been established. A lower starting dose (150 mg/4 weeks) is not routinely indicated, but should be considered for those 65 and over when clinical factors warrant. ZYPADHERA is not recommended to be started in patients >75 years.' RENAL AND/OR HEPATIC IMPAIRMENT (§4.2, verbatim): 'Unless a well-tolerated and effective dose regimen using oral olanzapine has been established in such patients, ZYPADHERA should not be used. A lower starting dose (150 mg every 4 weeks) should be considered for such patients. In cases of moderate hepatic insufficiency (cirrhosis, Child-Pugh Class A or B), the starting dose should be 150 mg every 4 weeks and only increased with caution.' SMOKERS (§4.2): the starting dose and dose range need not be routinely altered for non-smokers relative to smokers, but the metabolism of olanzapine may be induced by smoking, clinical monitoring is recommended and a dose increase may be considered; where more than one factor slowing metabolism is present (female gender, geriatric age, non-smoking status), consideration should be given to decreasing the dose. SWITCHING OFF (§4.2, verbatim): 'Due to the slow dissolution of the olanzapine pamoate salt which provides a slow continuous release of olanzapine that is complete approximately six to eight months after the last injection, supervision by a clinician, especially during the first 2 months after discontinuation of ZYPADHERA, is needed when switching to another antipsychotic product.' RELAPSE MONITORING (§4.2, verbatim): 'Patients should be monitored carefully for signs of relapse during the first one to two months of treatment.'