Zyprexa/Zyprexa Zydis再普樂

Zyprexa/Zyprexa Zydis Dosage/Direction for Use

olanzapine

Manufacturer:

Eli Lilly

Distributor:

Zuellig
/
Agencia Lei Va Hong
Full Prescribing Info
Dosage/Direction for Use
Zyprexa: Coated tablet: Adults: Schizophrenia: The recommended starting dose for olanzapine is 10 mg/day.
Manic episode: The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see Pharmacology: Pharmacodynamics under Actions).
Preventing recurrence in bipolar disorder: The recommended starting dose is 10 mg/day. For patients who have been receiving olanzapine for treatment of manic episode, continue therapy for preventing recurrence 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.
During treatment for schizophrenia, manic episode and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5-20 mg/day. An increase to a dose greater than the recommended starting dose is advised only after appropriate clinical reassessment and should generally occur at intervals of not less than 24 hours. Olanzapine can be given without regards for meals as absorption is not affected by food. Gradual tapering of the dose should be considered when discontinuing olanzapine.
Special populations: Elderly: A lower starting dose (5 mg/day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant (see Precautions).
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.
Smokers: The starting 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 Interactions).
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.
(See Interactions and Pharmacology: Pharmacokinetics under Actions.)
Paediatric population: Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy. A greater magnitude of weight gain, lipid and prolactin alterations has been reported in short term studies of adolescent patients than in studies of adult patients (see Precautions, Adverse Reactions, Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
Powder for injection: 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 Precautions). 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 Special precautions for disposal under Cautions for Usage.
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.
Special populations: Elderly: The recommended starting dose in elderly patients (> 60 years) is 2.5 - 5 mg. Depending on the patient's clinical status (see Precautions), 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.
Smokers: 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 Interactions).
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 Interactions and Pharmacology: Pharmacokinetics under Actions.)
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.
Zyprexa Zydis: Adult: Schizophrenia: Recommended Starting Dose: 10 mg/day.
Manic Episode: Starting Dose: 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see Pharmacology: Pharmacodynamics under Actions).
Preventing Recurrence in Bipolar Disorder: Recommended Starting Dose: 10 mg/day. For patients who have been receiving olanzapine for treatment of manic episode, continue therapy for preventing recurrence 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.
During treatment for schizophrenia, manic episode and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5-20 mg/day. An increase to a dose greater than the recommended starting dose is advised only after appropriate clinical reassessment and should generally occur at intervals of not less than 24 hrs. Olanzapine can be given without regards for meals as absorption is not affected by food. Gradual tapering of the dose should be considered when discontinuing olanzapine.
Children and Adolescents: Zyprexa/Zyprexa Zydis: Olanzapine is not recommended for use in children and adolescents <18 years due to a lack of data on safety and efficacy. A greater magnitude of weight gain, lipid and prolactin alterations has been reported in short-term studies of adolescent patients than in studies of adult patients (see Pharmacology under Actions, Precautions and Adverse Reactions).
Elderly: A lower starting dose (5 mg/day) is not routinely indicated but should be considered for those ≥65 years when clinical factors warrant (see Precautions).
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 starting dose and dose range need not be routinely altered for female patients relative to male patients.
Smokers: The starting dose and dose range need not be routinely altered for nonsmokers relative to smokers.
When >1 factor is present which might result in slower metabolism (female gender, geriatric age, nonsmoking status), consideration should be given to decreasing the starting dose. Additional injections, and oral dose escalation when indicated, should be conservative in such patients.
In cases where dose increments of 2.5 mg are considered necessary, Zyprexa coated tablets should be used (see Pharmacology: Pharmacokinetics under Actions and Interactions).
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