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MINT-OLANZAPINE ODT is a brand name for Olanzapine, supplied as a tablet (orally disintegrating). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ......................................................................................3 CONTRAINDICATIONS ...........................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
ORAL ADMINISTRATION
Schizophrenia and Related Disorders Adults:
MINT-OLANZAPINE ODT (olanzapine) should be administered on a once-a-day schedule without regard to meals, generally beginning with 5 to 10 mg, with a target dose of 10 mg/day within several days. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 1 week, since steady state for olanzapine would not be achieved for approximately 1 week in the typical patient.
When dosage adjustments are necessary, dose increments/ decrements of 5 mg per day are recommended. , to a dose of 15 mg/day or greater) is normally recommended only after clinical assessment.
In clinical trials a dose range of 5-20 mg/day was studied (see Part II:
CLINICAL TRIALS). Doses above 20 mg/day have been evaluated from a safety perspective (see Table 6 in Adverse Events, Dose-Dependent Adverse Events subsection); however, efficacy at doses above 20 mg/day has not been systematically evaluated.
Maintenance Therapy in Schizophrenia:
It is recommended that responding patients with schizophrenia be continued on MINT- OLANZAPINE ODT at the lowest dose needed to maintain remission. Patients should be reassessed periodically to determine the need for maintenance treatment.
While there is no body of evidence available to answer the question of how long the patient should be treated with MINT-OLANZAPINE ODT, the effectiveness of maintenance treatment is well established for many other antipsychotic drugs.
Bipolar Disorder Bipolar Mania Adults:
The recommended starting dose for olanzapine is 15 mg administered once a day in monotherapy and 10 mg daily in combination therapy. It may be given without regard to meals as its absorption is not affected by food. The dosage range of olanzapine is from 5 mg to 20 mg per day.
Daily dosage should be adjusted in response to clinical assessment.
Maintenance Therapy in Bipolar Disorder:
Patients who have been receiving and responding to olanzapine for the treatment of acute manic or mixed episodes of bipolar disorder should initially continue maintenance therapy at the same dose (see Part II: CLINICAL TRIALS). Subsequent daily dosage should be adjusted on the basis of clinical status within a range of 5-20 mg per day.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Olanzapine in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment. Page 33 of 60 General Considerations for Oral Dosing in Special Populations The Elderly or Debilitated Patient: In clinical trials, 44 patients with schizophrenia or related disorders who were 65 years of age or over were treated with olanzapine (5-20 mg daily) (see WARNINGS AND PRECAUTIONS, Special Populations).
Given the limited experience with olanzapine in the elderly, and the higher incidence of concomitant illness and concomitant medication in this population, MINT- OLANZAPINE ODT should be used with caution. , nonsmoking female patients), or who may be pharmacodynamically more sensitive to MINT-OLANZAPINE ODT.
When indicated, dose escalation should be performed with caution in these patients.
Patients with Hepatic and/or Renal Impairment:
As clinical experience is lacking in these patients, the lower initial starting dose and slower titration to initial target dose should be considered. Further dose escalation, when indicated, should be conservative (see WARNINGS AND PRECAUTIONS, Special Populations).
Missed Dose If a patient misses a dose by a few hours, advise patient to take as soon as he/she remembers. If most of the day has passed, advise patient to wait until the next scheduled dose. Advise patients to not take 2 doses of MINT-OLANZAPINE ODT at once.
Administration of MINT-OLANZAPINE ODT MINT-OLANZAPINE ODT (orally disintegrating tablets) is intended for oral administration only. It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid.
The orally disintegrating tablet breaks easily and should be handled carefully, with dry hands. Direct contact with hands should be avoided if possible. One blister cell must be separated from the strip prior to peeling the blister backing.
The blister backing should be carefully peeled back and the orally disintegrating tablet pushed out and placed directly in the mouth. The orally disintegrating tablet may also be stirred into 125 mL (4 ounces) of water, milk, coffee, orange juice or apple juice and the contents promptly consumed.
OVERDOSAGE Signs and Symptoms Very common symptoms reported in olanzapine 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 olanzapine overdose include delirium, convulsion, Page 34 of 60 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 of oral olanzapine but survival has also been reported following acute overdose of approximately 2,000 mg of oral olanzapine. Management of Overdose There is no specific antidote for olanzapine.
Induction of emesis is not recommended. , gastric lavage, administration of activated charcoal). The concomitant administration of activated charcoal was shown to reduce the oral bioavailability of olanzapine by 50 to 60%. Symptomatic treatment and monitoring of vital organ function should be instituted according to clinical […]