Olanzapine-Teva (Tablets) Instructions for Use

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Teva Kutno S.A. (Poland)

ATC Code

N05AH03 (Olanzapine)

Active Substance

Olanzapine (Rec.INN registered by WHO)

Dosage Forms

	Olanzapine-Teva	Film-coated tablets, 5 mg: 28 or 35 pcs.
		Film-coated tablets, 10 mg: 7, 28 or 35 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from white, round, biconvex, with the engraving “OL5” on one side; on the cross-section – a yellow core.

Excipients: lactose monohydrate – 75.2 mg, hyprolose – 3 mg, crospovidone type A – 5 mg, prosolv 50 (microcrystalline cellulose 98% – 3.92 mg, colloidal silicon dioxide 2% – 0.08 mg), prosolv 90 (microcrystalline cellulose 98% – 9.8 mg, colloidal silicon dioxide 2% – 0.2 mg), magnesium stearate – 0.5 mg.

Film coating composition opadry II white Y-22-7719 (titanium dioxide (E171) – 1.5 mg, polydextrose – 1.2 mg, hypromellose 3cP – 0.9 mg, hypromellose 6cP – 0.7715 mg, hypromellose 50 cP – 0.1285 mg, triacetin – 0.3750 mg, macrogol 8000 – 0.1250 mg).

7 pcs. – blisters (4) – cardboard packs.
7 pcs. – blisters (5) – cardboard packs.

Film-coated tablets from white, round, biconvex, with the engraving “OL10” on one side; on the cross-section – a yellow core.

Excipients: lactose monohydrate – 145 mg, hyprolose – 6 mg, crospovidone type A – 10 mg, prosolv 50 (microcrystalline cellulose 98% – 7.84 mg, colloidal silicon dioxide 2% – 0.16 mg), prosolv 90 (microcrystalline cellulose 98% – 19.6 mg, colloidal silicon dioxide 2% – 0.4 mg), magnesium stearate – 1 mg.

Film coating composition opadry II white Y-22-7719 (titanium dioxide (E171) – 3 mg, polydextrose – 2.4 mg, hypromellose 3cP – 1.8 mg, hypromellose 6cP – 1.543 mg, hypromellose 50 cP – 0.2570 mg, triacetin – 0.75 mg, macrogol 8000 – 0.25 mg).

7 pcs. – blisters (1) – cardboard packs.
7 pcs. – blisters (4) – cardboard packs.
7 pcs. – blisters (5) – cardboard packs.

Clinical-Pharmacological Group

Antipsychotic drug (neuroleptic)

Pharmacotherapeutic Group

Antipsychotic (neuroleptic) agent

Pharmacological Action

Olanzapine is an antipsychotic drug (neuroleptic) with a broad pharmacological spectrum of action on a number of receptor systems.

Antipsychotic action is due to antagonism towards 5HT2A/2C, 5HT3, 5HT6 serotonin receptors, D1, D2, D3, D4, D5 dopamine receptors; anticholinergic effects are due to blockade of M1-5 muscarinic cholinergic receptors; it also has affinity for alpha1-adrenergic and H1 histamine receptors. In vivo and in vitro, Olanzapine has a more pronounced affinity and activity towards 5HT2 serotonin receptors compared to D2 dopamine receptors.

Olanzapine selectively reduces the excitability of mesolimbic (A10) dopaminergic neurons and has a minor effect on striatal (A9) nerve pathways involved in the regulation of motor functions. Olanzapine reduces the conditioned avoidance response (a test characterizing antipsychotic activity) at lower doses than doses causing catalepsy (a disorder reflecting the effect on motor function). Unlike other neuroleptics, Olanzapine enhances the anti-anxiety effect in the “anxiolytic” test.

Olanzapine reduces delta rhythm (1-4 Hz) in the anterior parts of the fronto-central brain regions (F3,4, C3,4), diffusely enhances theta range (4-8 Hz) in the same fronto-central and parietal-central regions, and also enhances alpha rhythm (8-13 Hz) in the occipital and parietal cortical zones. The increase in alpha rhythm indicates normalization of the EEG structure under the influence of olanzapine, which produces a global inhibitory effect in almost all parts of the brain, except for the frontal regions.

It eliminates productive symptoms of psychoses (delusions, hallucinations, thought disorders, hostility, suspicion), reduces negative symptoms (emotional and social autism, introversion, poverty of speech). It dulls the acuity of emotional experiences, weakens aggressiveness and impulsiveness of behavioral reactions, forms tolerance to the surrounding reality and reduces initiative. It relieves agitation and corrects behavioral and thought disorders in patients with mental disorders.

Pharmacokinetics

After oral administration, Olanzapine is well absorbed from the gastrointestinal tract. Food intake does not affect the bioavailability of olanzapine. Bioavailability decreases by 40% due to the first-pass effect through the liver. Cmax in plasma is reached within 5-8 hours. Steady-state concentration is reached after 1 week of daily administration and is twice the plasma concentration after a single dose. Plasma concentration in the dose range from 1-20 mg changes linearly and is proportional to the dose.

At plasma concentrations from 7 to 1000 ng/ml, binding to plasma proteins, mainly albumin and alpha1-acid glycoprotein, is about 93%.

It passes through histohematic barriers, including the blood-brain barrier. The volume of distribution is about 1000 L.

Olanzapine is metabolized in the liver by conjugation and oxidation. The main circulating metabolite is 10-N-glucuronide, which theoretically does not penetrate the blood-brain barrier. Cytochrome P450 isoenzymes CYP1A2 and CYP2D6 are involved in the formation of N-desmethyl and 2-hydroxymethyl metabolites of olanzapine. The main pharmacological activity of the drug is due to the parent substance – olanzapine. Metabolites have significantly less pronounced pharmacological activity in vivo than Olanzapine. The activity of the cytochrome P450 isoenzyme CYP2D6 does not affect the rate of olanzapine metabolism. About 57% of the orally administered dose of olanzapine is excreted in the urine, mainly as metabolites.

T1/2 and clearance of olanzapine (CL) vary depending on gender, age, and smoking habit. In young healthy volunteers (mixed population), T1/2 averages 33 hours (21-54 hours), and the mean total plasma CL is 26 L/h (12-47 L/h). In healthy elderly volunteers (age 65 and older), T1/2 is prolonged to 51.8 hours, CL decreases to 17.7 L/h. In women compared to men, the T1/2 of olanzapine is higher (36.7 hours vs. 32.3 hours), and CL is lower (18.9 L/h vs. 27.3 L/h). In non-smoking men and women compared to smokers, T1/2 increases (38.6 hours vs. 30.4 hours), and CL decreases (18.6 L/h vs. 27.7 L/h). However, the degree of change in T1/2 and total plasma CL depending on gender, age, and smoking habit is significantly inferior to the degree of individual differences in these indicators.

No significant differences were found between the mean values of T1/2 and CL in patients with severe renal impairment compared to individuals with normal renal function.

In smoking patients with mild hepatic impairment, T1/2 is higher (48.8 hours) and CL is lower (14.1 L/h) than in non-smokers without hepatic impairment (T1/2 – 39.3 hours, CL – 18 L/h).

In individuals over 65 years of age, the T1/2 of olanzapine may be significantly prolonged, so the average daily dose of olanzapine should be lower than usual. In studies involving individuals of European, Japanese, and Chinese populations, no differences in the pharmacokinetics of olanzapine associated with race were found.

Indications

• Schizophrenia: treatment of exacerbations, maintenance and long-term relapse prevention therapy;
• Bipolar affective disorder: treatment of acute manic or mixed episodes;
• For the prevention of relapse in patients with bipolar affective disorder in whom Olanzapine was effective in treating the manic phase.

ICD codes

Dosage Regimen

Orally, regardless of meals.

For schizophrenia, the recommended initial dose is 10 mg once daily.

For the treatment of an acute manic episode in bipolar affective disorder, the recommended initial dose is 15 mg once daily (when used as monotherapy) or 10 mg once daily (when used in combination with lithium or valproic acid preparations).

For the prevention of relapse of bipolar affective disorder, the recommended initial dose is 10 mg once daily.

In the treatment of schizophrenia, acute manic episode in bipolar affective disorder, and for the prevention of relapse of bipolar affective disorder, the doses of olanzapine are selected individually depending on the clinical status of the patient and range from 5-20 mg once daily. Increasing the dose above the standard (15 mg once daily) is recommended only after an appropriate clinical examination of the patient. The dose should be increased gradually, with intervals of at least 24 hours.

A reduction in the initial dose is recommended in patients with a combination of factors (female patients, elderly age, non-smokers) that may contribute to a slowdown in olanzapine metabolism.

Elderly patients, as well as those with severe renal impairment or moderate hepatic impairment, should use the drug at an initial dose of 5 mg once daily.

Adverse Reactions

The frequency of side effects is classified according to World Health Organization recommendations: very common – not less than 10%; common – not less than 1%, but less than 10%; uncommon – not less than 0.1%, but less than 1%; rare – not less than 0.01%, but less than 0.1%; very rare – not less than 0.01%, including isolated reports.

Blood and lymphatic system disorders common – eosinophilia; rare – leukopenia; very rare – thrombocytopenia, neutropenia.

Metabolism and nutrition disorders very common – weight gain; common – increased appetite; unknown frequency – development or exacerbation of diabetes mellitus, diabetic ketoacidosis, diabetic coma, including fatal outcome.

Nervous system disorders very common – drowsiness; common – dizziness, akathisia, parkinsonism, dyskinesia, gait disturbance (in patients with Alzheimer’s type dementia); rare – extrapyramidal disorders (mainly when using high doses); very rare – sweating, insomnia, tremor, anxiety, nausea; unknown frequency – neuroleptic malignant syndrome (NMS), dystonia (including oculogyric crisis), tardive dyskinesia.

Cardiac disorders common – orthostatic hypotension; uncommon – bradycardia, QT interval prolongation; unknown frequency – ventricular tachycardia/ventricular fibrillation; sudden death, pulmonary embolism, deep vein thrombosis.

Gastrointestinal disorders common – dry mouth, constipation (anticholinergic effect); very rare – hepatitis (including hepatocellular, cholestatic, or mixed), pancreatitis.

Skin and subcutaneous tissue disorders uncommon – photosensitivity reaction; rare – skin rash; very rare – alopecia.

Musculoskeletal and connective tissue disorders very rare – rhabdomyolysis.

Renal and urinary disorders uncommon – urinary incontinence; very rare – priapism, urinary retention.

Laboratory parameters very common – increased plasma prolactin concentration*; common – increased plasma glucose, cholesterol and triglycerides, glucosuria, transient increase in liver enzyme activity (AST and ALT); uncommon – increased creatine phosphokinase (CPK) activity; very rare – increased alkaline phosphatase activity and total bilirubin concentration.

* The increase in plasma prolactin concentration was mild and transient (the mean maximum prolactin concentrations did not reach the upper limit of normal and were not statistically significantly different from placebo). Clinical manifestations of hyperprolactinemia possibly associated with olanzapine use (i.e., amenorrhea, galactorrhea, breast enlargement in women, gynecomastia in men) were rarely noted. Sexual dysfunction possibly associated with olanzapine use (erectile dysfunction in men, decreased libido in men and women) was commonly observed. In most patients, normalization of prolactin concentration was observed without discontinuing olanzapine.

General disorders and administration site conditions common – asthenia, fatigue, peripheral edema; unknown frequency – hypothermia, withdrawal syndrome (increased sweating, insomnia, tremor, anxiety, nausea, vomiting).

Special patient groups

In elderly patients with psychosis associated with dementia very common – cerebrovascular disorders (stroke, transient ischemic attacks), including fatal outcome, gait disturbance and falls; common – urinary incontinence and pneumonia.

In patients with drug-induced psychosis (dopamine receptor agonist) for the treatment of Parkinson’s disease very common – worsening of parkinsonian symptoms and hallucinations.

In patients with bipolar mania taking Olanzapine in combination with lithium or valproic acid preparations very common – weight gain, dry mouth, increased appetite, tremor; common – speech disorder.

Contraindications

• History of narrow-angle glaucoma;
• Breastfeeding period;
• Age under 18 years (efficacy and safety not established);
• Lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome;
• Hypersensitivity to olanzapine and other components of the drug.

With caution

Renal failure; hepatic failure; in patients receiving treatment with potentially hepatotoxic drugs; benign prostatic hyperplasia; neutropenia; myelosuppression (including due to concomitant diseases, chemotherapy and radiation therapy); myeloproliferative diseases; hypereosinophilic syndrome; conditions predisposing to the development of arterial hypotension (dehydration, hypovolemia, use of antihypertensive drugs); cardiovascular diseases (myocardial infarction, coronary heart disease, heart failure, intracardiac conduction disorders, etc.); history of epileptic seizures; elderly patients (over 65 years of age), including those with dementia associated with psychosis and/or behavioral disturbances; paralytic ileus and similar conditions; pneumonia; simultaneous use with centrally acting drugs, benzodiazepines, ethanol.

Use in Pregnancy and Lactation

Women should be informed about the need to inform the doctor about an occurred or planned pregnancy during therapy with Olanzapine-Teva.

Due to limited experience with the use of olanzapine during pregnancy, Olanzapine-Teva should be used to treat pregnant women only when the potential benefit of therapy for the mother outweighs the potential risk to the fetus.

Olanzapine is excreted in breast milk. If it is necessary to use Olanzapine-Teva, breastfeeding should be discontinued.

Use in Hepatic Impairment

Should be used with caution in hepatic insufficiency

Use in Renal Impairment

Should be used with caution in renal insufficiency

Pediatric Use

Contraindicated for patients under 18 years of age (efficacy and safety not established).

Geriatric Use

Use with caution in elderly patients (over 65 years of age), including those with dementia associated with psychosis and/or behavioral disturbances.

In individuals over 65 years of age, the T1/2 of olanzapine may be significantly prolonged, so the average daily dose of olanzapine should be lower than usual.

Special Precautions

Neuroleptic malignant syndrome. When using any neuroleptics, including Olanzapine, the development of NMS is possible, the clinical manifestations of which include a significant increase in body temperature, muscle rigidity, altered mental status, and autonomic disturbances (tachycardia, unstable pulse or blood pressure, cardiac arrhythmia, increased sweating). Additional signs may include increased serum CPK concentration, myoglobinuria (a symptom of rhabdomyolysis), and acute renal failure. Clinical manifestations of neuroleptic malignant syndrome or a significant increase in body temperature without other symptoms of this syndrome require discontinuation of all neuroleptics, including Olanzapine.

Parkinson’s disease. The use of Olanzapine-Teva is not recommended for the treatment of psychosis in Parkinson’s disease induced by the use of dopamine receptor agonists, because parkinsonian symptoms and hallucinations may worsen. The effectiveness of olanzapine for the treatment of psychotic symptoms in this case does not exceed that of placebo.

Psychoses associated with dementia and/or behavioral disturbances. Olanzapine-Teva is not recommended for use in elderly patients with psychosis associated with dementia and/or behavioral disturbances because this patient population has shown an increased reporting of cerebrovascular adverse events (stroke, transient ischemic attacks) and mortality. The increased mortality was not found to be related to olanzapine dose or duration of olanzapine treatment. Risk factors that may have predisposed to increased mortality in this population were age greater than 65 years, dysphagia, sedation, malnutrition, dehydration, lung disease (pneumonia with/without aspiration), or concomitant use of benzodiazepines. Furthermore, all patients who experienced cerebrovascular adverse events, both in the olanzapine and placebo groups, were found to have vascular or mixed-type dementia. The efficacy of olanzapine in this patient population was not established.

Hyperglycemia and/or development or exacerbation of diabetes. In some cases, hyperglycemia, diabetes, exacerbation of pre-existing diabetes, diabetic ketoacidosis, and diabetic coma, including fatal cases, may develop during treatment with olanzapine. Reported patient weight gain may be a predisposing factor for the development of these adverse effects. Caution should be exercised and monitoring for manifestations of hyperglycemia (polydipsia, polyuria, increased appetite, weakness) is necessary during treatment with Olanzapine-Teva in patients with diabetes or risk factors for diabetes; regular monitoring of patient body weight and plasma glucose concentration is also required.

Change in lipid concentrations. Changes in plasma lipid concentrations during treatment with Olanzapine-Teva should be monitored in patients with dyslipidemia and in patients with risk factors for lipid metabolism disorders.

Anticholinergic effect. Olanzapine therapy may be accompanied by adverse reactions associated with the manifestation of anticholinergic effects. Clinical experience with olanzapine in patients with comorbid conditions is limited; therefore, caution is recommended when using olanzapine in patients with clinically significant benign prostatic hyperplasia, paralytic ileus, narrow-angle glaucoma, and other similar conditions.

Liver function. Transient, asymptomatic elevation of hepatic transaminases (ALT and AST) was most frequently noted at the beginning of olanzapine treatment. Caution should be exercised in patients with initially elevated ALT and/or AST, in patients with hepatic insufficiency, limited hepatic functional reserve, or in patients receiving treatment with potentially hepatotoxic drugs. If hepatitis (including hepatocellular, cholestatic, or mixed etiology) develops, Olanzapine-Teva should be discontinued.

Neutropenia. Caution should be exercised in patients with a low white blood cell and/or neutrophil count due to any cause, including due to medications that cause neutropenia, bone marrow suppression due to comorbid conditions, a history of radiation or chemotherapy, as well as hypereosinophilia or myeloproliferative disease. Neutropenia generally occurs with the concomitant use of olanzapine and valproic acid. The use of olanzapine in patients with a history of clozapine-dependent neutropenia or agranulocytosis was not associated with recurrence of these disorders.

Withdrawal syndrome. Abrupt discontinuation of Olanzapine-Teva may, in some cases, lead to a condition accompanied by acutely occurring symptoms: increased sweating, insomnia, tremor, anxiety, nausea, and vomiting.

QT interval prolongation. In clinical studies, patients taking olanzapine, compared to patients in the placebo group, showed a clinically significant prolongation of the QTc interval (QT interval corrected using Fridericia’s formula; QTcF prolongation of at least 500 ms in patients with baseline QTcF less than 500 ms), which was not associated with any cardiovascular effects. However, as with other antipsychotic drugs, caution should be exercised when Olanzapine-Teva is used concomitantly with medications that prolong the QT interval, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, myocardial hypertrophy, hypokalemia, or hypomagnesemia. Periodic electrocardiogram monitoring should be performed during olanzapine treatment.

Thromboembolism. Isolated cases of venous thromboembolism (VTE) have been reported during olanzapine use. A causal relationship between VTE and olanzapine use has not been established. However, since patients with schizophrenia, along with acquired risk factors for VTE, may have all other possible VTE risk factors, for example, prolonged immobilization, these risk factors should be identified and VTE preventive measures should be implemented.

Seizure disorder. Olanzapine-Teva should be used with caution in patients with a history of seizure disorder or risk factors that may contribute to a lowering of the seizure threshold.

Tardive dyskinesia. In a comparative study, treatment with olanzapine for less than 1 year was associated with a significantly lower incidence of dyskinesia requiring drug treatment compared to treatment with haloperidol. However, the risk of developing tardive dyskinesia increases with longer duration of olanzapine use. If signs or symptoms of tardive dyskinesia appear, a dose reduction or discontinuation of Olanzapine-Teva should be considered. Symptoms of tardive dyskinesia may temporarily worsen or appear even after discontinuation of the drug.

Orthostatic hypotension. Due to its alpha-adrenergic blocking action, olanzapine can cause orthostatic hypotension, accompanied by dizziness, tachycardia, and syncope during initial dose titration. Orthostatic hypotension occurs most frequently in elderly patients and with the use of other antipsychotics. The development of these phenomena can be minimized by more gradual dose titration and initiation of therapy with the minimum dose. Blood pressure should be monitored during the use of Olanzapine-Teva, especially in patients over 65 years of age. If patients experience severe orthostatic hypotension, they should be advised not to get up abruptly and without assistance.

Sudden death. Clinical experience with any antipsychotics, including olanzapine, has revealed a similar, dose-dependent, two-fold increase in the risk of sudden death compared to cases of sudden death in patients not taking antipsychotics.

Effect on the central nervous system (CNS). Given the drug’s effect on the CNS, olanzapine should be used with caution in combination with other centrally acting drugs and ethanol.

In vitro, olanzapine exhibits antagonism of dopamine receptors and, like other antipsychotics, may theoretically suppress the effect of levodopa and dopamine receptor agonists.

Effect on the ability to drive vehicles and operate machinery

Caution should be exercised during the use of Olanzapine-Teva due to the possible development of adverse reactions that may negatively affect the ability to drive vehicles and perform potentially hazardous activities requiring increased concentration and speed of psychomotor reactions.

Overdose

Symptoms tachycardia, agitation/aggression, dysarthria, various extrapyramidal disorders, and impaired consciousness of varying severity (from sedative effect to coma), delirium, seizures, neuroleptic malignant syndrome (NMS), respiratory depression, aspiration, arterial hypertension or hypotension, ventricular tachycardia (less than 2% of overdose cases), cardiac and respiratory arrest. The minimum dose in an acute overdose with a fatal outcome was 450 mg, the maximum dose in an overdose with a favorable outcome (survival) was 1500 mg.

Treatment there is no specific antidote. Inducing vomiting artificially is not recommended. Standard detoxification methods are indicated (i.e., gastric lavage, administration of activated charcoal). Concomitant administration of activated charcoal reduces the bioavailability of orally administered olanzapine by 50-60%. Symptomatic treatment should be provided according to the clinical condition and vital organ functions should be monitored, including correction of arterial hypotension, vascular collapse, and support of respiratory function. Epinephrine, dopamine, and other sympathomimetics that are beta-adrenoceptor agonists should not be used, as stimulation of the latter may worsen arterial hypotension.

Drug Interactions

Olanzapine metabolism may be altered by inhibitors or inducers of cytochrome P450 isoenzymes exhibiting specific activity towards the CYP1A2 isoenzyme. Clearance increases in smoking patients and in patients taking carbamazepine (due to increased activity of the CYP1A2 isoenzyme). Known potential inhibitors of the CYP1A2 isoenzyme may reduce clearance. Olanzapine is not a potential inhibitor of CYP1A2 isoenzyme activity; therefore, the pharmacokinetics of drugs such as theophylline, which are metabolized primarily by the CYP1A2 isoenzyme, do not change when taken with olanzapine.

Fluvoxamine, a specific inhibitor of the CYP1A2 isoenzyme, significantly alters the pharmacokinetics of olanzapine, increasing its C_max by 54% in non-smoking women and by 77% in smoking men, with an increase in the area under the pharmacokinetic curve values by 52% and 108%, respectively. The dose of olanzapine should be reduced in patients taking fluvoxamine or other CYP1A2 isoenzyme inhibitors, for example, ciprofloxacin.

A single dose of olanzapine against the background of therapy with the following drugs: imipramine or its metabolite desipramine (CYP2D6, CYP3A4, CYP1A2 isoenzymes), warfarin (CYP2C19 isoenzyme), theophylline (CYP1A2 isoenzyme), or diazepam (CYP3A4, CYP2C19 isoenzymes) was not accompanied by suppression of their metabolism. No signs of drug interaction were identified when olanzapine was used concomitantly with lithium or biperiden.

Olanzapine has a very low potential for inhibiting the activity of the following cytochrome P₄₅₀ isoenzymes: CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4. A single dose of aluminum- and magnesium-containing antacid or cimetidine does not affect the oral bioavailability of olanzapine. Concomitant administration of activated charcoal reduces the bioavailability of olanzapine by 50-60%.

Fluoxetine (60 mg single dose or 60 mg daily for 8 days) causes an average increase in olanzapine C_max by 16% and an average decrease in clearance by 16%. The degree of fluoxetine’s influence is significantly less than the magnitude of individual differences in pharmacokinetic parameters; therefore, changing the olanzapine dose is not usually recommended when used in combination with fluoxetine.

In vitro studies using human liver microsomes have shown that olanzapine slightly inhibits the formation of valproic acid glucuronide (the main metabolic pathway of valproic acid). Valproic acid also slightly affects the metabolism of olanzapine. Therefore, a clinically significant pharmacokinetic interaction between olanzapine and valproic acid is unlikely.

Against a background of stable olanzapine concentration, no changes in the pharmacokinetics of ethanol were noted. However, taking ethanol together with olanzapine may be accompanied by an enhancement of the pharmacological effects of olanzapine, for example, sedative action.

Caution should be exercised when using olanzapine in patients who consume alcohol or take drugs that can cause central nervous system depression.

Concomitant use of olanzapine with antiparkinsonian drugs in patients with dementia associated with Parkinson’s disease is not recommended.

As with the use of other antipsychotic drugs, caution should be exercised when olanzapine is used concomitantly with medications that prolong the QT interval.

Storage Conditions

Store at a temperature not exceeding 25°C (77°F) in a light-protected place. Keep out of reach of children.

Shelf Life

The shelf life is 2 years. Do not use after the expiration date printed on the packaging.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.