Oleanz Tablets (Generic Olanzapine Tablets)

Oleanz Tablets (Generic Olanzapine Tablets)
© The Swiss Pharmacy

Oleanz (Generic Olanzapine Tablets) is used for the
treatment of schizophrenia. This medicine may also be
used alone or with other medicines (eg, Lithium or
Valproate) for the acute treatment of manic or mixed
episodes associated with bipolar I disorder and
maintenance treatment of bipolar I disorder.
Olanzapine may also be used together with Fluoxetine to
treat depression that is a part of bipolar disorder, and
depression in patients who received other antidepressants
that did not work well.

Oleanz Tablets are manufactured by SUN Pharmaceutical
Industries Limited, India in the strengths of 2.5 mg, 5 mg, 7.5
mg, 10 mg and 20 mg.

Chemical Structure

The active ingredient contained in Oleanz tablets is
Olanzapine.
Each film coated Oleanz tablet contains 2.5 mg, 5 mg,
7.5 mg, 10 mg or 20 mg mg of Olanzapine.

Uses of Oleanz 2.5 mg, 5 mg, 7.5 mg, 10 mg and 20 mg Tablets:
Oleanz (Olanzapine Tablets) is an antipsychotic medication that can
treat several mental health conditions like schizophrenia and bipolar
disorder. It balances the levels of dopamine and serotonin in your
brain.
Olanzapine tablets treats schizophrenia and bipolar disorder. It may
also be used in combination with other medication to treat
depression. This medication can help to decrease hallucinations and
help you to think more clearly and positively about yourself, feel less
agitated, and take a more active part in everyday life. It works by
balancing the levels of dopamine and serotonin in your brain,
substances that help regulate mood, behaviors, and thoughts. It
belongs to a group of medications called antipsychotics.
URL: https://www.theswisspharmacy.com/product_info.php?info=p9734_Olanzapine-Tablets.html

Recommended Adult Dosage
For most patients, the starting dose of Oleanz tablets
(Generic Olanzapine tablets) for the treatment of
Schizophrenia is 5 mg to 10 mg a day.
Oleanz should be administered on a once-a-day schedule
without regard to meals, with a target dose of 10 mg/day
within several days.

The starting dose to treat adult patients for Bipolar I Disorder
(Manic or Mixed Episodes) is 10 mg or 15 mg as monotherapy
on a once-a-day schedule without regard to meals.
Dosage adjustments, if indicated, should generally occur at
intervals of not less than 24 hours, reflecting the procedures in
the placebo-controlled trials. When dosage adjustments are
necessary, dose increments/decrements of 5 mg per day are
recommended.
The starting dose to treat adult patients for Bipolar I Disorder
(Manic or Mixed Episodes) with Lithium or Valproate is 10 mg
once daily.

The starting dose to treat adult patients for:
Depressive Episodes associated with Bipolar I Disorder in
combination with Fluoxetine: Start at 5 mg of oral Olanzapine and
20 mg of Fluoxetine once daily.
The starting dose to treat adult patients for:
Treatment Resistant Depression in combination with Fluoxetine:
Start at 5 mg of oral Olanzapine and 20 mg of Fluoxetine once
daily.

Contraindications
➔
Oleanz is contraindicated in patients with a known
hypersensitivity to Olanzapine or any component of the tablet.
➔
When using Oleanz (Olanzapine Tablets) and Fluoxetine in
combination, also refer to the Contraindications section of the
package insert for Fluoxetine tablets.
➔
For specific information about the contraindications of Lithium or
Valproate, refer to the Contraindications section of the package
inserts for these other products.

Storage Instructions
Oleanz Tablets (Generic Olanzapine Tablets) have to be stored at
controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F)
with excursions permitted between 15° to 30°C (59° to 86°F).
Keep this as well as all other medicines away from children and
pets.

Warnings
Elderly patients with dementia-related psychosis treated with antipsychotic
drugs are at an increased risk of death. Olanzapine tablets (Oleanz) are not
approved for the treatment of patients with dementia-related psychosis.
The possibility of a suicide attempt is inherent in schizophrenia and in bipolar I
disorder, and close supervision of high- risk patients should accompany drug
therapy.
A potentially fatal symptom complex sometimes referred to as Neuroleptic
Malignant Syndrome (NMS) has been reported in association with
administration of antipsychotic medicines, including Olanzapine. Clinical
manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status
and evidence of autonomic instability (irregular pulse or blood pressure,
tachycardia, diaphoresis and cardiac dysrhythmia). Additional signs may
include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis),
and acute renal failure.

Warnings
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been
reported with olanzapine exposure. DRESS may present with a cutaneous
reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, and/or
lymphadenopathy with systemic complications such as hepatitis, nephritis,
pneumonitis, myocarditis, and/or pericarditis. DRESS is sometimes fatal.
Discontinue Oleanz tablets if DRESS is suspected.
Atypical antipsychotic drugs have been associated with metabolic changes
including hyperglycemia, dyslipidemia, and weight gain. Metabolic changes
may be associated with increased cardiovascular/cerebrovascular risk.
A syndrome of potentially irreversible, involuntary, dyskinetic movements may
develop in patients treated with antipsychotic drugs. Although the prevalence
of the syndrome appears to be highest among the elderly, especially elderly
women, it is impossible to rely upon prevalence estimates to predict, at the
inception of antipsychotic treatment, which patients are likely to develop the
syndrome.

Warnings
Olanzapine (Oleanz tablets) could induce orthostatic hypotension associated
with dizziness, tachycardia, bradycardia and, in some patients, syncope,
especially during the initial dose-titration period, probably reflecting its
alpha1-adrenergic antagonistic properties.
Olanzapine may cause somnolence, postural hypotension, motor and sensory
instability, which may lead to falls and, consequently, fractures or other
injuries.
During clinical trial and/or postmarketing experience, events of
leukopenia/neutropenia have been reported temporally related to
antipsychotic agents, including Olanzapine tablets. Agranulocytosis has also
been reported.
Possible risk factors for leukopenia/neutropenia include pre-existing low
white blood cell count (WBC) and history of drug induced
leukopenia/neutropenia.

Warnings
Esophageal dysmotility and aspiration have been associated with antipsychotic drug
use. Aspiration pneumonia is a common cause of morbidity and mortality in patients
with advanced Alzheimer’s disease. Olanzapine tablets are not approved for the
treatment of patients with Alzheimer’s disease.
During premarketing testing, seizures occurred in 0.9% (22/2500) of olanzapine-treated
patients. There were confounding factors that may have contributed to the occurrence
of seizures in many of these cases. Olanzapine should be used cautiously in patients
with a history of seizures or with conditions that potentially lower the seizure threshold.
Somnolence was a commonly reported adverse reaction associated with olanzapine
treatment, occurring at an incidence of 26% in olanzapine patients compared to 15% in
placebo patients. This adverse reaction was also dose related.
Disruption of the body’s ability to reduce core body temperature has been attributed to
antipsychotic agents. Appropriate care is advised when prescribing Oleanz tablets for
patients who will be experiencing conditions which may contribute to an elevation in
core body temperature.

Warnings
Olanzapine exhibits in vitro muscarinic receptor affinity. During premarketing
clinical trials, Olanzapine (Oleanz tablets) was associated with constipation,
dry mouth, and tachycardia, all adverse reactions possibly related to
cholinergic antagonism. Such adverse reactions were not often the basis for
discontinuations, but olanzapine should be used with caution in patients with
a current diagnosis or prior history of urinary retention, clinically significant
prostatic hypertrophy, constipation, or a history of paralytic ileus or related
conditions.
As with other medicines that antagonize dopamine D2 receptors, Olanzapine
elevates prolactin levels, and the elevation persists during chronic
administration. Hyperprolactinemia may suppress hypothalamic GnRH,
resulting in reduced pituitary gonadotropin secretion. This, in turn, may inhibit
reproductive function by impairing gonadal steroidogenesis in both female
and male patients.

Warnings
When using Olanzapine tablets and Fluoxetine in combination, the
prescriber should also refer to the warnings and precautions section of
the package insert for Fluoxetine tablets. When using Olanzapine in
combination with lithium or valproate, the prescriber should refer to
the Warnings and Precautions sections of the package inserts for
Lithium or Valproate.
Fasting blood glucose testing and lipid profile at the beginning of, and
periodically during treatment with this medicine is recommended.

Possible Side Effects
Most common Olanzapine (Oleanz tablets) side effects with an
incidence rate of greater than or equal to 5% and at least twice
that for placebo observed during clinical trials for Schizophrenia
in adults were sedation, weight increased, headache, increased
appetite, dizziness, abdominal pain, pain in extremity, fatigue, dry
mouth.
Most common Olanzapine (Oleanz tablets) side effects with an
incidence rate of greater than or equal to 5% and at least twice
that for placebo observed during clinical trials for Manic or Mixed
Episodes, Bipolar I Disorder in adults were asthenia, dry mouth,
constipation, increased appetite, somnolence, dizziness, tremor.

Oleanz Tablets Overdosage
During premarketing trials involving more than 3100 patients and/or normal subjects,
accidental or intentional acute overdosage of Olanzapine tablets (Oleanz tablets) was
identified in 67 patients. In the patient taking the largest identified amount, 300 mg, the
only symptoms reported were drowsiness and slurred speech.
In postmarketing reports of overdose with Olanzapine (Oleanz tablets) alone,
symptoms have been reported in the majority of cases. In symptomatic patients,
symptoms with 10% or greater incidence included agitation/aggressiveness,
dysarthria, tachycardia, various extrapyramidal symptoms, and reduced level of
consciousness ranging from sedation to coma.
Among less commonly reported symptoms were the following potentially medically
serious reactions: aspiration, cardiopulmonary arrest, cardiac arrhythmias, delirium,
possible neuroleptic malignant syndrome, respiratory depression/arrest, convulsion,
hypertension, and hypotension.

Treatment of Oleanz Tablets Overdosage
The possibility of multiple drug involvement should be considered. In case of acute
overdosage, establish and maintain an airway and ensure adequate oxygenation and
ventilation, which may include intubation. Gastric lavage (after intubation, if patient is
unconscious) and administration of activated charcoal together with a laxative should
be considered. As peak Olanzapine levels are not typically obtained until about 6
hours after dosing, charcoal may be a useful treatment for Olanzapine (Oleanz tablets)
overdose.
The possibility of obtundation, seizures, or dystonic reaction of the head and neck
following overdose may create a risk of aspiration with induced emesis.
Cardiovascular monitoring should commence immediately and should include
continuous electrocardiographic monitoring to detect possible arrhythmias.
There is no specific antidote to Olanzapine (Oleanz tablets). Therefore, appropriate
supportive measures should be initiated.

Oleanz Tablets During Pregnancy
Olanzapine (Oleanz tablets) has been classified by the US FDA as
Pregnancy Category C.
Neonates exposed to antipsychotic drugs, including Oleanz, during the
third trimester are at risk for extrapyramidal and/or withdrawal
symptoms following delivery.
Olanzapine was not teratogenic when administered orally to pregnant
rats and rabbits at doses that are 9- and 30-times the daily oral
maximum recommended human dose (MRHD), based on mg/m2 body
surface area;some fetal toxicities were observed at these doses.

Oleanz Tablets (Generic Olanzapine Tablets) are
manufactured by Sun Pharmaceutical Industries
Limited, India.

Oleanz Tablets (Generic Olanzapine Tablets)

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