COMPOSITION:
Each Dispersible tablet contains: Olanzapine 5mg, 10mg.
DESCRIPTION:
Olentab DT (Olanzapine) atypical antipsychotic drug has antipsychotic and antimanic and
mood stabilizing effect, that by work to inhibit a number of receptors such as S-HT2A serotonin
receptors and D1 ,D2,D4 dopamine receptors, and has effect on histamine (H1) receptor. This
group of antipsychotic medicine characterized by higher affinity for serotonin receptors than
dopamine receptors, so the patients treated with olanzapine had a lower incidence to extrapyra-
midal side effect comparison to patients treated with typical antipsychotic drug.
INDICATION:
- Schizophrenia.
- Moderate to severe manic episodes.
- For the prevention of recurrence in patients with bipolar disorder.
DOSAGE AND ADMINISTRATION
Dose should be according to doctor consultation.
Schizophrenia in adults > 18 years : starting dose 5- 10 mg/day,
target dose 10 mg/day within several days.
Schizophrenia in adolescents (13-17) years : starting dose 2.5- 5 mg once daily,
target dose :10 mg/day.
Manic or mixed episode in adults > 18 years: The starting dose is 10 or 15 mg once daily.
Manic or mixed episode in adolescents (13-17)years: The starting dose is 2.5-Smg once daily,
target dose 10 mg/day .
Children under 13 years: safety and efficacy not established.
Preventing recurrence in bipolar disorder: The recommended starting dose is 10 mg/day.
Patients with renal and/or hepatic impairment: A starting dose (5 mg) should be taken.
Elderly patients over 65 years: A starting dose (Smg/day) when clinical factors warrant.
The patient Should consult the doctor if the symptoms return or to stop the medicine.
Note: The tablet dissolve directly in the mouth or place tablet in cup of water. Do not handle
the tablet with wet hands.
RESTRICTION ON USE :
Contraindication
- Patients with known hypersensitivity to olanzapine.
- Patients with known risk for narrow angle glaucoma.
Precaution
- Antipsychotic drug increase mortality in elderly patients with dementia related psychosis.
- The caution should be taken and consultation the doctor in the following case:
unusal movement mainly of the face and tonguue ,a blocked intestine ,Parkinson’s disease,
Neuroleptic Malignant Syndrome (NMS), Hyperglycemia, high fat level, weight gain,
hyperprolactinemia, family history of blood clots, stroke, Prostate problems, Liver or kidney
disease, Blood disorders, Heart disease, Seizures, low white blood cell counts.
Effects on the capacity to drive vehicles or use machines
Olentab DT may cause drowsiness, caution should be taken when Driving and using machines.
Use in Pregnancy & Lactation
Consult the doctor if you become pregnant or intend to become pregnant. this medicine should
not be given when breast-feeding, as small amounts of Olentab DT can pass into milk.
DRUG INTERACTION
The patient should consult the doctor if take one of the following drugs:
- Antidepressants or drugs for anxiety in combination with Olanzapine as they may cause
feeling drowsy.
- Drugs for parkinson’s disease.
- Carbamezepin, fluvoxamin or ciprofloxacin may be necessary to change Olanzapine dose.
- Antihypertensive drugs : as the antihypertensive effect enhance.
ADVERSE EFFECTS
Very common : weight gain, sleepiness and increases in levels of prolactin in the blood. In the
early stages of treatment, some patients may feel dizzy or faint (with a slow heart rate),
especially when getting up or sitting.
Common : changes in the levels of some blood cells, temporary increases in liver enzymes
and increases in levels of creatine phosphokinase in the blood, increase appetite, dizziness,
restlessness, tremor, unusual movements, constipation, dry mouth, rash, water retention, fever,
joint pain.
OVERDOSAGE :
symptoms of overdose:rapid beating of the heart, aggressiveness, problems with speech,
unusual movements especially of the face or tongue, reduced level of consciousness,confusion,
seizures (epilepsy), coma, fever, faster breathing, sweating, muscle stiffness, drowsiness,
sleepiness, slowing of the breathing rate, high blood pressure or low blood pressure and
abnormal rhythms of the heart.
Treatment: there is no specific antidot to olanzapine, ECG monitoring should be under taken.
gastric lavage within one hour of ingestion as well as administration of activated charcoal and
supportive treatment should be given to patient and hypotension should be treated.
STORAGE INSTRUCTIONS:
Store below 30°C, in a dry place.
PRESENTATION:
Olentab 5 mg DT tablet : Pack of 30 tablets and hospital packs of different sizes.
Olentab 10 mg DT tablet : Pack of 30 tablets and hospital packs of different sizes.
