- Olanzapine it is a drug belongs to a group of medicines called atypical
antipsychotics. This drug’s efficacy in schizophrenia is mediated through a
combination of dopamine and serotonin type 2 (5HT2) antagonism.
- Olanzapine binds with high affinity to the following receptors:
serotonin 5HT2A/2C, 5HT6 , dopamine D1 - 4 , histamine H1 and adrenergic α1
- Olanzapine is an antagonist with moderate affinity binding for serotonin
5HT3 and muscarinic M1-5 .
- Olanzapine binds weakly to GABAA, BZD, and β-adrenergic receptors.
- Olanzapine is well absorbed and reaches peak concentrations in approxima-
tely 6 hours following an oral dose. Food does not affect the rate or extent of
- It is eliminated extensively by first pass metabolism, with approximately
40% of the dose metabolized before reaching the systemic circulation. Its
half-life ranges from 21 to 54 hours and apparent plasma clearance ranges
from 12 to 47 L/hr. It is 93% bound to plasma proteins over the concentra-
tion range of 7 to 1100ng / mL, binding primarily to albumin and α1-acid
glycoprotein. Approximately 57% and 30% of the dose was recovered in the
urine and feces, respectively.
- Direct glucuronidation and cytochrome P450 (CYP) mediated oxidation are
the primary metabolic pathways for Olanzapine.
- Clearance of Olanzapine may vary between individuals on the basis of
smoking status, gender and age.
- Olanzapine it is a drug belongs to a group of medicines called atypical
- OLEZAN® is used to treat:-
• Symptoms of schizophrenia in people age 13 or older and related psychoses.
• Bipolar disorder.
• Alone, or in combination with lithium or valproate, is used for the short-term
treatment of acute manic episodes associated with Bipolar I disorder.
• OLEZAN® is also a mood stabiliser that prevents further occurrences
of the disabling high and low (depressed) extremes of mood associated
with Bipolar I disorder.
• Episodes of depression that happen with bipolar I disorder, when used with
the medicine fluoxetine in people age 10 or older.
• Episodes of depression that do not get better after 2 other medicines, also
called treatment resistant depression, when used with the medicine
fluoxetine, in adults.
Dosage & Administration
- Follow all directions given to you by your doctor or pharmacist carefully.
- The dose your doctor will prescribe for you will usually be in the range 5 mg
to 20 mg per day, once daily.
- Your doctor may increase or decrease your dose in order to find the
appropiate dose for your condition. A lower starting dose may be prescribed
for elderly patients over the age of 65 years.
- Tablets should be swallowed whole with a glass of water and can be taken
with or without food.
- If you forget to take your dose and it is almost time for your next dose, skip
the dose you missed and take your next dose when you are meant to.
Do not take a double dose to make up for the dose that you missed.
- Each film coated tablet of OLEZAN® 10 contains:
Olanzapine 10 mg
- Each film coated tablet of OLEZAN® 5 contains:
Olanzapine 5 mg
Before starting OLEZAN®, tell your doctor if you have or had:
- heart problems.
- diabetes or high blood sugar levels (hyperglycemia).
- high cholesterol or triglyceride levels in your blood.
- liver problems.
- low or high blood pressure.
- strokes or “mini-strokes” also called transient ischemic attacks (TIAs).
- Alzheimer’s disease.
- narrow-angle glaucoma.
- enlarged prostate in men.
- bowel obstruction.
- breast cancer.
- thoughts of suicide or hurting yourself.
- any other medical condition.
- allergic reaction to OLEZAN® or the product ingrediants.
- Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines may be affected by OLEZAN® or may affect how it
works. These include:
• medicines used to treat a fast or irregular heart beat (arrhythmia).
• medicines taken for anxiety or to help you sleep.
• medicines taken for depression.
• carbamazepine, a medicine used for mood stabilisation and to treat epilepsy.
• other centrally acting medicines (eg. tranquillisers).
• ciprofloxacin, a medicine used to treat bacterial infections.
• medicines that lower blood pressure.
• medicines used for Parkinson's disease.
• medicines that can change the heart's electrical activity or make it more likely to change.
- Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking OLEZAN®.
- Tell your doctor about these things before you take OLEZAN®.
- Like most antipsychotic medicinens OLEZAN® is not recommended for use
during pregnancy. If there is need to consider OLEZAN® during pregnancy,
your doctor will discuss with you the benefits and risks of using it.
- It is not recommended to the OLEZAN® if you are breastfeeding.
- Tell your doctor if you notice any of the following side effects and
they worry you.
- Common side effects:
- lack of energy, dry mouth, increased appetite, sleepiness, tremor (shakes),
having hard or infrequent stools, dizziness, changes in behavior, or
- Other common side effects in teenagers (13-17 years old) include: headache,
stomach-area (abdominal) pain, pain in arms or legs, or tiredness. Teenagers
experienced greater increases in prolactin, liver enzymes, and sleepiness, as
compared with adults.
- Drowsiness, unusual tiredness or weakness, fever, bloating, swelling of your
hands, feet and ankles, aching joints, nose bleeds, confusion, forgetfulness.
- Some people may feel dizzy in the early stages of treatment, especially when
getting up from a lying or sitting position. This side effect usually passes after
taking Olanzapine for a few days.
- Uncommon side effects:
Symptoms of sunburn (such as redness, itching, swelling or blistering of the
skin) which occur more quickly than normal, rash or allergic reaction, slow
heart beat, changes in sexual functioning or sex drive in men or women,
prolonged and/or painful erection, unusual secretion of breast milk, breast
enlargement in men or women, symptoms of high sugar levels in the blood,
reaction following abrupt discontinuation (profuse sweating, nausea or
vomiting), absence of menstrual periods and changes in the regularity of
menstrual periods, involuntary passing of urine or, difficulty in initiating
urination, unusual hair loss or thinning.
- Drug reaction with Eosinophilia and Systemic Symptoms (DRESS): (DRESS
may include rash, fever, swollen glands and other internal organ involvement
such as liver, kidney, lung and heart.)
- Tardive Dyskinesia: This condition causes body movements that keep
happening and that you can not control. These movements usually affect the
face and tongue. Tardive dyskinesia may not go away, even if you stop taking
OLEZAN®. It may also start after you stop taking OLEZAN®. Tell your
doctor if you get any body movements that you can not control.
- Decreased blood pressure when you change positions, with symptoms of
dizziness, fast or slow heartbeat, or fainting.
- Difficulty swallowing
- If you or anyone take too much OLEZAN® tablets, you should contact you
doctor directly or go to the nearest hospital even if there are no signs of
discomfort, the most common signs are fast heart beat, agitation
/aggression, difficulty speaking and uncontrollable movements and
- OLEZAN® can cause sleepiness and may affect your ability to make decisions,
think clearly, or react quickly. You should not drive, operate heavy machinery, or
do other dangerous activities until you know how OLEZAN® affects you.
- Avoid drinking alcohol while taking OLEZAN®. Drinking alcohol while you
take OLEZAN® may make you sleepier than if you take OLEZAN® alone.
- OLEZAN® 5 Tablet : Blister of 10 tablets, pack of 3 blisters.
- OLEZAN® 10 Tablet : Blister of 10 tablets, pack of 3 blisters.
- Store in a dry place, in temperature below 25º C.