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Prexal

Afrab-Chem Ltd
No. 22, Abimbola Street, Isolo Industrial Estate, Isolo, P.O. Box 1647, Lagos, Nigeria.
Email: info@afrabchem.com
Tel: 234-1-2700057
Fax: 234-1-4520328
Website: http://afrabchem.com/

Brand Name

Prexal

Manufacturer

Joswe Medicals, Na'ur Jordan.

Therapeutic Class

Antipsychotics

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Caplet (NRN:04-8675): Olanzapine 5 mg; film coated caplet.

Pack size: 30's.

Caplet (NRN:A4-0831): Olanzapine 10 mg; film coated caplet.

Pack size: 30's.

Pharmacology

Pharmacodynamics:

Olanzapine, a thienobenzodiazepine, is an antipsychotic agent, displaying high receptor affinity binding in vitro at serotonin 5-HT2A/C (Ki=4 and 11 nM, respectively), dopamine D1, D2, D3, D4 (Ki=11 to 31 nM), muscarinic M1-5 (Ki=1.9 to 2.5 nM), adrenergic a1(Ki=19 nM), and histamine H1 (Ki=7 nM) receptors. In a behavioral paradigm predictive of antipsychotic activity, olanzapine reduced conditioned avoidance response in rats at doses lower than 4 times those required to produce catalepsy. In a single dose (10 mg) PET study in healthy subjects, olanzapine produced higher 5-HT2A than dopamine D2 receptor occupancy. The percent of D2 occupancy was less than the threshold value predictive of extrapyramidal events.

Pharmacokinetics:

Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours. The absorption is not affected by food. Plasma concentrations of orally administered olanzapine were linear and dose proportional in trials studying doses from 1 to 15 mg. The maximum plasma concentrations (Cmax) of olanzapine after single oral doses of 5, 10 and 15 mg averaged 7, 14, and 21 ng/mL, respectively (20 ng/mL=0.064 µM). In young healthy volunteers, after once-a-day repeated dosing, steady-state Cmax was approximately twice that achieved after a single dose (e.g., 23 ng/mL versus 12 ng/mL for a 10 mg dose). In the elderly, the steady-state plasma concentration was approximately 3-fold higher than that achieved after a single dose (e.g., 16 ng/mL versus 5 ng/mL for a 5 mg dose). In both, young and elderly, steady-state concentrations of olanzapine were obtained after 7 days of once daily dosing.

Indications

Olanzapine belongs to a group of medicines called antipyschotics. Olanzapine is used to treat disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness and becoming withdrawn. People with this disease may also feel depressed, anxious or tensed.

Olanzapine can also be used to treat a condition with symptoms such as feeling "high", having abnormal amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.

Contra-indications

If you are hypersensitive (allergic) to Olanzapine, an allergic reaction may be recognised such as rash, itching, a swollen face, swollen lips or shortness of breath. If this has happened to you, tell your doctor.

If you have been previously diagnosed with narrow angle glaucoma.

Precautions/Warnings

Medicines of this type may cause unusual movements mainly of the face or tongue, if this happens after you have been given olanzapine, tell your doctor.

Very rarely, medicines of this type cause a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness. If this happens, contact your doctor at once.

If you suffer from any of the following illnesses, tell your doctor as soon as possible: Diabetes, heart failure, liver or kidney disease, parkinson's disease, epilepsy, prostate problems, a blocked intestine (paralytic ileus), blood disorders. As a routine precaution, if you are over 65 years, your blood pressure may be monitored by your doctor.

Pregnancy: Tell your doctor as soon as possible if you are pregnant or think you may be pregnant. You should not take this medicine when pregnant unless you have discussed this with your doctor.

Breast-feeding: You should not be given this drug when breast-feeding.

Driving and using machines: There is a risk of feeling drowsy when you are given olanzapine. If this happens, do not drive or operate machines.

Interactions

Inform your doctor if you are taking or have recently taken any other medicines, even those not prescribed. Especially tell your doctor if you are taking medicines for Parkinson's disease.

Do not drink any alcohol if you have been given olanzapine, as olanzapine and alcohol together may make you feel drowsy. You might feel drowsy if olanzapine is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillizers).

You should tell your doctor if you are taking Fluvoxamine (an antidepressant) or Ciprofloxacin (an antibiotic), as it may be necessary to change your olanzapine dose.

Adverse Effects

Include sleepiness or extreme tiredness, putting on weight, dizziness, feeling more hungry, water retention, constipation, dry mouth, restlessness, unusual movement, tremor, rigidity, problems with speech and changes in the levels of some blood cells and circulating fats. Very rarely, some patients have developed inflammation of the pancreas causing severe stomach pain, fever and sickness. Some people may feel dizzy or faint (with a slow heart rate) in the early stages of treatment, especially when getting up from a laying or sitting position. This will usually pass on its own but if it does not, tell your doctor.

Patients with Alzheimer's disease may have trouble walking. In patients with Parkinson's disease olanzapine may worsen the symptoms. Rarely, olanzapine may cause an allergic reaction (e.g. swelling in the mouth and throat, itching, rash) slow heart rate or make you sensitive to sunlight. Very rarely, there have been reports of liver disease, prolonged and/or painful erection or difficulty in passing urine. Some patients have experienced high blood sugar or worsening of diabetes with ketoacidosis (ketones in the blood and urine) or coma occurring very rarely. If you suddenly stop taking olanzapine, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur. Rarely women taking medicines of this type for a long time have started to secrete milk and have missed periods or had irregular periods. If this persists, tell your doctor. Very rarely babies born to mothers who have taken olanzapine in the last stage of pregnancy (3rd trimester) may have tremors, be sleepy or drowsy.

Seizures may occur rarely. In most cases, a history of seizures (epilepsy) has been reported. If you notice any side effects not mentioned, inform your doctor.

Dosage & Administration

Your doctor will tell you how many Olanzapine caplets to take and how long you should continue to take them. The daily dose of olanzapine is between 5-20 mg. You should take your olanzapine caplets once a day following the advice of your doctor. Olanzapine is not for patients who are under 18 years.

If you take more olanzapine than you should; contact your doctor. If you forget to take olanzapine, take your caplets as soon as you remember. Don't take two doses in a day.

Storage/Handling Recommendations

Store below 30oC.

Keep away from the reach of children.

Review Date

2017-09-27 07:18:16