Xytrex^®

Xytrex ® is a preparation of Olanzapine which is an atypical antipsychotic agent. Olanzapine may work by blocking receptors for several neurotransmitters in the brain. It has a greater affinity for serotonin 5HT2 receptor and has lesser affinities for dopamine (D1, D2, D3, D4 & D5); cholinergic muscarinic (M1-M5); adrenergic (?1); and histamine (H1) receptors.

No Data

Xytrex ® is indicated for the treatment of schizophrenia; treatment of acute mixed or manic episodes with bipolar I disorder; in combination with lithium or valproate for short-term treatmentof acute mixed or manic episodes associated with bipolar I disorder; maintenance treatment of bipolar patients on monotherapy after achieving a responder status for an average duration of 2 wk.

Adults
Schizophrenia: starting dose: 10 mg per day

Manic episode: starting dose: 15 mg once daily in monotherapy or 10 mg once daily in combination therapy
Preventing recurrence in bipolar disorder: starting dose: 10 mg per day. For patients who have been receiving Xytrex ® for treatment of manic episode, therapy should be continued for preventing recurrence at the same dose.
Maintenance dose range for Schizophrenia, mania and preventing recurrence in bipolar
disorder:
5-20 per day.

Children and adolescents
Olanzapine is not recommended for children and adolescents below 18 years of age.

Elderly
A lower starting dose (5 mg per day) is not routinely indicated, but should be considered for those aged 65 years and above when clinical factors warrant.

Patients with renal and/or hepatic impairment

A lower starting dose (5 mg) should be considered for such patients. In cases of moderate hepatic insufficiency (cirrhosis, Child-Pugh class A or B), the starting dose should be 5 mg and should be increased with caution.

Olanzapine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Patients taking Olanzapine should be advised not to breast-feed.

No Data

Olanzapine may cause somnolence and dizziness, so patients should be cautioned about operating machinery, including motor vehicles. Patients with clinically important prostatic hypertrophy, CV disease, conditions that predispose patients to hypotension (eg, dehydration, hypovolemia), narrow-angle glaucoma, a history of paralytic ileus, seizures should use Olanzapine with caution.

Common: weight gain, dizziness, extrapyramidal symptoms (usually mild and transient), drowsiness, speech difficulty, exacerbation of Parkinson’s disease, abnormal gait, hallucinations, akathisia, asthenia, fatigue, increased appetite, eosinophilia; Less Common: bradycardia, QT interval prolongation, photosensitivity. Rare: seizures, leucopenia, rash; Very Rare: thromboembolism, hypercholesterolaemia, hypothermia, urinary retention, thrombocytopenia, neutropenia, rhabdomyolysis, hepatitis, pancreatitis and alopecia

Olanzapine is contra-indicated in patients with known hypersensitivity to the active substance or to any of the excipients and also contra-indicated in narrow-angle glaucoma.

Drugs which inhibit or act as a substrate to Cytochrome P 450 isoenzymes or glucoronyl transferase enzymes (omeprazole, rifampicin, fluvoxamine), dopamine agonists, antiarrhythmics (methyl dopa, guanethidine, procainamide, quinidine), tricyclic antidepressants (fluvoxamine, fluoxetine), antiepileptics (phenobarbitone, carbamazepine, phenytoin), terfenadine.

Common symptoms include tachycardia, agitation/aggressiveness, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma. Other symptoms include delirium, convulsion, respiratory depression, aspiration, hypertension or hypotension, cardiac arrhythmias, and cardiopulmonary arrest.

No Data

Store in a cool and dry place. Protect from light.