| Composition |
| Each one F.C tablet contains: - OLANZAPINE 5 mg - 7.5 mg - 10 mg |
| Pharmacodynamics properties |
| Spiritex is an anti psychotic agent that demonstrates a broad pharmacological profile across number of receptor systems it exhibited a rang of receptor affinities for serotonin 5HT2A/2C, 5HT3, 5HT6, dopamine D1, D2, D3, D4, D5 cholinergic muscarinic receptors M1-M5, adrenergic and histamine H1 receptors. |
| Therapeutic indications |
| Spiritex is indicated for the acute and maintenance treatment of schizophrenia and other psychoses where positive symptoms (delusion, hallucinations, disordered thinking, hostility, suspiciousness). And / or negative symptoms (flattened affect, emotional and soical with drawl poverty of speech) are prominent. Spiritex is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment, it is effective to treat the moderate to severe episodes of mania. |
| Side effect |
| It may be happen in some cases somnolence, eosinophilia, dry mouth, dizziness, constipation, weight gain, increased appetite, orthostatic hypotension, peripheral odema, abnormal gait, asthenia, elevated gluscose level, elevated triglyceride level, worsening of parkinsonian symptomatology and hallucination with parkinson's disease, bradycardia, asymptomatic elevation of hepatic transaminases especially in early treatment, photosensitivity reaction. |
| Warnings and precautions |
Should take care in case of neuroleptic malignant syndrome, tardive dyskinesia, and while driving car or using sharp instruments, should avoid alcohol or extreme heat or dehydration, and inform the doctor if taking any medication, caution for orthostatic hypotension in the first use of this medication.
Olanzapine should be stopped abruptly, asymptomatic elevation of hepatic transaminases have been seen commonly, caution should be exercised in hapatic function disorder patient, caution should be taken in patient with history of seizure and doctor should be informed. |
| Contraindication |
| Hypersensitivity to Spiritex, patients with known risk for narrow angle glaucoma. |
| Pregnancy and lactation |
Doctor should informed in case of pregnancy, and this product should be used only if the potential benefit justifies the potential risk to the fetus.
It is not recommended in case of lactation. |
| Drug interactions |
Orthostatic hyotenstein with anti hypertensive, alcohol, benzodiazepines, caution with other CNS drugs, may antagonize levodopa, dopamine agonists.
It's clearance may be increased by rifampcin, omperazole, carbamazepine, or other drug which induce CYP1A2 enzymes or glucoronyl transferase. |
| Dosage & administration |
As doctor prescribe and each case
1. Schizophrenia: this product is used once a day with or without meal, the initial dose is between 5-10 mg could be increased weekly, the studies improved the efficacy of 10-15 mg daily in case of schizophrenia and not exceed 20 mg daily.
The recommended dose in special cases like debilitated patients or predisposition to hypotension is 5 mg daily could adjust after that.
The maintenance dose is between 10-20 mg daily and the decision of this dose is depend on doctor decision.
2. Bipolar mania: this product is used once a day with or without meal, and could adjust it after 1 day. It is anti-manic effect for short time (3-4 weeks) was improved between 5-20 mg daily.
The maintenance dose is depend on doctor decision and each case for mania prevention or keep improvement. |
| Package |
SPIRITEX 5 : BOX OF 20 F.C TABLETS.
SPIRITEX 7.5 : BOX OF 20 F.C TABLETS.
SPIRITEX 10 : BOX OF 20 F.C TABLETS. |
