Stilizan® 1 mg Formula: 1 Coated tablet Active Substance Excipient : Trifluoperazine hydrochloride equivalent to 1 mg Trifluoperazine : Powdered sugar, titanium dioxide, blue stain (FDC No: 2) 30 Coated Tablets Pharmacological Properties: Stilizan is a tranquilizer contains Trifluoperazine with antipsychotic, anxiolytic and antiemetic effect. It has sedative and hypotensive pharmacological profile; it is effective with lower doses and it dose not affect normal daily activities, does not reduce action strength and concentration ability. It may lead to extrapyramidal reactions in elevated doses. Indications: Lower Doses: Stilizan is used in the treatment of anxiety, agitation and secondary depression following anxiety. It is also used in symptomatic treatment of vomiting and nausea. Higher Doses: Stilizan is used in the treatment of schizophrenia symptoms, preventing relapses and other psychosis especially in paranoid types. It is suitable for short term treatment of severe psychomotor agitations and dangerous impulsive actions for example in individuals with mental retardation. Contraindications: It is contraindicated in patients in coma, in heart diseases, in patients with liver damage and in individuals who are sensitive to Stilizan active substance and similar compositions. Special Warnings and Precautions for Use: Initial dose should be administrated low and given cautiously in the treatment of elderly patients. These patients are particularly sensitive to extrapyramidal and hypotensive effects. Because of the phenothiazines reduces convulsion threshold, it should not be given to patients with epilepsy and should be avoided from metrazamide. Although Stilizan has minimal anticholinergic activity, it should be considered in the patients with narrow angle glaucoma, myasthenia gravis and prostate hypertrophy. Individuals who use machinery and driving vehicles should be warned about the fact that phenothiazines may lead drowsiness. Use in Pregnant and Lactating Women: Clinical studies which performed over 800 women and animals were demonstrated that Stilizan has no negative effect on fetus. Nevertheless, it should be avoided especially in the first trimester of pregnancy if it is not necessary. Side Effects/Advers Effects: Fatigue, drowsiness, dizziness, temporary restlessness, dry mouth, blurred vision, muscle weakness, anorexia, mild hypotension, skin reactions including light sensitivity, insomnia, increased weight, edema and swelling may occur. Rarely tachycardia, urinal complaints and urinary difficulty, constipation and fever are reported. Undesirable symptoms are dose related. In elevated doses, integrated effects as hyperprolactinemia, galactorrhea or amenorrhea may be occurred. Stilizan in lower doses may demonstrate reverse effect in the patients who are not psychotic and therefore may lead to restlessness, loss of attention or nervousness. Extrapyramidal symptoms are rare in or less than daily doses of 6 mg. these may be seen more frequently in elevated dose levels. These symptoms may include Parkinson’s disease, neuralgia, restlessness, acute dystonia or dyskinesia which can be seen in the early stages of the treatment, crick in neck, crick in face, face paralysis, trismus, tongue protrusion and abnormal eye movements including ocular crisis. These symptoms can be controlled by reducing the dose or discontinuation of the drug. Symptoms may last for years and may be permanent in some patients while they improve in others. Attention should be given in the treatment of the elderly patients with organic brain lesion. It can be diagnosed by gradually reducing the dosage if there is a permanent dyskinesia; treatment can be discontinued if necessary. Anticholinergic and anti-Parkinson drugs may increase the undesired symptoms. Because of tardive dyskinesia is related to elevated doses and the length of the treatment time, Stilizan should be taken for possible shortest period of time and with lower dosages. CONSULT YOUR DOCTOR IF AN UNEXPECTED EFFECT ENSUES. Drug Interactions and Other Forms of Interaction: Activity of antipsychotic drugs may be increased if they are combined with SSS depressants such as alcohol. Phenothiazines may be antagonized the effects of guanetidin. Administration Route and Dosage: Adults: Lower Doses: According to the severity of the disease, total amount of 2 to 4 mg coated tablets can be administrated daily in divided doses. If necessary, daily dose can be increased up to 6 mg. However, the probability of occurrence of extrapyramidal symptoms may be increased in some patients. Higher Doses: In physically healthy adults, the initials dose is 5 mg two times a day. Dosage can be increased up to 15 mg after one week. If more elevated doses are required, it should be administrated with 5 mg augmentations with the intervals less than 3 days. After achieving satisfactory results, dosage is reduced gradually to the level in which the effects of the treatment are occurred and constant treatment dose is obtained. Likewise all other tranquilizers, clinical recover with Stilizan may not be clear for the first weeks of treatment. In the same way, occurrence of symptoms after discontinuation of the drug may take several weeks. High dose treatment should be decreased gradually. Elderly: Initial dose is half of the normal dose in elderly and weak patients. Lower Doses in Children: Up to 4 mg a day as divided doses in children with the age of 6 to 12. Higher Doses in Children: In children over 12 years old, oral initial dose should not be more than 5 mg a day and it should be administered in divided doses. If dose increase is necessary, it should be done with care and minimum 3 days intervals. Dose should be arranged according to body weight and the severity of the symptoms. Overdose and Treatment: Over dose signs and symptoms are usually in extrapyramidal aspect. Hypotension may occur. Treatment is stomach washing with supportive and symptomatic precautions. Patient should not be compelled to vomit. Extrapyramidal symptoms can be treated with anticholinergic anti-Parkinson drugs. Hypotension should be treated with fluid reinforcement. If it is not decrease the intensity, noradrenalin should be considered. Adrenalin is contraindicated. Storage Conditions: Store in its packaging at room temperatures less than 25 °C. Keep out of reach of children. Do not use without consulting your doctor. Type of Supply and Container Content: Blisters containing 30 coated tablets. Other Pharmaceutical Dosage Forms Present in the Market: Stilizan Ampoule 1 mg/ml Stilizan Coated Tablets 2 mg Stilizan Coated Tablets 5 mg Registration Holder: Dr. F. Frik İlaç San. ve Tic. A.Ş. Küçükyalı / İSTANBUL Registration Date and No.: 11/11/1970 – 106/16 Place of Manufacture: Yeni İlaç ve Hammaddeleri San. Tic. A.Ş. Esenyurt / İSTANBUL Sold with prescription only.