Index of drugs

Short-term supportive therapy for moderate or severe psychomotor agitation. Treatment of agitation and anxiety in elderly patients.

1 tabl sugar coated contains 25 mg, 50 mg or 100 mg of promazine hydrochloride. The preparation contains lactose.

Promazin is a neuroleptic, an aliphatic derivative of phenothiazine. Has moderate sedative and antipsychotic effects. It also has a weak anti-trust and anti-emetic effect. Acting antagonistically to dopaminergic receptors, it inhibits dopaminergic transmission in the limbic and nigrostriatal system. It blocks the 5-HT receptor₂ and the α-adrenergic receptor₁ (which causes orthostatic pressure drops). It exhibits anticholinergic activity (by blocking the muscarinic receptor) and antihistamine (antagonist of H₁). It stimulates the secretion of protactin. The drug is quickly absorbed from the digestive tract. It is subject to the first-pass metabolism within the intestinal wall. It is also metabolized in the liver. It is excreted in urine and kalem in the form of numerous active and inactive metabolites. It is very much bound to plasma proteins. Is subject to extensive distribution in the body. It penetrates the blood-brain barrier reaching a higher concentration in the brain than in the blood plasma.

Hypersensitivity to promazin, other phenothiazine derivatives or to any of the excipients. Comatose states. Phaeochromocytoma tumor (phaeochromocytoma). Severe hepatic or renal failure. Agranulocytosis. Severe heart failure. Parkinson's disease. Neuroleptic malignant syndrome. The use of the drug during breastfeeding and in children is contraindicated.

Special care should be taken when using promazin in patients: long-term use of the preparation due to the possibility of developing disorders of the extrapyramidal system with parkinsonism including drug; with abnormalities of the extrapyramidal system or dyskinesias in the past due to the high risk of exacerbation of these disorders (long-term use of phenothiazine derivatives may cause tardive dyskinesia, especially in elderly patients - if dyskinesia occurs, promazin should be discontinued); with heart disease, cardiac arrhythmia or conditions predisposing to arrhythmias; with atherosclerosis of the cerebral arteries, with ischemic heart disease; with liver or kidney failure; with chronic and severe respiratory disorders, in patients with asthma, emphysema, acute respiratory infection due to the possibility of intensification or provocation by promasin of the symptoms of these disorders; with epilepsy or conditions predisposing to epilepsy due to the possibility of reducing the seizure threshold by promazin; in elderly patients, especially during hot or cold weather, because of the risk of hyper- or hypothermia - these patients have an increased risk of orthostatic hypotension. The product should be avoided in patients with a narrow-angle glaucoma or a family history of glaucoma; with hypothyroidism; in patients oncityhenia gravis; with hypertrophy of the prostate gland. In the case of an unexplained cause of fever, it is necessary to discontinue treatment and establish its foundation, because it may be the first symptom of a malignant neuroleptic syndrome. In case of unexplained infection or fever, blood test should be performed immediately (risk of hematopoietic system dysfunction). Patients with an increased risk of ventricular arrhythmias (eg heart disease, metabolic disorders such as hypokalaemia, hypocalcaemia or hypomagnesaemia, malnutrition, alcohol abuse, treated with other QT prolonging agents) require particularly careful treatment, especially at the initial stage. Antipsychotics may increase prolactin secretion.The product contains lactose - should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose. The product contains sucrose and should not be used by patients with rare inherited disorders associated with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency.

Do not use promazine during pregnancy, especially in the first trimester, unless promazin is necessary. Phenothiazine derivatives used during pregnancy and just before delivery can cause lowering of maternal blood pressure and hypoxia and neurological changes in the fetus. In neonates born to mothers receiving phenothiazine derivatives during pregnancy, prolonged jaundice, neurological symptoms associated with the extrapyramidal system, and reflex reflexes have been reported. Promazine and other phenothiazine derivatives are secreted with human milk and may cause drowsiness and developmental disturbances in the newborn baby o.u.n. - the use of the drug during breast-feeding is contraindicated.

Nervous system disorders: Parkinsonism receding after dose reduction or administration of anticholinergics, akathisia, acute dyskinesia, convulsive attacks, tardive dyskinesias or dystonic syndromes (especially in patients treated for a long time after abrupt discontinuation or significant dose reduction), hyperthermia (especially during hot and humid weather or in case of concomitant use of anti-Parkinsonian preparations) or hypothermia (especially in elderly or hypothyroid patients), also neuroleptic malignant syndrome (motor arrest until stupefied with a marked increase in skeletal muscle tone, tremor and single involuntary movements) tachycardia, hyperthermia, large fluctuations in blood pressure, vegetative disorders - sweating, salivation, facial flushing, increasing disturbances of consciousness up to the coma: leukocytosis, dehydration, disorders and electrolyte); accommodation disorders, urinary retention, constipation, dry mucous membranes. Mental disorders: drowsiness, impaired concentration, excessive motor inhibition, sleep disorders, depression. Immune system disorders: angioneurotic edema, bronchospasm, urticaria, anaphylactic reactions (extremely rare), systemic lupus erythematosus. Vascular disorders: hypotension (especially at the beginning of treatment), orthostatic decreases in blood pressure. Cardiac disorders: atrioventricular block, atrial arrhythmias, ventricular tachycardia, ventricular fibrillation, ECG changes (flattening or inversion of the T wave, prolongation of the PQ interval and QT interval, and appearance of the U wave). Endocrine disorders: galactorrhea, gynecomastia, menstrual disorders, hyper- and hypoglycemia, glycosuria, impotence, libido disorders, increased thirst, weight gain. Blood and lymphatic system disorders: granulocytopenia, agranulocytosis, eosinolilia, leukopenia, haemolytic or aplastic anemia, thrombocytopenia. Metabolism and nutrition disorders: nuisance constipation (associated with anticholinergic effects of the preparation) sometimes leading to habitual constipation, extremely rare nausea and vomiting. Hepatobiliary disorders: congestive jaundice (usually between 2 and 4 weeks of treatment) caused by bile duct contamination with an allergic mechanism - symptoms resemble viral hepatitis and laboratory tests indicate mechanical origin - if this occurs, discontinous should be discontinued give again. Skin and subcutaneous tissue disorders: cutaneous allergic reactions, hypersensitivity to light, pigmentary changes (discoloration of the skin, deposition of pigment in the cornea and retina of the eye). Reproductive system and breast disorders: priapism. Respiratory, thoracic and mediastinal disorders: respiratory depression in sensitive patients.
Very rarely after a sudden discontinuation of the preparation (primarily after long-term use of high doses), acute withdrawal symptoms may occur: nausea, vomiting, insomnia. Recurrence of the disease may also occur and extrapyramidal symptoms may occur.

Orally. Adults. Dosage should be adjusted individually for each patient.Psychomotor stimulation: usually 100-200 mg 4 times a day. Treatment should begin with the use of lower doses.The dose is then gradually increased to the optimal dose for the patient. The dose interval is usually 6-8 hours. Some patients may take a one-off daily dose before going to bed. Elderly patients should use half the initial dose; treatment should be carried out under close medical supervision.Agitation and anxiety in elderly patients: initially 25 mg, then, if necessary, up to 50 mg 4 times a day. The dose should be gradually increased. Treatment should be carried out under close medical supervision.