Symptomatic treatment of upper respiratory and skin allergic conditions including allergic rhinitis, urticaria and anaphylactic reactions to drugs and foreign proteins. Supportive to pre-operative sedation of patients in surgery and obstetrics. As an antiemetic, e.g. in kinetics.
Composition:
1 tabl it contains 10 mg or 25 mg of promethazine hydrochloride; Table. contain lactose and sucrose.
Action:
Antihistamine. Prometazine is a powerful and long-lasting first-generation antihistaminic drug. It blocks histamine H-receptors1. It also blocks the cholinergic, adrenergic, serotoninergic and dopaminergic receptors, thus also demonstrating antiemetic, central sedative and anticholinergic properties. After oral administration it is absorbed quickly and almost completely. Its bioavailability is limited due to the first-pass effect of the liver. It binds to blood proteins in 93%. It spreads widely in the body. It easily penetrates to o.u.n, passes through the placenta, and penetrates to breast milk to a small extent. It is metabolised in the liver, largely at the first pass. T0,5 is 7-15 hours. It is excreted in urine and bile.
Contraindications:
Hypersensitivity to the active substance, other phenothiazine derivatives or to any of the excipients. Coma. Depression o.u.n., regardless of its background. Treatment with MAO inhibitors and a period of 14 days after the end of their application. Prometasine should not be used in children up to 2 years of age due to the possibility of life-threatening respiratory depression.
Precautions:
Promethazine may cause thickening or drying of bronchial secretions and obstruct expectoration - care should be taken in patients with asthma, bronchitis or bronchiectasis. The drug should be used with caution in patients with severe coronary disease, narrow-angle glaucoma, epilepsy and in patients with liver or kidney failure, as well as patients with narrowing of the bladder neck or duodenal pylorus. The use of promethazine in children and adolescents with subjective and objective symptoms should be avoided, which indicate the presence of Reye's syndrome. Prometazine may mask the warning signs of ototoxicity induced by ototoxic drugs, e.g. salicylates. It may also delay early diagnosis of intestinal obstruction or increased intracranial pressure by inhibiting vomiting. The product should not be used in children under 5 years of age (in this age group prometazine should be used in the form of a syrup). The product contains sucrose and lactose monohydrate - should not be used in patients with rare inherited disorders associated with fructose or galactose intolerance, glucose-galactose malabsorption syndrome, sucrase-isomaltase deficiency or lactase deficiency (Lapp type). Table. 10 mg contain sunset yellow and tabl. 25 mg - cochineal red - both substances can cause allergic reactions.
Pregnancy and lactation:
Do not use the drug during pregnancy unless it is necessary in the doctor's opinion. The use of promethazine in the 2 weeks preceding labor is not recommended, due to the risk of irritability and agitation of the newborn. Available data indicate that the amount of promethazine which is excreted in milk is negligible. However, there is a risk of irritation and stimulation of a breastfed child. Therefore, during breast-feeding, prometazine should be used with caution.
Side effects:
The following may occur: drowsiness, dizziness and headaches, restlessness, nightmares, fatigue and disturbance of orientation, confusion, extrapyramidal reactions, blurred vision, dry mouth, stomach irritation, urinary retention, anorexia, palpitations, hypotension, arrhythmias, cramps muscle and head and facial movements reminiscent of tics, anaphylaxis, skin reactions hypersensitivity to light (during the treatment should be avoided strong sunlight), abnormal blood composition (including hemolytic anemia), jaundice.Promethazine can interfere with urinary immunoassays using urine, resulting in false positive or false negative results. Infants are susceptible to anticholinergic effects of promethazine, while older children may show paradoxical hyperactivity. Elderly people are particularly susceptible to anticholinergic effects and entanglement caused by promethazine.
Dosage:
Orally.Table. 10 mg. Allergic reactions. Adults, including the elderly and children from 10 years: initially 10 mg twice daily, if necessary, the dose is gradually increased to the optimal dose for the patient, up to a maximum of 20 mg three times a day. Children from 5 to 10 years: 10-25 mg once or 5-10 mg 2 times a day; maximum 25 mg daily.Prevention of motion sickness symptoms. Adults, including the elderly and children from 10 years: 20-25 mg overnight before the trip, if necessary, repeat the dose after 6-8 h. Children from 5 to 10 years: 10 mg the night before the trip, in case of Repeat the need after 6-8 h.premedication. Adults and children from 10 years: 25-50 mg for 1 hour before the procedure. Children from 5 to 10 years: 20-25 mg for 1 hour before the procedure.Table. 25 mg. Allergic reactions. Adults, including the elderly and children from 10 years: 25 mg once a day (preferably at night), increasing a maximum of 25 mg 2 times a day if necessary. Children from 5 to 10 years: 10-25 mg once (ideally overnight) or 5-10 mg twice daily; maximum 25 mg daily.Prevention of motion sickness symptoms. Adults, including the elderly and children from 10 years: 25 mg on the night before the trip, if necessary, repeat the dose after 6-8 hours.premedication. Adults and children from 10 years: 25-50 mg for 1 hour before the procedure. Children from 5 to 10 years: 25 mg for 1 hour before surgery.
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