Symptomatic treatment in acute allergic skin reactions with high pruritus; in post-transfusion reactions; nausea, vomiting and dizziness; in the course of motion sickness. In addition, in the short-term treatment of insomnia and anxiety, after surgery.
Composition:
5 ml of syrup contains 5 mg of promethazine hydrochloride; the syrup contains lactose.
Action:
A phenothiazine derivative, an H receptor antagonist1. It has antihistamine, hypnotics, antiemetics and anticholinergics. In therapeutic doses does not affect the circulatory system, does not work neuroleptically or antipsychotically. Prometasine is well absorbed from the digestive tract. The beginning of action occurs after 20 minutes. from oral administration and persists for 4-6 h, and in some patients even up to 12 h. It is metabolized in the liver and its metabolites are excreted in the urine.
Contraindications:
Hypersensitivity to promethazine, other phenothiazine derivatives or to any of the excipients. States of central nervous system inhibition. Coma. Use with MAO inhibitors and for 14 days after discontinuation. Children up to 2 years old. Third trimester of pregnancy. Breastfeeding period.
Precautions:
Use with caution in patients with: asthma, bronchitis, bronchodilation (the drug may cause thickening of the pulmonary secretion); severe coronary artery disease; narrow-angle glaucoma; epilepsy; hepatic or renal failure; urinary retention; hyperplasia of the prostate gland; stenosis of the bladder neck or duodenal pyloric obstruction; in the elderly (increased risk of side effects from the nervous system). Do not use in children and adolescents with symptoms of Reye's syndrome. Prometazine may mask the symptoms of ototoxicity caused by ototoxic drugs, e.g. salicylates. It may also delay early diagnosis of intestinal obstruction or increased intracranial pressure by inhibiting vomiting. During the treatment, strong sunlight should be avoided. Due to the sucrose content, the drug should not be used in patients with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency. 5 ml of syrup contains 4.25 g of sucrose, which corresponds to 0.4 carbohydrate exchanger (WW) - this should be taken into account in patients with diabetes.
Pregnancy and lactation:
The drug is contraindicated in the last trimester of pregnancy and breastfeeding.
Side effects:
The following may occur: drowsiness, dizziness, anxiety, headache, nightmares, fatigue, disorientation, urticaria, rash, pruritus, anorexia, gastric irritation, palpitations, hypotension, arrhythmia, extrapyramidal symptoms, muscle spasms and single movements involuntary head and face, hypersensitivity to light. Rare: anaphylaxis, jaundice, abnormal blood composition (including haemolytic anemia). Occasional: anticholinergic side effects such as blurred vision, dry mouth, urinary retention (older people and infants are particularly susceptible to anticholinergic side effects of promethazine). In children, promethazine may cause paradoxical hyperactivity.
Dosage:
Orally.Adults. In allergic reactions: one time 25 ml at bedtime, maximum 50 ml / day in 2 or 3 divided doses, if necessary. Antiemetic: 12-25 ml every 6 to 8 hours, if necessary. Calming: 25 ml in the evening, at bedtime.Children> 2 years. In allergic reactions: 0.125 mg / kg every 6-8 h or 0.5 mg / kg before bedtime, if necessary. Antiemetic: 0.25-0.5 mg / kg every 6-8 hours, if necessary. Nausea and dizziness: 0.5 mg / kg every 12 hours, if necessary. Do not exceed the dose for adults.
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