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Active ingredients
Fenspirid
Release form
Syrup
Composition
1 ml of fenspiride hydrochloride 2 mg.
Pharmacological effect
Fenspiride exhibits anti-inflammatory and anti-bronchoconstrictive activity by reducing the production of a number of biologically active substances (cytokines (especially TNFα), arachidonic acid derivatives, free radicals) that play an important role in the development of inflammation and bronchospasm. Inhibition of arachidonic acid metabolism by fenspiride is potentiated by the blockade of histamine H1 receptors, since Histamine stimulates the metabolism of arachidonic acid to form prostaglandins and leukotrienes. Fenspiride blocks α-adrenoreceptors, stimulation of which is accompanied by an increase in the secretion of bronchial glands. Thus, fenspirid reduces the effect of a number of factors that contribute to the hypersecretion of pro-inflammatory factors, the development of inflammation and bronchial obstruction. Fenspirid also has a spasmolytic effect.
Pharmacokinetics
Absorption: After oral administration, Fenspiride is well absorbed from the gastrointestinal tract. Cmax in the blood plasma after oral administration is reached after 2.3 ± 2.5 h (from 0.5 to 8 h). Excretion: T1 / 2 averages 12 hours. Excreted mainly by the kidneys (90% of the dose taken) and less than 10% through the intestines.
Contraindications
- fructose intolerance, glucose-galactose malabsorption syndrome, sucrase-isomaltase deficiency - pregnancy - lactation period (breastfeeding) - children under 2 years of age - hypersensitivity to fenspiride or other components of the drug. Precautions should be prescribed the drug for diabetes mellitus (due to the presence of sucrose in the composition of the drug).
Use during pregnancy and lactation
Use of the drug during pregnancy is not recommended. Therapy with fenspiride is not a basis for abortion of the onset of pregnancy. There are no clinical data on the fetotoxic effect of fenspiride or its ability to cause malformations when used during pregnancy. Do not use the drug Syresp during breastfeeding due to the lack of data on the ability of fenspiride to penetrate into breast milk.
Dosage and administration
The drug is taken orally, before eating. Children at the age of 2 years, the drug is prescribed at the rate of 4 mg / kg / day.For children weighing up to 10 kg - from 2 to 4 dosing spoons of syrup (10-20 ml) / day, can be added to a bottle with food for children weighing more than 10 kg - from 6 to 12 dosing spoons of syrup (from 2 to 4 tablespoons or 30-60 ml) / day. Adults appoint from 9 to 18 dosing spoons of syrup (from 3 to 6 tablespoons or 45-90 ml) / day. 1 scoop (5 ml syrup) contains 10 mg of fenspiride hydrochloride and 3 g of sucrose. 1 tablespoon (15 ml of syrup) contains 30 mg of fenspiride hydrochloride and 9 g of sucrose. The duration of treatment is determined by the doctor.
Side effects
The following side effects are given according to the frequency of occurrence: very often (1/10) often (1/100, less than 1/10) infrequently (1/1000, less than 1/100) rarely (1/10 000, less than 1/1000), very rarely (less than 1/10 000). The side effects registered in the post-marketing period, due to the lack of accurate data on their frequency, are marked as "frequency unknown." CNS: rarely - drowsiness frequency unknown - dizziness. Since the cardiovascular system: rarely - moderate tachycardia, the severity of which decreases with decreasing the dose of the drug. On the part of the digestive system: often - gastrointestinal disorders, nausea, epigastric pain, frequency unknown - diarrhea, vomiting. On the part of the skin and subcutaneous tissues: rarely - erythema, rash, urticaria, angioedema, fixed erythema pigment frequency is unknown - itchy skin. Other: frequency is unknown - asthenia, increased fatigue.
Overdose
Symptoms: drowsiness or agitation, nausea, vomiting, sinus tachycardia. Treatment: gastric lavage, ECG monitoring, maintenance of vital body functions.
Interaction with other drugs
Special studies on the interaction of fenspiride with other drugs have been conducted. Due to the possible increase in the sedative effect when taking histamine H1 receptor blockers, the use of the drug Syresp in combination with drugs that have a sedative effect, or together with ethanol is not recommended.
special instructions
The Syresp syrup contains parabens (methyl parahydroxybenzoate and propyl parahydroxybenzoate), as a result of which the use of the drug may provoke the development of allergic reactions, including deferred.When prescribing the drug to patients with diabetes, it is necessary to take into account that Syresp syrup contains sucrose (1 scoop (5 ml syrup) - 3 g sucrose = 0.25 XE). The composition of the drug includes sunset sunflower yellow dye (E110), which can cause the development of allergic reactions. Glycerol, which is part of the preparation, may cause headache, indigestion, diarrhea. Impact on the ability to drive motor vehicles and control mechanisms. Care should be taken when driving and engaging in potentially hazardous activities that require increased concentration and psychomotor speed, because during the use of the drug may develop drowsiness.