ERESPAL®

Active material: Fenspirid
When ATH: R03DX03
CCF: The drug with anti-inflammatory activity and antibronhokonstriktornoy
ICD-10 codes (testimony): H66, J00, J01, J02, J04, J10, J20, J31, J32, J37, J42, J44, J45
When CSF: 12.05.05
Manufacturer: Les Laboratoires Servier (France)

Pharmaceutical form, composition and packaging

Pills, coated white, round, lenticular.

1 tab.
fenspiride hydrochloride80 mg

Excipients: calcium hydrogen phosphate, gipromelloza, povidone, Colloidal anhydrous silica, magnesium stearate, Titanium dioxide, glycerol, macrogol 6000.

15 PC. – blisters (2) – packs cardboard.

Syrup clear, orange, sometimes with a slight precipitate, disappearing with shaking.

1 ml
fenspiride hydrochloride2 mg

Excipients: flavoring composition with hints of honey smell, Natural concentrated licorice extract, Vanilla tincture, glycerol, Sunset yellow CFC, metilparagidroksiʙenzoat, propilparagidroksibenzoat, saxarin, sucrose, potassium sorbate, water.

150 ml – dark plastic bottles (1) – packs cardboard.

 

Pharmacological action

Anti-inflammatory activity of the drug and antibronhokonstriktornaya Erespal® due to the fact, fenspiride that reduces the production of a number of biologically active substances (Cytokine, especially tumor necrosis factor α (ФНО-a), arachidonic acid, free radicals), play an important role in the development of inflammation and bronchoconstriction. The inhibition of arachidonic acid metabolism fenspiride potentiated the blockade of histamine H1-receptors, tk. Histamine stimulates the production of its products (prostaglandins and leukotrienes). Фенспирид блокирует a-адренорецепторы, stimulation of which is accompanied by an increase in the secretion of bronchial glands. Thus, fenspiride reduces the effect of a number of factors, which contribute to hypersecretion of proinflammatory factors, the development of inflammation and bronchial obstruction. For fenspiride characterized by the availability of antispasmodic activity.

 

Pharmacokinetics

Absorption

Absorbed from the gastrointestinal tract is relatively slow. After oral administration, tablets Cmax achieved through 6 no, after receiving syrup – after 2.3 ± 2.5 hours (from 0.5 to 8 no).

Deduction

T1/2 is 12 no. Write mainly with urine.

 

Testimony

Diseases of the upper and lower respiratory tract:

- Rhinopharyngitis and laryngitis;

- Otitis media and sinusitis various etiologies, including allergic (both seasonal, and permanent nature);

- Rynotraheobronhyt;

- Bronchitis (with chronic respiratory failure or without);

- Complications or isolated bronchial asthma (maintenance therapy);

- Respiratory effects in measles, whooping cough, Flu.

 

Dosage regimen

Adults the drug is prescribed for 80 mg (1 tab.) 2-3 times / day, or 3-6 tablespoons (45-90 ml) syrup per day. 1 tablespoon contains 30 fenspiride mg hydrochloride and 9 g sucrose.

Erespal® in the form of tablets is not intended for the treatment of children under the age of 14 years. For the use of the drug in children under 14 s recommended Erespal® Syrup.

Children and adolescents under the age of 14 years the drug is prescribed on the basis of 4 mg / kg body weight / day. Children aged 0 to 2 years (weight up 10 kg) – 2-4 teaspoons syrup (10-20 ml)/d, can be added to food bottle (1 teaspoon contains 10 fenspiride mg hydrochloride and 3 g sucrose). Children aged 2 to 16 years (weighing more than 10 kg) – 2-4 tablespoons syrup (30-60 ml)/d.

A course of treatment 20-30 days. Repeated course is possible after consultation with the doctor.

The drug should be taken before meals. The syrup should be shaken before use.

 

Side effect

From the digestive system: nausea, stomachache, vomiting.

Allergic reactions: rarely – эritema, angioedema, fixed pigmented erythema, rash; due to the presence in the composition of the syrup para-hydroxybenzoate may develop hives.

Other: drowsiness; rarely – moderate tachycardia, disappears after discontinuation of the drug.

 

Contraindications

- Children up to age 14 years (Pill);

- Increased sensitivity to the active ingredient and / or any of the components of the drug, especially to the colorant Sunset yellow CFC, methyl- and propylparaben (syrup).

 

Pregnancy and lactation

Not recommended for use Erespal® during pregnancy due to lack of sufficient clinical data. Therapy fenspiride is not grounds for termination of the ensuing pregnancy.

At the reception Erespal® lactation should abandon breastfeeding, tk. No details on the allocation fenspiride breast milk.

 

Cautions

When the infectious nature of the disease treatment Erespalom® carried in combination with standard antibiotic therapy.

Be wary appoint Erespal® in the form of a syrup patients with hypersensitivity to aspirin and other NSAIDs because of the risk of allergic reactions (incl. bronchospasm) in these patients due to the fact, that the composition of the syrup includes a dye Sunset Yellow CFC.

Since the sucrose syrup contains, it should be administered to patients with diabetes with caution, tk. may require dose adjustment of hypoglycemic drugs.

Due to the presence of sucrose Erespal® in the form of syrup should not be administered to patients with fructose intolerance, syndrome of glucose and galactose malabsorption or deficiency sukrazoizomaltazy (a rare metabolic disorder).

 

Overdose

Symptoms: drowsiness or agitation, nausea, vomiting, sinus tachycardia.

Treatment: gastric lavage, ECG monitoring.

 

Drug Interactions

Drug Interactions drug Erespal® not disclosed.

 

Conditions of supply of pharmacies

The preparation is available on medical prescription.

 

Conditions and terms

List B. The drug should be stored out of reach of children at or above 25 ° C. Shelf life Tablets – 2 year, Syrup – 3 year. Do not use after expiration date, on the package.

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