Sinuspal (fenspiride) syrup 200 mg/100 ml. 100 ml. vial

Description

Sinuspal (fenspiride) syrup 200 mg/100 ml. 100 ml. vial

Composition

active substance: fenspiride;

1 ml of syrup contains fenspiride hydrochloride 2 mg;

Excipients: glycerin, sucrose, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), potassium sorbate, licorice root dry extract, ammonium glycyrrhizinate, flavoring “Chocolate”, purified water.

Dosage form

Syrup.

Main physical and chemical properties: brown-yellow liquid. A slight precipitate that dissolves after shaking is allowed.

Pharmacotherapeutic group

Other agents for systemic use in obstructive diseases of the respiratory system.
ATX code R03D X03.

Pharmacological properties

It is a remedy used in obstructive diseases of the respiratory system. It has anti-bronchoconstrictive, anti-inflammatory properties. Its mechanism of action is associated with the ability to block H1-histamine receptors, to exert an antispasmodic effect on the smooth muscles of the bronchi. It also has an anti-inflammatory effect, which is explained by the ability to reduce the production of many pro-inflammatory factors (TNFa, leukotrienes, cytokines, free radicals, derivatives of arachidonic acid, prostaglandins, thromboxane), some of which also have a bronchoconstrictor effect. In addition, it inhibits alpha1-adrenergic receptors that stimulate the secretion of viscous mucus.

Indications

Sinuspal shown:

• with acute / chronic inflammatory processes of the respiratory tract (otitis media, sinusitis, rhinopharyngitis, rhinotracheobronchitis, rhinitis, tracheitis, bronchitis);
• as part of complex therapy for bronchial asthma;
• with seasonal or year-round allergic rhinitis, other allergic manifestations of the respiratory tract;
• with respiratory manifestations of influenza, measles;
• for the symptomatic treatment of whooping cough.

Contraindications

The drug Sinuspal is not used:

• with intolerance to the components;
• children under two years old.

It is used with caution in persons suffering from diabetes mellitus (one teaspoon of syrup contains 3 g of sugar, a tablespoon of 9 g of sugar).

Application during pregnancy and lactation

There is not enough data on the use of this drug during pregnancy, so the appointment is not recommended.
It is not known whether fenspiride can be excreted into breast milk, therefore, the drug is not prescribed during breastfeeding.

Method of administration and dosage

For oral use.

Sinuspal, syrup, is prescribed to children aged 2 years and adults.

The drug is contraindicated in children under 2 years of age.

The daily dose should be divided into 2 – 3 doses and taken before meals.

The recommended daily dose should be based on body weight and age, but should not exceed the daily dose (see below).

Use for children over 2 years.
The recommended daily dose is 4 mg / kg body weight (2 ml / kg body weight).

• For children over 2 years of age weighing less than 10 kg:
  the daily dose is from 2 to 4 teaspoons of syrup (10 – 20 ml), respectively 20 – 40 mg of fenspiride hydrochloride per day.
• For children aged 2 years with a body weight over 10 kg to 12 years:
  the daily dose is from 2 to 4 tablespoons of syrup (30 – 60 ml), respectively 60 – 120 mg of fenspiride hydrochloride per day.
• Use for adults and children over 12 years.
  The daily dose of syrup is from 3 to 6 tablespoons (45 – 90 ml), respectively 90 – 180 mg of fenspiride hydrochloride per day.

1 teaspoon of syrup (5 ml) contains 10 mg of fenspiride hydrochloride.

1 tablespoon of syrup (15 ml) contains 30 mg of fenspiride hydrochloride.

A 5 ml dosing spoon is added to dispense the syrup. If it is necessary to measure a dose that is more than 5 ml, measure first the first 5 ml of syrup, and then the remaining dose.

The course of treatment
The duration of treatment depends on the course of the disease and is determined by the doctor individually.

Children

The drug is used in pediatric practice for children over 2 years of age.

Overdose

Overdose signs: drowsiness or agitation, sinus tachycardia, vomiting.
Treatment: discontinuation of intake, gastric lavage, prescription of sorbents, ECG monitoring, symptomatic therapy.

Side effects:

• Neurological disorders: dizziness, drowsiness.
• Gastrointestinal disorders: nausea, dyspeptic disorders, diarrhea, stomach pain.
• Cardiovascular disorders: moderate tachycardia, palpitation, arterial hypotension.
• Dermatological disorders: fixed erythema, urticaria, rash, angioedema, Lyell’s syndrome, pruritus,
• Stevens-Johnson syndrome.
• Others: asthenia, increased fatigue, hypersensitivity reactions.