To Sinuforta

General characteristics. Structure:

Active agent: lyophilisate of juice and extract of tubers of a cyclamen European fresh (a hemolitic index 1:6000 — 1:12000) — 50 mg
Excipients: the bottle with solvent contains: water for injections — 5 ml
 
Description:
Lyophilisate from white till light brown color, is hygroscopic. The "water for injections" solvent — transparent colourless liquid. The solution received after dissolution of 0,05 g of drug in 5 ml of water has to be from colourless color to light yellow color.

Pharmacological properties:

Pharmacodynamics. Drug of a plant origin for treatment of inflammatory diseases of okolonosovy bosoms (ONP) and a nasal cavity. Drug influences sensitive receptors of a trifacial in the field of the average nasal course and causes reflex secretion in a mucous membrane of a nasal cavity and ONP. Stimulated hypersecretion is followed by change of rheological properties of a secret and normalization of its viscosity. Reflex hypersecretion in a combination with antiedematous effect of drug leads to evacuation of a secret from sine in a nasopharynx and provides a physiological drainage of all sine at the same time.
Drug promotes recovery of mukotsiliarny transport in a nasal cavity and ONP due to strengthening of presence at a blanket of slime of a liquid part of a secret.
Синуфорте® strengthens microblood circulation in a mucous membrane of a nose and ONP. It is connected with the fact that parasympathetic stimulation which activates secretion also causes vasodilation of the vessels supplying glands. The strengthened reflex secretion in the form of serous and mucous allocations is found in a few minutes and can continue from 30 to 120 minutes depending on specific features of an organism.

Pharmacokinetics. Effect of the drug Sinuforte® is caused by the net effects of components of a cyclamen which are the most studied from which triterpenovy saponins are. Carrying out kinetic researches is not possible as everything together components cannot be tracked by means of markers or bioresearches. For the same reason it is impossible to find also metabolites of drug.

Indications to use:

• Complex therapy of acute and chronic sinusitis: antritises, a frontal sinusitis, etmoidita and sphenoidites (in case of the purulent sinusitis proceeding with the phenomena of generalization of an infection and/or orbital complications, Sinuforte® should be applied only in a combination with antibiotics). At the uncomplicated course of a disease use of drug as means of monotherapy under observation of the doctor is possible;
• Complex therapy of the rinosinusit which are followed by exudative average otitises;
• The period of early postoperative rehabilitation after endoscopic operative measures on okolonosovy bosoms;

Route of administration and doses:

Intranazalno.
Adults and children are more senior than 5 years:

 1. To unscrew a cap at a bottle with drug and to take out a stopper.
 2. To open a solvent bottle, having broken off an upper part.
 3. To completely pour in solvent contents in a bottle with drug.
 4. To screw the sprayer — the doser on a bottle and to shake up before full dissolution of drug.
 5. To remove a protective cap from the sprayer — the doser.
 6. To make 2-3 trial sprayings in air.
 7. At vertical position of the head to enter the sprayer — the doser into each nasal course, to hold the breath and to make spraying by one pressing.

• By each pressing the doser sprays 0,13 ml (2-3 drops) of drug that makes about 1,3 mg of drug (single dose).
• The drug prepared in the above-stated way is administered once a day, by single spraying in each nasal course.
• Drug is recommended to be used daily, if necessary its use every other day is also allowed.
• Duration of one course of treatment makes 12-16 days at administration of drug every other day or 6-8 days at daily use.

 

Features of use:

During postoperative rehabilitation after the carried-out endoscopic interventions of Sinuforte® it is applied on second day to clarification (sanitation) of okolonosovy bosoms and a nasal cavity and reduction of hypostasis of a mucous membrane.
 
When using to avoid hit of Sinuforte® in eyes in connection with existence of the irritating effect of drug on a mucous membrane of an eye and possible development of the phenomena of acute conjunctivitis.
 
During administration of drug it is recommended to hold the breath.
 
Direct spraying of drug should be carried out one pressing at vertical position of the head.

Before use consultation of the otorhinolaryngologist is recommended.

Side effects:

Emergence of feeling of easy or moderate burning in a nasal cavity, salivary and/or dacryagogues in response to irritation of sensitive receptors of a trifacial is possible. In some cases there can be face reddening, a short headache in frontal area or appear the discharge painted in light pink color from a nose as a result of capillary emigration. Above-mentioned short-term physiological reactions confirm the reflex mechanism of effect of drug and do not demand the treatment termination. Allergic reactions are possible (including skin rash, an asthma and other). In these cases it is recommended to stop administration of drug and to address the specialist.

Interaction with other medicines:

It is necessary to refrain from preliminary administration, and also simultaneous use of local anesthetics and/or local decongestants, in connection with possible disturbance of the mechanism of effect of the drug Sinuforte®.
 
If necessary the drug Sinuforte® combination with antibacterial medicines is possible and admissible.
 
Interactions with other medicines are not studied so far.

Contraindications:

 • Hypersensitivity to drug components;
 • Polypostural rinosinusita;
 • Cysts of okolonosovy bosoms;
 • Allergic rhinosinusopathies;
 • Allergic reactions (the slowed-down and immediate type);
 • Arterial hypertension of the II-III degree;
 • Pregnancy and the period of a lactation (safety of use during these periods is not studied);
 • Children's age up to 5 years (use for children is younger than 5 years it is not studied).

Overdose:

Now about cases of overdose of the drug Sinuforte® it was not reported. Exceeding of a single dose does not lead to increase in medical effect and can cause a feeling of strong burning and nasopharynx pain.
At emergence of symptoms of overdose it is necessary to carry out symptomatic therapy: to wash out a nasal cavity, to rinse a throat warm water and to apply antihistamines.

Storage conditions:

At a temperature not above 25 °C, in the place protected from light.
After cultivation drug is stored at a temperature from 2 to 8 °C within 15 days, in the place protected from light.
To store in the place, unavailable to children! Period of validity of 5 years. Drug is not recommended to be used on expiry date

Issue conditions:

Without recipe

Packaging:

Lyophilisate for preparation of solution for intranasal introduction. On 50 mg of drug (a hemolitic index 1:6000-1:12000) in the bottle made of colourless glass (a hydrolytic class 1 EF) corked by a stopper from rubber of type 1 (EF) with the screwing-up plastic cover.
 
Each bottle together with a solvent bottle (5 ml of water for injections in the polyethylene bottle which is hermetically corked) and a nozzle sprayer is placed in the plastic pallet. The pallet together with the application instruction is placed in a cardboard pack.