SINUFORTE (Cyclamen europaeum)
basic physical and chemical properties: porous mass of white or white with cream and brown shade, hygroscopic;
composition: 1 vial contains a lyophilized powder of juice and aqueous extract from fresh tubers of cyclamen European (Сусlamen Aigerim) 0.05 g;
solvent – water for injections.
Form of issue. Powder lyophilized for preparation of solution for intranasal use.
Pharmacotherapeutic group. Drugs used in diseases of the nasal cavity. ATC code R01АХ.
The pharmacological properties.
The drug acts topically on the mucous membrane of the nose, causing a reinforced reflex
the secretion in the mucous membranes that line around the sinuses and, in fact,
the cavity of the nose. Enhanced reflex secretion in the form of serous secretions muconic
manifests itself in a few minutes and can last about 2 hours. Similar
stimulated secretion causes the natural drainage (leaching) around the nasal
sinuses and, as a result, high therapeutic effectiveness of the drug. The drug does not cause
any significant residual effects of irritation of the nasal mucosa, not
retained in the nasal cavity and has a General systemic action.
Pharmacokinetics. Has not been studied.
Indications for use.
a) Acute or chronic recurrent inflammation around the sinuses (sinusitis) -
catarrhal or purulent sinusitis, frontal sinusitis, ethmoiditis, stenogyne or combined
sinusitis; acute purulent sinusitis, which is accompanied by phenomena
generalized infection or orbital complications (in the latter case
Sinuforte used in combination with antibiotics);
b) exudative acute inflammation of the middle ear (otitis media) and chronic exudative otitis
(in the latter case, the treatment using Sinuforte may be done after
C) acute and chronic rhinitis; acute allergic rhinitis or allergic rhinitis in the stage
exacerbation, including hay fever in the complex therapy, to prevent
development of purulent complications;
d) post operating rehabilitation after endoscopic surgeries
(etmology, gamereactor, ProntoEdit).
Method of application and doses.
Each time you push the sprayer-dispenser sprays to 0.13 ml (2-3 drops) of the drug that is a single dose (0,0013 g). The final solution contains 35 doses of the drug.
Twist the cap off the vial and remove the cap.
To open the ampoule with solution and break off the top.
Completely pour the solvent into the vial with the drug.
Screw the sprayer dispenser on the bottle and shake well until completely dissolved
Remove the protective cap from the spray-dispenser.
Make 2-3 test spray into the air.
The vertical position of the head to introduce spray-dispenser in every
nostril and spray with one touch.
Adults and children older than 5 years prepared by the above method
the drug is administered in a unilateral sinus infection side sinusitis once a day;
bilateral sinusitis aerosol administered in each nostril.
The drug is recommended in a day, if necessary
it can be daily use.
The duration of a single course of treatment is 12-16 days with the introduction of the drug through the day and 6-8
days with daily use.
To achieve a therapeutic effect are enough 6-8 introductions of the preparation, but
a decrease in headache or termination may occur after
3-5 administration of the drug.
The dosage regimen and the duration of the assignment does not depend on nosological forms
disease. After endoscopic surgeries intranazalnoe introduction
Sinuforte begin on the second day with the purpose of the drainage of the respiratory tract and reduce
swelling of the mucous membranes.
Side effects. A short feeling weak or moderate burning in the nasopharynx, reflex effects in the form of salivation, at least - short of tearing and redness of the face; in rare cases, it may be short-lived headache in the frontal region or appear pale-pink color discharge from the nose as a result of capillary diapedese. In one of the cases there is no need of discontinuation of treatment.
Contraindications. Cystic polpot pair of nasal sinusitis; pregnancy and lactation because the safety of use during these periods has not been studied; children under the age of 5 years, clinical data on the efficacy and safety of the drug which is insufficient; hypersensitivity to the drug.
Overdose. The cases of drug overdose Sinuforte was not reported. However, exceeding the recommended dosage may cause a feeling of severe burning and pain in the nose and throat.
Features of the application.
DURING USE AVOID CONTACT WITH EYES!
DO NOT INHALE SIMULTANEOUSLY WITH THE INTRODUCTION OF THE DRUG!
Involuntary contact with eyes may cause severe irritation and
the phenomena of acute conjunctivitis.
In the case of allergic rhinitis the use of systemic antihistamines
allowed only two hours after intranasal administration Sinuforte.
Anti-allergic drugs can be used at least 8-10 hours before
intranasal Sinuforte. When applying Sinuforte after
surgical interventions there is no need to use the traditional after operating
rehabilitation measures, such as anemia, lavage of the sinuses and nasal toilet
Increasing the dose does not increase the therapeutic effect.
Interaction with other medicinal products. Unacceptable simultaneous introduction into the nasal cavity Sinuforte and local anesthetic drugs, and antihistamines or preliminary administration of such drugs; if necessary, permissible means of reducing local swelling of the mucous membranes of the nose, such as solutions containing adrenaline and ephedrine; in cases complicated by purulent infection, if necessary, apply antibiotic therapy.
The conditions and duration of storage. Store protected from light and inaccessible to children place at temperature from 15°C to 25°C.
Shelf life 3 years. Fresh prepared solution may be kept at a temperature of from 8°to 10°C in a place protected from light not more than 15 days.
Leave conditions. Without a prescription.
Packing. Powder lyophilized in a glass vial with a volume of 8 ml, the solvent – water for injection - 5 ml and atomizer-dispenser included.