Sinuphort® (Sinuforte®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspLyophilizate for the preparation of a solution for intranasal administration.
Composition:
a) the vial with the active ingredient contains: lyophilizate juice and extract
cyclamen tubers European fresh 50 mg
(hemolytic index 1: 6000 -1: 12,000)
b) the solvent bottle contains:
water for injections 5 ml
Description:
The lyophilizate is white to light brown in color, hygroscopic.
The water-for-injection solvent is a clear, colorless liquid.
The solution obtained after dissolving 0.05 g of the drug in 5 ml of water should be from colorless to light yellow.
Pharmacotherapeutic group:Nose disease is a cure.
ATX: & nbsp
  • Other drugs for topical use in diseases of the nose
    • Pharmacodynamics:
    Vegetable preparation for the treatment of inflammatory diseases of the paranasal sinuses (NNP) and the nasal cavity. The drug acts on sensitive receptors of the trigeminal nerve in the region of the middle nasal passage and causes reflex secretion in the mucous membrane of the nasal cavity and the ONP. Stimulated hypersecretion is accompanied by a change in the rheological properties of the secret and normalization of its viscosity. Reflex hypersecretion in combination with the anti-edematous effect of the drug leads to the evacuation of secretions from the sinuses to the nasopharynx and provides physiological drainage of all sinuses simultaneously.The drug promotes the restoration of mucociliary transport in the nasal cavity and ONP by increasing the presence of the liquid part of the secretion in the surface layer of the mucus. Sinuphorte® enhances blood microcirculation in the nasal mucosa and ONP. This is due to the fact that parasympathetic stimulation, which activates the secretion, also causes vasodilation of the vessels supplying the glands.
    Intensified reflex secretion in the form of serous-mucosal secretions is detected after a few minutes and can last from 30 to 120 minutes, depending on the individual characteristics of the organism.
    Pharmacokinetics:The effect of the Sinuphorte® preparation is due to the cumulative effects of cyclamen components, the most studied of which are triterpene saponins. Carrying out kinetic studies is not possible, since all the components together, can not be. traced using markers or bioassays. For the same reason, it is impossible to detect metabolites of the drug.
    Indications:
    -Complex therapy of acute and chronic sinusitis: sinusitis, frontal, etmoiditis and sphenoiditis (in the case of purulent sinusitis,taking place with the phenomena of generalization of infection and / or orbital complications, Sinuphorte® should be used
    only in combination with antibiotics). In uncomplicated course of the disease, it is possible to use the drug as a monotherapy under the supervision of a doctor;
    -Complex therapy of rhinosinusitis accompanied by exudative otitis media;
    -The period of early postoperative rehabilitation after endoscopic surgery on the paranasal sinuses.
    Contraindications:
    -Increased sensitivity to the components of the drug;
    -Polypic rhinosinusitis;
    -Cysts of the paranasal sinuses;
    -Allergic rhinosinusopathies;
    -Allergic reactions (delayed and immediate type);
    -Arterial hypertension II-III st .;
    -Pregnancy and lactation period (safety of use in these periods is not studied);
    -Children under 5 years old (use in children under 5 years old not studied).
    Pregnancy and lactation:The use of the drug during pregnancy and lactation is contraindicated.
    Dosing and Administration:

    1. Unscrew the cap from the bottle and take out the stopper.
    2. Open the bottle of solvent, breaking off the upper part.
    3. Fully pour the contents of the solvent into the vial with the drug.
    4. Screw the dispenser dispenser into the vial and shake until the preparation is completely dissolved.
    5. Remove the protective cap from the dispenser dispenser.
    6. Carry out 2-3 test sprays in the air.
    7. With the vertical position of the head, inject the dispenser into each nasal passage, hold the breath and spray with a single push.
    - Each time the dispenser dispenses 0.13 ml (2-3 drops) of the preparation, which is about 1.3 mg of the drug (single dose). - The preparation prepared by the above method is administered once a day by single spraying into each nasal passage. Preliminary it is recommended to make 2-3 test sprays in the air.
    - The drug is recommended to be used daily, if necessary, it is also possible to use it every other day.
    - The duration of one course of treatment is 12-16 days with the administration of the drug every other day or 6-8 days with daily use.
    Side effects:
    There may be a feeling of mild or moderate burning in the nasal cavity, saliva and / or lacrimation in response to irritation of sensitive receptors of the trigeminal nerve.
    In some cases, reddening of the face, a brief headache in the frontal region, or a pale pink color discharge from the nose as a result of capillary diapedesis may occur. The aforementioned short-term physiological reactions confirm the reflex mechanism of action of the drug and do not require discontinuation of treatment.
    Allergic reactions are possible (including skin rash, dyspnea, etc.). In these cases, it is recommended to stop taking the drug and consult a specialist.
    Overdose:
    At present, no cases of an overdose of Sinuphorte® have been reported. Excess of a single dose does not lead to an increase in the therapeutic effect and can cause a sensation of severe burning and pain in the nasopharynx.
    When symptoms of an overdose appear, symptomatic therapy should be performed: rinse the nasal cavity, rinse the throat with warm water and apply antihistamines.
    Interaction:
    It is necessary to refrain from the preliminary introduction, as well as the simultaneous use of local anesthetics and / or local decongestants in connection with possible disruption of the mechanism of action of the Sinuphorte® preparation.
    If necessary, a combination of Sinuphorte ® with antibacterial drugs is possible and permissible.
    Interactions with other drugs have not been studied to date.
    Special instructions:
    In the period of postoperative rehabilitation after endoscopic interventions, Sinuforte® is used on the second day for the purification (sanitation) of the paranasal sinuses and the nasal cavity and to reduce the edema of the mucous membrane.
    In use, avoid contact with Sinuphorte ® in the eye due to the presence of an irritant effect of the drug on the mucous membrane of the eye and the possible development of acute conjunctivitis.
    It is recommended to hold your breath during the injection.
    Direct spraying of the drug should be carried out with one touch with the vertical position of the head.
    Before use, consultation with an otorhinolaryngologist is recommended.
    Form release / dosage:Lyophilizate for the preparation of a solution for intranasal administration.
    Packaging:
    For 50 mg of the preparation (hemolytic index 1: 6000-1: 12000) in a vial made of colorless glass (hydrolytic class 1 EF), capped with a rubber stopper of type 1 (EF) and screwed with a plastic lid.
    Each vial with a solvent vial (5 ml of water for injection in a polyethylene bottle sealed with a cap) and a spray nozzle is placed in a plastic tray. The pallet together with the instruction for use is placed in a cardboard box.
    Storage conditions:
    At a temperature of no higher than 25 ° C in a dark place.
    After dilution, the drug is stored at a temperature of 2 to 8 ° C for 15 days in a dark place.
    Keep out of the reach of children!
    Shelf life:
    5 years.
    The drug is not recommended after the expiration date.
    Terms of leave from pharmacies:Without recipe
    Registration number:LS-000026
    Date of registration:05.02.2010
    The owner of the registration certificate:Invar, OOOInvar, OOO Spain
    Manufacturer: & nbsp
    Representation: & nbspINVAR LLC INVAR LLC Russia
    Information update date: & nbsp16.02.2016
    Illustrated instructions
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