Oralcept Spray 176 doses of 30 ml
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Active ingredients
Benzydamine
Release form
Spray
Composition
Benzydamine hydrochloride 0.255 mg. Additional substances: methyl parahydroxybenzoate - 0.17 mg, ethanol 96% - 17 mg, glycerol (glycerin) - 8.5 mg, peppermint flavoring 27198/14 - 0.17 mg, sodium saccharinate - 0.0408 mg, polysorbate 60 - 0.0085 mg, sodium hydrocarbonate - 0.0034 mg, quinoline yellow dye 70 (E104) - 0.0034 mg, indigotin dye 85% (E132) - 0.00017 mg, purified water - up to 170 μl.
Pharmacological effect
NSAIDs, indazole derivative without carboxyl group. The absence of a carboxyl group provides the following features: benzydamine is a weak base (whereas most NSAIDs are weak acids), it has high lipophilicity, it penetrates well into the inflammatory focus, where the pH is lower, and accumulates in therapeutic concentrations. It has anti-inflammatory and local anesthetic action. , has antiseptic (against a wide range of microorganisms), as well as antifungal effects. The anti-inflammatory effect of the drug is due to a decrease in n capillary immunity, stabilization of cell membranes due to inhibition of the synthesis and inactivation of prostaglandins, histamine, bradykinin, cytokines, complement factors and other nonspecific endogenous damaging factors. (IL-1β). Being a weak inhibitor of prostaglandin synthesis, benzydamine demonstrates potent inhibition of pro-inflammatory cytokines. For this reason, benzydamine can be classified as a cytokine-suppressing anti-inflammatory drug. The local anesthetic effect of benzydamine is related to the structural features of its molecule, similar to local anesthetics. The analgesic effect is due to an indirect decrease in the concentration of biogenic amines with algogenic properties and an increase in the sensitivity of the receptor Benzydamine also blocks the interaction of bradykinin with tissue receptors, restores microcirculation and reduces pain sensitivity in the inflammation. Benzidamine has an antibacterial effect due to the rapid penetration of microorganisms through the membranes and subsequent damage to cell lysosomes. It has antifungal activity against 20 strains of Candida albicans and Candida non-albicans,causing structural modifications of the cell wall of fungi and their metabolic chains, thus preventing their reproduction.
Pharmacokinetics
When applied topically, it is well absorbed through the mucous membranes and quickly penetrates into inflamed tissue. It is detected in the blood plasma in an amount insufficient to obtain systemic effects. Excreted mainly by the kidneys and through the intestines in the form of metabolites or conjugation products.
Indications
Symptomatic therapy of painful inflammatory diseases of the oral cavity and ENT organs (of various etiologies): - pharyngitis, laryngitis, tonsillitis; - gingivitis, glossitis, periodontal disease, stomatitis (including after radiation and chemotherapy); - calculous inflammation of the salivary glands; - after treatment or removal of teeth; - after surgery and injuries (tonsillectomy, fractures of the jaw); - candidiasis of the oral mucosa (as part of combination therapy). In infectious and inflammatory diseases requiring systemic treatment, prep Rat Oralsept; used in combination therapy.
Contraindications
- children's age up to 3 years; - hypersensitivity to benzydamine or other components of the drug. With caution: - hypersensitivity to acetylsalicylic acid or other NSAIDs; - bronchial asthma (including history).
Precautionary measures
During treatment, psoriasis may worsen. During pheochromocytoma, propranolol can only be used after taking an alpha blocker. After a long course of treatment, propranolol should be discontinued gradually, under the supervision of a physician. during anesthesia, you must stop taking propranolol or find a remedy for anesthesia with minimal negative inotropic effects. The impact on the ability to drive vehicles and control mechanisms of patients whose activities require increased attention, the question of the use of propranolol on an outpatient basis should be addressed only after evaluating the individual response of the patient.
Use during pregnancy and lactation
Data on animal studies regarding effects during pregnancy and during breastfeeding are insufficient,adequate and strictly controlled studies in pregnant women have not been carried out, in addition, it is not known whether benzidamine penetrates into breast milk, therefore, the potential risk to humans cannot be determined. During pregnancy and during breastfeeding, the drug Oralcept; it is applied only after consultation with the attending physician, in case the intended benefit to the mother outweighs the potential risk to the fetus and child.
Dosage and administration
Used locally. One dose of spray corresponds to 1 pressure. One dose corresponds to one breath and is equivalent to 0.17 ml of solution. Adults and children over 12 years old are prescribed 4-8 doses 2-6 times / day; children aged 3-6 years - 1 dose per 4 kg of body weight (maximum - 4 doses) 2-6 times / day; children aged 6-12 years - 4 doses 2-6 times / day. The course of treatment for inflammatory diseases of the oral cavity and pharynx is from 4 to 15 days; with odonto-dental pathology - from 6 to 25 days; after surgical interventions and injuries (tonsillectomy, fractures of the jaw) - from 4 to 7 days. When using the drug for a long time, consult a doctor. Instructions for use1. Holding the bottle vertically, raise the cap nozzle at a 90 ° angle to the bottle. Insert the nozzle into the oral cavity and press the cap several times according to the recommended dose. The period between two presses must be at least 5 seconds.3. Return the nozzle to its original position. Before the first application, you should press the sprayer several times, sending it into the air. Do not exceed the recommended dose. Before use, consult your doctor.
Side effects
Local reactions: dry mouth, numbness, burning sensation in the mouth. Allergic reactions: hypersensitivity reactions, including skin rash, pruritus, urticaria, photosensitization, angioedema, anaphylactic reactions. Others: laryngospasm. effects are compounded or you notice any other side effects that are not listed in the instructions, tell your doctor about it.
Overdose
To date, cases of overdose Oralsept; not reported. Symptoms: Benzydamine is known to be ingested with a high dose (hundreds of times higher than therapeutic) if accidentally ingested,especially in children, can cause agitation, convulsions, tremor, increased sweating, ataxia and vomiting. Treatment: acute overdose requires immediate gastric lavage, restoration of water and electrolyte balance, symptomatic therapy, adequate rehydration. If the patient has taken a dose that is more than the recommended dose, rinse the mouth with plenty of water. In the event of adverse reactions should consult your doctor.
Interaction with other drugs
Drug interactions have not been studied. The pharmaceutical incompatibility of the drug Oralcept has not been established; with other drugs.
special instructions
When using the drug Oralcept; possible development of hypersensitivity reactions. In this case, it is recommended to stop treatment and consult a doctor to prescribe appropriate therapy. If there is ulceration of the mucous membrane of the oropharynx, the patient should consult a doctor if symptoms persist for more than 3 days. Use of Oralcept; not recommended in patients with hypersensitivity to acetylsalicylic acid or other NPVS. Oralsept preparation; should be used with caution in patients with asthma, since development of a bronchospasm is possible. It is necessary to avoid hit of spray in eyes. If the spray gets into the eyes, it is necessary to rinse them with a large amount of water. Influencing the ability to drive vehicles and control mechanisms The drug does not affect the ability to drive and perform potentially hazardous activities that require increased concentration and psychomotor reactions, or other activities, requiring increased attention.