Description
Release form
ORALSEPT spray for topical use, dosed transparent, yellow-green color, with peppermint aroma.
Packaging
30 ml
Pharmacological action
Benzidamine hydrochloride is a non-steroidal anti-inflammatory drug derived from indazole without a carboxyl group. The absence of a carboxyl group gives the following features: Benzidamine is a weak base (whereas most NSAIDs are weak acids), has high lipophilicity, penetrates well into the focus of inflammation along a pH gradient (where the pH is lower) and accumulates in therapeutic concentrations.
It has an anti-inflammatory and local anesthetic effect, has antiseptic (against a wide range of microorganisms), as well as an antifungal effect.
The anti-inflammatory effect of the drug is due to a decrease in capillary permeability, stabilization of cell membranes due to inhibition of the synthesis and inactivation of prostaglandins, histamine, bradykinin, cytokines, complement factors and other non-specific endogenous “damaging” factors.
Benzidamine suppresses the production of pro-inflammatory cytokines, especially tumor necrosis factor- (TNF- ), To a lesser extent interleukin-1 (IL-1 ). The main feature of benzidamine is that, being a weak inhibitor of prostaglandin synthesis, it exhibits potent inhibition of pro-inflammatory cytokines. For this reason, benzidamine can be classified as a cytokine-suppressing anti-inflammatory drug.
The local anesthetic effect of benzidamine 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 threshold of pain sensitivity of the receptor apparatus, benzidamine also blocks the interaction of bradykinin with tissue receptors, restores microcirculation and reduces pain sensitivity in the focus of inflammation.
Benzidamine has an antibacterial effect due to the rapid penetration of microorganisms through the membranes, followed by damage to cellular structures, metabolic processes and cell lysosomes.
It has antifungal activity against 20 strains of Candida albicans and non-albicans strains, causing structural modifications of the cell wall of fungi and their metabolic chains, thus inhibiting their reproduction.
Indications
Symptomatic treatment of pain for inflammatory diseases of the oral cavity and ENT organs (of various etiologies): – pharyngitis, laryngitis, tonsillitis
– gingivitis, glossitis, periodontal disease, stomatitis (including after radiation therapy and chemotherapy) inflammation of the salivary glands
– after treatment or tooth extraction
– after surgical interventions and injuries (tonsillectomy, jaw fractures)
– candidiasis of the oral mucosa (as part of combination therapy)
For infectious and inflammatory diseases In cases requiring systemic treatment, ORALSEPT® is used as part of combination therapy.
Contraindications
– Hypersensitivity to benzidamine or other components of the drug.
– Children under 3 years old.
Caution.
Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
Bronchial asthma (including history).
Use during pregnancy and lactation
Animal data on the effects of pregnancy and breastfeeding are insufficient, and adequate and well-controlled studies in pregnant women have not been conducted, in addition, it is not known whether benzydamine passes into breast milk therefore, the potential risk to humans cannot be determined.
During pregnancy and during breastfeeding, the drug ORALSEPT® is used only after consultation with your doctor, if if the intended benefit to the mother outweighs the potential risk to the fetus and the baby.
Special instructions
Hypersensitivity reactions may occur with ORALSEPTВ®. In this case, it is recommended to discontinue treatment and consult a doctor to prescribe appropriate therapy. If there is an ulcerative lesion of the mucous membrane of the oropharynx, the patient should consult a doctor if the symptoms persist for more than three days. The use of ORALSEPTВ® is not recommended in patients with hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. ORALSEPTВ® should be used with caution in patients with bronchial asthma, since in this case the development of bronchospasm is possible.
Avoid contact with eyes. In case of contact with eyes, rinse with plenty of water.
Impact on the ability to drive vehicles and mechanisms.
The drug does not affect the ability to drive a car, the performance of potentially dangerous activities that require increased concentration of attention and the speed of psychomotor reactions, or other activities that require increased attention.
Composition
1 dose: – benzidamine hydrochloride 0.255 mg
Excipients: methyl parahydroxybenzoate – 0.17 mg, ethanol 96% – 17 mg, glycerol – 8.5 mg, peppermint flavor 27198/14 – 0.17 mg, sodium chloride, 0.18 mg 60 – 0.0085, sodium bicarbonate – 0.0034 mg, quinoline yellow dye 70 (E104) – 0.0034 mg, indigotine dye 85% (E132) – 0.00017 mg, purified water – up to 170 ?l.
Description: a clear solution of yellow-green color with the aroma of peppermint.
Dosage and administration
Topically applied.
One dose of ORALSEPT spray corresponds to 1 press. One dose corresponds to one breath and is equivalent to 0.17 ml of solution.
Adults and children over 12 years of age are prescribed 4-8 doses 2-6 times a day.
For children aged 3-6 years: 1 dose per 4 kg of body weight (maximum 4 doses) 2-6 times a day.
For children aged 6-12 years: 4 doses 2-6 times a day.
Course of treatment: – for inflammatory diseases of the oral cavity and pharynx: from 4 to 15 days
– for 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 ORALSEPT for a long time, you need to consult a doctor.
Directions for use: 1. Holding the bottle vertically, lift the cap nozzle at an angle of 90 ° to the bottle.
2. Insert the nozzle into the oral cavity and press the cap several times, according to the recommended dose. The period between two clicks must be at least 5 seconds.
3. Return the nozzle to its original position.
Caution: press the spray gun into the air several times before first use.
Do not exceed recommended dosage. Before use, consult your doctor.
Side effects
Local reactions: dry mouth, numbness, burning in the mouth.
Allergic reactions: hypersensitivity reactions, including skin rash, pruritus, urticaria, photosensitivity, angioedema, anaphylactic reactions.
Other: laryngospasm.
If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects not listed in the instructions, inform your doctor.
Drug Interactions
Interactions with other drugs have not been studied.
The pharmaceutical incompatibility of ORALSEPT® with other drugs has not been established.
Overdose
There have been no reports of overdose with ORALSEPT® at this time. However, it is known that benzidamine, if accidentally ingested at a high dose (hundreds of times higher than therapeutic), especially in children, can cause agitation, convulsions, tremors, sweating, ataxia and vomiting. Such acute overdose requires immediate gastric lavage, restoration of water-electrolyte balance, symptomatic treatment, adequate hydration.
If you take more than the recommended dose, rinse your mouth with plenty of water, consult your doctor if you experience any side effects.
Deystvuyuschee substances
benzydamine
Terms of delivery from pharmacies
Over-the-counter
Form of Treatment
spray dlya Polo PTA
Replek Farm, Macedonia
