More info
Active ingredients
Composition
active ingredient: benzydamine hydrochloride - 0.150 g; excipients: methyl parahydroxybenzoate - 0.100 g, ethanol (96%) - 10,000 g, glycerin (glycerol) - 5,000 g, peppermint flavoring 27198/14 - 0.100 g, sodium saccharinate - 0.024 g, polysorbate-60 (tween-60) - 0.005 g, sodium bicarbonate - 0.002 g, quinoline yellow dye 70 (E 104) - 0.002 g, indigotin 85% (E 132) - 0.0001 g, purified water to 100.0 ml.
Pharmacological effect
Pharmacodynamics
Benzydamine hydrochloride is a non-steroidal anti-inflammatory agent, indazole derivative, without carboxyl group. The absence of a carboxyl group imparts the following features: benzydamine is a weak base (whereas most NSAIDs are weak acids), has a 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 effect, has antiseptic (against a wide range of microorganisms), as well as antifungal action.
Anti-inflammatory effect of the drug 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 nonspecific endogenous "damaging" factors.
Benzydamine inhibits the production of pro-inflammatory cytokines, especially tumor necrosis factor-α (TNF-α), and to a lesser extent interleukin-1β (IL-1β). The main feature of benzydamine is that, as a weak inhibitor of prostaglandin synthesis, it demonstrates potent inhibition of pro-inflammatory cytokines. For this reason, benzydamine can be classified as a cytokine-suppressive anti-inflammatory drug.
The local anesthetic effect of benzydamine is associated with 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, which have algenic properties, and an increase in the pain sensitivity threshold of the receptor apparatus; Benzydamine also blocks the interaction of bradykinin with tissue receptors, restores microcirculation and reduces pain sensitivity in the focus of inflammation.
Benzydamine has an antibacterial effect due to the rapid penetration of microorganisms through the membranes with subsequent damage to cellular structures, impaired 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 preventing their reproduction.
Pharmacokinetics
When applied topically, it is well absorbed through the mucous membranes and quickly penetrates into the inflamed tissue; it is found 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 pain syndrome of 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 (in combination therapy).
In case of infectious and inflammatory diseases requiring systemic treatment, the ORALCEPT® preparation is used as part of a combination therapy.
Contraindications
Hypersensitivity to benzydamine or other components of the drug.
Children's age up to 12 years.
Precautionary measures
Hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.
Bronchial asthma (including in history).
The drug does not affect the ability to drive a car, the performance of potentially hazardous activities that require high concentration of attention and psychomotor speed reactions or to another type of activity that requires increased attention.
Use during pregnancy and lactation
There are not enough data from animal studies regarding the effects during pregnancy and during breastfeeding, and adequate and well-controlled studies in pregnant women have not been done, and it is not known whether benzidamine penetrates breast milk, therefore, the potential risk to humans cannot to be determined.
During pregnancy and during breastfeeding, ORALCEPT® is used only after consulting with the attending physician, if the intended benefit to the mother outweighs the potential risk to the fetus and child.
Dosage and administration
Used locally.
1 dose of the solution is 15 ml (measuring cup is attached).
Adults, elderly patients and children over 12 years old are prescribed to rinse the throat or oral cavity 1 dose 2-3 times a day.
Apply undiluted solution. If a burning sensation occurs when using the solution, the solution should be diluted with water (15 ml of the preparation and 15 ml of water should be mixed using a measuring cup).
A course of treatment:
with inflammatory diseases of the oral cavity and pharynx: from 4 to 15 days;
for odonto-dental pathology: from 6 to 25 days;
after surgery and injuries (tonsillectomy, jaw fractures): from 4 to 7 days.
Directions for use:
the solution is used to rinse the mouth or throat for 20-30 seconds, and then spit;
Do not swallow the solution.
When using the drug for a long time (more than 7 days), it is necessary to consult a doctor.
Side effects
Local reactions: dry mouth, feeling of 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 instruction are aggravated, or you have noticed any other side effects that are not indicated in the instruction, inform your doctor.
Overdose
To date, no cases of overdose with ORALEPT® have been reported. However, it is known that benzydamine in case of accidental ingestion in a high dose (hundreds of times higher than therapeutic), especially in children, can cause agitation, convulsions, tremor, sweating, ataxia and vomiting. Such an acute overdose requires immediate gastric lavage, restoration of water and electrolyte balance, symptomatic treatment, adequate hydration.
If you have taken a dose of more than the recommended dose, rinse your mouth with a sufficient amount of water. If you experience adverse reactions, contact your doctor.
Interaction with other drugs
Not studied. Pharmaceutical incompatibility of ORALCEPT® with other drugs has not been established.
special instructions
At use of the drug ORALEPT® development of reactions of hypersensitivity is possible. In this case, it is recommended to discontinue treatment and consult a physician to prescribe appropriate therapy. In the presence of ulcerative lesions of the mucous membrane of the oropharynx, the patient should consult a doctor if symptoms persist for more than three days. The use of the drug ORALEPT® is not recommended in patients with hypersensitivity to acetylsalicylic acid or other nonsteroid
anti-inflammatory drugs. ORALCEPT® should be used with caution in patients with bronchial asthma, as in this case the development of bronchospasm is possible.
Avoid contact with eyes. If the solution gets into the eyes, rinse them with plenty of water.
It is necessary to draw the attention of athletes and drivers that ethanol is present in the composition of the drug.
Storage conditions
Store in a dark place at a temperature not exceeding 25 ° C.
Keep out of the reach of children.