Oralcept spray for local use approx. doses 0.255mg/dose 176 doses 30ml
Indications
Symptomatic treatment 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 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 requiring systemic treatment, Oralcept® is used as part of combination therapy.
pharmachologic effect
Benzydamine hydrochloride is an NSAID, an indazole derivative, without a carboxyl group. The absence of a carboxyl group gives the following features: benzydamine is a weak base (whereas most NSAIDs are weak acids), has high lipophilicity, penetrates well into the site of inflammation along the pH gradient (where the pH is lower) and accumulates in therapeutic concentrations.
It has an anti-inflammatory and local analgesic effect, has an 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 nonspecific endogenous damaging factors.
Benzidamine suppresses the production of pro-inflammatory cytokines, especially tumor necrosis factor-alpha (TNF-α), and to a lesser extent interleukin-1β (IL-1β). The main feature of benzydamine is that while it is a weak inhibitor of prostaglandin synthesis, it demonstrates potent inhibition of proinflammatory cytokines. For this reason, benzydamine may be classified as a cytokine-suppressing 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 algogenic 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 at the site of inflammation.
Benzidamine has an antibacterial effect due to rapid penetration through the membranes of microorganisms with subsequent damage to cellular structures, disruption of metabolic processes and the function of cell lysosomes.
It has an antifungal effect 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.
Drug interactions
Drug interactions have not been studied.
No pharmaceutical incompatibility of Oralcept® with other drugs has been established.
Dosage regimen
Apply topically. One dose of 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/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; for odonto-dental pathology - from 6 to 25 days; after surgical interventions and injuries (tonsillectomy, jaw fractures) - from 4 to 7 days.
When using the drug for a long time, consult a doctor.
Directions for use
1. Holding the bottle vertically, lift the cap nozzle at an angle of 90° to the bottle (Figure 1).
2. Insert the nozzle into the oral cavity and press the cap (marked with an arrow in Fig. 2) 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 (Fig. 3).
Attention: before the first use, press the sprayer several times, pointing it into the air.
Fig 1.
Fig.2
Fig 3.
Do not exceed the recommended dose. Consult your physician before use.
Overdose
To date, no cases of overdose of Oralcept® have been reported. However, it is known that benzydamine, if accidentally ingested in a high dose (hundreds of times higher than the therapeutic dose), especially in children, can cause agitation, convulsions, tremors, increased sweating, ataxia and vomiting.
Treatment: acute overdose requires immediate gastric lavage, restoration of water and electrolyte balance, symptomatic therapy, and adequate rehydration. If the patient has taken more than the recommended dose, the mouth should be rinsed with plenty of water. If adverse reactions occur, you should consult your doctor.
Contraindications for use
- children under 3 years of age;
- hypersensitivity to benzydamine or other components of the drug.
Carefully:
- hypersensitivity to acetylsalicylic acid or other NSAIDs;
- bronchial asthma (including history).
Use in children
The use of the drug in children under 3 years of age is contraindicated.
Restrictions for children
Use with caution
Use during pregnancy and breastfeeding
Animal data on effects during pregnancy and breastfeeding are insufficient, adequate and well-controlled studies have not been conducted in pregnant women, and it is unknown whether benzydamine passes into breast milk, therefore the potential risk to humans cannot be determined. .
During pregnancy and breastfeeding, Oralcept® is used only after consultation with your doctor, if the expected benefit to the mother outweighs the potential risk to the fetus and child.
Restrictions when breastfeeding
Use with caution
Restrictions during pregnancy
Use with caution
Storage conditions
The drug should be stored out of the reach of children at a temperature not exceeding 25°C.
Terms of sale
The drug is available without a prescription.
special instructions
When using the drug Oralcept®, hypersensitivity reactions may develop. In this case, it is recommended to stop 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 symptoms persist for more than 3 days.
The use of Oralcept® is not recommended in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs.
The drug Oralcept® should be used with caution in patients with bronchial asthma, because bronchospasm may develop.
Avoid getting the spray in your eyes. If the spray gets into your eyes, rinse them with plenty of water.
Impact on the ability to drive vehicles and machinery
The drug does not affect the ability to drive a car or perform potentially dangerous activities that require increased concentration and speed of psychomotor reactions, or other activities that require increased attention.
Side effect
Classification of the frequency of side effects according to WHO: very often (≥1/10), often (from ≥1/100 to <1/10), infrequently (from ≥1/1000 to <1/100), rarely (from ≥1/100) 10,000 to <1/1000), very rare (<1/10,000), frequency unknown (cannot be estimated from available data).
Within each group, side effects are presented in decreasing order of severity.
Local reactions: rarely - dry mouth, burning sensation in the oral cavity; frequency unknown – feeling of numbness in the mouth.
Allergic reactions: uncommon – photosensitivity; rarely - sensitivity reactions, skin rash, itching; very rarely - angioedema, laryngospasm; frequency unknown - anaphylactic reactions.
Oralcept spray for topical use dosage 30ml
Compound
Active substance: benzydamine hydrochloride 0.255 mg.
Excipients: methyl parahydroxybenzoate - 0.17 mg, ethanol 96% - 17 mg, glycerol (glycerol) - 8.5 mg, peppermint flavor 27198/14 - 0.17 mg, sodium saccharinate - 0.0408 mg, polysorbate 60 - 0.0085 mg, 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 µl.
Pharmacokinetics
When applied topically, it is well absorbed through mucous membranes and quickly penetrates into inflamed tissues. Found in blood plasma in quantities insufficient to produce systemic effects. It is excreted mainly by the kidneys and through the intestines in the form of metabolites or conjugation products.
Indications for use
Symptomatic treatment 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 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 requiring systemic treatment, Oralcept® is used as part of combination therapy.
Contraindications
- Children under 3 years of age;
- hypersensitivity to benzydamine or other components of the drug.
Carefully:
- hypersensitivity to acetylsalicylic acid or other NSAIDs;
- bronchial asthma (including history).
Directions for use and doses
Apply topically. One dose of 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/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; for odonto-dental pathology - from 6 to 25 days; after surgical interventions and injuries (tonsillectomy, jaw fractures) - from 4 to 7 days.
When using the drug for a long time, consult a doctor.
Directions for use
1. Holding the bottle vertically, lift the cap nozzle at an angle of 90° to the bottle (Figure 1).
2. Insert the nozzle into the oral cavity and press the cap (marked with an arrow in Fig. 2) 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 (Fig. 3).
Attention: before the first use, press the sprayer several times, pointing it into the air.
Fig 1.
Fig.2
Fig 3.
Do not exceed the recommended dose. Consult your physician before use.
Storage conditions
The drug should be stored out of the reach of children at a temperature not exceeding 25°C.
Best before date
4 years. Do not use after the expiration date.
special instructions
When using the drug Oralcept®, hypersensitivity reactions may develop. In this case, it is recommended to stop 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 symptoms persist for more than 3 days.
The use of Oralcept® is not recommended in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs.
The drug Oralcept® should be used with caution in patients with bronchial asthma, because bronchospasm may develop.
Avoid getting the spray in your eyes. If the spray gets into your eyes, rinse them with plenty of water.
Description
Non-steroidal anti-inflammatory drug.
Use in children
The use of the drug in children under 3 years of age is contraindicated.
Pharmacodynamics
Benzydamine hydrochloride is an NSAID, an indazole derivative, without a carboxyl group. The absence of a carboxyl group gives the following features: benzydamine is a weak base (whereas most NSAIDs are weak acids), has high lipophilicity, penetrates well into the site of inflammation along the pH gradient (where the pH is lower) and accumulates in therapeutic concentrations.
It has an anti-inflammatory and local analgesic effect, has an 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 nonspecific endogenous damaging factors.
Benzidamine suppresses the production of pro-inflammatory cytokines, especially tumor necrosis factor-alpha (TNF-α), and to a lesser extent interleukin-1β (IL-1β). The main feature of benzydamine is that while it is a weak inhibitor of prostaglandin synthesis, it demonstrates potent inhibition of proinflammatory cytokines. For this reason, benzydamine may be classified as a cytokine-suppressing 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 algogenic 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 at the site of inflammation.
Benzidamine has an antibacterial effect due to rapid penetration through the membranes of microorganisms with subsequent damage to cellular structures, disruption of metabolic processes and the function of cell lysosomes.
It has an antifungal effect 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.
Side effects
Classification of the frequency of side effects according to WHO: very often (≥1/10), often (from ≥1/100 to <1/10), infrequently (from ≥1/1000 to <1/100), rarely (from ≥1/100) 10,000 to <1/1000), very rare (<1/10,000), frequency unknown (cannot be estimated from available data).
Within each group, side effects are presented in decreasing order of severity.
Local reactions: rarely - dry mouth, burning sensation in the oral cavity; frequency unknown – feeling of numbness in the mouth.
Allergic reactions: uncommon – photosensitivity; rarely - sensitivity reactions, skin rash, itching; very rarely - angioedema, laryngospasm; frequency unknown - anaphylactic reactions.
Use during pregnancy and breastfeeding
Animal data on effects during pregnancy and breastfeeding are insufficient, adequate and well-controlled studies have not been conducted in pregnant women, and it is unknown whether benzydamine passes into breast milk, therefore the potential risk to humans cannot be determined. .
During pregnancy and breastfeeding, Oralcept® is used only after consultation with your doctor, if the expected benefit to the mother outweighs the potential risk to the fetus and child.
Interaction
Drug interactions have not been studied.
No pharmaceutical incompatibility of Oralcept® with other drugs has been established.
Overdose
To date, no cases of overdose of Oralcept® have been reported. However, it is known that benzydamine, if accidentally ingested in a high dose (hundreds of times higher than the therapeutic dose), especially in children, can cause agitation, convulsions, tremors, increased sweating, ataxia and vomiting.
Treatment: acute overdose requires immediate gastric lavage, restoration of water and electrolyte balance, symptomatic therapy, and adequate rehydration. If the patient has taken more than the recommended dose, the mouth should be rinsed with plenty of water. If adverse reactions occur, you should consult your doctor.
Impact on the ability to drive vehicles and operate machinery
The drug does not affect the ability to drive a car or perform potentially dangerous activities that require increased concentration and speed of psychomotor reactions, or other activities that require increased attention.
Oralsept®
Benzydamine hydrochloride is a non-steroidal anti-inflammatory drug, an indazole derivative, 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 site of inflammation along the pH gradient (where the pH is lower) and accumulates in therapeutic concentrations.
It has an anti-inflammatory and local analgesic effect, has an 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 nonspecific endogenous “damaging” factors. Benzidamine suppresses the production of proinflammatory cytokines, especially tumor necrosis factor-α (TNF-α), and to a lesser extent interleukin-1β (IL-1β). The main feature of benzydamine is that, being a weak inhibitor of prostaglandin synthesis, it demonstrates powerful inhibition of proinflammatory cytokines. For this reason, benzydamine can be classified as a cytokine-suppressing 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 algogenic 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 at the site of inflammation.
Benzidamine has an antibacterial effect due to rapid penetration through the membranes of microorganisms with subsequent damage to cellular structures, disruption of metabolic processes and cell lysosomes.
It has an antifungal effect 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.
