Oralcept

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.

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.

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.

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.

ATX code: A01AD02 (Benzydamine) Active substance: benzydamine Rec.INN registered by WHO Dosage form ORALSEPT® spray for topical approx. dosed 0.255 mg/1 dose: 30 ml (176 doses) containers reg. No.: LP-002669 dated 10.22.14 - Active Release form, composition and packaging Spray for topical use, dosed, transparent, yellow-green in color, with the aroma of peppermint.

1 dose benzydamine 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 sugarinata - 0.0408 mg, polysorbate 60 - 0.0085, sodium hydr Ciclobonate - 0.0034 mg, dye of hyinolnic yellow 70 (E104) - 0.0034 mg, indigotine dye 85% (E132) - 0.00017 mg, purified water - up to 170 µl.

30 ml (176 doses) - plastic containers (1) with a dispenser and folding tip - cardboard packs.

Clinical and pharmacological group: NSAIDs for local use in ENT practice and dentistry Pharmaco-therapeutic group: NSAIDs Pharmacological action 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: benzydamine is a weak base (whereas most NSAIDs are weak acids), has high lipophilicity, along a pH gradient it penetrates well into the site of inflammation (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.

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 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.

Pharmacokinetics: When applied topically, it is well absorbed through the mucous membranes and quickly penetrates into inflamed tissues; it is found in the blood plasma in an amount insufficient to obtain systemic effects. It is excreted mainly by the kidneys and through the intestines in the form of metabolites or conjugation products.

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.

ICD-10 codes ICD-10 code Indication B37.0 Candidal stomatitis J02 Acute pharyngitis J03 Acute tonsillitis J04.0 Acute laryngitis J31.2 Chronic pharyngitis J35.0 Chronic tonsillitis J37.0 Chronic laryngitis K05 Gingivitis and periodontal diseases K11 Salivary gland disease K12 Stomatitis and related lesions R07.0 Sore throat

Dosage regimen: Applied 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 a 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.

A 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, jaw fractures): from 4 to 7 days.

When using the drug for long periods, consult a doctor.

Directions for use:

Read also: Glycised Max tablets 30 pcs.

1. Holding the bottle vertically, lift the cap tip at a 90° angle 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 presses must be at least 5 seconds.

3. Return the nozzle to its original position.

Attention: Before first use, press the sprayer into the air several times.

Do not exceed the recommended dosage. Consult your physician before use.

Side effects Local reactions: dry mouth, numbness, burning sensation in the oral cavity.

Allergic reactions: hypersensitivity reactions, including skin rash, itching, urticaria, photosensitivity, angioedema, anaphylactic reactions.

Other: laryngospasm.

If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Contraindications for use: hypersensitivity to benzydamine or other components of the drug,

- children under 3 years of age.

Carefully

- hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs,

- bronchial asthma (including history).

Use in Pregnancy and Lactation There is insufficient animal data regarding effects during pregnancy and breastfeeding, and there are no adequate and well-controlled studies in pregnant women; in addition, 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.

Use in children The use of the drug in children under 3 years of age is contraindicated.

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. Children over 12 years of age are prescribed 4-8 doses 2-6 times/day.

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 three days. The use of Oralcept® is not recommended in patients with hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. Oralcept® should be used with caution in patients with bronchial asthma, because in this case, 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, perform potentially dangerous activities that require increased concentration and speed of psychomotor reactions, or other activities that require increased attention.

Overdose To date, no cases of overdose with 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. Such an acute overdose requires immediate gastric lavage, restoration of water and electrolyte balance, symptomatic treatment, and adequate hydration.

If you take more than the recommended dose, rinse your mouth with plenty of water; if any adverse reactions occur, consult your doctor.

Drug interactions Not studied. No pharmaceutical incompatibility of Oralcept® with other drugs has been established.

Conditions for dispensing from pharmacies The drug is approved for use as an over-the-counter product. Conditions and periods of storage The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Shelf life: 4 years.

Do not use after the expiration date.

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: 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 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 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.