Septolete Plus - Instructions For Use, Price, Spray, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Septolete plus

Septolete plus: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. For violations of liver function
12. 12. Use in the elderly
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Septolete Plus

ATX code: R02AA

Active ingredient: benzocaine + cetylpyridinium chloride (benzocaine + cetylpyridinium chloride)

Manufacturer: KRKA (Slovenia)

Description and photo updated: 22.11.2018

Prices in pharmacies: from 376 rubles.

Buy

Septolete plus is a combined local anesthetic and antiseptic drug used to treat infectious and inflammatory lesions of the throat and oral cavity.

Release form and composition

Dosage forms of Septolete plus:

• dosed spray for topical use: clear, colorless or pale yellow solution [30 ml (160 doses) in a high density polyethylene bottle equipped with a dosing device (pump) with a spray head and applicator tube, and a colored protective cap; in a cardboard box 1 bottle];
• honey-lime lozenges / lozenges: biconvex, round, with a smooth surface, coated with a dark yellow (honey-lime) or blue shell (9 lozenges in a blister, 2 blisters in a cardboard box).

Composition of 1 ml / spray dose:

• active ingredients: cetylpyridinium chloride (in the form of monohydrate) - 2 / 0.3 mg, benzocaine - 10 / 1.5 mg, respectively;
• additional components: peppermint leaves oil, sodium saccharinate, ethanol 96%, glycerol, water.

The dose of the agent released with 1 press on the spray head is 0.15 ml (150 mg).

Composition of 1 honey-lime lozenge / lozenge:

• active ingredients: cetylpyridinium chloride (in the form of monohydrate) - 1 mg, benzocaine - 5 mg;
• additional components: peppermint leaves oil, mannitol, maltitol liquid (dry matter), levomenthol, colloidal silicon dioxide, castor oil (castor bean seed oil), glycerol, magnesium stearate, titanium dioxide (E 171), povidone, capol 600 pharma (carnauba wax, white beeswax, shellac), maltitol, additionally for lozenges - patented blue dye V (E 131), for honey-lime lozenges - lime and honey flavors, quinoline yellow dyes (E 104), caramel (E 150a) and red charming (E 129).

Pharmacological properties

Pharmacodynamics

Septolete plus is a combined preparation with antiseptic and local anesthetic properties characteristic of its active components.

Cetylpyridinium chloride is an antiseptic with antifungal, antimicrobial and virucidal action.

Benzocaine is a local anesthetic that reduces the intensity of pain when swallowing, which often occurs against the background of infectious and inflammatory processes in the mouth and throat.

Lozenges (including honey-lime) contain polyols (mannitol and maltitol) and do not include (like a spray) sucrose, which makes it possible to use both forms of the drug in patients with diabetes. The presence of a sugarless medium enhances the activity of the antiseptic.

Pharmacokinetics

Cetylpyridinium chloride, which is a quaternary ammonium compound, is absorbed only by 10–20%. The non-absorbed part of the agent is excreted unchanged through the intestines.

Because benzocaine is poorly soluble in water, absorption is minimal. In the predominant amount, the absorbed benzocaine is hydrolyzed by plasma cholinesterase, and only a small part of it is metabolized in the liver. The metabolites are excreted by the kidneys.

Indications for use

According to the instructions, Septolete plus is recommended for the treatment of the following infectious and inflammatory diseases of the throat and oral cavity (in order to relieve pain):

• laryngitis, pharyngitis; tonsillitis - for a spray, the initial stage of acute tonsillitis (tonsillitis) - for lozenges (including honey-lime);
• inflammation of the gums and oral mucosa (stomatitis, gingivitis).

Contraindications

Absolute:

• age up to 6 years - for all lozenges, up to 18 years - for spray;
• lactase deficiency, fructose intolerance, hereditary galactosemia, fructose intolerance - for honey-lime lozenges / lozenges (as they contain liquid maltitol and mannitol);
• methemoglobinemia and alcohol dependence - for the spray;
• hypersensitivity to any of the constituents of the drug, as well as (for the spray) to local anesthetic drugs in history.

Relative (Septolete plus should be used with caution):

• open wounds in the mouth (since cetylpyridinium chloride slows down their healing);
• diabetes mellitus (for honey-lime lozenges / lozenges).

Additional relative contraindications for the spray (due to the increased risk of methemoglobinemia, it is required to use the drug only after consulting a specialist):

• diseases of the brain, traumatic brain injury;
• liver and / or cardiovascular disease;
• bronchitis, bronchial asthma and other respiratory diseases;
• smoking;
• elderly age.

Instructions for use Septolete plus: method and dosage

Spray

Septolete Plus spray is used topically. During each procedure, it is recommended to make 2 sprays (0.3 ml), injecting the drug every 2-3 hours, but no more than 8 times a day. The spray should not be used for more than 7 days in a row.

Before the first injection of the drug or in the case when it has not been used for a long time, it is required to carry out 5-9 presses on the spray head and release a small amount of the drug to achieve a uniform spray.

Before carrying out the procedure, remove the protective cap from the bottle, and then, opening your mouth wide and holding your breath, direct the applicator tube into the oral cavity and press the atomizer head.

After each injection of the spray, the nebulizer is closed with a cap.

One bottle of the drug is intended for individual use only.

Lozenges / pastilles honey-lime

Septolete plus lozenges must be absorbed in the mouth until completely dissolved. The drug should not be taken immediately before meals.

Recommended dosage regimen, taking into account the patient's age:

• children 6-12 years old: 1 pc. every 4 hours, but not more than 4 pcs. per day;
• children over 12 years old and adults: 1 pc. every 2-3 hours, but no more than 8 pcs. per day.

Both dosage forms of Septolete plus should not be used simultaneously with milk intake, since the latter weakens the antimicrobial effect of cetylpyridinium chloride.

Side effects

For pastilles (including honey-lime):

• digestive system: rarely - diarrhea, abdominal pain, nausea;
• immune system: extremely rare - allergic reactions.

For spray:

• blood and lymphatic system: rarely - methemoglobinemia;
• nervous system: with an unknown frequency - numbness of the oral mucosa and pharynx;
• immune system: infrequently - hypersensitivity reactions in the form of skin rash, itching, swelling of the skin, shortness of breath (in persons with hypersensitivity to benzocaine, the risk of a cross-sensitivity reaction to procaine, tetracaine and other 4-aminobenzoic acid esters is aggravated, prolonged use of benzocaine in high doses may increase the likelihood of developing severe allergic reactions);
• digestive system: gastrointestinal disorders (especially when using excessively high doses), burning sensation in the mouth and throat, difficulty swallowing.

Overdose

Given the low concentrations of active substances in Septolet, plus the likelihood of overdose is minimal. If you use too high doses of the drug, diarrhea, nausea and vomiting may develop.

Against the background of long-term use of Septolet plus in doses exceeding the recommended ones, or frequent use with a short time interval, the threat of methemoglobinemia increases. Symptoms of this complication can be observed as early as 45-60 minutes after taking the spray. Depending on the oxidation state of hemoglobin, such disorders may occur: headache, weakness, fatigue, cyanosis, shortness of breath; in the case of severe methemoglobinemia, palpitations, arrhythmias, convulsions, coma.

Cetylpyridinium chloride can cause nausea and vomiting due to irritation of the gastrointestinal mucosa.

In case of severe intoxication, it is required to wash the stomach, take activated charcoal, inhale oxygen and consult a doctor.

special instructions

In the case of severe infectious processes occurring with headache, vomiting and fever, it is necessary to consult a specialist, especially if there is no improvement in the condition within 3 days of using Septolete plus.

Spray

The drug must not be inhaled.

Beware of contact with the mucous membrane of the eyes.

Within 1 hour after the administration of the spray, it is recommended to stop eating food, drinks, chewing gum, as well as brushing your teeth, as the drug can provoke a burning sensation / numbness of the oral mucosa and difficulty swallowing (with possible biting of the tongue / lips).

Spray Septolete Plus includes a small amount of ethanol 96%: in a single dose of 2 sprays - 99 mg, in the maximum daily dose - 792 mg.

Lozenges / pastilles honey-lime

In case of gastrointestinal disorders, the drug should be discontinued.

Do not take Septolete Plus in doses exceeding the recommended dosages.

Polyols (maltitol, mannitol), which are part of the product, in large quantities can lead to diarrhea, especially in children.

Diabetic patients need to know that each lozenge contains approximately 1000 mg of maltitol. Insulin is necessary for the metabolic transformation of this component, but due to slow hydrolysis and low absorption in the gastrointestinal tract, maltitol has a slight effect on blood glucose levels, as a result of which there is no need to change the dosage of hypoglycemic agents.

Influence on the ability to drive vehicles and complex mechanisms

Septolete plus in the form of lozenges does not adversely affect the ability to drive vehicles and other complex equipment. There is no information on the effect of the spray on concentration and speed of psychomotor reactions.

Application during pregnancy and lactation

Due to the fact that data on the use of Septolete plus during pregnancy and lactation are limited, it is not recommended for pregnant and lactating women to use the drug.

Pediatric use

Reception of honey-lime lozenges / lozenges for children under 6 years of age and a spray is contraindicated for children and adolescents under 18 years of age (due to the lack of data confirming the effectiveness and safety of using the drug).

For violations of liver function

In the presence of liver disease, the spray is recommended to be used with caution.

Use in the elderly

Elderly people should use Septolete Plus spray with caution.

Drug interactions

• cholinesterase inhibitors, non-narcotic analgesics: the effect of benzocaine increases;
• sulfonamides: the antibacterial activity of these agents decreases under the influence of benzocaine.

There is no information on drug interactions of cetylpyridinium chloride with other substances / drugs.

Analogs

The analogue of Septolete plus is Septolete total.

Terms and conditions of storage

Keep out of the reach of children at a temperature not exceeding 25 ° C.

The shelf life is 3 years. After opening the spray bottle, the drug must be used for 3 months.

Terms of dispensing from pharmacies

Available without a prescription.

Reviews about Septolet plus

Most of the reviews about Septolet Plus are positive. Patients who have used the drug note that it quickly and effectively relieves pain and sore throat. The effect of the remedy is especially noticeable at the first symptoms of the disease in combination with other drugs.

The disadvantages of the spray, patients include its side reactions, mainly numbness of the oral mucosa and pharynx, as well as contraindications for admission. Also, many people note the short applicator tube that is inconvenient to use. The main disadvantage of lozenges, according to reviews, is the presence of a large number of dyes in their composition. Many reviews indicate that the Septolete plus effect is too short.

Price for Septolet plus in pharmacies

The approximate price for Septolet Plus spray for topical application can range from 280 to 390 rubles per bottle containing 30 ml. The reliable price for Septolet Plus in the form of lozenges is unknown, since the drug is currently not available in pharmacies.

Septolete plus: prices in online pharmacies

Drug name Price Pharmacy

Septolete plus 1.5 mg + 0.3 mg / dose spray for topical application, dosed 30 ml 1 pc. 376 r Buy

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!