Septotlet® plus (Septolete® plus)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspspray for topical use
Composition:

1 ml of spray contains:

1 dose of spray contains:

Active substances:



Benzocaine

10.00 mg

1,500 mg

Cetylpyridinium chloride monohydrate in terms of cetylpyridinium chloride

2.00 mg

0.300 mg

Excipients:



Ethanol 96%

330.00 mg

49.500 mg

Glycerol

200.00 mg

30,000 mg

Sodium saccharinate

0.90 mg

0.135 mg

Peppermint leaves

1.00 mg

0.150 mg

Water

up to 1 ml

up to 0.15 ml
1 dose of the drug is 0.15 ml (150 mg) with a single click on the spray head. There are 160 doses in the bottle.
Description:

Transparent solution from colorless to light yellow color.

Pharmacotherapeutic group:Antiseptic + local anesthetic
Pharmacodynamics:

Combined drug, has antiseptic and local anesthetic effect.

Cetylpyridinium chloride is an antiseptic that has an antimicrobial, antifungal and virucidal effect.

Benzocaine is a local anesthetic, which reduces pain when swallowing, which often accompanies infectious inflammatory processes in the mouth and throat.

Pharmacokinetics:

Cetylpyridinium chloride is poorly absorbed (only 10-20%). The non-sucked part is excreted through the intestine in an unchanged form.

Benzocaine is poorly soluble in water, so its absorption is minimal. Sucked benzocaine hydrolyzed mainly by plasma cholinesterase, a small part of it is metabolized in the liver. Metabolites are excreted by the kidneys.

Indications:

To alleviate pain in infectious and inflammatory diseases of the oral cavity and pharynx (pharyngitis, laryngitis, tonsillitis, inflammation of the gums and oral mucosa (gingivitis, stomatitis)).

Contraindications:

- Hypersensitivity to the components that make up the drug;

- increased sensitivity to local anesthetics in history;

- alcohol addiction;

- methemoglobinemia;

- age to 18 years (due to lack of data on efficiency and safety).

Carefully:Liver diseases, traumatic brain injury or brain diseases, respiratory diseases (eg, bronchial asthma, bronchitis), smoking, diseases of the cardiovascular system, elderly patients (risk of developing methemoglobinemia), the presence of open wounds of the oral cavity, t. . cetylpyridinium chloride slows healing of wounds.
Pregnancy and lactation:

Data on the use of the drug Septolet® plus in pregnancy and during breastfeeding are absent,therefore, the use of the drug during pregnancy and during breastfeeding is not recommended.

Dosing and Administration:

Locally.

In each procedure, 2 sprays (0.300 ml) are performed. It is recommended to take every 2-3 hours up to 8 times a day.

The duration of therapy is no more than 7 consecutive days.

Before the first use of the drug Sepptelet Plus, or if the spray has not been used for a long time, several times (5-9 times), press the spray head of the spray and release a certain amount of the drug until a uniform spraying occurs.

Before use, remove the colored protective cap from polypropylene.

Widely open your mouth, direct the tube of the applicator into the mouth, hold your breath and press the spray head.

After each use of the spray, cover the spray head with a colored polypropylene protective cap.

One plastic bottle of the drug Sepotlet® plus should be used by only one patient.

With a single press on the spray head, 0.15 ml of the spray solution is dispensed, which contains 1.5 mg of benzocaine and 0.3 mg of cetylpyridinium chloride.

Side effects:

Classification of the incidence of side effects recommended by the World Health Organization (WHO):

Often

> 1/10

often

from> 1/100 to <1/10

infrequently

from> 1/1000 to <1/100

rarely

from> 1/10000 to <1/1000

rarely

< 1/10000

frequency unknown

can not be estimated from the available data.

Classification of organs and systems by MedDRA

Infrequently

Rarely

Frequency

unknown

Violations of the blood and lymphatic system


Methemoglobinemia


Immune system disorders:

Reactions

hypersensitivity1 (skin rash, skin itching, swelling of the skin, difficulty breathing).



Impaired nervous system:



Numbness of the mucous membrane of the mouth and pharynx.

Disturbances from the gastrointestinal tract:


Gastrointestinal disorders2, difficulty swallowing and a feeling of "burning" in the mouth and throat.


1 in patients with increased sensitivity to benzocaine (4-aminobenzoic acid ester), it is possible to develop cross-sensitivity reactions to other 4-aminobenzoic acid esters (for example, procaine, tetracaine). Long-term use of large doses of benzocaine may increase the likelihood of severe allergic reactions.

2 especially when the recommended dose is exceeded.

If you experience any other side effects, it is recommended that you consult a doctor.

Overdose:

Symptoms: taking into account low concentrations of active components in the preparation Septotelet® Plus, the possibility of an overdose is minimal. With prolonged intake of doses exceeding recommended, or with frequent use with a small time interval, the development of methemoglobinemia is possible. If signs of intoxication appear, discontinue use immediately. Symptoms

methemoglobinemia can develop within 45 - 60 minutes after the use of the drug Sepptetha Plus. Depending on the degree of oxidation of hemoglobin can develop: headache, cyanosis, fatigue, weakness and shortness of breath. With a more severe degree of methemoglobinemia, the development of palpitations, convulsions, arrhythmias and coma is possible. When taking doses that exceed recommended, gastrointestinal disorders such as nausea, vomiting and diarrhea can develop. Cetylpyridinium chloride can cause vomiting and nausea due to irritation of the mucous membrane of the gastrointestinal tract.

Treatment: In severe cases, gastric lavage, the use of activated charcoal, and inhalation of oxygen are indicated. In severe cases, you should see a doctor.
Interaction:

Non-narcotic analgesics and cholinesterase inhibitors increase the action of benzocaine.

Benzocaine reduces the antibacterial activity of sulfonamides.

There is no data on the drug interaction of cetylpyridinium chloride with other drugs.

Special instructions:

The drug Sepotlet® plus should not be used together with milk, as milk reduces the antimicrobial activity of cetylpyridinium chloride.

Due to the increased risk of developing methaemoglobinemia, the drug Sepotlet * plus should be used with caution in patients with difficulty breathing (including bronchial asthma or bronchitis), elderly patients, smokers, and cardiovascular diseases. Therefore, such patients should use the drug Septotelet® Plus only after consulting a doctor.

The drug Sepotlet® Plus should not be used with open mouth wounds, because cetylpyridinium chloride slows healing of wounds.

In case of severe infectious processes accompanied by fever, headache and vomiting, consult a doctor, especially if the condition does not improve within three days.

It is necessary to avoid contact of the drug Septotelet® plus with the mucous membrane of the eyes. Spray can not be inhaled.

After using the drug, a temporary sensation of "burning", numbness of the oral mucosa or difficulty swallowing (swallowing

food or drink), it is possible to bite the tongue or lips. In this regard, within an hour after using the drug should refrain from eating food, drinks, chewing gum or cleaning teeth.

The drug Sepptelet® Plus (spray for topical application dosed) does not contain sucrose, so it can be used by patients with diabetes mellitus.

The drug Sepotlet® Plus contains a small amount of ethanol 96%: 0.099 g in a single dose (two sprays) and 0.792 g in a maximum daily dose. In 1 ml of the drug Sepotlet ® plus contains 0.330 g of ethanol 96%.

The drug should be used within 3 months after opening the vial.

Effect on the ability to drive transp. cf. and fur:

There is no data on the effect of Septotelet® Plus on the ability to drive vehicles and work with technical devices, which requires an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Spray for topical use dosed, 1.5 mg + 0.3 mg / dose.

Packaging:

30 ml (160 doses) of the preparation in a vial of high-density polyethylene equipped with a metering device (pump), with a spray head with an applicator tube made of a combined material and a colored protective cap made of polypropylene.

1 bottle together with the instruction for use is placed in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C, in the original packaging.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:Without recipe
Registration number:LP-002597
Date of registration:21.08.2014
Expiration Date:21.08.2019
Date of cancellation:2019-08-21
The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO
Manufacturer: & nbsp
KRKA, d.d. Slovenia
Representation: & nbspKRKA KRKA Slovenia
Information update date: & nbsp21.08.2014
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