Dexadent

Package Leaflet: Information for the User

DEXADENT, (10 mg + 25 mg + 2.5 mg)/g, paste

(Dexamethasone acetate + Framycetin sulfate + Polymyxin B sulfate)

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is DEXADENT and what is it used for
• 2. Important information before using DEXADENT
• 3. How to use DEXADENT
• 4. Possible side effects
• 5. How to store DEXADENT
• 6. Contents of the pack and other information

1. What is DEXADENT and what is it used for

DEXADENT is a paste for application to the teeth, to the root canal.
DEXADENT is indicated for the treatment of pulp diseases and periapical tissues.
Pulp diseases: deep caries without symptoms from the pulp, pulpitis, acute serous pulpitis.
Periapical tissue diseases: acute and chronic exacerbated.
Pharmacotherapeutic group: digestive tract and metabolism, stomatological preparations, preparations for local oral use, others, ATC code: A 01 AD.

Pharmacodynamic Properties

DEXADENT paste contains active substances with different, complementary mechanisms of action. Such a combination of paste components determines its anti-inflammatory, anti-infective, and anti-allergic effects, resulting in a beneficial strong analgesic effect.
DEXADENT paste exhibits combined bactericidal action of polymyxin B (mainly against Gram-negative bacteria, especially Pseudomonas aeruginosaand Enterobacteriaceae) and framycetin (against Staphylococcus spp., Enterobacteriaceae, Mycobacterium tuberculosis), while dexamethasone acts anti-inflammatory, anti-edematous, and anti-allergic.
Polymyxin B acts bactericidally on Gram-negative microorganisms several dozen times stronger than on Gram-positive bacteria. It does not act on fungi. The mechanism of action of polymyxin B involves damaging the cytoplasmic membrane of bacteria.
Framycetin (neomycin B) belongs to the group of aminoglycosides, antibiotics with a broad spectrum of action. It acts antibacterially mainly on Gram-negative microorganisms, weaker on Gram-positive ones. Sensitive are Escherichia coli, Klebsiella, Enterobacter, Proteus, Pseudomonas aeruginosa, Brucella, Neisseria, Pasteurella, and to a lesser extent, it acts on actinomycetes, spirochetes, and some fungi. It does not act on anaerobes. At lower concentrations, it acts bacteriostatically, at higher concentrations bactericidally. The mechanism of action of aminoglycosides involves inhibiting the biosynthesis of proteins and nucleic acids.
Dexamethasone is a synthetic glucocorticosteroid with a very strong and long-lasting anti-inflammatory effect, 30 times stronger than hydrocortisone. In addition, glucocorticosteroids inhibit the action of hyaluronidase, an enzyme that reduces the cohesion of connective tissue. Inhibition of hyaluronidase activity reduces the permeability of the connective tissue and causes the isolation of the inflammatory focus from the body. This affects the absorption of bacterial toxins from the inflammatory focus, hence the lack of general inflammation symptoms, such as fever.
Glucocorticosteroids also inhibit the reaction of the allergen with the antibody, thus preventing the occurrence of an allergic reaction.

Pharmacokinetic Properties

Polymyxin B sulfate, like other antibiotics from the polymyxin group, is not absorbed from the gastrointestinal tract, mucous membrane surfaces, or after application to inflamed or burned skin. Polymyxin B is excreted mainly by the kidneys; up to 60% of the dose is excreted in the urine, but this process occurs with a delay, after 12 to 24 hours.
Framycetin does not absorb after external application to the skin but may absorb after application to body cavities.
Framycetin and polymyxin B do not undergo metabolic transformations in the body.
Dexamethasone is partially metabolized in the liver to 6-hydroxydexamethasone and dexamethasone glucuronide.
Dexamethasone acetate is easily absorbed from the gastrointestinal tract after oral administration. In addition to good absorption after oral administration, glucocorticosteroids are well absorbed from local administration sites in the case of locally administered preparations.
Most glucocorticosteroids present in the blood remain bound to plasma proteins, mainly globulins, and to a lesser extent also albumins. Glucocorticosteroids are metabolized mainly in the liver, but also in other tissues; in the process of eliminating glucocorticosteroids, urinary excretion dominates.

2. Important Information Before Using DEXADENT

When Not to Use DEXADENT

• in children under 4 years of age.

Warnings and Precautions

DEXADENT should not stay in the cavity for more than 3 to 4 days, as it may lead to pulp degeneration.
DEXADENT should not stay in the canal for more than 3 to 4 days, as it may inhibit the healing of pathological changes in the periapical tissue.
You should consult a doctor if the patient experiences swelling and weight gain, particularly on the torso and face, as these are usually the first symptoms of a disease called Cushing's syndrome. Inhibition of adrenal function may occur as a result of discontinuing long-term or intensive use of DEXADENT. You should consult a doctor before the patient decides to discontinue treatment. This risk is particularly important in children and patients treated with ritonavir or cobicistat.

Use of a Larger Than Recommended Dose of DEXADENT

No cases of overdose have been reported.

DEXADENT and Other Medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Tell your doctor if you are taking ritonavir or cobicistat, as these medicines may increase the dexamethasone content in the blood.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before using this medicine.
There are no data on the safety of use in pregnant women, so the medicine should not be used in pregnant women unless necessary, after weighing the benefit to risk ratio.
The safety of use in breastfeeding women has not been established.

Driving and Using Machines

DEXADENT has no influence or negligible influence on the ability to drive and use machines.

3. How to Use DEXADENT

• In cases of pulpitis: after cleaning the carious cavity, apply a small amount of paste to the bottom of the cavity with an instrument, e.g., an explorer or a small ball burnisher, and cover with a dry cotton swab. The cavity should be tightly closed with a temporary material for a maximum of 3 to 4 days, i.e., until the acute symptoms of pulpitis subside.
• In root canal treatment: after thorough mechanical preparation of the root canal (removal of necrotic or gangrenous masses, maximum canal enlargement, flushing with a preparation intended for flushing root canals, and drying the canal), introduce the paste into the canal with a Lentulo needle and close tightly for 3 to 4 days. Pain symptoms should subside after a single application of the preparation; if the symptoms do not subside or worsen, repeat the root canal preparation.

Do not use more paste at one time than the amount obtained by squeezing a 1 cm long strip from the tube.

4. Possible Side Effects

Like all medicines, DEXADENT can cause side effects, although not everybody gets them.
In very rare cases, during the treatment of teeth with pulp diseases and deep caries, immediately after applying the paste, pain in the treated tooth may occur. This usually passes after a few minutes to two hours. If the spontaneous pain persists (which, in the case of a diagnosis of reversible pulpitis, may indicate an incorrect diagnosis), the patient should consult a doctor to apply a different treatment method.
After using DEXADENT, the following side effects may occur:
Frequency not known (cannot be estimated from the available data):
Hormonal disorders: increased hair growth on the body (especially in women), muscle weakness, and muscle mass loss, purple striae on the skin, increased blood pressure, irregular menstrual periods or amenorrhea, changes in protein and calcium levels in the body, growth inhibition in children and adolescents, and swelling and weight gain, particularly on the torso and face (Cushing's syndrome) (see section 2 "Warnings and Precautions").

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to Store DEXADENT

Store the tube tightly closed. Store in a refrigerator (2°C - 8°C). Do not freeze.
Medicines should be kept out of the sight and reach of children.
Pay attention to the expiration date of the medicine.
Do not use this medicine after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What DEXADENT Contains

The active substances of DEXADENT are dexamethasone acetate, framycetin sulfate, polymyxin B sulfate.
1 g of paste contains: 10 mg of dexamethasone acetate, 25 mg (16,500 IU) of framycetin sulfate, 2.5 mg (20,000 IU) of polymyxin B sulfate.

Other ingredients are: macrogol 400 and macrogol 4000.

What DEXADENT Looks Like and Contents of the Pack

DEXADENT is a homogeneous, white mass with a cream-gray tint.
The tube contains 5 g of paste. The tube, along with the leaflet, is placed in a cardboard box.

Marketing Authorization Holder and Manufacturer

CHEMA-ELEKTROMET
Cooperative
ul. Przemysłowa 9
35-105 Rzeszów
phone: 17 862 05 90
e-mail: [email protected]

Date of Last Revision of the Leaflet: