Xerodent - instructions for use, dose, side effects, contraindications

Active substanceSodium Fluoride + Malic AcidSodium Fluoride + Malic Acid

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Xerodent

pills inwards

AKTAVIS, LTD. Russia

Dosage form: & nbsplozenges

Composition:

1 tablet for resorption contains:

Active substances: sodium fluoride - 0.5525 mg (in terms of fluoride - 0.25 mg), malic acid - 28.6 mg.

Excipients: xylitol 421.5 mg, povidone 15.9 mg, sodium hydrogen phosphate dihydrate 61.4 mg, macrogol 6000 - 60.0 mg, orange flavor 3.0 mg, sodium stearyl fumarate 6.0 mg, silicon dioxide colloid 3.0 mg .

Description:

Round biconvex tablets are white with the smell of orange.

Pharmacotherapeutic group:Fluorine preparation

ATX: & nbsp

A.01.A.A.01 Sodium Fluoride

Pharmacodynamics:

Sodium fluoride is a caries preventative. Fluorine ions directly affect the processes of mineralization of hard tooth tissues during their development. Additional introduction of fluorine provides the formation in the tissues of teeth the most stable form of apatite - fluoroapatite. In addition, fluoride helps reduce cariogenic activity of plaque, inhibits the formation of lactic acid from carbohydrates.

The drug contains malic acid, which due to acid taste stimulates salivation. Increased salivation along with fluoride may have an additional caries prophylactic effect. The pH of the tablets is selected in such a way that no demineralization of the fluoroapatite occurs.

Pharmacokinetics:

Sodium Fluoride

Fluoride is released from the tablet during its resorption. Absorption from the gastrointestinal tract with oral administration - 93-97%. Time to reach the maximum concentration in blood plasma - 4 hours. At any dose of 50% of the fluoride that is received accumulates in the hard tissues of the tooth and bone tissue. Accumulation in organs or soft tissues is not observed. Excreted mainly by the kidneys, about 10% - through the intestine (not involved in the process of formation of bone tissue fluoride).

Apple acid

Apple acid is almost completely absorbed from the gastrointestinal tract, is metabolized and excreted by the kidneys.

Indications:

- Symptomatic treatment of dryness of the oral cavity and elimination of feelings of discomfort caused by insufficient saliva secretion.

- Prevention of caries in patients suffering from xerostomia.

Contraindications:

- Hypersensitivity to the active substances of the drug or to any of the excipients;

- hypothyroidism;

- peptic ulcer of the stomach and duodenum (in the stage of exacerbation);

- hepatic and / or renal insufficiency;

- children's age till 12 years;

- pregnancy, lactation;

- living in an area with sufficient fluorine content in drinking water (more 0.8 mg / l).

Carefully:

When the content of natural fluoride in drinking water is more than 0.75 mg / l.

Pregnancy and lactation:

There is no data on the effect of Xerodent on the fetus and the baby in pregnant and lactating women, so you should refrain from taking it during pregnancy and lactation.

Dosing and Administration:

Inside.

The tablet should be resorbed until it is dissolved in the mouth.

Adults and children over 12 years of age: 6 tablets a day at regular intervals. In adults with pronounced symptoms of dry mouth or with the development of caries, the dose can be increased to 12 tablets per day.

The daily dose should be taken regularly throughout the day.

The maximum daily dose is 16 tablets per day.

The course of treatment with Xerodent is individual for each patient and depends on the cause of xerostomia. >

You should seek medical advice if there is no improvement in the condition 7 days after the beginning of taking the drug or it worsens.

Side effects:

As a rule, the drug Xerodent is well tolerated when taken in the recommended doses.

Disorders from the gastrointestinal tract: nausea, vomiting, decreased appetite, diarrhea.

Disturbances from the nervous system: increased fatigue, headache.

Allergic reactions: rhinitis, eosinophilia, skin rash.

Other: ossification of the attachment sites of tendons and ligaments, hypothyroidism (with prolonged use), fluorosis (disruption of the formation and calcification of the enamel, the appearance of yellow, brown spots, speckles, increased brittleness and abrasion of the teeth).

Overdose:

Symptoms: an overdose with prolonged admission may lead to the development of fluorosis (daily dose of more than 0.2-0.4 mg / kg). In acute overdose, there are mainly reactions from the gastrointestinal tract (nausea, vomiting, diarrhea, abdominal pain), lacrimation, hypersalivation, decreased appetite, pain in the lower extremities, arthralgia, fatigue, miosis, visual impairment, weakness, myasthenia gravis, tremor, seizures, fever, tachycardia, lowering blood pressure, respiratory failure, stopping breathing.

Treatment: the introduction of large amounts of liquid and calcium (a solution of calcium gluconate or calcium lactate, milk) to precipitate fluorides; gastric lavage with acidified water or 1% solution of sodium chloride, the appointment of salt laxatives (30 grams of sodium sulfate), intravenous electrolytes (10-20% calcium gluconate solution), vitamins; symptomatic therapy, control of calcium concentration in the blood; hemodialysis.

Interaction:

With simultaneous administration of calcium, magnesium and aluminum containing preparations, fluoride absorption is slowed down (poorly soluble compounds are formed).

Retinol and Vitamin D contribute to the development of ectopic calcification.

Special instructions:

Do not exceed recommended doses and follow the instructions of your doctor.

You should consider the additional intake of fluoride in the body with other drugs and nutritional supplements.

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

The X-ray does not affect the ability to drive or operate machinery.

Form release / dosage:

Lozenges.

Packaging:For 90 or 270 tablets in a container of high-density polyethylene. 1 container in a cardboard box with instructions for use.

Storage conditions:

At a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

2 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-001369

Date of registration:19.12.2011

Expiration Date:19.12.2016

The owner of the registration certificate:AKTAVIS, LTD. AKTAVIS, LTD. Russia

Manufacturer: & nbsp

ALLPHAMED PHARBIL ARZNEIMITTEL, GmbH Germany

Representation: & nbspAktavis, Open Company Aktavis, Open Company

Information update date: & nbsp05.02.2018

Illustrated instructions

Instructions

Xerodent (Xerodent)