Ultracaine D-C forte, ampoules, 2ml, 10pcs

Composition

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1 ml of solution for injection contains:  

active ingredients:

articaine hydrochloride-40 mg and epinephrine hydrochloride-0.012 mg;

excipients:

sodium metabisulfite-0.5 mg,

sodium chloride-1 mg,

water for injection

Pharmacological action

Pharmacodynamics

Ultracaine D-S forte is a local anesthetic for infiltration and conduction anesthesia in dental practice. It has a fast action (latency period – from 1 to 3 minutes). The duration of anesthesia is at least 75 minutes.

Due to the low content of epinephrine in the drug, its effect on the cardiovascular system is expressed insignificantly: there is almost no increase in blood pressure and an increase in heart rate.

Pharmacokinetics

The binding to plasma proteins of articaine is 95%. After injection into the submucosa of the oral cavity, the elimination half-life is on average 25 minutes. The drug penetrates the placental barrier to a minimum extent, and is practically not excreted in breast milk.

Articaine is excreted primarily through the kidneys.

Indications

Infiltration and conduction anesthesia in dentistry (including in patients with concomitant severe somatic diseases):

• surgical intervention in the mucosa and bone, requiring ischemia;
• surgical intervention on the tooth pulp (the destruction and extirpation);
• removal of diseased periodontal disease and decayed teeth (osteotomy); long surgical intervention, such as surgery Caldwell-Luc, percutaneous fixation, removal of cysts, the intervention of the mucous membrane of the gums, the root apex resection, treatment of cavities and sensitive teeth grinding before prosthetics.

Contraindications

Hypersensitivity to articaine, epinephrine, or any other component of the drug. Since the drug contains epinephrine, it is contraindicated in the following cases: :

• paroxysmal tachycardia and other cardiac arrhythmias,
• angle-closure glaucoma,
• anemia (including B-12 deficiency anemia),
• methemoglobinemia,
• hypoxia.

Do not use in patients with bronchial asthma with hypersensitivity to sulfites.

Side effects

Depending on the dosage, disorders of the central nervous system may occur: blurred consciousness up to its loss, respiratory disorders up to a life-threatening stop, muscle tremor and muscle twitching up to generalized convulsions, nausea, vomiting. A drop in blood pressure and cardiac arrest can also occur when the drug is administered.

Allergic reactions can manifest themselves: in the form of swelling or inflammation at the injection site, skin hyperemia, itching, conjunctivitis, rhinitis, facial swelling (Quincke’s edema) with swelling of the upper and / or lower lip, swelling of the vocal cords with a feeling of a lump in the throat and difficulty swallowing, urticaria, difficulty breathing up to anaphylactic shock. Often there is a headache.

Other side effects caused by epinephrine-tachycardia, cardiac arrhythmias, increased blood pressure-are rare at a small concentration of 1: 200,000 (0.5 mg/100 ml).

Occasionally, with an accidental intravascular injection, areas of ischemia may appear up to tissue necrosis at the injection site.

Due to the content of sodium disulfite in some cases, patients with bronchial asthma may experience hypersensitivity reactions, manifested in the form of vomiting, diarrhea, rapid breathing, acute asthma attack, impaired consciousness or shock.

Interaction

The effect of vasoconstrictors that increase blood pressure, such as adrenomimetics, such as epinephrine, can be enhanced by tricyclic antidepressants or MAO inhibitors.

Similar observations have been reported for concentrations of 1: 25,000 norepinephrine and 1: 80,000 epinephrine as vasoconstrictors.

The concentration of epinephrine in Ultracaine D-C is significantly lower – 1: 200,000. However, it is necessary to take into account the possibilities of such strengthening of the action.

How to take, course of use and dosage

With uncomplicated removal of upper jaw teeth in the absence of inflammation,1.7 ml of Ultracaine D-S (for each tooth) is usually injected into the submucosa in the area of the transitional fold from the vestibular side.

In rare cases, an additional injection 1 ml to 1.7 ml is required to achieve complete anesthesia. A painful palatal injection can be dispensed with in most cases.

Anesthesia for palatal incisions and suturing to create a palatal depot requires about 0.1 ml of anesthetic per injection. When several adjacent teeth are removed, the number of injections can usually be limited.

In the case of removal of premolars of the lower jaw in the absence of inflammation, mandibular anesthesia can be dispensed with, since infiltration anesthesia provided by an injection of 1.7 ml per tooth is usually sufficient. If the desired effect could not be achieved in this way, an additional injection of 1-1.7 ml of anesthetic should be performed in the submucosa in the area of the transitional fold of the lower jaw from the vestibular side. If in this case it was not possible to achieve complete anesthesia, it is necessary to block the mandibular nerve.

In surgical interventions, Ultracaine D-S is dosed individually depending on the severity and duration of the intervention. When performing one treatment procedure, adults can be administered up to 7 mg of Ultracaine (articaine) per 1 kg of body weight. It was noted that patients well tolerated doses up to 500 mg (corresponding to 7 cylindrical ampoules).

Intravenous use is contraindicated! 

Do not inject into the inflamed area!

Overdose

Treatment is symptomatic.

When the first signs of side effects or intoxication appear, such as nausea, motor restlessness, or blurred consciousness during the injection, it should be interrupted, the patient should be moved to a horizontal position, clear the airway, and monitor pulse and blood pressure. It is recommended, even if the symptoms do not seem too pronounced, to provide intravenous access.

In case of respiratory disorders, depending on the severity, give oxygen, in some cases perform artificial respiration. Central analeptics are contraindicated. Muscle twitches or generalized seizures are relieved by intravenous injection of short-or ultra-short-acting barbiturates.

A drop in blood pressure, tachycardia, or bradycardia is often resolved by moving the patient to a horizontal position. In case of severe circulatory disorders and shock of any genesis after stopping the injection, emergency measures are indicated: ensuring airway patency (oxygen insufflation), intravenous fluid infusion (electrolyte solution), and glucocorticosteroids. Additionally, you can enter plasma substitutes, albumin. With threatening circulatory disorders and increasing bradycardia,0.25 ml to 1 ml of epinephrine is administered. Intravenous injection of epinephrine should be performed slowly under the control of pulse rate and blood pressure.

A single dose of intravenous injection of epinephrine should not exceed 0.1 mg, in the future, if necessary, epinephrine can be administered dropwise (the rate of infusion through the dropper is regulated depending on the pulse rate and blood pressure).

Severe forms of tachycardia and tachyarrhythmia can be eliminated by using antiarrhythmic drugs, but non-selective beta-blockers should not be used. Oxygen supply and blood circulation control are essential in any case. If blood pressure increases in patients with arterial hypertension, peripheral vasodilators should be used, if necessary.

Special instructions

In order to avoid intravascular injection, it is essential to perform an aspiration test, for which the Uniject K/Uniject K vario injection syringes are particularly suitable when using cartridges.

The injection pressure should correspond to the sensitivity of the tissue.

To prevent infections (including hepatitis), care should be taken to ensure that new sterile syringes and needles are always used every time the solution is taken from vials or ampoules. Open cartridges cannot be used again for other patients!

Do not use a damaged cartridge for injection. Maximum safety from damage to the glass and perfect functioning is ensured by the use of accessories such as syringe stands (infiltration anesthesia: Uniject K or Uniject K vario; intra-ligamentous anesthesia: Ultraject).

You can take food only when the sensitivity returns.

Form of production

Solution for injection.

Storage conditions

In a dark place, at a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Articaine, Epinephrine

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Purpose

For adults as prescribed by a doctor, for children as prescribed by a doctor

Indications

Anesthesia