ULTRAKAIN D-S FORTE SOLUTION CARTRIDGE 1.7 ML

Trade name of the drug:

Ultracain® D-S Forte. INN or grouping name: artikain + epinephrine and. Dosage form: injection.

Composition

1 ml of solution contains: active substances: articaine hydrochloride - 40 mg and epinephrine hydrochloride - 0.012 mg (equivalent to the base content of epinephrine - 0.010 mg, which corresponds to the content of epinephrine in a solution of 1: 100,000); excipients: sodium disulfite (sodium metabisulfite), sodium chloride, water for injection.

Transparent colorless liquid.

local anesthetic agent + alpha and beta adrenomimetic.

Pharmacology

Pharmacodynamics

The drug Ultracain® D-S forte, used for natural infiltration and conduction anesthesia in tomato, is a combination drug, which includes articaine (amide-type local anesthetic contingency) and epinephrine (adrenaline) a vasoconstrictor). Epinephrine is added to the rest of the drug to prolong the action of non-aesthesia.

Artikain has a local anesthetic effect due to the blockade of potential-dependent sodium channels in the cell membrane of neurons, which leads to a reversible inhibition of the conduction of impulses along the nerve fiber and a reversible loss of sensitivity.The drug Ultracain® D-C Forte has a fast (latency period from 1 to 3 min) and a strong anesthetic effect and has good tissue tolerance. The duration of anesthesia is at least 75 minutes.

Children

In a clinical study involving 210 children aged from 3.5 to 16 years, the use of Ultracain® DR-Forte at a dose of 7 mg / kg body weight provided a sufficient local anesthetic effect during mandibular infiltration or maxillary conduction anesthesia. The duration of anesthesia was comparable in all age groups and depended on the amount of the drug administered.

Artikain is rapidly and practically immediately after administration, it is metabolized (by hydrolysis) by nonspecific plasma esterases in tissues and blood (90%);

the remaining 10% of the dose of articaine is metabolized by microsomal liver enzymes. The articaine's main metabolite, articaic acid, which is formed during this process, does not have local anesthetic activity and systemic toxicity, which allows repeated administration of the drug.

The concentration of articaine in the blood in the area of ​​the alveoli of the tooth after submucosal administration is hundreds of times higher than the concentration of articaine in the systemic circulation. The binding of articaine to plasma proteins is approximately 95%.

Artikain is excreted through the kidneys, mainly in the form of articaic acid.After submucosal administration, the half-life is approximately 25 minutes.

Artikain penetrates the placental barrier, practically does not stand out with breast milk.

Indications and usage

It is indicated for local anesthesia (infiltration and conduction anesthesia) in dentistry during traumatic interventions and, if necessary, pronounced hemostasis or improvement of visualization of the surgical field: dental operations on the mucous membrane or bones, which require the creation of more pronounced ischemia; operations on the dental pulp (amputation or extirpation); removal of a broken tooth (osteotomy) or a tooth affected by apical periodontitis; long surgical interventions; percutaneous osteosynthesis; excision of cysts; interventions on the gingival mucosa; resection of the apex of the tooth root.

Contraindications

- Hypersensitivity to articaine or to other local anesthetic agents of the amide type, except for cases when allergy to articuin was excluded with hypersensitivity to the local anesthetic agents of the amide type using appropriate studies conducted in compliance with all necessary rules and requirements.

- Hypersensitivity to epinephrine.

- Hypersensitivity to sulfites (in particular, in patients with asthma and hypersensitivity to sulfites, since the development of acute allergic reactions is possible,such as bronchospasm) and any other auxiliary components of the drug.

Contraindications

- Severe sinus dysfunction or severe conduction disturbances (such as severe bradycardia, atrioventricular block 2nd or 3rd degree).

- Acute decompensated heart failure.

- Severe arterial hypotension.

- Children's age up to 4 years (lack of sufficient clinical experience).

Contraindications

- Paroxysmal tachycardia, tachyarrhythmia.

- Recently transferred (3-6 months ago) myocardial infarction.

- Recently conducted (3 months ago) coronary artery bypass surgery.

- Simultaneous use of non-cardio selective beta-blockers, for example, propranolol (risk of hypertensive crisis and severe bradycardia).

- angle-closure glaucoma.

- Hyperthyroidism.

- Pheochromocytoma.

- Severe arterial hypertension.

- In patients with chronic heart failure, coronary heart disease, angina pectoris, atherosclerosis, history of myocardial infarction, cardiac arrhythmias, arterial hypertension.

- In patients with cerebrovascular disorders, history of stroke.

- In patients with chronic bronchitis, emphysema.

- In patients with diabetes mellitus (potential risk of changes in glucose concentration in the blood).

- In patients with cholinesterase deficiency (use is possible only if absolutely necessary, since prolongation and a pronounced increase in the action of the drug are possible).

- In patients with bleeding disorders.

- In patients with severe impaired liver and kidney function.

- In patients with marked arousal.

- In patients with epilepsy in history.

- When combined with halogen-containing agents during inhalation anesthesia (see section "Interaction with drugs").

Pregnancy and Breastfeeding

Pregnancy

Artikain and epinephrine penetrate the placental barrier.

The concentration of articaine in the serum of newborns (after administration of the drug to the mother) is approximately 30% of the concentration of articaine in the serum of the mother.

Due to the lack of clinical data, the decision on the use of the drug by the dentist can be made only if the potential benefit of its use for the mother justifies the potential risk to the fetus. If you need to use articaine during pregnancy, it is better to use drugs that do not contain epinephrine, or with a lower concentration of epinephrine (that is, drugs Ultrakain® D and Ultrakain® DS-C). In case of accidental intravascular administration, epinephrine may reduce the blood supply to the uterus.

With short-term use of the drug during the breastfeeding period, as a rule, it is not necessary to interrupt breastfeeding, since no clinically significant concentrations of articaine and epinephrine are found in breast milk.

Fertility

In animal studies using articaine 40 mg / ml and epinephrine 0.01 mg / ml, no effect on fertility was observed in males and females. No effect on fertility in humans is expected when therapeutic doses of articaine and epinephrine are used.

The drug is intended for use in the oral cavity and can be administered only in tissues where there is no inflammation.

Impact on ability to drive vehicles and engage in other potentially hazardous activities

The decision about when the patient after dental surgery can return to driving and other potentially hazardous activities that require increased concentration and psychomotor speed must be taken by a doctor.

Storage conditions

Ampoules

At a temperature not higher than 25 ° С in the place protected from light.

Cartridges

At a temperature not higher than 30 ° C in a dark place.

Keep the drug out of the reach of children.

List B.

Shelf life Ampoules - 36 months.

Cartridges - 30 months.

After the expiration date of the drug can not be used.

Vacation conditions

Prescription