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Brilocaine®-adrenaline (Solution) Instructions for Use

ATC Code

N01BB58 (Articaine in combination with other drugs)

Active Substances

Articaine (Rec.INN registered by WHO)

Epinephrine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Local anesthetic for use in dentistry

Pharmacotherapeutic Group

Anesthetics; local anesthetics; amides

Pharmacological Action

A combined medicinal product that exerts a local anesthetic effect.

Articaine is a local anesthetic of the amide type from the thiophene series. Its mechanism of action is due to the stabilization of neuronal membranes and the prevention of the generation and conduction of nerve impulses.

Epinephrine is an adrenomimetic. It causes vasoconstriction at the site of injection, which reduces the absorption of articaine and prolongs the duration of the local anesthetic effect.

The onset of action is 0.5-3 minutes, and the duration of action is 45 minutes.

Indications

Infiltration and conduction anesthesia (including in dentistry – tooth extraction, cavity filling, tooth preparation for crowns).

ICD codes

ICD-10 code Indication
Z51.4 Preparatory procedures for subsequent treatment or examination, not elsewhere classified
ICD-11 code Indication
QB9A Preparatory procedures for subsequent treatment

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Solution

Infiltration anesthesia: tonsillectomy (for each tonsil) – 5-10 ml; reduction of fractures – 5-20 ml; perineal suture – 5-15 ml.

Conduction anesthesia: Oberst’s anesthesia – 2-4 ml, retrobulbar – 1-2 ml, intercostal – 2-4 ml (per segment), paravertebral – 5-10 ml, peridural (epidural) – 10-30 ml, sacral – 10-30 ml, trigeminal nerve block – 1-5 ml, stellate ganglion block – 5-10 ml, brachial plexus block – 10-30 ml (supraclavicular or axillary approach), external genitalia block – 7-10 ml (per side), paracervical block – 6-10 ml (per side).

For uncomplicated extraction of upper jaw teeth in a non-inflammatory stage, inject under the mucous membrane in the area of the transitional fold – vestibular depot 1.7 ml per tooth, if necessary – additionally 1-1.7 ml; palatal incision or suture – palatal depot 0.1 ml.

For extraction of lower jaw premolars (5-5) in an uncomplicated stage, infiltration anesthesia provides an effect equivalent to conduction anesthesia.

For cavity preparation and tooth preparation for crowns, except for lower jaw molars – vestibular injection of 0.5-1.7 ml per tooth. The maximum dose is 7 mg/kg.

Adverse Reactions

From the central nervous system (dose-dependent): headache, impaired consciousness (up to loss of consciousness); respiratory disorders (up to apnea); tremor, muscle twitching, convulsions.

From the digestive system: nausea, vomiting, diarrhea.

From the sensory organs: rarely – transient visual disturbances (up to blindness), diplopia.

From the cardiovascular system: decreased blood pressure, tachycardia, bradycardia, arrhythmia.

Allergic reactions: skin hyperemia and itching, conjunctivitis, rhinitis, angioedema of varying severity (including edema of the upper and/or lower lip and/or cheeks, laryngeal edema with difficulty swallowing, urticaria, difficulty breathing), anaphylactic shock.

Local reactions: swelling or inflammation at the injection site, appearance of ischemic zones at the injection site (up to the development of tissue necrosis – in case of accidental intravascular injection); nerve damage (up to the development of paralysis) – occurs only due to improper injection technique.

Contraindications

B12-deficiency anemia; methemoglobinemia; paroxysmal ventricular tachycardia; atrial tachyarrhythmia; angle-closure glaucoma; hypoxia; intolerance to sulfogroups (especially in bronchial asthma); hypersensitivity to the components of the combination.

With caution: cholinesterase deficiency, renal failure, bronchial asthma, diabetes mellitus, hyperthyroidism, arterial hypertension, children’s age (under 4 years – efficacy and safety have not been established).

For paracervical block: preeclampsia, bleeding in the third trimester of pregnancy, amnionitis.

Use in Pregnancy and Lactation

It does not have a harmful effect on the fetus (except for possible bradycardia) with any technique of application and dosage.

During lactation, there is no need to interrupt breastfeeding, as clinically significant concentrations of articaine are not detected in breast milk.

Use in Renal Impairment

With caution in renal failure.

Pediatric Use

With caution in children (under 4 years of age – efficacy and safety have not been established).

Special Precautions

Do not administer intravenously! To avoid intravascular injection, an aspiration test must be performed. The injection pressure should correspond to the sensitivity of the tissue.

Do not inject into an inflamed area.

Food intake is possible only after the sensitivity is restored.

Effect on the ability to drive vehicles and mechanisms

The patient’s admission to driving vehicles or engaging in activities requiring high mental and motor reactions is determined by the doctor.

Drug Interactions

Tricyclic antidepressants, MAO inhibitors enhance the hypertensive effect.

The local anesthetic effect of articaine is enhanced and prolonged by vasoconstrictors.

Non-selective beta-blockers increase the risk of hypertensive crisis and severe bradycardia.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Bryntsalov-A, JSC (Russia)

Dosage Form

Bottle Rx Icon Brilocaine®-adrenaline Solution for injection 40 mg+0.005 mg/1 ml: cartridges 1.7 ml or 1.8 ml 5, 10, 15, 20, 25, 30, 40, 50 or 100 pcs.; amp. 2 ml 5, 10, 15, 20, 25 or 50 pcs.

Dosage Form, Packaging, and Composition

Solution for injection in the form of a colorless, transparent liquid with a characteristic odor.

1 ml
Epinephrine bitartrate 0.009 mg,
   Calculated as epinephrine (adrenaline) 0.005 mg
Articaine hydrochloride 40 mg

Excipients: sodium disulfite – 0.5 mg, sodium chloride – 1.6 mg, disodium edetate – 0.25 mg, sodium hydroxide – to adjust pH to 5.0, water for injection – up to 1 ml.

1.7 ml – glass cartridges (5) – contour cell packaging (1) – cardboard boxes.
1.7 ml – glass cartridges (5) – contour cell packaging (2) – cardboard boxes.
1.7 ml – glass cartridges (5) – contour cell packaging (3) – cardboard boxes.
1.7 ml – glass cartridges (5) – contour cell packaging (4) – cardboard boxes.
1.7 ml – glass cartridges (5) – contour cell packaging (5) – cardboard boxes.
1.7 ml – glass cartridges (5) – contour cell packaging (10) – cardboard boxes.
1.7 ml – glass cartridges (10) – contour cell packaging (1) – cardboard boxes.
1.7 ml – glass cartridges (10) – contour cell packaging (2) – cardboard boxes.
1.7 ml – glass cartridges (10) – contour cell packaging (3) – cardboard boxes.
1.7 ml – glass cartridges (10) – contour cell packaging (4) – cardboard boxes.
1.7 ml – glass cartridges (10) – contour cell packaging (5) – cardboard boxes.
1.7 ml – glass cartridges (10) – contour cell packaging (10) – cardboard boxes.
1.8 ml – glass cartridges (5) – contour cell packaging (1) – cardboard boxes.
1.8 ml – glass cartridges (5) – contour cell packaging (2) – cardboard boxes.
1.8 ml – glass cartridges (5) – contour cell packaging (3) – cardboard boxes.
1.8 ml – glass cartridges (5) – contour cell packaging (4) – cardboard boxes.
1.8 ml – glass cartridges (5) – contour cell packaging (5) – cardboard boxes.
1.8 ml – glass cartridges (5) – contour cell packaging (10) – cardboard boxes.
1.8 ml – glass cartridges (10) – contour cell packaging (1) – cardboard boxes.
1.8 ml – glass cartridges (10) – contour cell packaging (2) – cardboard boxes.
1.8 ml – glass cartridges (10) – contour cell packaging (3) – cardboard boxes.
1.8 ml – glass cartridges (10) – contour cell packaging (4) – cardboard boxes.
1.8 ml – glass cartridges (10) – contour cell packaging (5) – cardboard boxes.
1.8 ml – glass cartridges (10) – contour cell packaging (10) – cardboard boxes.
2 ml – glass ampoules (5) – contour cell packaging (1) – cardboard boxes.
2 ml – glass ampoules (5) – contour cell packaging (2) – cardboard boxes.
2 ml – glass ampoules (5) – contour cell packaging (3) – cardboard boxes.
2 ml – glass ampoules (5) – contour cell packaging (4) – cardboard boxes.
2 ml – glass ampoules (5) – contour cell packaging (5) – cardboard boxes.
2 ml – glass ampoules (5) – contour cell packaging (10) – cardboard boxes.

Marketing Authorization Holder

Bryntsalov-A, JSC (Russia)

Dosage Form

Bottle Rx Icon Brilocaine®-Adrenaline Forte Solution for injection 40 mg+0.01 mg/1 ml: cartridges 1.7 ml or 1.8 ml 5, 10, 15, 20, 25, 30, 40, 50 or 100 pcs.; amp. 2 ml 5, 10, 15, 20, 25 or 50 pcs.

Dosage Form, Packaging, and Composition

Solution for injection in the form of a colorless, transparent liquid with a characteristic odor.

1 ml
Epinephrine bitartrate 0.018 mg,
   Calculated as epinephrine (adrenaline) 0.01 mg
Articaine hydrochloride 40 mg

Excipients: sodium disulfite – 0.5 mg, sodium chloride – 1.6 mg, disodium edetate – 0.25 mg, sodium hydroxide – to adjust pH to 5.0, water for injection – up to 1 ml.

1.7 ml – glass cartridges (5) – contour cell packaging (1) – cardboard boxes.
1.7 ml – glass cartridges (5) – contour cell packaging (2) – cardboard boxes.
1.7 ml – glass cartridges (5) – contour cell packaging (3) – cardboard boxes.
1.7 ml – glass cartridges (5) – contour cell packaging (4) – cardboard boxes.
1.7 ml – glass cartridges (5) – contour cell packaging (5) – cardboard boxes.
1.7 ml – glass cartridges (5) – contour cell packaging (10) – cardboard boxes.
1.7 ml – glass cartridges (10) – contour cell packaging (1) – cardboard boxes.
1.7 ml – glass cartridges (10) – contour cell packaging (2) – cardboard boxes.
1.7 ml – glass cartridges (10) – contour cell packaging (3) – cardboard boxes.
1.7 ml – glass cartridges (10) – contour cell packaging (4) – cardboard boxes.
1.7 ml – glass cartridges (10) – contour cell packaging (5) – cardboard boxes.
1.7 ml – glass cartridges (10) – contour cell packaging (10) – cardboard boxes.
1.8 ml – glass cartridges (5) – contour cell packaging (1) – cardboard boxes.
1.8 ml – glass cartridges (5) – contour cell packaging (2) – cardboard boxes.
1.8 ml – glass cartridges (5) – contour cell packaging (3) – cardboard boxes.
1.8 ml – glass cartridges (5) – contour cell packaging (4) – cardboard boxes.
1.8 ml – glass cartridges (5) – contour cell packaging (5) – cardboard boxes.
1.8 ml – glass cartridges (5) – contour cell packaging (10) – cardboard boxes.
1.8 ml – glass cartridges (10) – contour cell packaging (1) – cardboard boxes.
1.8 ml – glass cartridges (10) – contour cell packaging (2) – cardboard boxes.
1.8 ml – glass cartridges (10) – contour cell packaging (3) – cardboard boxes.
1.8 ml – glass cartridges (10) – contour cell packaging (4) – cardboard boxes.
1.8 ml – glass cartridges (10) – contour cell packaging (5) – cardboard boxes.
1.8 ml – glass cartridges (10) – contour cell packaging (10) – cardboard boxes.
2 ml – glass ampoules with a capacity of 2 ml (5) – contour cell packaging (1) – cardboard boxes.
2 ml – glass ampoules with a capacity of 2 ml (5) – contour cell packaging (2) – cardboard boxes.
2 ml – glass ampoules with a capacity of 2 ml (5) – contour cell packaging (3) – cardboard boxes.
2 ml – glass ampoules with a capacity of 2 ml (5) – contour cell packaging (4) – cardboard boxes.
2 ml – glass ampoules with a capacity of 2 ml (5) – contour cell packaging (5) – cardboard boxes.
2 ml – glass ampoules with a capacity of 2 ml (5) – contour cell packaging (10) – cardboard boxes.

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