Articaine (Solution) Instructions for Use

Instructions
Dosage forms

ATC Code

N01BB08 (Articaine)

Active Substance

Articaine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Local anesthetic for use in dentistry

Pharmacotherapeutic Group

Anesthetics; local anesthetics; amides

Pharmacological Action

A local anesthetic of the amide type from the thiophene series. The mechanism of action is due to the stabilization of neuronal membranes and the prevention of the occurrence and conduction of nerve impulses.

The anesthetic effect develops within 1-11 minutes and lasts for 60-225 minutes.

Pharmacokinetics

After intramuscular administration, the C_max of the active substance in blood plasma is reached within 20-40 minutes.

It is completely metabolized in the liver. T_1/2 is 39.8±3.1 minutes.

Elimination of articaine from tissues occurs rapidly. It is excreted mainly by the kidneys – 54-63% within 6 hours.

Indications

Infiltration and conduction anesthesia for surgical and diagnostic procedures, in obstetrics, for pain syndromes.

ICD codes

Open the list of 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.

Determine the dosage individually based on the procedure type, tissue vascularity, and anesthesia depth required.

For infiltration and conduction anesthesia in adults, administer the smallest effective dose and the lowest concentration that provides adequate anesthesia.

Calculate the dose based on patient body weight and physical status.

Do not exceed the maximum single dose of 6 mg per kg of body weight.

For healthy adult patients, the maximum single dose typically should not exceed 400 mg (10 mL of a 40 mg/mL solution).

Reduce the total dose for elderly or debilitated patients, and for those with significant systemic disease.

Administer injections slowly and with frequent aspiration to avoid intravascular injection.

For most dental procedures, a dose of 0.5 mL to 2.5 mL (20 mg to 100 mg of articaine) is usually sufficient.

Adverse Reactions

From the nervous system headache, visual impairment, dyspnea, apnea, tremor, muscle twitching, convulsions; rarely – impaired consciousness, blurred vision, diplopia, blindness.

From the digestive system nausea, vomiting, diarrhea.

From the cardiovascular system rarely – decreased blood pressure, tachycardia, bradycardia.

Allergic reactions rarely – skin rash, itching, rhinitis, angioedema, anaphylactic shock.

Contraindications

Meningitis, tumors, poliomyelitis, intracranial hemorrhage. Osteochondrosis, spondylitis, tuberculosis or metastatic lesions of the spine, pernicious anemia with neurological symptoms, heart failure in the decompensation stage, massive pleural effusion, significantly increased intra-abdominal pressure, severe ascites, abdominal tumors, severe arterial hypotension (cardiogenic or hypovolemic shock), septicemia, pustular skin lesions at the injection site, blood clotting disorders or anticoagulant therapy, intravenous regional anesthesia by Bier. Hypersensitivity to local anesthetics of the amide type. Children under 4 years of age (for articaine in the form of an injection solution 40 mg/ml).

Use in Pregnancy and Lactation

When used in obstetrics, especially with paracervical blockade, fetal bradycardia is possible.

Articaine is excreted in breast milk in clinically insignificant amounts, therefore, if it is necessary to use it in the mother during lactation, it is not required to interrupt breastfeeding.

Use in Hepatic Impairment

Use with caution in severe liver dysfunction.

Use in Renal Impairment

Use with caution in severe renal impairment.

Pediatric Use

The use of articaine in the form of an injection solution 40 mg/ml is contraindicated in children under 4 years of age.

Geriatric Use

Use with caution in elderly patients to avoid the risk of exacerbation of concomitant diseases.

Special Precautions

Use with caution and for strict indications in pseudocholinesterase deficiency, vegetative-vascular dystonia, diseases of the central nervous system, malignant anemia, conditions of chronic hypoxia.

It can be used in combination with epinephrine, with glucose solution.

Drug Interactions

Tricyclic antidepressants enhance the hypotensive effect of articaine.

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

Articaine Velpharm [Velpharm, LLC (Russia)]
Injection solution 10 mg/ml
Injection solution 20 mg/ml
Injection solution 40 mg/ml

Marketing Authorization Holder

Velpharm, LLC (Russia)

Dosage Forms

	Articaine Velpharm	Injection solution 10 mg/ml
		Injection solution 20 mg/ml
		Injection solution 40 mg/ml

Dosage Form, Packaging, and Composition

Injection solution

	1 ml
Articaine	10 mg

1 ml – ampoules (10 pcs.) – cardboard packs – By prescription
1 ml – ampoules (100 pcs.) – cardboard container – for hospitals
1 ml – ampoules (240 pcs.) – cardboard container – for hospitals
1 ml – ampoules (250 pcs.) – cardboard container – for hospitals
1 ml – ampoules (480 pcs.) – cardboard container – for hospitals
1 ml – ampoules (5 pcs.) – cardboard packs – By prescription
1 ml – ampoules (500 pcs.) – cardboard container – for hospitals
10 ml – ampoules (10 pcs.) – cardboard packs – By prescription
10 ml – ampoules (100 pcs.) – cardboard container – for hospitals
10 ml – ampoules (240 pcs.) – cardboard container – for hospitals
10 ml – ampoules (250 pcs.) – cardboard container – for hospitals
10 ml – ampoules (480 pcs.) – cardboard container – for hospitals
10 ml – ampoules (5 pcs.) – cardboard packs – By prescription
10 ml – ampoules (500 pcs.) – cardboard container – for hospitals
2 ml – ampoules (10 pcs.) – cardboard packs – By prescription
2 ml – ampoules (100 pcs.) – cardboard container – for hospitals
2 ml – ampoules (240 pcs.) – cardboard container – for hospitals
2 ml – ampoules (250 pcs.) – cardboard container – for hospitals
2 ml – ampoules (480 pcs.) – cardboard container – for hospitals
2 ml – ampoules (5 pcs.) – cardboard packs – By prescription
2 ml – ampoules (500 pcs.) – cardboard container – for hospitals
20 ml – ampoules (10 pcs.) – cardboard packs – By prescription
20 ml – ampoules (100 pcs.) – cardboard container – for hospitals
20 ml – ampoules (240 pcs.) – cardboard container – for hospitals
20 ml – ampoules (250 pcs.) – cardboard container – for hospitals
20 ml – ampoules (480 pcs.) – cardboard container – for hospitals
20 ml – ampoules (5 pcs.) – cardboard packs – By prescription
20 ml – ampoules (500 pcs.) – cardboard container – for hospitals
5 ml – ampoules (10 pcs.) – cardboard packs – By prescription
5 ml – ampoules (100 pcs.) – cardboard container – for hospitals
5 ml – ampoules (240 pcs.) – cardboard container – for hospitals
5 ml – ampoules (250 pcs.) – cardboard container – for hospitals
5 ml – ampoules (480 pcs.) – cardboard container – for hospitals
5 ml – ampoules (5 pcs.) – cardboard packs – By prescription
5 ml – ampoules (500 pcs.) – cardboard container – for hospitals

Injection solution

	1 ml
Articaine	20 mg

Injection solution

	1 ml
Articaine	40 mg

Articaine-Ferein^® [Bryntsalov-A, JSC (Russia)]
Injection solution 40 mg/ml

Marketing Authorization Holder

Bryntsalov-A, JSC (Russia)

Dosage Form

Articaine-Ferein^®

Injection solution 40 mg/ml

Dosage Form, Packaging, and Composition

Injection solution

	1 ml
Articaine	40 mg

1.7 ml – cartridges (10 pcs.) – cardboard packs – By prescription
1.7 ml – cartridges (100 pcs.) – cardboard packs – for hospitals
1.7 ml – cartridges (100 pcs.) – cardboard packs – By prescription
1.7 ml – cartridges (1000 pcs.) – cardboard packs – for hospitals
1.7 ml – cartridges (125 pcs.) – cardboard packs – for hospitals
1.7 ml – cartridges (15 pcs.) – cardboard packs – By prescription
1.7 ml – cartridges (150 pcs.) – cardboard packs – for hospitals
1.7 ml – cartridges (1620 pcs.) – cardboard packs – for hospitals
1.7 ml – cartridges (175 pcs.) – cardboard packs – for hospitals
1.7 ml – cartridges (20 pcs.) – cardboard packs – By prescription
1.7 ml – cartridges (200 pcs.) – cardboard packs – for hospitals
1.7 ml – cartridges (2000 pcs.) – cardboard packs – for hospitals
1.7 ml – cartridges (220 pcs.) – cardboard packs – for hospitals
1.7 ml – cartridges (25 pcs.) – cardboard packs – By prescription
1.7 ml – cartridges (250 pcs.) – cardboard packs – for hospitals
1.7 ml – cartridges (30 pcs.) – cardboard packs – By prescription
1.7 ml – cartridges (300 pcs.) – cardboard packs – for hospitals
1.7 ml – cartridges (3240 pcs.) – cardboard packs – for hospitals
1.7 ml – cartridges (350 pcs.) – cardboard packs – for hospitals
1.7 ml – cartridges (40 pcs.) – cardboard packs – By prescription
1.7 ml – cartridges (400 pcs.) – cardboard packs – for hospitals
1.7 ml – cartridges (440 pcs.) – cardboard packs – for hospitals
1.7 ml – cartridges (5 pcs.) – cardboard packs – By prescription
1.7 ml – cartridges (50 pcs.) – cardboard packs – By prescription
1.7 ml – cartridges (500 pcs.) – cardboard packs – for hospitals
1.8 ml – cartridges (10 pcs.) – cardboard packs – By prescription
1.8 ml – cartridges (100 pcs.) – cardboard packs – for hospitals
1.8 ml – cartridges (100 pcs.) – cardboard packs – By prescription
1.8 ml – cartridges (1000 pcs.) – cardboard packs – for hospitals
1.8 ml – cartridges (125 pcs.) – cardboard packs – for hospitals
1.8 ml – cartridges (15 pcs.) – cardboard packs – By prescription
1.8 ml – cartridges (150 pcs.) – cardboard packs – for hospitals
1.8 ml – cartridges (1620 pcs.) – cardboard packs – for hospitals
1.8 ml – cartridges (175 pcs.) – cardboard packs – for hospitals
1.8 ml – cartridges (20 pcs.) – cardboard packs – By prescription
1.8 ml – cartridges (200 pcs.) – cardboard packs – for hospitals
1.8 ml – cartridges (2000 pcs.) – cardboard packs – for hospitals
1.8 ml – cartridges (220 pcs.) – cardboard packs – for hospitals
1.8 ml – cartridges (25 pcs.) – cardboard packs – By prescription
1.8 ml – cartridges (250 pcs.) – cardboard packs – for hospitals
1.8 ml – cartridges (30 pcs.) – cardboard packs – By prescription
1.8 ml – cartridges (300 pcs.) – cardboard packs – for hospitals
1.8 ml – cartridges (3240 pcs.) – cardboard packs – for hospitals
1.8 ml – cartridges (350 pcs.) – cardboard packs – for hospitals
1.8 ml – cartridges (40 pcs.) – cardboard packs – By prescription
1.8 ml – cartridges (400 pcs.) – cardboard packs – for hospitals
1.8 ml – cartridges (440 pcs.) – cardboard packs – for hospitals
1.8 ml – cartridges (5 pcs.) – cardboard packs – By prescription
1.8 ml – cartridges (50 pcs.) – cardboard packs – By prescription
1.8 ml – cartridges (500 pcs.) – cardboard packs – for hospitals
2 ml – ampoules (10 pcs.) – cardboard packs – By prescription
2 ml – ampoules (100 pcs.) – cardboard packs – for hospitals
2 ml – ampoules (1000 pcs.) – cardboard packs – for hospitals
2 ml – ampoules (125 pcs.) – cardboard packs – for hospitals
2 ml – ampoules (15 pcs.) – cardboard packs – By prescription
2 ml – ampoules (150 pcs.) – cardboard packs – for hospitals
2 ml – ampoules (1620 pcs.) – cardboard packs – for hospitals
2 ml – ampoules (175 pcs.) – cardboard packs – for hospitals
2 ml – ampoules (20 pcs.) – cardboard packs – By prescription
2 ml – ampoules (200 pcs.) – cardboard packs – for hospitals
2 ml – ampoules (220 pcs.) – cardboard packs – for hospitals
2 ml – ampoules (25 pcs.) – cardboard packs – By prescription
2 ml – ampoules (250 pcs.) – cardboard packs – for hospitals
2 ml – ampoules (5 pcs.) – cardboard packs – By prescription
2 ml – ampoules (50 pcs.) – cardboard packs – By prescription

Medixlife (Author)

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