Certacaine^® (Solution) Instructions for Use

Marketing Authorization Holder

Grotex, LLC (Russia)

ATC Code

N01BB58 (Articaine in combination with other drugs)

Active Substances

Articaine (Rec.INN WHO registered)

Epinephrine (Rec.INN WHO registered)

Dosage Forms

	Certacaine®	Solution for injection 40 mg+0.01 mg/1 ml: amp. 2 ml 10, 50 or 100 pcs.
		Solution for injection 40 mg+0.005 mg/1 ml: amp. 2 ml 10, 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Solution for injection as a clear, colorless or brownish-yellow liquid.

Excipients : sodium chloride – 1 mg, sodium disulfite – 0.5 mg, 5M hydrochloric acid solution or 3M sodium hydroxide solution – to pH 2.7-5.2, water for injection – to 1 ml.

2 ml – glass ampoules (5) – contour cell packs (2) – cardboard packs.
2 ml – glass ampoules (5) – contour cell packs (10) – cardboard packs.
2 ml – glass ampoules (5) – contour cell packs (20) – cardboard packs.
2 ml – glass ampoules (10) – contour cell packs (1) – cardboard packs.
2 ml – glass ampoules (10) – contour cell packs (5) – cardboard packs.
2 ml – glass ampoules (10) – contour cell packs (10) – cardboard packs.
2 ml – glass ampoules (5) – cardboard blister packs (2) – cardboard packs.
2 ml – glass ampoules (5) – cardboard blister packs (10) – cardboard packs.
2 ml – glass ampoules (5) – cardboard blister packs (20) – cardboard packs.
2 ml – glass ampoules (10) – cardboard blister packs (1) – cardboard packs.
2 ml – glass ampoules (10) – cardboard blister packs (5) – cardboard packs.
2 ml – glass ampoules (10) – cardboard blister packs (10) – cardboard packs.

Solution for injection as a clear, colorless or brownish-yellow liquid.

Excipients : sodium chloride – 1 mg, sodium disulfite – 0.5 mg, 5M hydrochloric acid solution or 3M sodium hydroxide solution – to pH 2.7-5.2, water for injection – to 1 ml.

2 ml – glass ampoules (5) – contour cell packs (2) – cardboard packs.
2 ml – glass ampoules (5) – contour cell packs (10) – cardboard packs.
2 ml – glass ampoules (5) – contour cell packs (20) – cardboard packs.
2 ml – glass ampoules (10) – contour cell packs (1) – cardboard packs.
2 ml – glass ampoules (10) – contour cell packs (5) – cardboard packs.
2 ml – glass ampoules (10) – contour cell packs (10) – cardboard packs.
2 ml – glass ampoules (5) – cardboard blister packs (2) – cardboard packs.
2 ml – glass ampoules (5) – cardboard blister packs (10) – cardboard packs.
2 ml – glass ampoules (5) – cardboard blister packs (20) – cardboard packs.
2 ml – glass ampoules (10) – cardboard blister packs (1) – cardboard packs.
2 ml – glass ampoules (10) – cardboard blister packs (5) – cardboard packs.
2 ml – glass ampoules (10) – cardboard blister packs (10) – cardboard packs.

Clinical-Pharmacological Group

Local anesthetic with a vasoconstrictor component for use in dentistry

Pharmacotherapeutic Group

Local anesthetic agent + alpha- and beta-adrenomimetic

Pharmacological Action

A combined medicinal product that has a local anesthetic effect.

Articaine is a local anesthetic of the amide type from the thiophene series. The mechanism of action is due to the stabilization of neuron membranes and the prevention of the occurrence and conduction of a nerve impulse.

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

The onset of action is 0.5-3 minutes, 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

Dosage Regimen

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 maxillary 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 mandibular premolars (5-5) in an uncomplicated stage, infiltration anesthesia provides the effect of conduction anesthesia.

For cavity preparation and tooth preparation for crowns, except for mandibular molars – vestibular injection 0.5-1.7 ml per tooth. Maximum dose – 7 mg/kg.

Adverse Reactions

From the central nervous system (depends on the dose used): headache, impaired consciousness (up to its loss); 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, glottis 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 when the injection technique is violated.

Contraindications

B₁₂-deficiency anemia; methemoglobinemia; paroxysmal ventricular tachycardia; atrial tachyarrhythmia; closed-angle 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 not 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 (with the exception of possible bradycardia) with any technique of application and dosage.

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

Use in Renal Impairment

With caution renal failure.

Pediatric Use

With caution children’s age (under 4 years – efficacy and safety not established).

Special Precautions

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

Injection should not be performed into an inflamed area.

Food intake is possible only after sensitivity is restored.

Effect on 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.

Vasoconstrictors enhance and prolong the local anesthetic effect of articaine.

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.