Articadent 1 / 100 000

Articadent 1 / 100 000® and Articadent 1 / 100 000® forte, an amide local anesthetic containing a vasoconstrictor, are indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures.

Articadent 1 / 100 000 are anesthetics (numbing medicines). They work by blocking nerve signals in your body.

Articadent 1 / 100 000 is a combination medicine used to numb your mouth for a dental procedure.

Articadent 1 / 100 000 may also be used for purposes not listed in this medication guide.

General Dosing Information

Table 1 (below) summarizes the recommended volumes and concentrations of Articadent 1 / 100 000® for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults, administered by submucosal infiltration or nerve block.

The recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures. The actual volumes to be used depend on a number of factors such as type and extent of surgical procedure, depth of anesthesia, degree of muscular relaxation, and condition of the patient. In all cases, the smallest dose that will produce the desired result should be given.

The onset of anesthesia and the duration of anesthesia are proportional to the volume and concentration (i.e., total dose) of local anesthetic used. Caution should be exercised when employing large volumes because the incidence of side effects may be dose-related.

For most routine dental procedures, Articadent 1 / 100 000® containing Epinephrine (Articadent 1 / 100 000) 1:200,000 is preferred. However, when more pronounced hemostasis or improved visualization of the surgical field are required, Articadent 1 / 100 000® containing Epinephrine (Articadent 1 / 100 000) 1:100,000 may be used.

Maximum Recommended Dosages

• Adults: For normal healthy adults, the maximum dose of Articadent 1 / 100 000® administered by submucosal infiltration and/or nerve block should not exceed 7 mg/kg (0.175 mL/kg) of Articaine (Articadent 1 / 100 000) HCl.
• Pediatric Patients Ages 4 to 16 Years: The quantity of Articadent 1 / 100 000® in children ages 4 to 16 years of age to be injected should be determined by the age and weight of the child and the magnitude of the operation. The maximum dose of Articadent 1 / 100 000® should not exceed 7 mg/kg (0.175 mL/kg) of Articaine (Articadent 1 / 100 000) HCl..
• Safety and effectiveness of Articadent 1 / 100 000® in pediatric patients below the age of 4 years have not been established.

Dosing in Special Populations

Dose reduction may be required in debilitated patients, acutely ill patients, elderly patients, and pediatric patients commensurate with their age and physical condition. No studies have been performed in patients with renal or liver dysfunction. Caution should be used in patients with severe liver disease.

See also:
What is the most important information I should know about Articadent 1 / 100 000?

Articadent 1 / 100 000® and Articadent 1 / 100 000® forte are contraindicated in patients who are hypersensitive to products containing sulfites. Products containing sulfites may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

Use: Labeled Indications

Dental anesthesia: Local, infiltrative, or conductive anesthesia in both simple and complex dental procedures

See also:
What other drugs will affect Articadent 1 / 100 000?

Beta-blockers increase the risk of bradycardia and hypotension. Norepinephrine and beta-blockers by reducing hepatic blood flow decrease (increased toxicity), isadrine and glucagon - increase the clearance of lidocaine. Cimetidine increases the plasma concentration of Articadent 1 / 100 000 (displaces from its association with proteins and slows inactivation in the liver). Barbiturates causing induction of microsomal enzymes stimulate the degradation of lidocaine and reduce its activity. Anticonvulsants (hydantoin derivatives) accelerate the biotransformation in the liver (decreased concentration in the blood), for IV injections it may increases cardiodepressive action of lidocaine. Antiarrhythmics (amiodarone, verapamil, quinidine, aymalin) potentiate cardiac depression. Combination with novocainamide may cause CNS excitement and hallucinations. Articadent 1 / 100 000 strengthens the inhibitory effect of anesthesia (hexobarbital, thiopental sodium), hypnotics and sedatives on the respiratory center, weakens the cardiac effects of digitoxin, enhances muscle relaxation caused by drugs curare like (possible paralysis of respiratory muscles). MAO inhibitors prolong local anesthesia.

See also:
What are the possible side effects of Articadent 1 / 100 000?

Reactions to Articaine (Articadent 1 / 100 000) are characteristic of those associated with other amide-type local anesthetics. Adverse reactions to this group of drugs may also result from excessive plasma levels (which may be due to overdosage, unintentional intravascular injection, or slow metabolic degradation), injection technique, volume of injection, or hypersensitivity or they may be idiosyncratic.

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The reported adverse reactions are derived from clinical trials in the United States and the United Kingdom. Table 2 displays the adverse reactions reported in clinical trials where 882 individuals were exposed to Articadent 1 / 100 000® containing Epinephrine (Articadent 1 / 100 000) 1:100,000. Table 3 displays the adverse reactions reported in clinical trials where 182 individuals were exposed to Articadent 1 / 100 000® containing Epinephrine (Articadent 1 / 100 000) 1:100,000 and 179 individuals were exposed to Articadent 1 / 100 000® containing Epinephrine (Articadent 1 / 100 000) 1:200,000.

Adverse reactions observed in at least 1% of patients:

Adverse reactions observed in less than 1% of patients:

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Articadent 1 / 100 000®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a casual relationship to drug exposure.

Persistent paresthesias of the lips, tongue, and oral tissues have been reported with use of Articaine (Articadent 1 / 100 000) hydrochloride, with slow, incomplete, or no recovery. These postmarketing events have been reported chiefly following nerve blocks in the mandible and have involved the trigeminal nerve and its branches.

Hypoesthesia has been reported with use of Articaine (Articadent 1 / 100 000), especially in pediatric age groups, which is usually reversible. Prolonged numbness can result in soft tissue injuries such as that of the lips and tongue in these age groups.

Ischemic injury and necrosis have been described following use of Articaine (Articadent 1 / 100 000) with Epinephrine (Articadent 1 / 100 000) and have been postulated to be due to vascular spasm of terminal arterial branches.

Paralysis of ocular muscles has been reported, especially after posterior, superior alveolar injections of Articaine (Articadent 1 / 100 000) during dental anesthesia. Symptoms include diplopia, mydriasis, ptosis, and difficulty in abduction of the affected eye. These symptoms have been described as developing immediately after injection of the anesthetic solution and persisting one minute to several hours, with generally complete recovery.

A local anesthetic and cardiac depressant used as an antiarrhythmia agent. Its actions are more intense and its effects more prolonged than those of procaine but its duration of action is shorter than that of bupivacaine or prilocaine.