Septanest Injection 1/100,000

Adult administration

Administered as a local intraoral injection or a localized injection. An aspiration test must be conducted to ensure it is not injected into a blood vessel. The injection rate should not exceed 1 mL per minute. The recommended dosage for standard procedures is as shown in Table 1, while the actual dosage should be determined based on the type and extent of the surgical procedure, depth of anesthesia, degree of muscle relaxation, and the patient's condition. The total dosage of articaine hydrochloride must not exceed 7 mg per kg of body weight.

Child administration

For children aged 4 years and older, the dosage is determined based on age, weight, and type of procedure. The minimum dosage should be used for effective dental anesthesia, with the dose for 4-year-olds (or those weighing 20 kg or more) carefully adjusted.

This medication can lead to severe seizures or central nervous system and cardiac respiratory failure if accidentally injected into a blood vessel, causing sudden systemic exposure to epinephrine and articaine, potentially resulting in loss of consciousness or, in severe cases, respiratory and circulatory arrest. Therefore, an aspiration test must be conducted before injection to ensure that the needle does not enter a blood vessel. Patients with hypertension or diabetes should be cautious as the use of this drug may increase the risk of local tissue necrosis. This drug should not be administered to specific patients, including those allergic to this drug or amide local anesthetics, patients with cardiac conduction disturbances not compensated by a pacemaker, patients with intermittent acute porphyria, uncontrolled epilepsy, children under 4 years old, those who are to be co-administered with medications like guanethidine, patients with cardiovascular diseases, hyperthyroidism, myasthenia gravis, those using monoamine oxidase inhibitors or tricyclic antidepressants, and patients who may need general anesthesia, among others. Patients on antiplatelet or anticoagulant medications are at increased risk of bleeding and should be especially cautious when using this drug. Patients with cardiovascular diseases may be affected in heart function due to the included epinephrine, and their conditions should be closely monitored during use. Patients with a history of strokes should avoid using this drug for six months post-stroke due to the risk of recurrence. Patients with a history of epilepsy or plasma cholinesterase deficiency, liver or kidney disorders, elderly patients, uncontrolled diabetes, pulmonary disease, hyperthyroidism, pheochromocytoma, acute closed-angle glaucoma, those taking phenothiazines, and non-selective beta-blockers should also be administered this drug with care. This drug contains sodium metabisulfite, which can cause allergic reactions, particularly in asthma patients, leading to severe asthma attacks, so caution is required. Various adverse effects may occur with this drug, ranging from common to very rare, affecting multiple areas including the nervous system, heart, blood vessels, respiratory tract, gastrointestinal tract, and skin. In particular, neurological adverse reactions may include sensory disturbances, headache, and neuralgia, while cardiovascular effects may present as bradycardia or tachycardia, and changes in blood pressure. Before injection, the patient's allergy history and constitution, as well as recent treatment history, must be verified. It is advisable to perform a small test injection if there is a risk of allergy. During injection, the drug should be administered slowly while performing repeated aspiration checks to prevent intra-vascular injection, avoiding nerve blocks, and maintaining continuous communication with the patient to detect any abnormal symptoms. This drug may interact with other local anesthetics, sedatives, certain antidepressants, beta-blockers, and others, so caution is needed when co-administering with other drugs. During pregnancy, this drug should be used only when the benefits outbalance the risks, and similar caution is advised during breastfeeding. This drug can cause dizziness or visual disturbances, which can affect driving or operating machinery, so caution is advised after administration. In case of overdose, severe side effects can occur in the central nervous and cardiovascular systems, requiring immediate cessation of administration and appropriate emergency treatment. Before use, cartridges must be disinfected, used immediately after opening, and should not be mixed with other medications.

Serious side effects

• Hives
• severe swelling (angioedema)
• chest tightness
• difficulty breathing
• cold sweat
• pallor
• anaphylaxis
• anaphylactoid reactions
• severe rash with high fever
• blisters

Mild side effects

• Headache
• anxiety
• agitation
• sensory disturbances (around the mouth)
• taste disturbances
• drowsiness
• nystagmus
• diplopia
• visual disturbances
• tinnitus

This drug should be stored in a sealed container to prevent air ingress. The storage temperature should be maintained between 1 degree and 25 degrees Celsius (room temperature), and it is recommended to store it in a dark place away from direct sunlight.

Appearance

A cartridge-type ampoule filled with a colorless, transparent liquid

Package unit

1.7㎖ × 50 cartridges