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SEPTANEST SP is a brand name for Epinephrine (also known as Adrenaline), supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: SEPTANEST (articaine hydrochloride and epinephrine injection) is indicated for infiltration anesthesia and nerve block anesthesia in clinical dentistry. Local or loco-regional dental anesthesia suitable for operations such as: single extractions, with no complications; multiple extractions; extractions of impacted…
Verbatim from this product's HC label. Tap a section to expand.
]. 2 CONTRAINDICATIONS Septanest (articaine hydrochloride and epinephrine injection) is contraindicated in: • Patients with known allergies to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see
1 Adverse Reaction Overview Reactions to Septanest (articaine hydrochloride) are characteristic of amide-type local anesthetics. The most frequently adverse reactions are gingivitis, oral hypoesthesia/ numbness, dysesthesia, headache, tremor, bradycardia / tachycardia, hypotension, swelling of face and lip.
Septanest SP; Septanest N (Articaine Hydrochloride and Epinephrine Injection) Page 10 of 25 The most frequently reported serious adverse reactions are loss of consciousness, paraesthesia, dyspnoea, angioedema, hypersensitivity, syncope, dizziness.
Allergic reactions may manifest as dermatologic reactions, edema, urticaria and other allergy symptoms. [See 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS] Persistent paresthesias of the lips, tongue, and oral tissues have been reported with use of articaine hydrochloride, with slow, incomplete, or no recovery.
These post-marketing events have been reported chiefly following nerve blocks in the mandible and have involved the trigeminal nerve and its branches. 2 Clinical Trial Adverse Reactions This information is not available for this drug product.
5 Post-Market Adverse Reactions a) Summary of the safety profile Adverse reactions following administration of articaine / epinephrine are similar to those observed with other local amide anesthetics / vasoconstrictors. These adverse reactions are, in general, dose-related.
They may also result from hypersensitivity, idiosyncrasy, or diminished tolerance by patient. Nervous system disorders, local injection site reaction, hypersensitivity, cardiac disorders and vascular disorders are the most frequently occurring adverse reactions.
Serious adverse reactions are generally systemic. b) Tabulated list of adverse reactions The reported adverse reactions come from spontaneous reports, clinical studies and literature.
]. 4 Administration Infiltration and nerve block anesthesia in clinical dentistry. The rate of injection should be slow (1 mL/min). 7 Instructions for Preparation and Use Visually inspect SEPTANEST for particulate matter and discoloration prior to administration.
Prior to using the glass cartridges, disinfect by wiping the cap thoroughly with USP grade isopropyl alcohol (70%). Avoid use of isopropyl alcohol, as well as solutions of ethyl alcohol that are not of USP grade because they may contain denaturants that are injurious to rubber.
Immersion is not recommended. Discard unused portion. 5 OVERDOSAGE Local anesthetic overdose in the largest sense is often used to describe: • absolute overdose, • relative overdose such as: - inadvertent injection into a blood vessel, or - abnormal rapid absorption into the systemic circulation, or - delayed metabolism and elimination of drug.
In case of relative overdose, patients generally present symptoms within the first minutes. Whereas in case of absolute overdose, signs of toxicity, depending on the injection site, appear later after the injection. The type of toxic reaction depends on factors such as dosage, rate of absorption and clinical status of patient.
Adverse reactions of this group of drugs are generally dose-related and may result from high plasma concentrations of anesthetic caused by inadvertent intravascular administration, overdosage, or rapid absorption from the injection site as well as reduced patient tolerance, idiosyncrasy, or hypersensitivity.
High plasma concentrations of anesthetic affect the central nervous system and cardiovascular system. Generally, high plasma concentrations of the drug initially produce CNS stimulatory effects manifested by anxiety, apprehension, restlessness, nervousness, disorientation, confusion, dizziness, blurred vision, tremors, twitching, shivering and seizures, followed by CNS depression manifested by drowsiness, syncope, unconsciousness, and respiratory arrest.
Septanest (articaine hydrochloride and epinephrine injection) is contraindicated in: • Patients with known allergies to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Patients with a known hypersensitivity to sulphites or patients with asthma who may have bronchospastic allergic reactions induced by sulphites. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
• Intravascular injection: therefore, it is imperative to ensure that the needle being used for the injection does not go into a vessel. • Patients with epilepsy not controlled by treatment. Since Septanest contains epinephrine the caution required of any vasoconstrictor drug is in order.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Epinephrine in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
The frequency classification follows the convention:
Very common (≥ 1/10), Common (≥1/100 - <1/10), Uncommon (≥1/1,000 - <1/100), Rare (≥1/10,000 - <1/1,000), and Very rare (< 1/10,000). , rash, urticaria, pruritus, conjunctivitis, rhinitis, bronchospasm/asthma, and angioedema including oedema of face / tongue / lip / throat / larynx / periorbital oedema.
Laryngo-pharyngeal oedema may characteristically occur with dysphagia. Bronchospasm (bronchoconstriction) may characteristically occur with dyspnoea. Anaphylactic or anaphylactoid reactions were described with the product with a rare frequency.
Nausea, vomiting, chills, miosis and tinnitus may also occur. The adverse cardiovascular effects are depressant and include myocardial depression, bradycardia, cardiac arrhythmias, hypotension, cardiovascular collapse, cardiac arrest, and respiratory depression may occur tachypnea, then bradypnea, which could lead to apnea.
Treatment Each time a local anesthetic is used, anti-convulsant medicines (benzodiazepines or barbiturates which can be injected), myorelaxants, atropine and vasopressors, resuscitating equipment (in particular a source of oxygen) enabling artificial ventilation, should be available.
The safety and effectiveness of local anesthetics depend upon proper dosage, correct technique, adequate precautions, and readiness for emergencies. Since cardiac arrest symptoms may occur rapidly and with little warning, the resuscitation equipment treatment should be readily available to enable prompt treatment of any respiratory and cardiovascular emergencies.
The patient’s state of consciousness should be monitored after each local anesthetic injection. For management of a suspected drug overdose, contact your regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764-7669).
Septanest SP; Septanest N (Articaine Hydrochloride and Epinephrine Injection) Page 7 of 25 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 2 – Dosage Forms, Strengths, and Composition Route of Administration Dosage Form/Strength/ Composition Non-Medicinal Ingredients Perineural (Nerve Block) or Infiltration Use Solution.
01 mg/mL (1:100,000) of epinephrine (as epinephrine bitartrate). 005 mg/mL (1:200,000) of epinephrine (as epinephrine bitartrate). Hydrochloric acid (as a pH adjuster), sodium chloride, sodium hydroxide (as a pH adjuster), sodium metabisulfite (as an antioxidant), and water for injection.
Formulated without parahydroxybenzoates. 7 mL glass cartridges, box of 50 cartridges. 7 WARNINGS AND PRECAUTIONS General Toxic reactions, such as convulsions followed by coma and respiratory arrest, may occur in the case of overdosage or accidental intravenous injection.
Therefore, it is imperative to ensure that the needle being used for the injection does not go into a vessel. Resuscitative equipment, oxygen and other resuscitative drugs should be available. Avoid injection into an inflamed or infected area.
Cardiovascular SEPTANEST N and SP contain epinephrine, a vasoconstrictor. Vasoconstrictor agents should be used in local anesthetic solutions during dental practice only when it is clear that the procedure will be shortened or the analgesia rendered more profound.
When a vasoconstrictor is indicated, extreme care should be taken to avoid intravascular injection. The minimum possible amount of vasoconstrictor should be used. It is essential to aspirate before any injection to avoid administration of the drug into the blood stream.
Local toxicity may include ischemic injury or necrosis, which may be related to vascular spasm. SEPTANEST should be used with caution in patients during and following the administration of potent general anesthetic agents. Concurrent use or immediately following the administration of chloroform, halothane, cyclopropane, trichloroethylene or related anesthetics may sensitize the heart to epinephrine and may cause dose-related cardiac arrhythmias.
Septanest SP; Septanest N (Articaine Hydrochloride and Epinephrine Injection) Page 8 of 25 Patients with peripheral vascular disease and those with hypertensive vascular disease may exhibit exaggerated vasoconstrictor response. In patients with peripheral […]
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