Septocaine and Epinephrine 40 mg/mL
Articaine Hydrochloride and Epinephrine Bitartrate · INJECTION, SOLUTION · Septodont Inc.
Septocaine and Epinephrine is a injection, solution containing articaine hydrochloride and epinephrine bitartrate at 40 mg/mL, taken submucosal. Manufactured by Septodont Inc..
Key Facts
- Brand Name
- Septocaine and Epinephrine
- Generic Name
- Articaine Hydrochloride and Epinephrine Bitartrate
- NDC Code (Product)
0362-9048- Manufacturer
- Septodont Inc.
- Strength
- 40 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBMUCOSAL
- Marketing Status
- Application #
- NDA020971
- Marketing Start
- 01/12/2011
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE SEPTOCAINE is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older. SEPTOCAINE is a combination of articaine HCl, an amide local anesthetic, and epinephrine, a vasoconstrictor, indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For dental procedures by intraoral submucosal infiltration or nerve block. ( 2.1 ) - For infiltration: 0.5-2.5 mL (20-100 mg articaine HCl) - For nerve block: 0.5-3.4 mL (20-136 mg articaine HCl) - For oral surgery: 1.0-5.1 mL (40-204 mg articaine HCl) For most routine dental procedures, SEPTOCAINE containing epinephrine 1:200,000 is preferred. However, when more pronounced hemostasis or improved visualization of the surgical field are required, SEPTOCAINE containing epinephrine 1:100,000 may be used. ( 2.1 ) Maximum recommended dosages ( 2.2 ): - Healthy adults: 7 mg/kg of articaine HCl and 0.0017mg/kg of epineprhine (equivalent to 0.175 mL/kg for either product presentation, articaine HCl and epinephrine 1:100,000 or 1:200,000) - Pediatric patients 4-16 years: 7 mg/kg of articaine HCl and 0.0017mg/kg of epineprhine (equivalent to 0.175 mL/kg for either product presentation, articaine HCl and epinephrine 1:100,000 or 1:200,000). 2.1 Important Dosage Information Table 1 summarizes the recommended dosages of SEPTOCAINE administered by intraoral submucosal infiltration or nerve block for various types of anesthetic dental procedures in healthy adults and p…
Contraindications
4 CONTRAINDICATIONS SEPTOCAINE is 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 [see Warnings and Precautions (5.5) ]. Known hypersensitivity to sulfite. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS The administration of local anesthetic solutions containing epinephrine to patients receiving monoamine oxidase inhibitors, nonselective beta-adrenergic antagonists, or tricyclic antidepressants may produce severe, prolonged hypertension. Phenothiazines and butyrophenones may reduce or reverse the pressor effect of epinephrine. Concurrent use of these agents should be avoided; however, in situations when concurrent therapy is necessary, careful patient monitoring is essential [see Warnings and Precautions (5.2) ]. Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics: Table 5. Examples of Drugs Associated with Methemoglobinemia: Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic agents cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroqu…
Adverse Reactions
6 ADVERSE REACTIONS Reactions to articaine 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. The most common adverse reactions (incidence >2%) are headache and pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Septodont at 1-800-872-8305 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 SEPTOCAINE containing epinephrine 1:100,000. Table 3 displays the adverse react…
Frequently Asked Questions
What is Septocaine and Epinephrine used for?
Septocaine and Epinephrine contains Articaine Hydrochloride and Epinephrine Bitartrate. It is a injection, solution taken submucosal. Consult your doctor for specific uses.
Is Septocaine and Epinephrine a controlled substance?
Septocaine and Epinephrine is not classified as a controlled substance by the DEA.
What is the generic name for Septocaine and Epinephrine?
The generic name for Septocaine and Epinephrine is Articaine Hydrochloride and Epinephrine Bitartrate. There are 6 other brand versions of Articaine Hydrochloride and Epinephrine Bitartrate.
What is the NDC code for Septocaine and Epinephrine 40 mg/mL?
The NDC (National Drug Code) for Septocaine and Epinephrine 40 mg/mL is 0362-9048, listed by Septodont Inc..