SEPTOCAINE AND EPINEPHRINE- articaine hydrochloride and epinephrine bitartrate injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Articaine Hydrochloride (UNII: QS9014Q792) (Articaine - UNII:D3SQ406G9X), Epinephrine Bitartrate (UNII: 30Q7KI53AK) (Epinephrine - UNII:YKH834O4BH)

Available from:

Septodont Inc.

INN (International Name):

Articaine Hydrochloride

Composition:

Articaine Hydrochloride 40 mg in 1 mL

Administration route:

SUBMUCOSAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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)]. Teratogenic Effects - Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women with SEPTOCAINE. Articaine hydrochloride and epinephrine (1:100,000) has been shown to increase fetal deaths and skeletal variations in rabbits when given in doses approximately 4 times the maximum recommended human dose (MRHD). SEPTOCAINE should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In embryo-fetal toxicity studies in rabbits, 80 mg/kg, subcutaneously (approximately 4 times the MRHD based on body surface area) caused fetal death and increased fetal skeletal variations, but these effects may be attributable to severe maternal toxicity, including seizures, observed at this dose. In contrast, no embryo-fetal toxicities were observed when articaine and epinephrine (1:100,000) was administered subcutaneously throughout organogenesis at doses up to 40 mg/kg in rabbits and 80 mg/kg in rats (approximately 2 times the MRHD based on body surface area). In pre- and postnatal developmental studies subcutaneous administration of articaine hydrochloride to pregnant rats throughout gestation and lactation, at a dose of 80 mg/kg (approximately 2 times the MRHD based on body surface area) increased the number of stillbirths and adversely affected passive avoidance, a measure of learning, in pups. This dose also produced severe maternal toxicity in some animals. A dose of 40 mg/kg (approximately equal to the MRHD on a mg/m2 basis) did not produce these effects. A similar study using articaine and epinephrine (1:100,000) rather than articaine hydrochloride alone produced maternal toxicity, but no effects on offspring. It is not known whether SEPTOCAINE is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when SEPTOCAINE is administered to a nursing woman. When using SEPTOCAINE, nursing mothers may choose to pump and discard breast milk for approximately 4 hours (based on plasma half life) following an injection of SEPTOCAINE (to minimize infant ingestion) and then resume breastfeeding. Safety and effectiveness of SEPTOCAINE in pediatric patients below the age of 4 years have not been established. Safety of doses greater than 7 mg/kg (0.175 mL/kg) in pediatric patients has not been established. The safety and effectiveness of SEPTOCAINE for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures have been established in pediatric patients ages 4 to 16 years old. Safety and effectiveness was established in clinical trials with 61 pediatric patients between the ages of 4 and 16 years administered articaine hydrochloride 4% and epinephrine 1:100,000 injections. Fifty-one of these patients received doses from 0.76 mg/kg to 5.65 mg/kg (0.9 to 5.1 mL) for simple dental procedures and 10 patients received doses between 0.37 mg/kg and 7.48 mg/kg (0.7 to 3.9 mL) for complex dental procedures. Approximately 13% of these pediatric patients required additional injections of anesthetic for complete anesthesia. Dosages in pediatric patients should be reduced, commensurate with age, body weight, and physical condition [see Dosage and Administration (2.2)]. In clinical trials, 54 patients between the ages of 65 and 75 years, and 11 patients 75 years and over received SEPTOCAINE containing epinephrine 1:100,000. Among all patients between 65 and 75 years, doses from 0.43 mg/kg to 4.76 mg/kg (0.9 to 11.9 mL) were administered to 35 patients for simple procedures and doses from 1.05 mg/kg to 4.27 mg/kg (1.3 to 6.8 mL) were administered to 19 patients for complex procedures. Among the 11 patients ≥ 75 years old, doses from 0.78 mg/kg to 4.76 mg/kg (1.3 to 11.9 mL) were administered to 7 patients for simple procedures and doses of 1.12 mg/kg to 2.17 mg/kg (1.3 to 5.1 mL) were administered to 4 patients for complex procedures. Approximately 6% of patients between the ages of 65 and 75 years and none of the 11 patients 75 years of age or older required additional injections of anesthetic for complete anesthesia compared with 11% of patients between 17 and 65 years old who required additional injections. No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. No studies have been performed with articaine hydrochloride 4% and epinephrine 1:200,000 injection or articaine hydrochloride 4% and epinephrine 1:100,000 injection in patients with renal or hepatic impairment [see Warnings and Precautions (5.2)].

Product summary:

SEPTOCAINE (articaine hydrochloride and epinephrine) injection is a clear, colorless solution available in 1.7 mL single-dose glass cartridges, packaged in boxes of 50 cartridges in the following two strengths (less than a full cartridge or more than one cartridge may be used for an individual patient): Storage and Handling Store at controlled room temperature 25°C (77°F) with brief excursions permitted between 15° and 30°C (59°F-86°F) [see USP Controlled Room Temperature]. Protect from light. Do Not Freeze.

Authorization status:

New Drug Application

Summary of Product characteristics

SEPTOCAINE AND EPINEPHRINE- ARTICAINE HYDROCHLORIDE AND EPINEPHRINE
BITARTRATE INJECTION, SOLUTION
SEPTODONT INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SEPTOCAINE® SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SEPTOCAINE®.
SEPTOCAINE® (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION), FOR
INTRAORAL SUBMUCOSAL
INFILTRATION USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
WARNINGS AND PRECAUTIONS, Methemoglobinemia (5.4)
INDICATIONS AND USAGE
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.
(1)
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).
DOSAGE FORMS AND STRENGTHS
Injection provided in:
Glass cartridges (single-dose) containing:
- Articaine hydrochloride 4% (40 mg/mL) and epineprhine 1:200,000 (as
epinephrine bitartrate 0.009
mg/mL) (3)
- Articaine hydrochloride 4% (40 mg/mL) and epinephri