Septocaine
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Septocaine
Septocaine Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Septocaine in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling or puffiness of your face, lips, tongue, or throat.
Tell your caregivers at once if you have a serious side effect such as:
- weak or shallow breathing;
- slow heart rate, weak pulse;
- feeling like you might pass out;
- swelling in your face;
- swollen or bleeding gums;
- anxiety, confusion, restless feeling, tremors or shaking;
- blurred vision, ringing in your ears; or
- seizure (convulsions).
Less serious side effects may include:
- tongue pain or swelling, mouth sores;
- nausea, vomiting, constipation, diarrhea, upset stomach;
- increased thirst, drooling;
- nervousness, dizziness, drowsiness;
- ear pain, neck pain, joint or muscle pain;
- unusual or unpleasant taste in your mouth;
- numbness or tingly feeling;
- mild skin rash or itching; or
- runny nose, sore throat.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Septocaine (Articane HCl and Epinephrine Injection) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Septocaine FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
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.
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® (articane hcl and epinephrine injection) containing epinephrine 1:100,000. Table 3 displays the adverse reactions reported in clinical trials where 182 individuals were exposed to Septocaine® (articane hcl and epinephrine injection) containing epinephrine 1:100,000 and 179 individuals were exposed to Septocaine® (articane hcl and epinephrine injection) containing epinephrine 1:200,000.
Adverse reactions observed in at least 1% of patients:
Table 2: Adverse Reactions in Controlled Trials with an Incidence
of 1% or Greater in Patients Administered Septocaine® (articane hcl and epinephrine injection) containing Epinephrine
1:100,000
| Body System/Reaction | Septocaine® containing epinephrine 1:100,000 (N=882) Incidence |
| Body as a whole | |
| Face Edema | 13 (1%) |
| Headache | 31 (4%) |
| Infection | 10 (1%) |
| Pain | 114 (13%) |
| Digestive system | |
| Gingivitis | 13 (1%) |
| Nervous system | |
| Paresthesia | 11 (1%) |
Table 3: Adverse Reactions in Controlled Trials with an Incidence
of 1% or Greater in Patients Administered Septocaine® (articane hcl and epinephrine injection) containing Epinephrine
1:200,000 and Septocaine® (articane hcl and epinephrine injection) containing Epinephrine 1:100,000
| Reaction | Septocaine® (articane hcl and epinephrine injection) withe pinephrine 1:200,000 (N=179) Incidence |
Septocaine® (articane hcl and epinephrine injection) withe pinephrine 1:100,000 (N=182) Incidence |
| Any adverse reaction | 33 (18%) | 35 (19%) |
| Pain | 11 (6.1%) | 14 (7.6%) |
| Headache | 9 (5%) | 6 (3.2%) |
| Positive blood aspiration into syringe | 3 (1.6%) | 6 (3.2%) |
| Swelling | 3 (1.6%) | 5 (2.7%) |
| Trismus | 1 (0.5%) | 3 (1.6%) |
| Nausea and emesis | 3 (1.6%) | 0 (0%) |
| Sleepiness | 2 (1.1%) | 1 (0.5%) |
| Numbness and tingling | 1 (0.5%) | 2 (1%) |
| Palpitation | 0 (0%) | 2 (1.%) |
| Ear symptoms (earache, otitis media) | 1 (0.5%) | 2 (1%) |
| Cough, persistent cough | 0 (0%) | 2 (1%) |
Adverse reactions observed in less than 1% of patients:
Table 4: Adverse Reactions in Controlled Trials with an Incidence
of Less than 1% but Considered Clinically Relevant in Patients Administered
Septocaine® (articane hcl and epinephrine injection)
| Body System | Reactions |
| Body as a Whole | Asthenia; back pain; injection site pain; burning sensation above injection site; malaise; neck pain |
| Cardiovascular System | Hemorrhage; migraine; syncope; tachycardia; elevated blood pressure |
| Digestive System | Dyspepsia; glossitis; gum hemorrhage; mouth ulceration; nausea; stomatitis; tongue edemas; tooth disorder; vomiting |
| Hemic and Lymphatic System | Ecchymosis; lymphadenopathy |
| Metabolic and Nutritional System | Edema; thirst |
| Musculoskeletal System | Arthralgia; myalgia; osteomyelitis |
| Nervous System | Dizziness; dry mouth; facial paralysis; hyperesthesia; increased salivation; nervousness; neuropathy; paresthesia; somnolence; exacerbation of Kearns-Sayre Syndrome |
| Respiratory System | Pharyngitis; rhinitis; sinus pain; sinus congestion |
| Skin and Appendages | Pruritus; skin disorder |
| Special Senses | Ear pain; taste perversion |
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of Septocaine® (articane hcl and epinephrine injection) . 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 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, 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 with epinephrine 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 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.
Read the entire FDA prescribing information for Septocaine (Articane HCl and Epinephrine Injection) »
Additional Septocaine Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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