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Septocaine

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Septocaine

Septocaine Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Septocaine (articaine HCl and epinephrine) Injection is a numbing medicine used as an anesthetic for dental procedures. This medication is available in generic form. Common side effects 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, runny nose, or sore throat.

The dose of Septocaine to be used depends on factors such as type and extent of surgical procedure, depth of anesthesia, degree of muscular relaxation, and condition of the patient. Septocaine may interact with cold medicines, diet pills, stimulants, medication to treat ADHD, medicines to treat psychiatric disorders, medications to treat nausea and vomiting, or MAO inhibitors. Tell your doctor or dentist all medications and supplements you use. Septocaine may be harmful to a fetus. Before you receive Septocaine, tell your dentist if you are pregnant. It is unknown if Septocaine passes into breast or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Septocaine (articaine HCl and epinephrine) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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) »

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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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