Orabase (benzocaine)
Oral Topical Anesthetics Mucous Membrane Paste (GRAM)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Benzocaine is a local anesthetic.
Benzocaine is used in the form of oral lozenges for the temporary relief of minor sore throat pain or in the form of topical aerosols, gels, creams, ointments, or solutions for the temporary relief of pain associated with various oral or dental conditions (e.g., toothache, sore gums, orthodontic appliances, denture irritation, cold sores, ulcerations, canker sores, minor injury/irritation); benzocaine is commercially available in a variety of over-the-counter (OTC) preparations as a single entity or in fixed combination with other drugs (e.g., dextromethorphan, menthol) for self-medication of these conditions. However, FDA states that OTC benzocaine products are associated with serious risk (e.g., methemoglobinemia) and provide little to no benefit in treating oral pain. (See Methemoglobinemia under Cautions: Precautions and Contraindications.) Benzocaine or other local anesthetics should not be used for the treatment of teething pain in infants because such therapy is not useful and is associated with a risk of methemoglobinemia that outweighs any potential benefit of the drug. Because of the risk of methemoglobinemia, OTC benzocaine preparations should not be used in infants and children younger than 2 years of age and should be used sparingly and only as needed in adults and children 2 years of age or older.
Generic name: benzocaine
Drug class: Oral Topical Anesthetics
Therapeutic class: Mouth-Throat-Dental - Preparations
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
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Indications
The following indications are listed for Orabase:
- Aphthous Stomatitis
- Denture Stomatitis
- Gingivostomatitis
- Mouth Irritation
- Sore Throat
Also known as: Aphthous Ulcer, Burning Sensation Of Throat, Denture Sore Mouth, Oral Irritation, Pharyngeal Pain, Pharyngeal Soreness, Sore Throat Symptom, Ulcerative Stomatitis.
Dosing
No dosing information is available for this tab.
Benzocaine is administered orally as a lozenge or applied topically to mucous membranes as an aerosol spray, swab, gel, solution, cream, or ointment. The drug should not be administered as an injection. Benzocaine is commercially available alone or in fixed combination with other drugs (e.g., antitussives, analgesics, demulcents, other local anesthetics) in many dosage forms, some of which are intended for self-medication; the manufacturer's product labeling should be consulted for complete directions for appropriate dosage and administration of the specific product. The smallest amount required to produce the desired response should be administered.
Benzocaine lozenges are administered orally by dissolving the lozenge slowly in the mouth.
For topical application, benzocaine may be applied to any accessible mucous membrane except for the eyes.
When using aerosol preparations, the amount of benzocaine contained in a single spray varies based on the concentration of the solution, amount of time the actuator is depressed, residual volume in the can, and spatial orientation of the can during administration.
The manufacturer of benzocaine in fixed combination with butamben and tetracaine hydrochloride (Cetacaine(R)) recommends application directly to the site where pain control is required; it is not necessary to dry the tissue prior to application.
The manufacturers of some topical benzocaine products intended for self-medication suggest that adults supervise children younger than 12 years of age during drug administration.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
Local Anesthetics/Long-Acting Bupivacaine
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: Concurrent use of other local anesthetics or use of other local anesthetics within 96 hours following long-acting bupivacaine may result in additive neurologic and cardiovascular effects. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also increase the risk of methemoglobinemia.(1,2) Non-liposomal bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally.(1)
CLINICAL EFFECTS: Concurrent or use of local anesthetics with 96 hours of use of long-acting bupivacaine may result in neurologic and cardiovascular toxicity. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also result in methemoglobinemia.(1,2) Non-liposomal bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally.(1)
PREDISPOSING FACTORS: Use of additional agents that are associated with methemoglobinemia may further increase the risk of methemoglobinemia.(1) Patients who are at increased risk of developing methemoglobinemia include those with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.(1)
PATIENT MANAGEMENT: Avoid the use of other local anesthetics within 96 hours following the administration of long-acting bupivacaine. In patients for whom use is required, monitor for neurologic and cardiovascular effects. Also monitor for methemoglobinemia with use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine.(1,2) Non-liposomal bupivacaine may be administered in the same syringe as bupivacaine liposomal or injected immediately before bupivacaine liposomal as long as the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Lidocaine may be administered 20 minutes or more prior to bupivacaine. It is unknown if other local anesthetics may be used without compromising the release characteristic of bupivacaine liposomal.(1)
DISCUSSION: Concurrent use of other local anesthetics or use of other local anesthetics within 96 hours following long-acting bupivacaine may result in additive neurologic and cardiovascular effects. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also increase the risk of methemoglobinemia.(1,2) Non-liposome bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally. Lidocaine may be administered 20 minutes or more prior to bupivacaine. It is unknown if other local anesthetics may be used without compromising the release characteristic of bupivacaine liposomal.(1)
There are no moderate interactions for this drug.
Contraindications
There is no enhanced messaging for this drug.
- Methemoglobinemia
- Glucose-6-phosphate dehydrogenase (g6Pd) deficiency
- Hemolytic anemia from pyruvate kinase and g6PD deficiencies
- NADH methemoglobin reductase deficiency
- Pregnancy
- Systemic mastocytosis
There are no moderate contraindications for this drug.
Adverse reactions
There is no enhanced messaging for this drug.
Less Frequent
- Angioedema
Rare or Very Rare
- Methemoglobinemia
Less Frequent
- Contact dermatitis
- Erythema
- Mouth irritation
- Pruritus of skin
- Skin rash
- Urticaria
Precautions
No enhanced messaging available.
No enhanced messaging available.
No enhanced messaging available.
No enhanced messaging available.
No enhanced messaging available.
ICD codes
| Code | Type | Description |
|---|---|---|
| Aphthous stomatitis | ||
| K12.0 | ICD10CM | Recurrent oral aphthae |
| Denture stomatitis | ||
| K12.1 | ICD10CM | Other forms of stomatitis |
| Gingivostomatitis | ||
| K05.10 | ICD10CM | Chronic gingivitis, plaque induced |
| Mouth irritation | ||
| K13.79 | ICD10CM | Other lesions of oral mucosa |
| Sore throat | ||
| R07.0 | ICD10CM | Pain in throat |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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