Orajel and pregnancy. Orajel During Pregnancy: Safety, Usage, and Precautions for Dental Pain Relief
Is Orajel safe to use during pregnancy. What are the recommended dosages and application methods for Orajel Dental Gel. How does Orajel work to relieve toothache pain. What are the potential side effects and risks of using Orajel while pregnant.
Understanding Orajel Dental Gel: Composition and Purpose
Orajel Dental Gel is a widely used over-the-counter medication designed to provide temporary relief from toothache pain. The active ingredient in Orajel is benzocaine, a local anesthetic that comprises 10% of the gel’s composition. This topical analgesic works by numbing the affected area, offering quick relief from dental discomfort.
The primary indication for Orajel Dental Gel is the temporary rapid relief of toothache pain associated with open carious lesions and direct exposure of vital dental pulp. It’s important to note that while Orajel provides symptomatic relief, it does not address the underlying cause of dental pain and should not be used as a substitute for proper dental care.
Key Components of Orajel Dental Gel
- Benzocaine 10% w/w (active ingredient)
- Macrogol 400
- Polyethylene Glycol 3350S
- Sodium Saccharin
- Sorbic Acid
- Natural Spearmint Flavor
- Clove Oil
- Citric Acid
Proper Application and Dosage Guidelines for Orajel
Correct application of Orajel Dental Gel is crucial for its effectiveness and safety. The product is intended for use by adults and children aged 12 years and over. Here’s a step-by-step guide on how to apply Orajel:
- Remove the cap from the tube.
- Cut off the tip of the tube at the score mark.
- Using a clean finger or swab, apply an amount of gel equivalent to the size of a green pea into the affected tooth cavity.
- Use up to 4 times daily as needed.
- Do not use continuously; if toothache persists, consult a dentist.
Does Orajel require a prescription? No, Orajel Dental Gel is available over-the-counter, but it’s essential to follow the recommended dosage and application instructions carefully.
Orajel and Pregnancy: Safety Considerations
The use of Orajel during pregnancy is a topic of concern for many expectant mothers experiencing dental pain. While benzocaine has been widely used for many years without apparent adverse consequences, there is limited clinical data on its safety during pregnancy and lactation.
The product’s Summary of Product Characteristics (SmPC) states that there is inadequate evidence of safety for benzocaine in human pregnancy. This lack of conclusive data doesn’t necessarily mean the product is unsafe, but it does warrant caution and consultation with a healthcare provider before use.
Potential Risks and Considerations
Are there any specific risks associated with using Orajel during pregnancy? While direct risks haven’t been established, there are several factors to consider:
- Absorption: Benzocaine can be absorbed through mucous membranes and damaged skin, potentially entering the bloodstream.
- Methaemoglobinaemia: In rare cases, benzocaine has been associated with this condition, which affects oxygen transport in the blood.
- Allergic reactions: Some individuals may experience hypersensitivity reactions to benzocaine.
Given these considerations, it’s advisable for pregnant women to consult their obstetrician or dentist before using Orajel, especially if planning to use it regularly or for an extended period.
Pharmacological Properties of Benzocaine in Orajel
Understanding how Orajel works can help users appreciate its benefits and limitations. Benzocaine, the active ingredient in Orajel, belongs to the pharmacotherapeutic group of local anesthetics (ATC code: N01BA05).
How does benzocaine provide pain relief? Benzocaine acts by producing a reversible loss of sensation near the site of application. It does this by preventing or diminishing the generation and transmission of sensory nerve impulses. This process involves the reversible inhibition of depolarization of the neuronal membrane and ion exchange.
Pharmacokinetics of Benzocaine
What happens to benzocaine once it’s applied? The pharmacokinetics of benzocaine in Orajel are as follows:
- Absorption: Benzocaine is absorbed through mucous membranes and damaged skin.
- Metabolism: Anesthetics of the ester type, like benzocaine, are hydrolyzed primarily by esterases in the plasma and, to a lesser extent, in the liver.
- Onset of action: Benzocaine has a rapid onset of action, providing quick relief from dental pain.
Potential Side Effects and Precautions When Using Orajel
While Orajel is generally well-tolerated, it’s important to be aware of potential side effects and take necessary precautions, especially during pregnancy. Common side effects may include:
- Burning or stinging sensation at the application site
- Pruritis (itching)
- Erythema (redness)
- Rash
- Oedema (swelling)
In rare cases, more serious side effects can occur. Can Orajel cause methaemoglobinaemia? Yes, although rare, methaemoglobinaemia has been reported in infants, children, and adults using benzocaine products. This condition affects the blood’s ability to carry oxygen effectively.
Precautions and Warnings
To ensure safe use of Orajel, consider the following precautions:
- Short-term use: Orajel is intended for short-term use until a dentist can be consulted.
- Avoid continuous use: Do not use the product continuously or exceed the recommended dose.
- Allergies: Do not use if you have a known sensitivity to benzocaine or any other ingredients in the product.
- Hot liquids: Avoid drinking hot liquids while using Orajel.
- Family history: Do not use if there is a family history of methaemoglobinaemia.
- Age restriction: Not for use in children below the age of 12 years.
Interactions and Contraindications of Orajel
When considering the use of Orajel, it’s crucial to be aware of potential drug interactions and contraindications, particularly during pregnancy. This knowledge can help prevent adverse effects and ensure safe usage of the product.
Drug Interactions
Can Orajel interact with other medications? Yes, there are some known interactions to be aware of:
- Sulfonamides: Benzocaine, like other derivatives of para-aminobenzoic acid, inhibits the actions of sulfonamides. Therefore, Orajel should not be used concomitantly with any sulfonamide medications.
- Other local anesthetics: Using multiple products containing local anesthetics may increase the risk of side effects.
Contraindications
Orajel is contraindicated in the following situations:
- Known sensitivity to benzocaine or any other ingredients in the product
- Individuals suspected of lacking the normal ability to convert methaemoglobin to haemoglobin
- Children under 12 years of age
It’s important to note that these contraindications apply to all individuals, including pregnant women. If you fall into any of these categories, it’s essential to consult with a healthcare provider before using Orajel.
Alternative Pain Relief Options During Pregnancy
Given the limited data on the safety of Orajel during pregnancy, some expectant mothers may prefer to explore alternative methods for managing dental pain. Here are some options to consider:
Non-Pharmacological Approaches
- Salt water rinses: Gargling with warm salt water can help reduce inflammation and provide temporary relief.
- Cold compress: Applying a cold compress to the outside of the cheek near the affected area can help numb pain and reduce swelling.
- Clove oil: Known for its natural analgesic properties, clove oil can be applied directly to the affected tooth or gum.
- Teabags: Applying a cooled, used tea bag to the affected area may help reduce pain and inflammation.
Pregnancy-Safe Pain Relievers
Are there safer alternatives to Orajel for pregnant women? Some over-the-counter pain relievers are considered relatively safe during pregnancy, but should always be used under the guidance of a healthcare provider:
- Acetaminophen (Tylenol): Generally considered safe during pregnancy when used as directed.
- Ibuprofen: May be used in the second trimester, but should be avoided in the first and third trimesters unless directed by a healthcare provider.
It’s crucial to consult with an obstetrician or dentist before taking any medication during pregnancy, including over-the-counter pain relievers.
When to Seek Professional Dental Care During Pregnancy
While Orajel and other temporary pain relief methods can provide short-term comfort, they are not substitutes for professional dental care. Dental issues during pregnancy should not be ignored, as they can potentially affect both the mother’s and baby’s health.
Signs You Should See a Dentist
When should a pregnant woman seek professional dental care? Consider consulting a dentist if you experience any of the following:
- Persistent toothache that lasts more than a day or two
- Swelling in the gums or face
- Fever accompanying dental pain
- Difficulty opening your mouth or swallowing
- Bleeding or pus from the gums or around a tooth
- Chipped or broken teeth
- Lost fillings or crowns
Is it safe to receive dental treatment during pregnancy? Many dental procedures are safe during pregnancy, especially in the second trimester. However, it’s important to inform your dentist about your pregnancy so they can take appropriate precautions and choose safe treatments and medications.
Preventive Dental Care During Pregnancy
Maintaining good oral hygiene is crucial during pregnancy to prevent dental issues. Here are some tips for preventive dental care:
- Brush teeth twice daily with fluoride toothpaste
- Floss daily to remove plaque between teeth
- Use an antiseptic mouthwash to reduce bacteria in the mouth
- Limit sugary and acidic foods that can contribute to tooth decay
- Schedule regular dental check-ups and cleanings
By prioritizing oral health and seeking professional care when needed, pregnant women can minimize the need for pain relief products like Orajel and ensure the best possible dental health for themselves and their developing babies.
Orajel Dental Gel – Summary of Product Characteristics (SmPC)
Last updated on emc: 30 Apr 2015
Print SmPC information
1. Name of the medicinal productOrajel®Dental Gel
2. Qualitative and quantitative compositionBenzocaine 10% w/w.
For full list of excipients, see Section 6.1.
3. Pharmaceutical formDental gel
4. Clinical particulars
4.1 Therapeutic indicationsFor temporary rapid relief of toothache pain associated with presence of open carious lesions and direct exposure of a vital dental pulp.
4.2 Posology and method of administration
Adults and children aged 12 years and over.
Directions:
• Remove cap
• Cut off tip of tube on score mark.
• With a clean finger or swab apply an amount of gel the size of a green pea into the tooth cavity.
• Use up to 4 times daily.
• Do not use continuously. If toothache persists, consult your dentist.
Not for use in children below the age of 12 years.
4.3 ContraindicationsKnown sensitivity to benzocaine or any of the other ingredients.
Not to be used in those individuals suspected of lacking the normal ability to convert methaemoglobin to haemoglobin, see section 4.4 Special warnings and precautions for use and section 4.8 Undesirable effects.
Not for use in children below the age of 12 years.
4.4 Special warnings and precautions for useOrajel® is intended for short-term use until a dentist can be consulted. Do not use continuously. Do not exceed recommended dose.
The product contains sorbic acid which may cause local skin reactions, e.g. contact dermatitis.
Avoid drinking hot liquids whilst using Orajel®.
Do not use if there is a family history of methaemoglobinaemia.
4.5 Interaction with other medicinal products and other forms of interaction Benzocaine, like other derivatives of para-aminobenzoic acid, inhibits the actions of sulphonamides and therefore should not be used concomitantly with any sulphonamide.
4.6 Pregnancy and lactation There is inadequate evidence of safety of benzocaine in human pregnancy, but it has been in wide use for many years without apparent ill consequences. No clinical data are available on the use of this product during pregnancy and lactation.
4.7 Effects on ability to drive and use machines No effect on subjects’ ability to drive or operate machines.
4.8 Undesirable effects Application of benzocaine on skin and mucous membranes has resulted in hypersensitivity reactions (burning, stinging, pruritis, erythema, rash and oedema), contact dermatitis and methaemoglobinaemia in a few cases in infants, children and adults.
If symptoms persist, or are severe, or are accompanied by fever, headache, breathlessness, nausea and vomiting, consult a doctor.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose Excessive absorption of benzocaine may produce methaemoglobinaemia in infants, children, and adults. The first clinical signs are cyanotic (greyish) skin discolouration (most notably on mucous membranes) and signs of unusual breathing or breathlessness.
Methaemoglobinaemia may be treated by the intravenous administration of 1% methylene blue. Treatment of overdose should be symptomatic and supportive.
5. Pharmacological properties
5.1 Pharmacodynamic propertiesPharmacotherapeutic group: Local anaesthetics, ATC code: N01BA05
Benzocaine is a local anaesthetic of the ester type with rapid onset, acting to produce reversible loss of sensation by preventing or diminishing the generation and transmission of sensory nerve impulses near the site of application.
Depolarisation of the neuronal membrane and ion exchange are reversibly inhibited.
5.2 Pharmacokinetic propertiesBenzocaine is absorbed through mucous membranes and damaged skin.
Anaesthetics of the ester type are hydrolysed by esterases in the plasma and, to a lesser extent, in the liver.
5.3 Preclinical safety data There are no additional pre-clinical data of relevance to the prescriber.
6. Pharmaceutical particulars
6.1 List of excipients Macrogol 400
Polyethylene Glycol 3350S
Sodium Saccharin
Sorbic Acid
Natural Spearmint Flavour
Clove Oil
Citric acid
6.2 Incompatibilities Not applicable.
6.3 Shelf life 3 years
6.4 Special precautions for storage No special precautions for storage.
6.5 Nature and contents of container Low density polyethylene tube with external acrylate coating, medium density polypropylene cap.
Tubes contain 5.3 g gel.
6.6 Special precautions for disposal and other handlingNot applicable
7. Marketing authorisation holderChurch & Dwight UK Limited
Premier House, Shearway Business Park
Pent Road,
Folkestone, Kent,
CT19 4RJ
United Kingdom
8. Marketing authorisation number(s) PL 00203/0227
9. Date of first authorisation/renewal of the authorisation 21 September 2000
10. Date of revision of the text08 April 2015
IF APPLICABLE
IF APPLICABLE
Benzocaine topical Use During Pregnancy
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Medically reviewed by Drugs.com. Last updated on May 29, 2023.
Benzocaine topical is also known as: Anbesol, BeeGentle, Benz-O-Sthetic, Benzodent, Boil Ease Pain Relieving, Cepacol Dual Relief Sore Throat, Cepacol Fizzlers, Cepacol Sensations Hydra, Cepacol Sensations Warming, Cepacol Sore Throat & Coating, Cepacol Ultra, Chloraseptic Sore Throat Relief Strips, Dermoplast, Hurricaine, Kank-a, Laryngesic, Opahl, OraMagic Plus, Orabase, Orajel, Outgro Pain Relief, Sting Relief, Topical Anesthetic Dental Gel, Zilactin Tooth and Gum Instant Pain Reliever, Zilactin-B
Benzocaine topical Pregnancy Warnings
Benzocaine topical has been assigned to pregnancy category C by the FDA.
Animal studies have not been reported. There are no controlled data in human pregnancy. Benzocaine topical is only recommended for use during pregnancy when benefit outweighs risk.
See references
Benzocaine topical Breastfeeding Warnings
There are no data on the excretion of benzocaine topical into human milk.
See references
See also
- Benzocaine use while Breastfeeding (in more detail)
- benzocaine topical Consumer Information
- Pregnancy Support Group
- FDA Pregnancy Categories
- Medicine use during Pregnancy
- Medicine use while Breastfeeding
- Safe Medications during Breastfeeding
References for pregnancy information
- Product Information. Solarcaine Plus Aloe (benzocaine topical). Schering-Plough Healthcare Products. 2005.
- Product Information. Americaine Hemorrhoidal (benzocaine topical). Novartis Consumer Health. 2005.
- Product Information. Dermoplast (benzocaine topical).
MedTech Inc. 2005. - Product Information. Outgro Pain Relief (benzocaine topical). MedTech Inc. 2005.
- Product Information. Cepacol Lozenges (cetylpyridinium topical). GlaxoSmithKline Inc. 2005.
- Product Information. Chloraseptic (benzocaine topical). Procter and Gamble Pharmaceuticals. 2005.
- Product Information. Vagisil Feminine Cream (benzocaine topical). Combe Inc. 2005.
- Product Information. Lanacane (benzocaine topical). Combe Inc. 2005.
- Product Information. Lanacane with Aloe (benzocaine topical). Combe Inc. 2005.
- Product Information. Hurricaine (benzocaine topical). Beutlich. 2005.
MedTech Inc. 2005.References for breastfeeding information
- Product Information. Solarcaine Plus Aloe (benzocaine topical). Schering-Plough Healthcare Products. 2005.
- Product Information. Americaine Hemorrhoidal (benzocaine topical). Novartis Consumer Health. 2005.
- Product Information. Dermoplast (benzocaine topical). MedTech Inc. 2005.
- Product Information. Outgro Pain Relief (benzocaine topical). MedTech Inc. 2005.
- Product Information. Cepacol Lozenges (cetylpyridinium topical). GlaxoSmithKline Inc. 2005.
- Product Information. Chloraseptic (benzocaine topical). Procter and Gamble Pharmaceuticals. 2005.
- Product Information. Vagisil Feminine Cream (benzocaine topical). Combe Inc. 2005.
- Product Information. Lanacane (benzocaine topical). Combe Inc. 2005.
- Product Information. Lanacane with Aloe (benzocaine topical). Combe Inc. 2005.
- Product Information. Hurricaine (benzocaine topical). Beutlich. 2005.
2005.Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medical Disclaimer
Benzocaine – description of the substance, pharmacology, use, contraindications, formula
Contents
Structural formula
Russian name
English title
Latin name
chemical name
Gross formula
Pharmacological group of the substance Benzocaine
Nosological classification
CAS code
pharmachologic effect
Characteristic
Pharmacology
The use of the substance Benzocaine
Contraindications
Application restrictions
Use during pregnancy and lactation
Side effects of Benzocaine
Interaction
Overdose
Dosage and administration
Trade names with the active substance Benzocaine
Structural formula
Russian name
Benzocaine
English name
Benzocaine
Latin name
Benzocainum (born 9 0062 Benzocaini)
Chemical name
4-Aminobenzoic acid ethyl ester
Gross formula
C 9 H 11 NO 2
Pharmacological group of the substance Benzocaine
Local anesthetics
Nosological classification
ICD-10 code list
CAS code
94-09-7
Pharmacological action
Pharmacological action 90 095-
local anesthetic .
Description
Odorless white crystalline powder, slightly bitter taste; causes a feeling of numbness in the tongue. 1 g of benzocaine is soluble in 2500 ml of water, 5 ml of ethanol, 4 ml of ether, 2 ml of chloroform, in fatty oils (from 30 to 50 ml), in dilute hydrochloric acid. pKa 2.5. Molecular weight 165.19.
Pharmacology
Reduces the permeability of the cell membrane for Na ions + , displaces Ca 2+ from receptors located on the inner surface of the membrane, blocks the occurrence and conduction of nerve impulses. When applied topically and orally, absorption is minimal. When applied to mucous membranes, the action develops within 1 minute and lasts 15-20 minutes.
No long-term studies have been conducted in animals or humans to evaluate potential carcinogenicity, mutagenicity, or effects on fertility.
Use of the substance Benzocaine
Inside: gastralgia, esophagitis, peptic ulcer of the stomach and duodenum.
Locally: acute inflammation of the middle ear, pain in the external auditory canal, urticaria, skin diseases accompanied by itching; perianal fissures, hemorrhoids. Performing diagnostic manipulations on the mucous membranes (gastroscopy, rectoscopy, otoscopy, ureteroscopy, gynecological procedures). In dentistry: superficial anesthesia.
Contraindications
Hypersensitivity.
Restrictions for use
Children (under 2 years of age).
Use during pregnancy and lactation
Use during pregnancy only if necessary (it is not known whether benzocaine has harmful effects on fetal and reproductive ability).
FDA fetal category C.
Use with caution during breastfeeding (it is not known if benzocaine passes into breast milk).
Side effects of the substance Benzocaine
Contact dermatitis and/or hypersensitivity reactions (burning, stinging, itching, erythema, rash, urticaria, swelling), persistent decrease in sensitivity at the application site; rarely, with excessive use – methemoglobinemia (especially in infants and young children).
Interactions
Cholinesterase inhibitors inhibit the metabolism of benzocaine.
Overdose
Symptoms: methemoglobinemia, shortness of breath, cyanosis, dizziness.
Treatment: symptomatic and intravenous methylene blue.
Dosage and administration
Inside, outside. Externally, on the affected area is applied as a 5% ointment, solution, powder. In case of inflammation of the hearing aid – 4-5 drops into the external auditory canal, followed by tamponade with cotton cloth, the application is repeated (if necessary) every 1-2 hours
Inside, for adults – 0.3 g 3-4 times a day; higher doses for adults: single – 0.5 g, daily – 1.5 g. Doses for children – depending on age.
In dentistry. Topically, a 5-20% solution in oil or glycerin is applied to the oral mucosa, powder or 50-70% paste – to anesthetize the hard tissues of the tooth.
Brand names with active substance Benzocaine
Reset filters
Lek.
form
All lek. forms ointment for rectal and external use powder substance rectal suppositories
Dosage
All dosages 200 mg/g 206 mg No dosage
Manufacturer
All manufacturers Ivanovo Pharmaceutical Factory Institut de Angeli S.r.l. Isida NIZHFARM JSC Organika JSC Samaramedprom Tatkhimfarmpreparaty JSC Usolye-Sibirsky CPP JSC Famar A.V.E. Famar S.A.
Information for healthcare professionals only.
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📜 Instructions for use Relief ® Advance 💊 Composition of Relief ® Advance ✅ Application of Relief ® Advance 📅 Storage conditions Relief ® Advance ⏳ Shelf life Relief ® Advance Save Search for analogues Interaction Product Description Relief ® Advance Based on the official instructions for use of the drug, approved by the manufacturer Marketing authorization holder: BAYER JSC Manufactured:ISTITUTO de ANGELI, S.r.L. (Italy) (Russia) Contacts for inquiries: BAYER AG ATX code: D04AB04 (benzocaine) Active substance: Rec.INN WHO registered Dosage form
Release form, packaging and composition |
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06.30
rectal 206 mg: 12 pcs.
| K60 | Fissure and fistula of the anus and rectum |
| K64 | Hemorrhoids and perianal venous thrombosis |
| Z51.4 | Preparatory procedures for subsequent treatment or examination, not elsewhere classified |
Z98. 8 | Other specified post-surgical conditions |
Dosing regimen
Rectal. The drug should be used after hygiene procedures.
Adults and children over 12 years of age: Inject into the rectum 1 suppository up to 4 times / day (morning, at night and after each bowel movement) for 7 days. If necessary, on the recommendation of a doctor, the course of treatment can be extended up to 3 weeks.
Children under 12 years of age: should only be used as directed by a physician.
If there is no improvement after treatment, or symptoms worsen or new symptoms appear, the patient should consult a doctor.
The drug should be used according to the indications, the method of application and in the doses indicated in the instructions.
Side effects
The following adverse reactions have been reported with the use of preparations containing benzocaine under various conditions.
Since these reactions are listed in the reference materials, or voluntarily come from the population in an indefinite number, it is not always possible to reliably estimate their frequency or establish a causal relationship with the use of the drug.
From the immune system: allergic reactions.
From the blood and lymphatic system: methemoglobinemia.
Skin and subcutaneous tissue disorders: allergic dermatitis.
General and local reactions: erythema, local irritation, swelling, pain, rash at the application site.
If the patient notices other side effects, the physician should be informed.
Contraindications for use
- hypersensitivity to drug components;
- thromboembolic disease;
- granulocytopenia.
Use during pregnancy and lactation
Relief ® Advance is used during pregnancy and lactation (breastfeeding) only after consulting a doctor.
Use in children
Do not use the drug in children under 12 years of age without medical advice.
Special instructions
In case of accidental ingestion, seek qualified help immediately.
In case of heavy bloody discharge from the anus or if symptoms persist for more than 7 days, consult a doctor.
It is not recommended to use the drug on damaged skin, because. this may increase systemic absorption.
Products containing benzocaine have been reported to cause methemoglobinemia. Symptoms such as cyanosis of the skin, lips and nails, headache, dizziness, shortness of breath (difficulty in breathing), weakness, tachycardia that are observed during treatment may indicate a potentially life-threatening methemoglobinemia that requires immediate medical attention.
To minimize systemic side effects, do not exceed the recommended daily dose unless directed otherwise by your physician.
Pediatric use
Not recommended for children under 12 years of age without medical advice.
Influence on the ability to drive vehicles and mechanisms
No effect.
Overdose
Symptoms of may be related to the pharmacological effects of benzocaine. Its systemic absorption in case of overdose can be manifested by drowsiness, anxiety, agitation; in severe cases – convulsions. Very rarely, benzocaine in high doses can cause methemoglobinemia, which is manifested by respiratory disorders and cyanosis.
Treatment: for methemoglobinemia – intravenous administration of methylene blue.
Drug interactions
Drug interactions with Relief ® Advance are not described.
Storage conditions for Relief
® Advance
The drug should be stored out of the reach of children at a temperature not exceeding 25°C.
Shelf life of Relief
® Advance
Shelf life – 2 years. Do not use after the expiration date.