Orajel and pregnancy. Orajel Dental Gel: Safe Use During Pregnancy and Beyond

03.08.202112.07.2023 by alexxlab

Is Orajel safe to use during pregnancy. What are the active ingredients in Orajel Dental Gel. How should Orajel be applied for toothache relief. What are the potential side effects of using Orajel. When should you avoid using Orajel.

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Understanding Orajel Dental Gel: Composition and Uses

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 works by numbing the affected area. Specifically, Orajel contains 10% w/w benzocaine, making it a potent solution for dental discomfort.

The gel form of Orajel is particularly effective for dental use, as it allows for easy application directly to the affected tooth or gum area. But what exactly does benzocaine do?

How Does Benzocaine Work?

Benzocaine belongs to a class of drugs known as local anesthetics. It works by temporarily blocking nerve signals in the area where it’s applied. This action results in a numbing effect, effectively reducing pain sensation. In the context of dental pain, this can provide significant relief, especially when dealing with open cavities or exposed dental pulp.

Rapid onset of action
Reversible loss of sensation
Prevents or diminishes sensory nerve impulses
Inhibits neuronal membrane depolarization

Proper Usage and Dosage Guidelines for Orajel

Knowing how to use Orajel correctly is crucial for maximizing its benefits while minimizing potential risks. The product is intended for adults and children aged 12 years and over. Here’s a step-by-step guide on how to apply Orajel Dental Gel:

Remove the cap from the tube
Cut off the tip of the tube at the score mark
Apply an amount of gel equivalent to the size of a green pea into the tooth cavity
Use a clean finger or swab for application
Apply up to 4 times daily

Can Orajel be used continuously for persistent toothache? No, Orajel is not intended for continuous use. If toothache persists, it’s essential to consult a dentist for proper diagnosis and treatment.

Orajel and Pregnancy: Safety Considerations

The use of any medication during pregnancy often raises concerns. When it comes to Orajel, the situation is not entirely clear-cut. According to the Summary of Product Characteristics (SmPC), there is inadequate evidence of safety for benzocaine use in human pregnancy. However, it’s worth noting that benzocaine has been in wide use for many years without apparent ill consequences.

Does this mean Orajel is completely safe during pregnancy? Not necessarily. The lack of clinical data on the use of this product during pregnancy and lactation means that caution is advised. Pregnant women should always consult with their healthcare provider before using Orajel or any other medication.

Alternatives for Pregnant Women

For pregnant women experiencing dental pain, it’s crucial to explore alternative pain management strategies that may be safer. These could include:

Salt water rinses
Cold compresses
Clove oil (under guidance from a healthcare provider)
Consultation with a dentist for professional treatment

Potential Side Effects and Precautions

While Orajel is generally considered safe when used as directed, it’s important to be aware of potential side effects and take necessary precautions. Some individuals may experience hypersensitivity reactions when using benzocaine-containing products.

What are the common side effects of Orajel? The most frequently reported adverse reactions include:

Burning sensation
Stinging
Pruritis (itching)
Erythema (redness)
Rash
Oedema (swelling)

In rare cases, more serious side effects such as contact dermatitis and methaemoglobinaemia have been reported. Methaemoglobinaemia is a condition where the blood cannot effectively carry oxygen, and it can be particularly dangerous in infants and young children.

When to Seek Medical Attention

If symptoms persist or are severe, or if they are accompanied by fever, headache, breathlessness, nausea, or vomiting, it’s crucial to consult a doctor immediately. These could be signs of a more serious reaction to the medication.

Contraindications and Special Precautions

Certain individuals should avoid using Orajel altogether. The product is contraindicated for:

Individuals with known sensitivity to benzocaine or any other ingredients in the product
Those suspected of lacking the normal ability to convert methaemoglobin to haemoglobin
Children below the age of 12 years

Are there any special precautions to consider when using Orajel? Yes, several important precautions should be kept in mind:

Orajel is intended for short-term use only
Do not exceed the recommended dose
Avoid drinking hot liquids while using Orajel
Do not use if there is a family history of methaemoglobinaemia

Drug Interactions and Considerations

Like all medications, Orajel has the potential to interact with other drugs. One significant interaction to be aware of involves sulfonamides. Benzocaine, the active ingredient in Orajel, inhibits the actions of sulfonamides. Therefore, Orajel should not be used concomitantly with any sulfonamide medications.

Why does this interaction occur? Benzocaine is a derivative of para-aminobenzoic acid, which can interfere with the antibacterial action of sulfonamides. This interaction could potentially reduce the effectiveness of sulfonamide medications, which are commonly used as antibiotics.

Other Potential Interactions

While the interaction with sulfonamides is the most significant, it’s always wise to inform your healthcare provider about all medications you’re taking, including over-the-counter products like Orajel. This allows for a comprehensive assessment of potential drug interactions and ensures your safety.

Long-term Use and Dental Health Considerations

While Orajel can provide effective temporary relief from toothache pain, it’s important to understand that it’s not a long-term solution for dental problems. Persistent toothache often indicates an underlying dental issue that requires professional attention.

How long can you safely use Orajel? The product is designed for short-term use only. Continuous use is not recommended, and if toothache persists, it’s crucial to consult a dentist. Relying on Orajel for extended periods without addressing the root cause of dental pain can lead to worsening of the underlying condition.

Importance of Regular Dental Check-ups

Regular dental check-ups are essential for maintaining good oral health and preventing issues that might lead to toothache. These visits allow dentists to:

Detect early signs of decay or gum disease
Perform professional cleaning
Provide guidance on proper oral hygiene practices
Address any dental concerns before they become painful or require extensive treatment

By prioritizing regular dental care, you can potentially reduce the need for products like Orajel and maintain better overall oral health.

Alternative Pain Relief Methods for Dental Discomfort

While Orajel can be effective for temporary pain relief, there are several other methods that can help manage dental discomfort. Some of these alternatives may be particularly useful for individuals who cannot use Orajel due to contraindications or personal preferences.

Natural Remedies

Several natural remedies have been traditionally used for dental pain relief. These include:

Clove oil: Contains eugenol, a natural anesthetic and anti-inflammatory
Peppermint tea bags: Can be applied to the affected area for a soothing effect
Salt water rinse: Can help reduce inflammation and kill bacteria
Cold compress: Can numb the area and reduce swelling

It’s important to note that while these natural remedies can provide temporary relief, they are not substitutes for professional dental care. Any persistent tooth pain should be evaluated by a dentist.

Over-the-Counter Pain Relievers

In addition to topical treatments like Orajel, systemic pain relievers can also help manage dental discomfort. These include:

Ibuprofen: An anti-inflammatory that can reduce pain and swelling
Acetaminophen: Effective for pain relief but doesn’t address inflammation
Aspirin: Can help with pain but should not be placed directly on the gums or tooth

Always follow the recommended dosage for these medications and consult with a healthcare provider if you have any concerns or underlying health conditions.

By understanding the proper use of Orajel, its potential risks and benefits, and alternative pain relief methods, individuals can make informed decisions about managing dental discomfort. Remember, while temporary pain relief solutions can be helpful, they are not substitutes for professional dental care. Regular dental check-ups and prompt attention to dental issues are key to maintaining good oral health and preventing the need for pain relief products in the first place.

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

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

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

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

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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.

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Relief Advance instructions for use: indications, contraindications, side effects – description Relief Advance supp. rectal 206 mg: 12 pcs. (17504)

📜 Instructions for use Relief ^® Advance

💊 Composition of Relief ^® Advance

✅ Application of Relief ^® Advance

📅 Storage conditions Relief ^® Advance

⏳ Shelf life Relief ^® Advance

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Product Description

Relief ^® Advance
(Relief Advance)

Based on the official instructions for use of the drug, approved by the manufacturer
and prepared for the electronic edition of the Vidal Handbook 2023
year, update date: 2023. 06.30

Marketing authorization holder:

BAYER JSC
(Russia)

Manufactured:

ISTITUTO de ANGELI, S.r.L.

(Italy)
or
NIZHFARM JSC

(Russia)

Contacts for inquiries:

BAYER AG
(Germany)

ATX code:

D04AB04

(benzocaine)

Active substance:
benzocaine
(benzocaine)

Rec.INN

WHO registered

Dosage form

Relief ^® Advance

Supp. rectal 206 mg: 12 pcs.

reg. No.: P N014500/01
from 01.10.07
– Indefinitely

Re-registration date: 05/24/22

Release form, packaging and composition
Relief

^® Advance

Rectal suppositories pale white to light yellow, opaque, torpedo-shaped.

Excipients : cocoa butter – 1448 mg, corn starch – 340 mg, methyl parahydroxybenzoate – 2 mg, propyl parahydroxybenzoate – 4 mg.

6 pcs. – blisters (2) – packs of cardboard.

Clinical and pharmacological group:

Local anesthetic for use in proctology

Pharmacotherapeutic group:

Local anesthetic