Orajel and pregnancy. Orajel Dental Gel: Safety and Usage During Pregnancy

30.07.202112.07.2023 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 dental gel.

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Understanding Orajel Dental Gel: Composition and Purpose

Orajel Dental Gel is a medicinal product designed to provide temporary relief from toothache pain. The active ingredient in this gel is benzocaine, present at a concentration of 10% w/w. Benzocaine belongs to the ester type of local anesthetics, known for its rapid onset of action.

The gel’s primary therapeutic indication is to alleviate pain associated with open carious lesions and direct exposure of vital dental pulp. It works by producing a reversible loss of sensation in the affected area, effectively preventing or diminishing the transmission of sensory nerve impulses.

Key Ingredients and Their Functions

Benzocaine (10% w/w): The active ingredient responsible for local anesthetic effects
Macrogol 400 and Polyethylene Glycol 3350S: Serve as base ingredients for the gel formulation
Sodium Saccharin: Provides sweetness to improve taste
Sorbic Acid: Acts as a preservative
Natural Spearmint Flavor and Clove Oil: Enhance the gel’s flavor profile
Citric Acid: Helps maintain the pH balance of the formulation

Proper Application and Dosage Guidelines for Orajel Dental Gel

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 the gel:

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 tooth cavity
The gel can be used up to 4 times daily

It’s important to note that Orajel should not be used continuously. If toothache persists, it’s advisable to consult a dentist. The product is not recommended for use in children below the age of 12 years.

Can Orajel be used more than 4 times a day?

No, it is not recommended to use Orajel more than 4 times a day. Exceeding the recommended dosage may increase the risk of side effects and potential complications. Always follow the prescribed usage instructions and consult a healthcare professional if pain persists.

Safety Considerations and Contraindications for Orajel Use

While Orajel Dental Gel is generally safe when used as directed, there are several contraindications and precautions to be aware of:

Known sensitivity to benzocaine or any other ingredients in the gel
Suspected inability to convert methemoglobin to hemoglobin
Family history of methemoglobinemia
Not suitable for children under 12 years of age

Additionally, individuals should avoid drinking hot liquids while using Orajel. The product contains sorbic acid, which may cause local skin reactions such as contact dermatitis in some users.

Why is Orajel not recommended for children under 12?

Orajel is not recommended for children under 12 due to the risk of methemoglobinemia, a rare but serious condition where the blood cannot carry oxygen effectively. Young children are more susceptible to this condition, which can be caused by the excessive absorption of benzocaine.

Orajel and Pregnancy: Safety Considerations for Expectant Mothers

The use of Orajel during pregnancy is a topic of concern for many expectant mothers experiencing dental pain. 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.

No specific clinical data are available on the use of Orajel during pregnancy and lactation. This lack of definitive information means that pregnant women should consult their healthcare provider before using Orajel or any benzocaine-containing products.

Are there any safer alternatives to Orajel for pregnant women?

While Orajel’s safety during pregnancy is not fully established, there are some safer alternatives that pregnant women can consider for dental pain relief:

Salt water rinses to reduce inflammation
Cold compresses applied to the outside of the cheek
Clove oil, which has natural analgesic properties
Over-the-counter pain relievers approved by a healthcare provider

Always consult with a dentist or obstetrician before using any pain relief method during pregnancy.

Potential Side Effects and Adverse Reactions of Orajel Dental Gel

While Orajel is generally well-tolerated, some users may experience side effects. The most common adverse reactions include:

Hypersensitivity reactions (burning, stinging, pruritus, erythema, rash, and edema)
Contact dermatitis
In rare cases, methemoglobinemia (particularly in infants, children, and adults with certain predispositions)

If symptoms persist, become severe, or are accompanied by fever, headache, breathlessness, nausea, or vomiting, it’s crucial to consult a doctor immediately.

How can you recognize signs of methemoglobinemia?

Methemoglobinemia is a rare but serious side effect that can occur with benzocaine use. Signs to watch for include:

Cyanotic (greyish) skin discoloration, particularly on mucous membranes
Unusual breathing or breathlessness
Fatigue or lack of energy
Headache
Dizziness

If any of these symptoms occur, seek immediate medical attention.

Pharmacological Properties and Mechanism of Action of Orajel

Orajel’s primary active ingredient, benzocaine, belongs to the pharmacotherapeutic group of local anesthetics (ATC code: N01BA05). Its mechanism of action involves:

Rapid onset of action
Reversible inhibition of nerve impulse generation and transmission
Temporary depolarization of the neuronal membrane
Inhibition of ion exchange in the affected area

Benzocaine is absorbed through mucous membranes and damaged skin. Once absorbed, it is primarily metabolized by esterases in the plasma and, to a lesser extent, in the liver.

How long does the numbing effect of Orajel typically last?

The numbing effect of Orajel typically lasts between 15 to 40 minutes. However, this can vary depending on factors such as the individual’s metabolism, the amount of gel applied, and the specific area of application. The temporary nature of the relief underscores the importance of seeking professional dental care for persistent toothache.

Interactions and Precautions: What to Know Before Using Orajel

While Orajel is available over-the-counter, it’s important to be aware of potential interactions and precautions:

Benzocaine inhibits the actions of sulfonamides and should not be used concomitantly with any sulfonamide medications
Avoid using Orajel if you have a family history of methemoglobinemia
Do not use the product continuously without consulting a dentist
Be cautious when applying the gel to avoid swallowing, especially in children

It’s always advisable to inform your healthcare provider about all medications and supplements you’re taking before using Orajel.

Can Orajel be used alongside other pain relief medications?

While Orajel can generally be used alongside other pain relief medications, it’s important to exercise caution:

Consult your healthcare provider or pharmacist before combining Orajel with other pain relievers
Be aware of the total amount of pain medication you’re taking to avoid exceeding recommended doses
If using Orajel with oral pain medications, ensure you’re not numbing the area to the point where you might accidentally bite or injure your mouth

Always follow professional medical advice when combining different pain relief methods.

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