Mouth Gel Uses

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What is Mouth Gel?

Mouth Gel topical jelly or ointment is used on different parts of the body to cause numbness or loss of feeling for patients having certain medical procedures. It is also used to relieve pain and itching caused by conditions such as sunburn or other minor burns, insect bites or stings, poison ivy, poison oak, poison sumac, minor cuts, or scratches.

Mouth Gel viscous topical solution is also used to treat sore mouth or throat and also reduce gagging during the taking of X-ray pictures and dental impressions.

Mouth Gel skin patch is used to relieve pain caused by shingles (postherpetic neuralgia).

Mouth Gel belongs to the family of medicines called local anesthetics. Mouth Gel prevents pain by blocking the signals at the nerve endings in the skin. Mouth Gel does not cause unconsciousness as general anesthetics do when used for surgery.

Mouth Gel is available only with your doctor's prescription.

Mouth Gel indications

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Mouth Gel (Mouth Gel HCl) Injections are indicated for production of local or regioinal anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.

How should I use Mouth Gel?

Use Mouth Gel aerosol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Mouth Gel aerosol.

Uses of Mouth Gel in details

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How to use Mouth Gel topical

Mouth Gel description

Each gram contains Lidocaine 50 mg equivalent to Mouth Gel 700 mg per 10 cm x 14 cm medicated plaster.

It also contains the following excipients: Self-Adhesive Layer: Glycerol, liquid sorbitol (crystallizing), carmellose sodium, propylene glycol (E1520), urea, heavy kaolin, tartaric acid, gelatin, polyvinyl alcohol, aluminum glycinate, disodium edetate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), polyacrylic acid, sodium polyacrylate, purified water.

Backing Fabric and Release Liner: Polyethylene terephthalate (PET).

Mouth Gel dosage

Mouth Gel Dosage

Generic name: Mouth Gel

Dosage form: Transoral Delivery System

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

When the Mouth Gel® system is used concomitantly with other products containing Mouth Gel, the total dose contributed by all formulations must be kept in mind.

Isolate the procedure area with cotton rolls and use suction as appropriate. Dry the tissue with air or gauze. Remove the Mouth Gel® system from its packaging and peel off the clear protective liner. Immediately apply the Mouth Gel® system using firm pressure. Allow the patch to remain in place until the desired anesthetic effect is produced but not for longer than 15 minutes. Experience in children is inadequate to recommend a pediatric dose at this time.

More about Mouth Gel (Mouth Gel)

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Mouth Gel interactions

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What other drugs will affect Mouth Gel?

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Beta-blockers increase the risk of bradycardia and hypotension. Norepinephrine and beta-blockers by reducing hepatic blood flow decrease (increased toxicity), isadrine and glucagon - increase the clearance of Mouth Gel. Cimetidine increases the plasma concentration of Mouth Gel Haffkine Bio-Pharmaceutical Corporation (displaces from its association with proteins and slows inactivation in the liver). Barbiturates causing induction of microsomal enzymes stimulate the degradation of Mouth Gel and reduce its activity. Anticonvulsants (hydantoin derivatives) accelerate the biotransformation in the liver (decreased concentration in the blood), for IV injections it may increases cardiodepressive action of Mouth Gel. Antiarrhythmics (amiodarone, verapamil, quinidine, aymalin) potentiate cardiac depression. Combination with novocainamide may cause CNS excitement and hallucinations. Mouth Gel Haffkine Bio-Pharmaceutical Corporation strengthens the inhibitory effect of anesthesia (hexobarbital, thiopental sodium), hypnotics and sedatives on the respiratory center, weakens the cardiac effects of digitoxin, enhances muscle relaxation caused by drugs curare like (possible paralysis of respiratory muscles). MAO inhibitors prolong local anesthesia.

Mouth Gel side effects

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What are the possible side effects of Mouth Gel?

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Clinical Trials 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 clinical practice.

The safety of Mouth Gel™ has been evaluated in 10 clinical trials, five in adults and five in pediatric patients.

The five adult clinical trials consisted of a randomized, double-blind, parallel-arm, sham-placebo controlled Phase 3 trial that enrolled 693 patients, two randomized, double-blind, crossover design, sham-placebo controlled Phase 1 trials that enrolled 455 patients, and two open-label studies that enrolled 44 patients. A total of 742 adults received an active treatment with an active treatment that delivered a 0.5 mg dose of Mouth Gel, while 775 received placebo.

The five pediatric clinical trials consisted of five randomized, double-blind, parallel-arm, sham-placebo controlled trials in which 1761 patients, ages 3 to 18, received either Mouth Gel™ or a sham placebo device. A total of 906 pediatric patients received active treatment, while 855 received placebo.

Application Site Reaction

The application site was specifically assessed for four categories of skin site reaction (erythema, edema, pruritus, and petechiae).

In adults, erythema occurred in 67.3% of Mouth Gel™-treated patients, and in 25.0% of placebo-treated patients. Petechiae occurred in 46.4% of Mouth Gel™-treated patients, and in 7.0% of placebo-treated patients. Edema occurred in 4.3% of Mouth Gel™-treated patients, and in 0.8% of placebo-treated patients. Pruritus occurred in 9.4% of Mouth Gel™-treated patients and in 6.2% of placebo-treated patients.

In pediatric patients, erythema occurred in 53% of Mouth Gel-treated patients, and in 27% of placebo-treated patients. Petechiae occurred in 44% of Mouth Gel-treated patients, and in 5% of placebo-treated patients. Edema occurred in 8% of Mouth Gel-treated patients, and in 3% of placebo-treated patients. Pruritus occurred in 1% of patients in both treatment groups.

Adverse Reactions

Amongst the 742 adult patients receiving active treatment and 775 adult patients receiving sham placebo treatment in the 5 adult studies, the percentage of adult patients with any adverse reactions was 3.9% in the active-treated patients and 4.9% in the sham placebo treated patients.

Most adverse reactions were application-site related (i.e., hypoaesthesia (0% active, 0.5% sham placebo), burning (0.54% active, 0.4% sham placebo), and venipuncture site hemorrhage (0.4% active, 1.7% sham placebo)).

The most common systemic adverse reaction was dizziness, which occurred in 0.9% of active-treated adult patients and in 0.7% of sham placebo treated adult patients. No other systemic adverse events occurred in more than two patients in either treatment group.

Amongst the 906 pediatric patients receiving active treatment and 855 pediatric patients receiving sham placebo treatment, the percentage of pediatric patients with any adverse reactions was approximately 9% in each treatment group.

Most adverse reactions were application-site related (i.e., bruising, burning, pain, contusion, hemorrhage), occurring in 4% of pediatric patients in each treatment group.

The most common systemic adverse reactions were nausea (2%) and vomiting (1%).

Mouth Gel contraindications

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What is the most important information I should know about Mouth Gel?

You should not receive this medication if you are allergic to Mouth Gel or any other type of numbing medicine.

Before you receive Mouth Gel injection, tell your doctor if you have liver or kidney disease, heart disease, coronary artery disease, circulation problems, or a history of malignant hyperthermia.

To treat irregular heart rhythms, your doctor may prescribe a LidoPen auto-injector. This is a prefilled automatic injection device to be used in an emergency. Keep the device with you at all times.

Your doctor will describe the signs and symptoms to watch for when deciding when it's time to use Mouth Gel injection at home. Never use the LidoPen auto-injector without first calling your doctor.

With the LidoPen auto-injector you will also receive a CardioBeeper to transmit your heart rate and rhythm to your doctor over a telephone. Read all provided instructions and practice using the CardioBeeper.

Mouth Gel can cause side effects that may impair your thinking or reactions. Unless absolutely necessary, do not drive after using this medication



Active ingredient matches for Mouth Gel:

Lidocaine in United Kingdom.

Lidocaine hydrochloride in United Kingdom.


List of Mouth Gel substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Injectable; Injection; Lidocaine Hydrochloride 1%
Patch; Topical; Lidocaine 700 mg (Ibsa)
NIRCAINE INJECTION 1 vial / 30 ML injection each (Nirlife Healthcare)$ 0.97
Nitra Dent Mouth/Throat 15 gm Gel (Eros Pharma Ltd (Micro Labs Ltd))$ 0.48
Gel; Topical; Lidocaine Hydrochloride 0.5%
Gel; Topical; Lidocaine Hydrochloride 0.5%
No-AD Sunburn Relief Gel gel 0.5 % (Solar Cosmetic Labs, Inc. (Canada))
Nobucaine / vial 10 mg/1 mL x 50 mL x 5's
Nummit 15% w/w SPY / 100g (ICPA)$ 2.46
15 % w/w x 100g (ICPA)$ 2.46
NUMMIT 15% W/W SPRAY 1 packet / 100 GM spray each (ICPA)$ 2.65
NUMMIT topical spray 15 % w/w x 100g (ICPA)$ 2.65
Nummit 15% w/w Spray (ICPA)$ 2.77
Injectable; Injection; Lidocaine Hydrochloride
OCU-LIGNO 1% INJECTION 1 vial / 1 ML injection each (Entod Pharmaceuticals Ltd)$ 0.98
Oculigno 1% w/v INJ / 1ml (Entod)$ 1.02
OCULIGNO inj 1 % w/v x 1ml (Entod)$ 1.02

References

  1. DailyMed. "LIDOCAINE; TETRACAINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "lidocaine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "lidocaine". http://www.drugbank.ca/drugs/DB00281 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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