Consists of Choline Salicylate, Lidocaine
Choline Salicylate (Dologel) warnings
* this medicine should not be applied more than once every three hours. Do not exceed the recommended dose.
* For denture irritation, leave 30 minutes after applying the gel before putting the dentures back in. Don’t apply the gel directly to the dentures, as this can further irritate the gums.
* If symptoms persist for more than seven days, consult a doctor or dentist.
What should I discuss with my healthcare provider before taking Choline Salicylate (Dologel)?
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Do not give aspirin or other salicylates to a child or a teenager with a fever or other symptoms of a virus infection, especially flu or chickenpox, without first discussing its use with your child's doctor. This is very important because salicylates may cause a serious illness called Reye's syndrome in children and teenagers with fever caused by a virus infection, especially flu or chickenpox.
Some children may need to take aspirin or another salicylate regularly (as for arthritis). However, your child's doctor may want to stop the medicine for a while if a fever or other symptoms of a virus infection occur. Discuss this with your child's doctor, so that you will know ahead of time what to do if your child gets sick.
Children who do not have a virus infection may also be more sensitive to the effects of salicylates, especially if they have a fever or have lost large amounts of body fluid because of vomiting, diarrhea, or sweating. This may increase the chance of side effects during treatment.
Geriatric
Elderly people are especially sensitive to the effects of salicylates. This may increase the chance of side effects during treatment.
Pregnancy
Salicylates have not been shown to cause birth defects in humans. Studies on birth defects in humans have been done with aspirin but not with other salicylates. However, salicylates caused birth defects in animal studies.
Some reports have suggested that too much use of aspirin late in pregnancy may cause a decrease in the newborn's weight and possible death of the fetus or newborn infant. However, the mothers in these reports had been taking much larger amounts of aspirin than are usually recommended. Studies of mothers taking aspirin in the doses that are usually recommended did not show these unwanted effects. However, there is a chance that regular use of salicylates late in pregnancy may cause unwanted effects on the heart or blood flow in the fetus or in the newborn infant.
Use of salicylates, especially aspirin, during the last 2 weeks of pregnancy may cause bleeding problems in the fetus before or during delivery or in the newborn infant. Also, too much use of salicylates during the last 3 months of pregnancy may increase the length of pregnancy, prolong labor, cause other problems during delivery, or cause severe bleeding in the mother before, during, or after delivery. Do not take aspirin during the last 3 months of pregnancy unless it has been ordered by your doctor.
Studies in humans have not shown that caffeine (present in some aspirin products) causes birth defects. However, studies in animals have shown that caffeine causes birth defects when given in very large doses (amounts equal to those present in 12 to 24 cups of coffee a day).
Breast Feeding
Salicylates pass into the breast milk. Although salicylates have not been reported to cause problems in nursing babies, it is possible that problems may occur if large amounts are taken regularly, as for arthritis (rheumatism).
Caffeine passes into the breast milk in small amounts.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.
- Influenza Virus Vaccine, Live
- Ketorolac
- Methenamine
Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abciximab
- Alipogene Tiparvovec
- Alteplase, Recombinant
- Anagrelide
- Anisindione
- Apixaban
- Ardeparin
- Argatroban
- Azathioprine
- Beta Glucan
- Bivalirudin
- Certoparin
- Cilostazol
- Citalopram
- Clopidogrel
- Clovoxamine
- Cyclosporine
- Dabigatran Etexilate
- Dalteparin
- Danaparoid
- Dasabuvir
- Desirudin
- Desvenlafaxine
- Dicumarol
- Dipyridamole
- Dipyrone
- Duloxetine
- Edoxaban
- Enoxaparin
- Eptifibatide
- Erlotinib
- Escitalopram
- Femoxetine
- Feverfew
- Flesinoxan
- Flufenamic Acid
- Fluoxetine
- Fluvoxamine
- Fondaparinux
- Ginkgo
- Gossypol
- Heparin
- Choline Salicylate (Dologel)
- Ketoprofen
- Lepirudin
- Levomilnacipran
- Meadowsweet
- Mefenamic Acid
- Mercaptopurine
- Methotrexate
- Milnacipran
- Nadroparin
- Naproxen
- Nefazodone
- Ombitasvir
- Paritaprevir
- Parnaparin
- Paroxetine
- Pemetrexed
- Pentosan Polysulfate Sodium
- Pentoxifylline
- Phenindione
- Phenprocoumon
- Piroxicam
- Pralatrexate
- Prasugrel
- Propyphenazone
- Protein C
- Reteplase, Recombinant
- Reviparin
- Riluzole
- Rivaroxaban
- Sertraline
- Sibutramine
- Sulindac
- Tacrolimus
- Ticagrelor
- Ticlopidine
- Tinzaparin
- Tirofiban
- Topotecan
- Treprostinil
- Varicella Virus Vaccine
- Venlafaxine
- Vilazodone
- Vortioxetine
- Warfarin
- Zimeldine
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:
- Anemia or
- Overactive thyroid or
- Stomach ulcer or other stomach problems—Salicylates may make your condition worse.
- Asthma, allergies, and nasal polyps (history of) or
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency or
- High blood pressure (hypertension) or
- Kidney disease or
- Liver disease—The chance of side effects may be increased.
- Gout—Salicylates can make this condition worse and can also lessen the effects of some medicines used to treat gout.
- Heart disease—The chance of some side effects may be increased. Also, the caffeine present in some aspirin products can make some kinds of heart disease worse.
- Hemophilia or other bleeding problems—The chance of bleeding may be increased, especially with aspirin.
Choline Salicylate (Dologel) precautions
Peptic ulcers, errosive gastritis; asthma, allergic disorders; renal and hepatic impairment; dehydrated patients; uncontrolled hypertension; elderly.
What happens if I overdose Lidocaine (Dologel)?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include apprehension; blurred vision; confusion; difficulty breathing; nervousness; ringing in the ears; seizures; sensations of heat, cold, or numbness; severe dizziness, drowsiness, or lightheadedness; slow or irregular heartbeat; tremor; twitching; unconsciousness; vomiting.
Proper storage of Lidocaine (Dologel):
Store Lidocaine (Dologel) at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Keep Lidocaine (Dologel) out of the reach of children and away from pets.
Overdose of Lidocaine (Dologel) in details
In adults following a single administration of Lidocaine (Dologel)™ (lindocaine hydrochloride monohydrate) the plasma levels of lidocaine were below the limit of detection (5 ng/mL). Signs of central nervous system (CNS) toxicity may start at plasma concentrations of lidocaine as low as 1000 ng/mL, and the risk of seizures generally increases with increasing plasma levels. Very high levels of lidocaine can cause respiratory arrest, coma, decreases in cardiac output, total peripheral resistance, and mean arterial pressure, ventricular arrhythmias, and cardiac arrest. The toxicity of coadministered local anesthetics is thought to be at least additive. In the absence of massive topical overdose or oral ingestion, other etiologies for the clinical effects or overdosage from other sources of lidocaine or other local anesthetics should be considered. The management of overdosage includes close monitoring, supportive care, and symptomatic treatment. Dialysis is of negligible value in the treatment of acute overdosage of lidocaine.
What should I avoid while taking Lidocaine (Dologel)?
Lidocaine injection can cause side effects that may impair your thinking or reactions. Unless absolutely necessary, do not drive after receiving this medicine.
Avoid eating or chewing within 1 hour after lidocaine injection is used to numb your mouth or throat. You may have trouble swallowing which could lead to choking. You may also accidentally bite the inside of your mouth if you are still numb an hour after treatment with lidocaine injection.
Lidocaine (Dologel) warnings
Accidental Exposure in Children
Even a used Lidocaine (Dologel) contains a large amount of lidocaine (at least 665 mg). The potential exists for a small child or a pet to suffer serious adverse effects from chewing or ingesting a new or used Lidocaine (Dologel), although the risk with this formulation has not been evaluated. It is important for patients to store and dispose ofLidocaine Patch 5% out of the reach of children, pets and others.
Excessive Dosing
Excessive dosing by applying Lidocaine (Dologel) 5% to larger areas or for longer than the recommended wearing time could result in increased absorption of lidocaine and high blood concentrations, leading to serious adverse effects. Lidocaine toxicity could be expected at lidocaine blood concentrations above 5 mcg/mL. The blood concentration of lidocaine is determined by the rate of systemic absorption and elimination. Longer duration of application, application of more than the recommended number of patches, smaller patients, or impaired elimination may all contribute to increasing the blood concentration of lidocaine. With recommended dosing of Lidocaine (Dologel) 5%, the average peak blood concentration is about 0.13 mcg/mL, but concentrations higher than 0.25 mcg/mL have been observed in some individuals.
What should I discuss with my healthcare provider before taking Lidocaine (Dologel)?
Some medical conditions may interact with Lidocaine (Dologel). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a blood infection or severe injury of the mouth, throat, or other area where you are applying Lidocaine (Dologel)
- if you have heart, liver, or kidney problems
- if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any anesthetic medicine
Some MEDICINES MAY INTERACT with Lidocaine (Dologel). Tell your health care provider if you are taking any other medicines, especially any of the following:
- Amiodarone, beta-adrenergic blockers (eg, metoprolol), cimetidine, or mexiletine because side effects, such as confusion, dizziness, lightheadedness, or tiredness, may occur
This may not be a complete list of all interactions that may occur. Ask your health care provider if Lidocaine (Dologel) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Lidocaine (Dologel) precautions
General
Hepatic Disease: Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of lidocaine, because of their inability to metabolize lidocaine normally.
Allergic Reactions: Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine. However, Lidocaine (Dologel) 5% should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain.
Non-intact Skin: Application to broken or inflamed skin, although not tested, may result in higher blood concentrations of lidocaine from increased absorption. Lidocaine (Dologel) 5% is only recommended for use on intact skin.
External Heat Sources: Placement of external heat sources, such as heating pads or electric blankets, over Lidocaine (Dologel) 5% is not recommended as this has not been evaluated and may increase plasma lidocaine levels.
Eye Exposure: The contact of Lidocaine (Dologel) 5% with eyes, although not studied, should be avoided based on the findings of severe eye irritation with the use of similar products in animals. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns.
Drug Interactions
Antiarrhythmic Drugs: Lidocaine (Dologel) 5% should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic.
Local Anesthetics: When Lidocaine (Dologel) 5% is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis: A minor metabolite, 2,6-xylidine, has been found to be carcinogenic in rats. The blood concentration of this metabolite is negligible following application of Lidocaine (Dologel) 5%.
Mutagenesis: Lidocaine HCl is not mutagenic in Salmonella/mammalian microsome test nor clastogenic in chromosome aberration assay with human lymphocytes and mouse micronucleus test.
Impairment of Fertility: The effect of Lidocaine (Dologel) 5% on fertility has not been studied.
Pregnancy
Teratogenic Effects: Pregnancy Category B. Lidocaine (Dologel) 5% has not been studied in pregnancy. Reproduction studies with lidocaine have been performed in rats at doses up to 30 mg/kg subcutaneously and have revealed no evidence of harm to the fetus due to lidocaine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Lidocaine (Dologel) 5% should be used during pregnancy only if clearly needed.
Labor and Delivery
Lidocaine (Dologel) 5% has not been studied in labor and delivery. Lidocaine is not contraindicated in labor and delivery. Should Lidocaine (Dologel) 5% be used concomitantly with other products containing lidocaine, total doses contributed by all formulations must be considered.
Nursing Mothers
Lidocaine (Dologel) 5% has not been studied in nursing mothers. Lidocaine is excreted in human milk, and the milk:plasma ratio of lidocaine is 0.4. Caution should be exercised when Lidocaine (Dologel) 5% is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
What happens if I miss a dose of Lidocaine (Dologel)?
Since lidocaine is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
References
- DailyMed. "MENTHOL; METHYL SALICYLATE: 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).
- 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).
- DailyMed. "IBUPROFEN: 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).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
