Dologel Side effects

Rating: 1 - 1 review(s)
How do you administer this medicine?
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Consists of Choline Salicylate, Lidocaine

What are the possible side effects of Choline Salicylate (Dologel)?

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Get emergency help immediately if any of the following side effects occur:

Symptoms of overdose in children

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Copyright 2016 Truven Health Analytics, Inc. All Rights Reserved.

Side effects of Choline Salicylate (Dologel) in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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No known side effects, Choline Salicylate (Dologel) is safe for pregnant women and children.

Choline Salicylate (Dologel) contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.

Not to be used in

* Children and adolescents under 16 years of age.

* Allergy to salicylates, eg aspirin.

* Active peptic ulcer.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

What are the possible side effects of Lidocaine (Dologel)?

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild itching, redness, or swelling where Lidocaine (Dologel) was used; small red or purple spots on the skin.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bruising, burning, pain, or bleeding where Lidocaine (Dologel) was used; severe or persistent itching, redness, or swelling where Lidocaine (Dologel) was used.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side effects of Lidocaine (Dologel) in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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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 Lidocaine (Dologel)™ (lindocaine hydrochloride monohydrate) 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 lidocaine, 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 Lidocaine (Dologel)™ (lindocaine hydrochloride monohydrate) 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 Lidocaine (Dologel)™ (lindocaine hydrochloride monohydrate) -treated patients, and in 25.0% of placebo-treated patients. Petechiae occurred in 46.4% of Lidocaine (Dologel)™ (lindocaine hydrochloride monohydrate) -treated patients, and in 7.0% of placebo-treated patients. Edema occurred in 4.3% of Lidocaine (Dologel)™ (lindocaine hydrochloride monohydrate) -treated patients, and in 0.8% of placebo-treated patients. Pruritus occurred in 9.4% of Lidocaine (Dologel)™ (lindocaine hydrochloride monohydrate) -treated patients and in 6.2% of placebo-treated patients.

In pediatric patients, erythema occurred in 53% of Lidocaine (Dologel) (lindocaine hydrochloride monohydrate) -treated patients, and in 27% of placebo-treated patients. Petechiae occurred in 44% of Lidocaine (Dologel) (lindocaine hydrochloride monohydrate) -treated patients, and in 5% of placebo-treated patients. Edema occurred in 8% of Lidocaine (Dologel) (lindocaine hydrochloride monohydrate) -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%).

Drug Abuse And Dependence

Lidocaine (Dologel)™ (lindocaine hydrochloride monohydrate) is not known to possess drug abuse or dependence potential.

What is the most important information I should know about Lidocaine (Dologel)?

Lidocaine (Dologel) contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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You should not receive this medication if you are allergic to lidocaine or any other type of numbing medicine.

Before you receive lidocaine 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 lidocaine 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.

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



References

  1. 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).
  2. 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).
  3. 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).

Reviews

The results of a survey conducted on ndrugs.com for Dologel are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Dologel. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

User reports

1 consumer reported side effects

Did you experience side effects while taking Dologel drug?
According to the report by ndrugs.com, the below mentioned statistics discuss the number of people who experienced side effects after taking Dologel drug. Every drug produces at least minor unwanted effects, which we call side effects. The side effects can be bothersome, or they can be minor so patients do not know they are experiencing them. The side effects of the drug depend on the individual, severity of disease, symptom, and associated conditions in the patient. The most deciding factor is the drug dosage. The higher the dosage, the higher the therapeutic result, and the more side effects. Every patient need not have the same intensity of side effect. When the side effects are greater, immediately consult your health care provider.
Users%
It has side effects1
100.0%


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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