What are the possible side effects of Lox -2%?
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 Lox -2% 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 Lox -2% was used; severe or persistent itching, redness, or swelling where Lox -2% 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 Lox -2% in details
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 Lox -2%™ 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 Lox -2%, 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 Lox -2%™ 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 Lox -2%™-treated patients, and in 25.0% of placebo-treated patients. Petechiae occurred in 46.4% of Lox -2%™-treated patients, and in 7.0% of placebo-treated patients. Edema occurred in 4.3% of Lox -2%™-treated patients, and in 0.8% of placebo-treated patients. Pruritus occurred in 9.4% of Lox -2%™-treated patients and in 6.2% of placebo-treated patients.
In pediatric patients, erythema occurred in 53% of Lox -2%-treated patients, and in 27% of placebo-treated patients. Petechiae occurred in 44% of Lox -2%-treated patients, and in 5% of placebo-treated patients. Edema occurred in 8% of Lox -2%-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%).
What is the most important information I should know about Lox -2%?
- Lox -2% foam is for external use only. Do not get it in your eyes, ears, nose, or mouth. If you get it in your eyes, rinse at once with cool tap water and contact your doctor. Protect the eye until the numbness goes away.
- Lox -2% foam may cause harm if it is swallowed. If you may have taken it by mouth, contact your or emergency room right away.
- Lox -2% foam may cause a numbing effect at the application site. Do not scratch, rub, or expose the area to extreme hot or cold temperatures until the numbness is gone.
- Do not apply Lox -2% foam over large areas of the body unless your doctor tells you to. Do not use more medicine, apply more often, or use for longer than prescribed. Your condition will not improve faster, but the risk of side effects may be increased.
- Tell your doctor or dentist that you take Lox -2% foam before you receive any medical or dental care, emergency care, or surgery.
- Lox -2% foam should not be used in CHILDREN younger than 2 years old without checking with a doctor.
- PREGNANCY and BREAST-FEEDING: It is not known if Lox -2% foam can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Lox -2% foam while you are pregnant. It is not known if Lox -2% foam is found in breast milk after topical use. If you are or will be breast-feeding while you use Lox -2% foam, check with your doctor. Discuss any possible risks to your baby.
Lox -2% contraindications
You should not receive this medication if you are allergic to Lox -2% or any other type of numbing medicine.
Before you receive Lox -2% 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 Lox -2% 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.
Lox -2% can cause side effects that may impair your thinking or reactions. Unless absolutely necessary, do not drive after using this medication
References
- 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).
- DTP/NCI. "lidocaine: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "Lidocaine: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Lox -2% 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 Lox -2%. 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
Consumer reported side effects
No survey data has been collected yetConsumer reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
