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 Versatis 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 Versatis was used; severe or persistent itching, redness, or swelling where Versatis 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 Versatis 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.
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 Versatis™ (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 Versatis, 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 Versatis™ (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 Versatis™ (lindocaine hydrochloride monohydrate) -treated patients, and in 25.0% of placebo-treated patients. Petechiae occurred in 46.4% of Versatis™ (lindocaine hydrochloride monohydrate) -treated patients, and in 7.0% of placebo-treated patients. Edema occurred in 4.3% of Versatis™ (lindocaine hydrochloride monohydrate) -treated patients, and in 0.8% of placebo-treated patients. Pruritus occurred in 9.4% of Versatis™ (lindocaine hydrochloride monohydrate) -treated patients and in 6.2% of placebo-treated patients.
In pediatric patients, erythema occurred in 53% of Versatis (lindocaine hydrochloride monohydrate) -treated patients, and in 27% of placebo-treated patients. Petechiae occurred in 44% of Versatis (lindocaine hydrochloride monohydrate) -treated patients, and in 5% of placebo-treated patients. Edema occurred in 8% of Versatis (lindocaine hydrochloride monohydrate) -treated patients, and in 3% of placebo-treated patients. Pruritus occurred in 1% of patients in both treatment groups.
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
Versatis™ (lindocaine hydrochloride monohydrate) is not known to possess drug abuse or dependence potential.
What is the most important information I should know about Versatis?
Versatis liquid may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Versatis liquid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Tell your doctor or dentist that you take Versatis liquid before you receive any medical or dental care, emergency care, or surgery.
Versatis liquid may make it difficult for you to swallow. Do not eat anything for at least 1 hour after Versatis liquid has been applied in the mouth or throat area.
Numbness of the tongue may cause you to bite the inside of your mouth accidentally. Do not eat any food or chew gum while your mouth or throat area is numb.
Versatis liquid may cause a numbing effect at the application site. Do not scratch, rub, or expose the area to extreme hot or cold temperature until the numbness is gone.
Do not use more medicine, apply it more often, or use it for longer than prescribed. Your condition will not improve faster, but the risk of side effects may be increased.
If your symptoms do not get better within 7 days or if they get worse, check with your doctor.
Versatis liquid should not be used in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: It is not known if Versatis liquid can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Versatis liquid while you are pregnant. It is not known if Versatis liquid is found in breast milk after topical use. If you are or will be breast-feeding while you use Versatis liquid, check with your doctor. Discuss any possible risks to your baby.
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.
You should not receive this medication if you are allergic to Versatis or any other type of numbing medicine.
Before you receive Versatis 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 Versatis 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.
Versatis can cause side effects that may impair your thinking or reactions. Unless absolutely necessary, do not drive after using this medication
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).
The results of a survey conducted on ndrugs.com for Versatis 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 Versatis. 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.
1 consumer reported side effects
Did you experience side effects while taking Versatis drug? According to the report by ndrugs.com, the below mentioned statistics discuss the number of people who experienced side effects after taking Versatis 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.
No side effects
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