Recommended Topic Related To:

Zingo

"Oct. 22, 2012 -- One in three kids in America is overweight or obese, and having stressed-out parents may be contributing to these rates, a new study suggests.

The more stress the parents report, the more likely their children are to "...

Zingo

Zingo

Zingo Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Zingo (lidocaine hydrochloride monohydrate) is a local anesthetic used on intact skin to provide topical local analgesia prior to venipuncture or peripheral intravenous cannulation. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include application site reactions including redness, broken blood vessels, swelling, itching, pain, and burning.

Apply one Zingo to the site planned for venipuncture or intravenous cannulation, one to three minutes prior to needle insertion. Zingo may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Zingo should only be used if prescribed. Tell your doctor if you are pregnant before receiving Zingo. This drug passes into breast milk. Consult your doctor before breastfeeding.

Our Zingo (lidocaine hydrochloride monohydrate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Zingo FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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 Zingo™ (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 Zingo™ (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 Zingo™ (lindocaine hydrochloride monohydrate) -treated patients, and in 25.0% of placebo-treated patients. Petechiae occurred in 46.4% of Zingo™ (lindocaine hydrochloride monohydrate) -treated patients, and in 7.0% of placebo-treated patients. Edema occurred in 4.3% of Zingo™ (lindocaine hydrochloride monohydrate) -treated patients, and in 0.8% of placebo-treated patients. Pruritus occurred in 9.4% of Zingo™ (lindocaine hydrochloride monohydrate) -treated patients and in 6.2% of placebo-treated patients.

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

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

Read the entire FDA prescribing information for Zingo (Lidocaine Hydrochloride Monohydrate) »

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Parenting and Pregnancy

Get tips for baby and you.

Health Resources
advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations