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Zingo

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Zingo

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Do not use around the eyes.

Do not use Zingo™ (lindocaine hydrochloride monohydrate) on body orifices, mucous membranes, or on areas with a compromised skin barrier. Only use Zingo™ (lindocaine hydrochloride monohydrate) on skin locations where an adequate seal can be maintained.

Patients with severe hepatic disease or pseudocholinesterase deficiency, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations of lidocaine.

Patients with bleeding tendencies or platelet disorders could have a higher risk of superficial dermal bleeding.

NonClinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Long-term studies in animals have not been performed to evaluate the carcinogenic potential of lidocaine.

Mutagenesis

No mutagenic potential of lidocaine was demonstrated in the in vitro Ames Bacterial Reverse Mutation Assay, the in vitro chromosome aberration assay using Chinese hamster ovary cells, and the in vivo mouse micronucleus assay.

Impairment of Fertility

Zingo™ (lindocaine hydrochloride monohydrate) was not formally evaluated for effects on fertility. Significant systemic exposure to lidocaine is not expected under recommended conditions of use of Zingo™ (lindocaine hydrochloride monohydrate) , as lidocaine levels were below the limit of detection in human studies. Lidocaine has been previously tested in animal studies for effects on fertility, however. The following ratios are based on the assumption that the applied dose is completely absorbed through the skin.

Lidocaine did not affect fertility in female rats when given via continuous subcutaneous infusion via osmotic minipumps up to doses of 250 mg/kg/day [1500 mg/m2 or 5000-fold higher than the SDA of 0.5 mg lidocaine in a 60 kg individual (0.3 mg/m2)]. Although lidocaine treatment of male rats increased the copulatory interval and led to a dose-related decreased homogenization resistant sperm head count, daily sperm production, and spermatogenic efficiency, the treatment did not affect overall fertility in male rats when given subcutaneous doses up to 60 mg/kg (360 mg/m2 or 1200-fold the SDA).

Use In Specific Populations

Pregnancy

Zingo™ (lindocaine hydrochloride monohydrate) was not formally evaluated for effects on reproduction. Significant systemic exposure to lidocaine is not expected under recommended conditions of use of Zingo™ (lindocaine hydrochloride monohydrate) as lidocaine levels were below the limit of detection in human studies. Lidocaine has been previously tested for reproductive toxicity in animal studies, however. The following ratios are based on the assumption that the applied dose is completely absorbed through the skin.

Teratogenic Effects

Pregnancy Category B. Lidocaine was not teratogenic in rats given subcutaneous doses up to 60 mg/kg [360 mg/m2 or 1200-fold the single dermal administration (SDA) of 0.5 mg lidocaine in a 60 kg individual (0.3 mg/m2)] or in rabbits up to 15 mg/kg (180 mg/m2 or 600-fold the SDA). There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Zingo™ (lindocaine hydrochloride monohydrate) should be used during pregnancy only if clearly needed.

Nonteratogenic Effects

Lidocaine, containing 1:100,000 epinephrine, at a dose of 6 mg/kg (36 mg/m2 or 120-fold the SDA) injected into the masseter muscle of the jaw or into the gum of the lower jaw of Long-Evans hooded pregnant rats on gestation day 11 led to developmental delays in neonatal behavior among offspring. Developmental delays were observed for negative geotaxis, static righting reflex, visual discrimination response, sensitivity and response to thermal and electrical shock stimuli, and water maze acquisition. The developmental delays of the neonatal animals were transient with responses becoming comparable to untreated animals later in life. The clinical relevance of the animal data is uncertain. No adequate and well-controlled studies have been conducted in pregnant women. Because animal studies are not always predictive of human response, Zingo™ (lindocaine hydrochloride monohydrate) should be used during pregnancy only if the potential benefit justifies risk to the fetus.

Labor and Delivery

Lidocaine is not contraindicated in labor and delivery. In humans, the use of lidocaine for labor conduction analgesia has not been associated with an increased incidence of adverse fetal effects either during delivery or during the neonatal period. Should Zingo™ (lindocaine hydrochloride monohydrate) be used concomitantly with other products containing lidocaine, total doses contributed by all formulations must be considered.

Nursing Mothers

Lidocaine is excreted into human milk; therefore, caution should be exercised when Zingo™ (lindocaine hydrochloride monohydrate) is administered to a nursing mother. Because no plasma concentrations of lidocaine are detected after topical administration of Zingo™ (lindocaine hydrochloride monohydrate) in recommended doses, the small amount of lidocaine that would be ingested orally by a suckling infant is unlikely to cause adverse effects.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 3 years have not been established.

Geriatric Use

Safety and effectiveness in geriatric patients have not been established.

Drug Abuse And Dependence

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

Last reviewed on RxList: 2/27/2009
This monograph has been modified to include the generic and brand name in many instances.

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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.


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