Zingo Side Effects
Please note - some side effects for Zingo may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Side Effects of Zingo - for the Consumer
Zingo System
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 when using Zingo System:
Seek medical attention right away if any of these SEVERE side effects occur when using Zingo System:Mild bruising, pain, redness or swelling at the application site.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue; hoarseness); burning, irritation, or bleeding at the application site.
Zingo Side Effects - for the Professional
Zingo
The most common adverse reactions (>5%) are skin reactions at the site of administration: erythema, petechiae, edema. (6.1)
Revised: April 2008
To report SUSPECTED ADVERSE REACTIONS, contact Anesiva, Inc. at 1-866-ZingoRx (1-866-946-4679) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
See 17 for PATIENT COUNSELING INFORMATION
Revised: 06/2008
| FULL PRESCRIBING INFORMATION: CONTENTS* | |
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6.1 Clinical Trials Experience 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION |
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FULL PRESCRIBING INFORMATION Top
Side Effects by Body System
Local
Local side effects associated with lidocaine topical patch have included erythema, edema, bruising, papules, vesicles, discoloration, depigmentation, burning sensation, pruritus, dermatitis, petechiae, blisters, exfoliation, skin irritation, and locus of abnormal sensation.
Local side effects associated with other forms of lidocaine topical have included erythema, edema, and locus of abnormal sensation.
Local side effects reported with the use of lidocaine topical patch were generally experienced during or immediately following treatment. The reactions were generally reported as transient and mild, and appeared to resolve spontaneously within a few minutes to a few hours.
Hypersensitivity
Hypersensitivity reactions associated with systemic lidocaine have rarely included urticaria, angioedema, bronchospasm, laryngospasm, dermatitis, pruritus, dyspnea, and shock.
Other
Other side effects associated with lidocaine topical patch have included asthenia, tinnitus, tremor, and flushing. Causality has not been established.
Nervous system
Systemic lidocaine can exhibit CNS excitation and/or depression. Excitatory CNS effects may occur briefly or not at all. Drowsiness may be an early clinical symptom of high lidocaine serum levels.
Nervous system side effects associated with lidocaine topical patch have included paresthesia, hyperesthesia, hypoesthesia, headache, dizziness, lightheadedness, nervousness, somnolence, disorientation, and confusion. Causality has not been established.
Nervous system side effects associated with systemic lidocaine have included lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold, or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression, and respiratory arrest.
Gastrointestinal
Gastrointestinal side effects associated with lidocaine topical patch have included metallic taste, taste alteration, nausea, and vomiting. Causality has not been established.
Ocular
Ocular side effects associated with lidocaine topical patch have included visual disturbances and blurred vision. Causality has not been established.
Cardiovascular
Cardiovascular side effects associated with systemic lidocaine have included bradycardia, hypotension, and cardiovascular collapse leading to possible cardiac arrest.
Respiratory
Respiratory side effects have included occlusion of the endotracheal tube. This effect is typically the result of the presence of dried lidocaine topical jelly residue in the inner lumen of the tube.
TopMore resources:
Xylocaine Viscous Dental - Includes detailed dosage instructions.
Lidoderm Topical - Includes detailed dosage instructions.
DermaFlex Topical - Includes detailed dosage instructions.
Bactine Topical - Includes detailed dosage instructions.
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