"The U.S. Food and Drug Administration today approved the VenaSeal closure system (VenaSeal system) to permanently treat varicose veins of the legs by sealing the affected superficial veins using an adhesive agent.
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Prior to treatment, advise patient of the following:
- PLIAGLIS CREAM is intended for use in a clinical setting under the supervision of a healthcare provider, and is not for home use by patients.
- PLIAGLIS Cream is contraindicated in patients with a known history of sensitivity to lidocaine, tetracaine, local anesthetics of the amide or ester type, or any other component of the product and in patients with para-aminobenzoic acid (PABA) hypersensitivity.
- PLIAGLIS Cream should be used with caution in patients who may be more sensitive to the systemic effects of lidocaine and tetracaine, including the acutely ill, the debilitated, and those with compromised hepatic function. Patients with severe hepatic disease or pseudocholinesterase deficiency are at greater risk of developing toxic plasma concentrations.
- PLIAGLIS Cream should be used with caution in patients receiving class I antiarrhythmics and/or other local anesthetics, because the systemic toxic effects may be additive and potentially synergistic with lidocaine and tetracaine.
- PLIAGLIS Cream should not be used if the patient has a history of methemoglobinemia.
- Contact of PLIAGLIS Cream with the eyes should be avoided. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns.
- PLIAGLIS Cream is not for use on mucous membranes or on broken skin.
- If skin irritation or a burning sensation occurs during application, the product should be removed.
- If signs of an allergic or anaphylactoid reaction (urticaria, angioedema, bronchospasm, and shock) occur, instruct patients to seek immediate emergency help.
- Topical application of local anesthetics such as PLIAGLIS Cream may lead to diminished or blocked sensation in the treated skin; therefore, patients should avoid inadvertent trauma (rubbing, scratching, or exposure to heat or cold) before complete sensation returns.
- The effect of PLIAGLIS Cream on intradermal injections of live vaccines has not been determined.
Last reviewed on RxList: 12/12/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Pliaglis Information
- Pliaglis Drug Interactions Center: lidocaine-tetracaine top
- Pliaglis Side Effects Center
- Pliaglis FDA Approved Prescribing Information including Dosage
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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