DailyMed Label: Gen7T Plus

DailyMed Label: Gen7T Plus

2024

DailyMed Prescription

Gen7T Plus

Lidocaine, Menthol

Beijing HKKY Medical Tech. Co., Ltd.

NDC: 71073-207

NDC: 71073-207

NDC: 71073-207

Gen7T Plus Patch ®  is a prescription topical patch containing 15 articulated patches or 10 articulated patches. Lidocaine is present in a 3.5% concentration (w/w). It is chemically designated as 2-(diethylamino)-N-(2,6-dimethylphenyl) acetamide and has an empirical formula of C 14 H 22 N 2 O. The molecular weight of lidocaine is 234.34 g/mol. Lidocaine has an octanol: water partition ration of 43 at pH 7.4, and has the following structure: ** Lidocaine ** Menthol is present in a 7% concentration (w/w). The chemical name is (1R,2S,5R)‐2‐isopropyl-5-methylcyclohexanol. The empirical formula for Menthol is C 10 H 20 O with a molecular weight of 156.27 g/mol. Menthol contains colorless, hexangonal crystals, usually needle-like; fused masses or crystalline powder with a pleasant, peppermint-like odor. It has a melting point between 31 O C to 36 O C and has the following structure: ** Menthol ** Gen7T Plus Patch ® uses an adhesive hydrogel technology containing lidocaine 3.5% and menthol 7%, applied to a flexible woven polyester backing and protected by a plastic film. The protective film is removed prior to application to the skin. Lidocaine Menthol

Gen7T Plus Patch ®  is contraindicated in patients with a known hypersensitivity to lidocaine, or any of the topical amide-like local anesthetic preparations or to any other component of the product.

Because of the possibility of sedation, patients should be cautioned regarding the operation of heavy machinery or automobiles, and any activities made hazardous by decreased alertness. Hepatic Disease: Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of Lidocaine, because of their inability to metabolize Lidocaine normally. Allergic Reactions: Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to Lidocaine. However, this product should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain. Non-intact Skin: Application to broken or inflamed skin, although not tested, may result in higher blood concentrations of Lidocaine from increased absorption. Gen7T Plus Patch ® is only recommended for use on intact skin. Eye Exposure: The contact of this product with the eyes, although not studied, should be avoided based on the findings of severe eye irritations with the use of similar products in animals. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns. External Heat Sources: Placement of external heat sources, such as heating pads or electric blankets, over patches is not recommended as this has not been evaluated and may increase plasma Lidocaine levels. Antiarrhythmic Drugs: Gen7T Plus Patch ® should be used with caution in patients receiving Class 1 antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. Local Anesthetics: When Gen7T Plus Patch ® is used concurrently with other products containing local anesthetic agents the amount absorbed from all formulations must be considered. A minor metabolite, 2,6-xylidine, has been found to be carcinogenic in rats. The blood concentration of this metabolite is negligible following application of topical lidocaine. The effect of Gen7T Plus Patch ® on fertility has not been studied. The safety of Gen7T Plus Patch ®  has not been established during pregnancy. There are no well-controlled studies in pregnant women.  Gen7T Plus Patch ® should not be used during pregnancy unless absolutely needed and discussed with a physician. The effect of Gen7T Plus Patch ® on the nursing infant has not been evaluated. Caution should be exercised when Gen7T Plus Patch ® is administered to a nursing mother. Safety and effectiveness in pediatric and geriatric patients have not been established. The most common adverse reactions are application site reactions, including dermatitis, itching or scaling. These tend to be dose-limiting and diminish with time. Serious adverse experiences following the administration of Gen7T Plus Patch ®  are similar in nature to those observed in other amide anesthetic-containing agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage, rapid absorption, or may result from hypersensitivity, idiosyncrasy, or a diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature.

The most common adverse reactions are application site reactions, including dermatitis, itching or scaling. These tend to be dose-limiting and diminish with time.

Antiarrhythmic Drugs: Gen7T Plus Patch ® should be used with caution in patients receiving Class 1 antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. Local Anesthetics: When Gen7T Plus Patch ® is used concurrently with other products containing local anesthetic agents the amount absorbed from all formulations must be considered.

Lidocaine is a topical anesthetic and stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action.  Menthol has local anesthetic and counterirritant qualities. It also acts as a weak kappa (ĸ) opioid receptor agonist. Menthol chemically triggers the cold-‐sensitive TRPM-8 receptors in the skin, which are responsible for the well-‐documented cooling sensation that occurs when applied to the skin. Menthol’s analgesic properties are not fully understood; however, they are mediated through a selective activation of ĸ-opioid receptors. Menthol also blocks voltage-‐sensitive sodium channels, reducing neural activity that may stimulate muscle tissue. Menthol works by targeting the k-‐opioid receptor on the TRPM8 neuron. The TRPM8 neuron is normally activated at temperatures between (8°-28°C). Menthol causes the neuron to fire at temperatures above normal activation, which triggers the characteristic cooling sensation. Also because of menthol's specific targeting of the k-‐opioid receptor, it is endowed with analgesic properties. Lidocaine is an amide-‐type local anesthetic agent and is suggested to stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses. The penetration of Lidocaine into intact skin after application of patch is sufficient to produce an analgesic effect, but less than the amount necessary to produce a complete sensory block.

PATCH Lidocaine 3.5% + Menthol 7% 15 PATCHES PRINCIPAL DISPLAY PANEL NDC 70645-628-35 GEN 7T PLUS PATCH Lidocaine 3.5% + Menthol 7% 15 PATCHES