GEN 7T by is a Prescription medication manufactured, distributed, or labeled by Beijing HKKY Medical Tech. Co., Ltd.. Drug facts, warnings, and ingredients follow.
7T Pharma, LLC
What is Gen7T Patch®?
This is a topical hydrogel patch consisting of the local anesthetic, lidocaine.
What is Gen7TPatch®used for?
The patch is applied topically for use on normal intact skin for temporary relief of pain and itching due to minor cuts, minor scrapes, minor skin irritations, minor burns and insect bites. Read the information sheet provided before you start using this medication and each time you get a refill. If you have any questions, please consult your doctor or pharmacist. Inform your doctor if your condition does not improve or if it worsens. The use of this medication shall be used under the supervision of a physician only as it may be used in conjunction with other therapies.
This information may not include all of the information needed to use Gen7T Patch ® safely and effectively.
For Topical Use Only
What are the possible side effects with Gen7TPatch®
This is not a complete list of the possible side effects. For more information, talk with your doctor or pharmacist. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
KEEP OUT OF REACH OF CHILDREN
Adults and children 12 years and over:
Apply 1 patch to the affected area of intact skin. Gen7T Patch ® should be removed after 12 hours of continuous use and remain off for at least 12 hours.
Children under 12 years of age: Consult a doctor
FOR EXTERNAL USE ONLY
1. Do not use:
2. Consult physician for children under 12 years of age
3. Stop and consult your prescriber
Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:
Excessive dosage, or short interval between doses, can result in high plasma levels and serious adverse effects. Patients should be instructed to strictly adhere to the recommended dosage and administration guidelines set forth in this literature and on your prescription label. The management of serious adverse reactions may require the use of resuscitative equipment, oxygen or other resuscitative drugs.
General information about the safe and effective use Gen7TPatch®
Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use this product for another indication unless instructed and prescribed by a physician. Do not give this drug to anyone else, even if they have the same condition. This product is intended for use as prescribed by a physician.
How should I store Gen7TPatch®
Store product at room temperature at 68°F to 77°F (20°C to 25°C). Keep away from heat or sunlight. Protect from excessive moisture. Safely discard product after expiration date posted on the product label. Discard patches away from small children or animals.
DO NOT use the product after the expiration date printed on the box.
What are the active ingredients in Gen7TPatch® ?
The patch consists of 3.5% lidocaine.
Gen7TPatch® 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 14H 22N 2O. The molecular weight of lidocaine is 234.34 g/mol.
The structural formulas are:
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. Gen7TPatch® 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:Gen7TPatch® 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 Gen7TPatch® 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 Gen7TPatch® on fertility has not been studied.
The safety of Gen7TPatch® has not been established during pregnancy. There are no well-controlled studies in pregnant women. Gen7TPatch® should not be used during pregnancy unless absolutely needed and discussed with a physician.
The effect of Gen7T Patch ® on the nursing infant has not been evaluated. Caution should be exercised when Gen7TPatch® is administered to a nursing mother.
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 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.
|Labeler - Beijing HKKY Medical Tech. Co., Ltd. (544434817)|
|Beijing HKKY Medical Tech. Co., Ltd.||544434817||manufacture(71073-206)|